Venlafaxine - Congenital, Prenatal & Neonatal Adverse Rections

This table shows all Adverse Drug Reactions reported to the FDA's Adverse Event Reporting System between 2004 and the 2nd Quarter of 2008 where the listed psychiatric drug was identified as the Primary Suspect Drug (FDA's term) deemed responsible for causing or inducing these reactions and where one or more of the Adverse Reactions reported for the Case described a congenital, prenatal or neonatal condition. Where no Age, Date of Event or Indication (the condition being treated) are shown, none were present in the FDA records.

Reported By: CN-Consumer, LW-Lawyer, MD-Physician, OT-Other Healthcare Provider, PH-Pharmacist, Blank-Not Reported in ISR (Individual Safety Report).

The Oxford English Dictionary defines a poison as "a substance that causes death or harm when introduced into or absorbed by a living organism."  This psychiatric drug fits that definition.


Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 4012128 4304298 09/15/2003 02/23/2004 Effexor Depression Congenital Renal Cyst, Kidney Malformation, Maternal Drugs Affecting Foetus
M 4054890 4274591 08/30/2003 01/15/2004 Effexor Dyskinesia, Maternal Drugs Affecting Foetus, Myoclonus, Neonatal Disorder, Tremor Neonatal
M 4054890 4277140 08/31/2003 01/20/2004 Effexor Central Nervous System Function Test Abnormal, Drug Exposure During Pregnancy, Myoclonus, Neonatal Tachypnoea, Tremor
M 4069048 4270182 01/01/2003 01/12/2004 Effexor XR MD Depression Drug Exposure Via Breast Milk, Dyskinesia Neonatal, Maternal Drugs Affecting Foetus, Myoclonus, Neonatal Respiratory Distress Syndrome
M 4072917 4273884 08/09/2003 01/15/2004 Effexor Depression Drug Exposure During Pregnancy, Premature Baby
M 4072917 4283897 08/09/2003 01/30/2004 Effexor Depression Artificial Rupture of Membranes, Complications of Maternal Exposure To Therapeutic Drugs, Premature Baby
M 4087883 4286055 02/03/2004 Effexor Foetal Distress Syndrome, Maternal Drugs Affecting Foetus
M 4087883 4288764 02/05/2004 Effexor Drug Exposure During Pregnancy, Foetal Distress Syndrome, Premature Baby
M 4087883 4293938 02/10/2004 Effexor OT Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Foetal Distress Syndrome
M 4112384 4319283 06/09/2003 03/16/2004 Effexor Cardiac Murmur, Foetal Disorder, Foetal Heart Rate Disorder, Maternal Drugs Affecting Foetus
M 4112384 4339109 06/09/2003 04/12/2004 Effexor MD Cardiac Murmur, Drug Exposure During Pregnancy, Foetal Arrhythmia
4126748 4336918 04/08/2004 Effexor XR MD Convulsion Neonatal, Maternal Drugs Affecting Foetus
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
4137445 4350669 04/28/2004 Effexor Drug Exposure During Pregnancy, Renal Agenesis
4137445 4354156 05/03/2004 Effexor XR Depression Drug Exposure During Pregnancy, Potter's Syndrome
4137445 4357475 05/07/2004 Effexor XR Depression Congenital Anomaly, Drug Exposure During Pregnancy, Potter's Syndrome
M 4137445 4378643 05/16/2004 06/09/2004 Effexor XR Depression Drug Exposure During Pregnancy, Potter's Syndrome, Premature Baby, Stillbirth
M 4137445 4388962 05/16/2004 06/28/2004 Effexor XR Depression Drug Exposure During Pregnancy, Potter's Syndrome, Stillbirth
F 4137600 4352600 01/01/2004 04/29/2004 Effexor Anxiety, Major Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Premature Baby
F 4137600 4837283 01/01/2004 11/22/2005 Effexor Anxiety, Major Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Induced Labour, Premature Baby
F 4137742 4352657 04/29/2004 Effexor Anxiety, Major Depression Complications of Maternal Exposure To Therapeutic Drugs, Pregnancy Induced Hypertension
F 4142071 4357714 05/11/2004 Effexor XR OT Depression Abortion Spontaneous, Drug Exposure During Pregnancy
4145293 4360732 01/01/2003 05/14/2004 Effexor Drug Exposure During Pregnancy, Ear Malformation
F 4145293 4384124 10/12/2003 06/18/2004 Effexor Depression Drug Exposure During Pregnancy, Ear Malformation
4148303 4364721 05/21/2004 Effexor XR OT Maternal Drugs Affecting Foetus, Talipes
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 4157293 4377170 06/08/2004 Effexor Affective Disorder Abortion Induced, Drug Exposure During Pregnancy, Drug Interaction
F 4157840 4378705 10/01/2003 06/10/2004 Effexor Bradycardia Foetal, Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypokinesia Neonatal, Neonatal Respiratory Failure, Premature Baby
M 4157842 4378703 10/01/2003 06/10/2004 Effexor Bradycardia Foetal, Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypokinesia Neonatal, Neonatal Respiratory Distress Syndrome, Neonatal Respiratory Failure, Premature Baby
4166141 4388953 06/28/2004 Effexor XR Congenital Anomaly, Drug Exposure During Pregnancy, Kidney Small
F 4166316 4388963 06/28/2004 Venlafaxine Caesarean Section, Cleft Palate, Congenital Cerebellar Agenesis, Drug Exposure During Pregnancy, Hand Deformity, Head Deformity, Hypotonia Neonatal, Multiple Congenital Abnormalities, Neonatal Disorder, Reflexes Abnormal, Ventricular Internal Diameter Abnormal
M 4167192 4392582 04/03/2004 07/01/2004 Venlafaxine Depression Caesarean Section, Drug Exposure During Pregnancy, Tachycardia Foetal
F 4171860 4395869 01/01/2000 07/08/2004 Effexor XR CN Depression Drug Exposure During Pregnancy, Failure To Thrive, Neutropenia Neonatal
4173572 4398820 09/01/2003 07/12/2004 Effexor XR PH Anxiety, Depression Drug Exposure During Pregnancy, Premature Baby, Respiratory Syncytial Virus Infection
M 4180627 4407890 01/01/2003 07/21/2004 Effexor XR Depression Drug Exposure During Pregnancy, Foetal Disorder, Hydronephrosis
M 4180627 4457175 01/01/2003 09/21/2004 Effexor XR MD Depression Drug Exposure During Pregnancy, Foetal Disorder, Hydronephrosis
M 4187570 4412896 04/12/2004 07/30/2004 Effexor PH Depression Crying, Drug Exposure During Pregnancy, Encephalopathy Neonatal, Feeling Jittery, Hyperreflexia, Hypertonia Neonatal, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Pneumonia Aspiration
F 4188535 4415338 07/30/2004 Effexor XR MD Drug Exposure During Pregnancy, Oligohydramnios
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 4192253 4422996 07/26/2004 08/05/2004 Effexor OT Drug Exposure During Pregnancy, Hyporeflexia, Hypotonia Neonatal, Neonatal Disorder, Poor Sucking Reflex
M 4195386 4427458 04/12/2004 08/12/2004 Effexor MD Drug Exposure During Pregnancy, Transient Tachypnoea of the Newborn
M 4195386 4435834 07/01/2003 08/26/2004 Effexor MD Drug Exposure During Pregnancy, Transient Tachypnoea of the Newborn
4196981 4430029 08/17/2004 Effexor Depression Cleft Lip and Palate, Drug Exposure During Pregnancy
4196981 4431770 08/19/2004 Effexor Depression Cleft Lip and Palate, Congenital Anomaly, Drug Exposure During Pregnancy
4196981 4433205 08/23/2004 Effexor Depression Cleft Lip and Palate, Drug Exposure During Pregnancy
4196981 4593992 02/22/2005 Effexor Depression Cleft Lip and Palate, Drug Exposure During Pregnancy
F 4198902 4432404 08/20/2004 Effexor MD Depression Caesarean Section, Drug Exposure During Pregnancy, Hyperemesis Gravidarum
4208341 4443526 12/01/2003 09/01/2004 Effexor XR MD Caesarean Section, Congenital Bladder Anomaly, Drug Exposure During Pregnancy, Electroconvulsive Therapy, Meningomyelocele, Multiple Congenital Abnormalities, Premature Baby
4208341 4474222 12/01/2003 10/08/2004 Effexor XR MD Major Depression Caesarean Section, Congenital Ectopic Bladder, Drug Exposure During Pregnancy, Meningocele, Multiple Congenital Abnormalities, Premature Baby
4208341 4595105 12/01/2003 02/23/2005 Effexor XR OT Major Depression Anorectal Agenesis, Caesarean Section, Congenital Anomaly, Drug Exposure During Pregnancy, Electroconvulsive Therapy, Meningomyelocele, Premature Baby
F 4222911 4461641 08/14/2004 09/23/2004 Effexor OT Drug Exposure During Pregnancy, Hypertonia Neonatal, Hypotonic-Hyporesponsive Episode, Neonatal Disorder, Nervous System Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 4224128 4462895 08/15/2004 09/27/2004 Effexor Panic Disorder Apgar Score Low, Base Excess Negative, Blood Glucose Decreased, Drug Exposure During Pregnancy, Dyspnoea, Feeding Problem In Newborn, Hypotonia Neonatal, Muscle Twitching, Neonatal Disorder, PH Body Fluid Abnormal
M 4224132 4463413 04/27/2004 09/28/2004 Effexor XR OT Depression, Panic Attack Convulsion Neonatal, Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome, Premature Baby
F 4224137 4463414 01/01/2002 09/28/2004 Effexor XR OT Depression, Panic Attack Abnormal Behaviour, Aggression, Bradycardia Neonatal, Communication Disorder, Developmental Delay, Excitability, Gait Disturbance, Gastrooesophageal Reflux Disease, Hypotonia Neonatal, Insomnia, Maternal Drugs Affecting Foetus, Neonatal Disorder, Neonatal Respiratory Arrest, Poor Sucking Reflex, Premature Baby, Self Mutilation, Sensory Integrative Dysfunction, Sepsis Neonatal
M 5215650 4846257 11/09/1994 11/30/2005 Effexor OT Depression Drug Exposure During Pregnancy, Hernia Congenital, Intestinal Perforation, Neonatal Disorder
M 5650190 4476013 09/21/2004 10/12/2004 Effexor XR MD Depression Apgar Score Low, Drug Exposure During Pregnancy, Oligohydramnios, Transient Tachypnoea of the Newborn
5653368 4478969 10/15/2004 Venlafaxine Depression Cleft Lip and Palate, Drug Exposure During Pregnancy
M 5654650 4480683 01/01/2004 10/19/2004 Effexor XR Depression Transmission of Drug Via Semen, Trisomy 18
5654650 4536993 01/01/2004 12/20/2004 Effexor XR Depression Drug Exposure During Pregnancy, Transmission of Drug Via Semen, Trisomy 18
M 5661999 4468044 10/04/2004 Effexor XR Bipolar Disorder Drug Exposure During Pregnancy, Spina Bifida
M 5661999 4490615 10/27/2004 Effexor XR Bipolar Disorder Drug Exposure During Pregnancy, Spina Bifida
M 5669221 4474076 09/01/2004 10/08/2004 Effexor XR PH Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Premature Baby
F 5669263 4474204 01/01/2003 10/08/2004 Effexor Bradycardia Neonatal, Chondrodystrophy, Congenital Anomaly, Congenital Myopathy, Drug Exposure During Pregnancy, Hypochondroplasia, Hypotonia Neonatal, Muscular Dystrophy, Neonatal Apnoeic Attack
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5669263 4556660 01/01/2003 01/18/2005 Effexor Depression Bradycardia Neonatal, Chondrodystrophy, Congenital Myopathy, Drug Exposure During Pregnancy, Hypochondroplasia, Hypotonia Neonatal, Muscular Dystrophy, Neonatal Apnoeic Attack
F 5669263 4975690 01/01/2003 04/11/2006 Effexor MD Depression Bradycardia Neonatal, Chondrodystrophy, Congenital Myopathy, Developmental Delay, Drug Exposure During Pregnancy, Dysphagia, Eating Disorder, Facioscapulohumeral Muscular Dystrophy, Hypochondroplasia, Hypotonia Neonatal, Infantile Apnoeic Attack, Mastication Disorder, Neonatal Disorder, Psychomotor Skills Impaired
F 5669263 5026184 01/01/2003 06/08/2006 Effexor MD Depression Aspiration, Bradycardia Neonatal, Bronchomalacia, Cardio-Respiratory Arrest Neonatal, Chondrodystrophy, Congenital Myopathy, Developmental Delay, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dysphagia, Dystrophia Myotonica, Eating Disorder, Electrocardiogram T Wave Abnormal, Gastrooesophageal Reflux Disease, Haematocrit Decreased, Hypochondroplasia, Hypotonia Neonatal, Infantile Apnoeic Attack, Laryngomalacia, Loss of Consciousness, Mastication Disorder, Myoclonus, Neonatal Disorder, Neonatal Hyponatraemia, Neonatal Respiratory Failure, Platelet Count Decreased, Psychomotor Skills Impaired, Respiratory Rate Increased, Sleep Apnoea Syndrome, Small for Dates Baby, Snoring, Tracheomalacia, White Blood Cell Count Decreased
F 5669271 4474224 01/01/2003 10/08/2004 Effexor MD Drug Exposure During Pregnancy, Pregnancy Induced Hypertension
M 5673856 4495872 11/04/2004 Effexor XR MD Depression Arrested Labour, Caesarean Section, Drug Exposure During Pregnancy, Neonatal Aspiration, Neonatal Pneumonia
F 5677127 4498341 11/04/2004 Venlafaxine Drug Abuser, Drug Exposure During Pregnancy
M 5679782 4502688 08/15/2004 11/09/2004 Effexor Moaning, Neonatal Infection, Neonatal Tachypnoea, Shoulder Dystocia
5679785 4502689 11/09/2004 Effexor Depression Adenomatous Polyposis Coli, Drug Exposure During Pregnancy
5679785 4502690 11/09/2004 Effexor Depression Adenomatous Polyposis Coli, Drug Exposure During Pregnancy
5679785 4805279 10/18/2005 Effexor XR Depression Drug Exposure During Pregnancy, Intestinal Polyp
M 5684705 4505152 07/23/2004 11/16/2004 Effexor Depression Drug Exposure During Pregnancy, Premature Baby
M 5686253 4506853 01/01/2004 11/17/2004 Effexor XR MD Anxiety, Depression Apgar Score Low, Congenital Floppy Infant, Drug Exposure During Pregnancy, Hypotonia Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5689460 4510653 09/17/2004 11/22/2004 Effexor XR Depression Congenital Anomaly, Drug Exposure During Pregnancy, Hernia Congenital
5689860 4513491 11/24/2004 Effexor Drug Exposure During Pregnancy, Hospitalisation
M 5689860 4518107 02/20/2004 11/30/2004 Effexor XR Drug Exposure During Pregnancy
5692558 4518700 12/01/2004 Effexor Depression Drug Exposure During Pregnancy, Feeding Problem In Newborn, Hypokinesia, Lethargy
5699190 4526355 10/01/2003 12/13/2004 Effexor Depression Congenital Cardiac Septal Defect, Congenital Central Nervous System Anomaly, Drug Exposure During Pregnancy, Microcephaly
F 5706206 4537532 12/16/2004 Effexor XR MD Drug Exposure During Pregnancy, Suicidal Ideation
F 5707466 4537682 12/16/2004 Effexor XR MD Abortion Spontaneous, Drug Exposure During Pregnancy
M 5707796 4538601 03/01/2004 12/22/2004 Effexor OT Depression Agitation Neonatal, Asthenia, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hyperbilirubinaemia Neonatal, Irritability, Malnutrition, Neonatal Disorder, Neonatal Respiratory Depression, Premature Baby
M 5709388 4541161 12/27/2004 Effexor Cleft Lip and Palate, Congenital Anomaly, Drug Exposure During Pregnancy
M 5709388 4570738 07/23/2004 02/02/2005 Effexor Depression Cleft Lip and Palate, Congenital Anomaly, Drug Exposure During Pregnancy, Ear Malformation
5711127 4542227 03/01/2004 12/27/2004 Effexor XR MD Anxiety Disorder, Major Depression, Social Phobia Drug Exposure During Pregnancy, Dyspnoea, Lethargy, Neonatal Disorder
5711127 4562272 01/01/2004 01/21/2005 Effexor XR MD Anxiety Drug Exposure During Pregnancy, Dyspnoea, Lethargy, Neonatal Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5712524 4545380 01/01/2003 01/03/2005 Effexor Affective Disorder Drug Exposure During Pregnancy, Fear, Uterine Contractions During Pregnancy
F 5713702 4546195 11/18/2004 01/03/2005 Effexor XR MD Affective Disorder Cyanosis Neonatal, Drug Exposure During Pregnancy, Induced Labour, Prolonged Labour
F 5719760 4551434 12/02/2004 01/10/2005 Effexor Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Myoclonus
F 5719760 4553294 12/02/2004 01/13/2005 Effexor Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Myoclonus, Neonatal Disorder
M 5724945 4557798 01/18/2005 Effexor OT Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Problem In Newborn, Feeling Jittery, Hypertonia, Irritability, Restlessness
M 5724945 4568121 01/31/2005 Effexor Depression Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome Neonatal, Feeding Problem In Newborn, Feeling Jittery, Hypertonia Neonatal, Hypoglycaemia Neonatal, Irritability, Neonatal Disorder, Premature Baby, Restlessness, Tremor Neonatal
F 5731257 4567394 01/27/2005 Effexor Abortion Spontaneous, Drug Exposure During Pregnancy
F 5731257 4568404 01/31/2005 Effexor Abortion Spontaneous, Drug Exposure During Pregnancy
F 5731257 4590135 02/17/2005 Effexor Abortion Spontaneous, Drug Exposure During Pregnancy
M 5749440 4587954 11/01/2004 02/15/2005 Venlafaxine OT Congenital Oral Malformation, Drug Exposure During Pregnancy
M 5749440 4590137 11/01/2004 02/17/2005 Venlafaxine Major Depression Congenital Oral Malformation, Drug Exposure During Pregnancy
M 5749440 4590160 11/01/2004 02/17/2005 Vandral OT Major Depression Congenital Oral Malformation, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5752325 4592833 01/01/2004 02/22/2005 Effexor Depression Drug Exposure During Pregnancy, Microphthalmos
5753279 4596027 01/01/2004 02/25/2005 Effexor OT Abortion Induced, Anencephaly, Drug Exposure During Pregnancy, Encephalocele, Meningocele, Skull Malformation
F 5757924 4599565 01/01/2005 03/03/2005 Effexor XR PH Depressive Symptom Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Problem In Newborn, Meconium In Amniotic Fluid, Neonatal Respiratory Distress Syndrome, Pulmonary Oedema Neonatal
M 5767694 4615246 02/24/2005 03/17/2005 Effexor OT Depression Cerebral Haemorrhage, Congenital Anomaly, Congenital Brain Damage, Congenital Cerebral Cyst, Drug Exposure During Pregnancy
M 5767694 4617012 02/24/2005 03/18/2005 Effexor Depression Brain Damage, Cerebral Cyst, Cerebral Haemorrhage Neonatal, Drug Exposure During Pregnancy, Neonatal Disorder
F 5768271 4616897 05/01/2004 03/18/2005 Trevilor Depression Drug Exposure During Pregnancy, Haemangioma Congenital
5768954 4616447 03/18/2005 Effexor XR Congenital Anomaly, Drug Exposure During Pregnancy
F 5771031 4620496 01/01/2004 03/24/2005 Effexor XR Drug Exposure During Pregnancy, Foetal Growth Retardation
F 5777559 4631465 04/07/2005 Effexor XR Drug Exposure During Pregnancy, Sudden Infant Death Syndrome
F 5777559 4635329 04/11/2005 Effexor XR Drug Exposure During Pregnancy, Sudden Infant Death Syndrome
M 5777559 4778971 09/22/2005 Effexor XR Drug Exposure During Pregnancy, Sudden Infant Death Syndrome
5779307 4634425 04/11/2005 Effexor XR Drug Exposure During Pregnancy, Lymphocytic Leukaemia
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
5780219 4635294 01/01/2004 04/11/2005 Effexor XR Drug Exposure During Pregnancy, Feeding Problem In Newborn, Hypotonia Neonatal
M 5789555 4647697 04/01/2005 04/26/2005 Effexor XR MD Asthenopia, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, Night Sweats, Premature Baby
F 5791385 4648425 01/01/2004 04/27/2005 Effexor Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Hypotension, Neonatal Respiratory Failure
F 5797984 4656965 01/01/2003 05/06/2005 Effexor Drug Exposure During Pregnancy, Neonatal Disorder, Poland's Syndrome, Skin Hypoplasia
5810772 4677185 05/26/2005 Effexor Drug Exposure During Pregnancy, Gastroschisis
5810772 4677710 04/13/2005 05/27/2005 Effexor Congenital Anomaly, Drug Exposure During Pregnancy, Gastroschisis
5810772 4679011 04/13/2005 05/31/2005 Effexor Congenital Anomaly, Drug Exposure During Pregnancy, Gastroschisis
5826652 4693671 06/16/2005 Effexor OT Convulsion Neonatal, Drug Exposure During Pregnancy, Status Epilepticus
5827164 4692986 06/15/2005 Effexor XR OT Drug Exposure During Pregnancy, Intra-Uterine Death
F 5831202 4699827 01/01/2004 06/22/2005 Effexor XR Asthenia, Drug Exposure During Pregnancy, Feeding Problem In Newborn, Floppy Infant, Gastrooesophageal Reflux Disease, Hypotonia Neonatal, Respiratory Disorder Neonatal, Vomiting Neonatal, Weight Decrease Neonatal
F 5831202 4723876 01/01/2004 07/21/2005 06/20/2005 Effexor XR Asthenia, Bacterial Infection, Blood Lactic Acid Increased, Drug Exposure During Pregnancy, Dyspnoea, Feeding Disorder Neonatal, Floppy Infant, Gastrooesophageal Reflux Disease, Hypotonia Neonatal, Neonatal Disorder, Poor Weight Gain Neonatal, Respiratory Disorder Neonatal, Vomiting Neonatal, Weight Decrease Neonatal
M 5832373 4701007 10/17/2002 06/24/2005 Effexor XR Developmental Delay, Drug Exposure During Pregnancy, Feeding Problem In Child, Hypotonia Neonatal, Speech Disorder Developmental, Underweight
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5833323 4704553 01/01/2004 06/30/2005 Effexor XR MD Drug Exposure During Pregnancy, Hip Dysplasia
F 5833323 4753488 01/01/2004 08/24/2005 Effexor XR MD Major Depression Congenital Anomaly, Drug Exposure During Pregnancy, Hip Dysplasia
M 5836106 4708510 05/26/2003 07/05/2005 Effexor XR CN Depression, Post-Traumatic Stress Disorder Birth Trauma, Caesarean Section, Drug Exposure During Pregnancy, Horner's Syndrome, Polydactyly, Premature Baby, Resuscitation
M 5836106 4837273 05/26/2003 11/22/2005 Effexor XR Depression, Post-Traumatic Stress Disorder Birth Trauma, Caesarean Section, Drug Exposure During Pregnancy, Horner's Syndrome, Polydactyly, Premature Baby
M 5836262 4707268 07/01/2005 Effexor Post-Traumatic Stress Disorder Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, High-Pitched Crying, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Poor Sucking Reflex, Premature Baby, Respiratory Rate Increased
M 5836272 4707279 02/04/2005 07/01/2005 Effexor XR Depression, Schizoaffective Disorder Agitation Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Large for Dates Baby
M 5836272 4711152 02/04/2005 07/08/2005 Effexor XR MD Depression, Schizoaffective Disorder Agitation Neonatal, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Large for Dates Baby
M 5836272 4816421 02/04/2005 10/28/2005 Effexor XR OT Depression, Schizoaffective Disorder Agitation Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Large for Dates Baby
M 5836807 4708386 07/05/2005 Effexor XR Drug Exposure During Pregnancy, Premature Baby
M 5836807 4728194 07/27/2005 Effexor OT Drug Exposure During Pregnancy, Premature Baby
M 5836807 4733091 07/29/2005 Effexor Drug Exposure During Pregnancy, Premature Baby
5845713 4714898 07/13/2005 Venlafaxine Depression Abortion Induced, Congenital Anomaly, Drug Exposure During Pregnancy, Foetal Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5862103 4741506 07/23/2005 08/08/2005 Effexor Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal
F 5862103 4743876 07/23/2005 08/09/2005 Effexor Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal
F 5862103 4743890 07/23/2005 08/09/2005 Effexor Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal
F 5862103 4743961 08/09/2005 Effexor Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder of Infancy or Early Childhood
F 5862103 4761379 07/23/2005 09/01/2005 Effexor Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder of Infancy or Early Childhood
F 5862103 4799900 07/23/2005 10/13/2005 Effexor Depression Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder of Infancy or Early Childhood, Irritability, Neonatal Disorder
F 5862103 4978340 07/23/2005 04/17/2006 Effexor Depression Agitation Neonatal, Blood Glucose Decreased, Cerebral Disorder, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder of Infancy or Early Childhood, Irritability, Premature Baby
F 5862103 5042473 07/23/2005 06/27/2006 Effexor Depression Agitation Neonatal, Blood Glucose Decreased, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder of Infancy or Early Childhood, Irritability, Premature Baby, Ultrasound Skull Abnormal
M 5868226 4750283 11/01/2004 08/18/2005 Effexor XR Depression Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Premature Baby
M 5873175 4757829 10/01/2004 08/30/2005 Effexor Caesarean Section, Congenital Anomaly, Drug Exposure During Pregnancy, Foetal Distress Syndrome, Foetal Growth Retardation, Premature Baby
M 5873175 5046914 06/30/2006 Effexor Caesarean Section, Drug Exposure During Pregnancy, Foetal Distress Syndrome, Foetal Growth Retardation, Premature Baby
M 5873175 5403056 10/01/2004 08/01/2007 Venlafaxine OT Drug Exposure During Pregnancy, Foetal Distress Syndrome, Foetal Growth Retardation, Premature Baby
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5879846 4766857 06/30/2005 09/09/2005 Effexor XR Postpartum Depression, Psychotic Disorder Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Induced Labour, Poor Sucking Reflex
F 5879846 4767799 06/30/2005 09/12/2005 Effexor XR Postpartum Depression, Psychotic Disorder Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Poor Sucking Reflex
F 5879846 4768934 06/30/2005 09/14/2005 Effexor XR Postpartum Depression, Psychotic Disorder Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Poor Sucking Reflex
F 5879846 4853105 06/30/2005 12/12/2005 Effexor XR Major Depression, Postpartum Depression, Psychotic Disorder Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Oral Candidiasis, Poor Sucking Reflex, Somnolence Neonatal
F 5888711 4777502 01/01/2005 09/15/2005 Effexor XR Postpartum Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Abnormal, Headache, Palpitations, Rash Pruritic, Therapeutic Response Unexpected, Tinnitus, Vertigo
5906640 4802359 10/12/2005 Effexor XR Drug Exposure During Pregnancy, Infantile Apnoeic Attack
M 5906640 4811451 10/25/2005 Effexor XR Depression Drug Exposure During Pregnancy, Infantile Apnoeic Attack
F 5908771 4804530 10/17/2005 Venlafaxine Antidepressant Drug Clearance Increased, Drug Exposure During Pregnancy
F 5908771 4895127 01/25/2006 Venlafaxine Caesarean Section, Drug Clearance Increased, Drug Exposure During Pregnancy
M 5919084 4816333 07/24/2005 10/27/2005 Effexor Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Floppy Infant
M 5919084 4819825 07/24/2005 11/02/2005 Effexor Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Floppy Infant
F 5930087 4833373 10/14/2005 11/17/2005 Effexor XR Drug Exposure During Pregnancy, Laryngomalacia
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
5933770 4836647 07/01/2004 11/21/2005 Effexor XR Depression Developmental Delay, Drug Exposure During Pregnancy, Facial Dysmorphism, Insomnia, Psychomotor Hyperactivity
F 5934192 4708468 07/05/2005 Effexor XR Depression Caesarean Section, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Poor Weight Gain Neonatal, Premature Baby, Vomiting Neonatal
M 5936727 4839847 11/19/1997 11/25/2005 Effexor Depression Ankyloglossia Congenital, Anorectal Disorder, Drug Exposure During Pregnancy, Haemangioma Congenital
F 5936830 4839829 01/17/2002 11/25/2005 Effexor OT Anxiety Disorder Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital
5938984 4843537 11/25/2005 Effexor XR PH Congenital Anomaly, Drug Exposure During Pregnancy, Hypoplastic Left Heart Syndrome
M 5940896 4845763 10/01/2005 11/30/2005 Effexor Bipolar Disorder Drug Exposure During Pregnancy, Polydactyly, Premature Baby
M 5940896 4846215 10/01/2005 12/01/2005 Effexor Bipolar Disorder Congenital Anomaly, Drug Exposure During Pregnancy, Polydactyly, Premature Baby
F 5941024 4845757 11/30/2005 Effexor XR Depression Abortion Spontaneous, Depression, Disease Recurrence, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome, Foetal Growth Retardation, Intra-Uterine Death
F 5941024 4845761 11/30/2005 Effexor XR Depression Abortion Spontaneous, Depression, Disease Recurrence, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome, Intra-Uterine Death
F 5941039 4845766 11/30/2005 Effexor Major Depression Drug Exposure During Pregnancy, Pre-Eclampsia
F 5941039 4851407 12/08/2005 Effexor OT Major Depression Drug Exposure During Pregnancy, Induced Labour, Pre-Eclampsia
F 5941039 4866851 12/22/2005 Effexor Major Depression Drug Exposure During Pregnancy, Induced Labour, Pre-Eclampsia
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5941044 4845767 07/01/2005 11/30/2005 Effexor Major Depression Drug Exposure During Pregnancy, Oral Candidiasis, Poor Sucking Reflex, Somnolence
F 5941044 4846943 07/01/2005 12/01/2005 Effexor Major Depression Drug Exposure During Pregnancy, Neonatal Disorder, Oral Candidiasis, Poor Sucking Reflex, Somnolence Neonatal
F 5941044 4851396 07/01/2005 12/08/2005 Effexor Major Depression Drug Exposure During Pregnancy, Neonatal Disorder, Oral Candidiasis, Poor Sucking Reflex, Somnolence Neonatal
5948583 4852333 12/09/2005 Effexor XR MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Premature Baby
M 5948583 4867096 04/01/2005 12/20/2005 Effexor XR MD Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Irritability, Neonatal Disorder, Premature Baby
F 5950136 4853125 06/30/2005 12/12/2005 Effexor XR Major Depression, Postpartum Depression, Psychotic Disorder Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Oral Candidiasis, Poor Sucking Reflex, Somnolence Neonatal
F 5950249 4853019 05/10/2003 12/12/2005 Effexor Depression Alpha 1 Foetoprotein Decreased, Chromosome Abnormality, Congenital Anomaly, Congenital Ureteric Anomaly, Drug Exposure During Pregnancy, Foetal Disorder, Foetal Growth Retardation, Foetal Malformation, Intra-Uterine Death, Oligohydramnios, Osteogenesis Imperfecta, Osteopenia, Pathological Fracture, Pulmonary Artery Atresia, Renal Aplasia, Trisomy 21, Ventricular Septal Defect
F 5950249 4853323 12/12/2005 Effexor Depression Abortion Spontaneous, Chromosome Abnormality, Drug Exposure During Pregnancy, Pathological Fracture, Pulmonary Artery Atresia, Renal Aplasia, Trisomy 21, Ventricular Septal Defect
M 5952003 4861175 09/13/2005 12/15/2005 Effexor XR Depression Drug Exposure During Pregnancy, Dyskinesia, Hydrocele, Neonatal Disorder, Premature Baby, Tongue Disorder, Tremor Neonatal
M 5952003 4863952 09/13/2005 12/19/2005 Effexor XR Depression Congenital Tongue Anomaly, Drug Exposure During Pregnancy, Hydrocele, Premature Baby, Tremor Neonatal
M 5952003 4865264 09/13/2005 12/19/2005 Effexor XR MD Depression Congenital Tongue Anomaly, Drug Exposure During Pregnancy, Hydrocele, Premature Baby, Tremor Neonatal
M 5952003 4941566 09/13/2005 03/07/2006 Effexor XR Depression Congenital Tongue Anomaly, Drug Exposure During Pregnancy, Hydrocele, Hyperexplexia, Neonatal Disorder, Premature Baby, Tremor Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5952462 4863096 11/01/2005 12/19/2005 Effexor XR MD Drug Exposure During Pregnancy, Premature Labour, Premature Separation of Placenta
M 5952935 4863962 11/24/2005 12/19/2005 Effexor OT Dextrocardia, Drug Exposure During Pregnancy
M 5952935 4867118 11/24/2005 12/21/2005 Effexor Dextrocardia
M 5952935 4869662 11/24/2005 12/23/2005 Effexor Dextrocardia, Drug Exposure During Pregnancy
M 5952935 4899058 11/24/2005 01/30/2006 Effexor Dextrocardia, Drug Exposure During Pregnancy
M 5952935 4899261 11/24/2005 01/31/2006 Effexor Depression Dextrocardia, Drug Exposure During Pregnancy
F 5953795 4866066 01/01/2005 12/21/2005 Effexor Abortion Spontaneous, Drug Exposure During Pregnancy
M 5955915 4868133 10/03/2003 12/27/2005 Effexor XR PH Abnormal Behaviour, Aggression, Dissociation, Disturbance In Social Behaviour, Drug Exposure During Pregnancy
F 5956933 4869161 01/01/2005 12/27/2005 Effexor Depression Congenital Anomaly, Congenital Hand Malformation, Drug Exposure During Pregnancy, Facial Dysmorphism, Limb Reduction Defect, Microglossia, Micrognathia
F 5956933 4869610 01/01/2005 12/27/2005 Effexor Depression Drug Exposure During Pregnancy, Facial Dysmorphism, Limb Reduction Defect, Microglossia, Micrognathia
5956990 4869691 01/01/2005 12/23/2005 Effexor OT Adactyly, Drug Exposure During Pregnancy, Finger Hypoplasia, Syndactyly, Talipes
M 5957522 4870060 09/19/2005 12/23/2005 Effexor XR Post-Traumatic Stress Disorder Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome, Neonatal Tachycardia
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5957616 4870018 10/01/2005 12/23/2005 Effexor XR MD Depression Areflexia, Feeding Disorder Neonatal, Hyperbilirubinaemia Neonatal, Lethargy, Nervous System Disorder
F 5965762 4881299 12/26/2005 01/12/2006 Effexor XR MD Depression, Post-Traumatic Stress Disorder Congenital Infection, Congenital Intestinal Malformation, Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Premature Baby
F 5965762 4914374 12/26/2005 02/13/2006 Effexor XR MD Depression, Major Depression, Post-Traumatic Stress Disorder Congenital Infection, Congenital Intestinal Malformation, Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Premature Baby
F 5965827 4882021 12/01/2003 01/12/2006 Effexor Blood Calcium Increased, Congenital Anomaly, Drug Exposure During Pregnancy, Electroencephalogram Abnormal, Erythrosis, Gastrooesophageal Reflux Disease, Infantile Apnoeic Attack, Muscle Contractions Involuntary, Neonatal Disorder, Premature Baby
F 5965827 4885730 12/01/2003 01/17/2006 Effexor Blood Calcium Increased, Congenital Anomaly, Drug Exposure During Pregnancy, Electroencephalogram Abnormal, Erythrosis, Gastrooesophageal Reflux Disease, Muscle Contractions Involuntary, Neonatal Disorder, Premature Baby, Sleep Apnoea Syndrome, Therapy Non-Responder
F 5965827 4886186 12/01/2003 01/17/2006 Effexor OT Blood Calcium Abnormal, Congenital Anomaly, Drug Exposure During Pregnancy, Electroencephalogram Abnormal, Erythrosis, Gastrooesophageal Reflux Disease, Muscle Contractions Involuntary, Neonatal Disorder, Premature Baby, Sleep Apnoea Syndrome
M 5965829 4882022 11/24/2005 01/12/2006 Effexor Depression Dextrocardia, Drug Exposure During Pregnancy
M 5965829 4886126 03/01/2005 01/17/2006 Effexor OT Depression Dextrocardia, Drug Exposure During Pregnancy
M 5965829 4899031 03/25/2005 01/30/2006 Effexor Depression Dextrocardia, Drug Exposure During Pregnancy
5970115 4886910 01/19/2006 Effexor XR Drug Exposure During Pregnancy, Intra-Uterine Death, Multiple Congenital Abnormalities
5973174 4885606 12/20/2005 Effexor XR MD Drug Exposure During Pregnancy, Hypotonia Neonatal
M 5973660 4889465 01/20/2006 Effexor OT Congenital Musculoskeletal Anomaly, Congenital Nose Malformation, Drug Exposure During Pregnancy, Facial Dysmorphism, Neonatal Disorder, Palatal Disorder, Premature Baby, Pulmonary Valve Stenosis Congenital, Ventricular Septal Defect
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5973660 4891117 01/23/2006 Effexor Congenital Musculoskeletal Anomaly, Congenital Nose Malformation, Drug Exposure During Pregnancy, Facial Dysmorphism, High Arched Palate, Premature Baby, Pulmonary Valve Stenosis Congenital, Ventricular Septal Defect
M 5973660 4907174 02/06/2006 Effexor Anomaly of External Ear Congenital, Congenital Musculoskeletal Anomaly, Congenital Nose Malformation, Drug Exposure During Pregnancy, Facial Dysmorphism, High Arched Palate, Premature Baby, Pulmonary Valve Stenosis Congenital, Rib Deformity, Ventricular Septal Defect
F 5978720 4885666 12/20/2005 Effexor XR MD Drug Exposure During Pregnancy, Infection
F 5997997 4919607 09/10/2005 02/15/2006 Effexor Depression Agitation Neonatal, Coarctation of the Aorta, Congenital Pulmonary Hypertension, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Fever Neonatal, Heart Disease Congenital, Hypertonia Neonatal, Neonatal Tachypnoea, Small for Dates Baby
F 5997997 4977588 09/10/2005 04/14/2006 Effexor Depression Agitation Neonatal, Congenital Pulmonary Hypertension, Congenital Pulmonary Valve Disorder, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Fever Neonatal, Hypertonia Neonatal, Neonatal Tachypnoea, Patent Ductus Arteriosus, Small for Dates Baby
M 5998796 4921038 01/01/2005 02/16/2006 Effexor Depression Atrial Septal Defect, Drug Exposure During Pregnancy, Patent Ductus Arteriosus
F 6008473 4939435 03/06/2006 Effexor XR Depression Drug Exposure During Pregnancy, Pyelonephritis, Urinary Tract Infection
F 6011035 4943876 03/10/2006 Effexor Drug Exposure During Pregnancy, Ebstein's Anomaly
M 6016294 4951616 03/20/2006 Effexor XR Congenital Torticollis, Drug Exposure During Pregnancy, Hyperbilirubinaemia Neonatal, Premature Baby
F 6017468 4953658 01/01/2000 03/21/2006 Effexor XR Congenital Brain Damage, Convulsion Neonatal, Drug Exposure During Pregnancy, Polytraumatism, Skull Fracture
F 6017468 5224879 01/01/2000 01/26/2007 Effexor XR Drug Use for Unknown Indication Blood Culture Positive, Breath Holding, Catheter Related Complication, Congenital Brain Damage, Convulsion Neonatal, Drug Exposure During Pregnancy, Encephalopathy Neonatal, Eye Movement Disorder, Feeding Disorder Neonatal, Gastrooesophageal Reflux Disease, Inborn Error of Metabolism, Klebsiella Infection, Multiple Injuries, No Therapeutic Response, Respiratory Depression, Road Traffic Accident, Skull Fracture, Small for Dates Baby, Staphylococcal Sepsis
F 6017468 5231334 01/01/2000 02/06/2007 Effexor XR CN Cerebral Palsy, Congenital Brain Damage, Convulsion Neonatal, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6017468 5264885 01/01/2000 03/14/2007 Effexor XR CN Cerebral Palsy, Congenital Brain Damage, Convulsion Neonatal, Drug Exposure During Pregnancy
F 6017468 5333303 01/01/2000 05/24/2007 Effexor XR CN Cerebral Palsy, Congenital Brain Damage, Convulsion Neonatal, Drug Exposure During Pregnancy
6021698 4957689 03/24/2006 Effexor XR Attention Deficit Hyperactivity Disorder, Developmental Delay, Drug Exposure During Pregnancy
6021701 4957707 03/24/2006 Effexor XR MD Autism, Drug Exposure During Pregnancy, Premature Baby
M 6026440 4964817 03/01/2006 04/03/2006 Venlafaxine Depression Caesarean Section, Drug Exposure During Pregnancy, Testicular Torsion, Umbilical Cord Abnormality
M 6028484 4969509 01/01/2005 04/06/2006 Effexor XR OT Depression Agitation Neonatal, Caesarean Section, Diarrhoea Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Foetal Distress Syndrome, Irritability, Joint Hyperextension, Muscle Rigidity, Muscle Spasms, Nasal Flaring, Neonatal Disorder, Neonatal Tachypnoea, Rebound Effect, Restlessness, Tremor Neonatal, Vomiting Neonatal, Vomiting Projectile
M 6028484 5032223 01/01/2005 06/19/2006 Effexor XR OT Depression Agitation Neonatal, Blood Bilirubin Increased, Caesarean Section, Diaphragmatic Disorder, Drug Exposure During Pregnancy, Drug Ineffective, Drug Toxicity, Drug Withdrawal Syndrome Neonatal, Foetal Distress Syndrome, Hyperacusis, Hyperaesthesia, Irritability, Joint Hyperextension, Muscle Rigidity, Muscle Spasms, Nasal Flaring, Neonatal Disorder, Neonatal Tachypnoea, Nervous System Disorder, Photophobia, Poor Sucking Reflex, Rebound Effect, Restlessness, Vomiting Projectile
6028587 4968129 02/16/2006 04/05/2006 Effexor XR Generalised Anxiety Disorder, Phobia Abortion Induced, Drug Exposure During Pregnancy, Foetal Cystic Hygroma, Foetal Malformation, Trisomy 21
6033716 4974004 03/28/2006 04/10/2006 Effexor XR MD Anxiety, Depression Drug Exposure During Pregnancy, Transposition of the Great Vessels, Ventricular Septal Defect
F 6035593 4977719 04/14/2006 Effexor Depression Drug Exposure During Pregnancy, Premature Rupture of Membranes
F 6035593 5128059 10/10/2006 Effexor Depression Drug Exposure During Pregnancy, Premature Rupture of Membranes
6040906 4985077 09/07/2005 04/19/2006 Effexor XR Pyramidal Tract Syndrome Brain Malformation, Cerebral Cyst, Drug Exposure During Pregnancy, Exomphalos, Intra-Uterine Death, Talipes
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6042519 4971134 07/01/2005 02/23/2006 Effexor Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Nausea, Paraesthesia, Tremor
M 6042723 4988121 04/25/2006 Effexor Congenital Anomalies of Ear Ossicles, Drug Exposure During Pregnancy, External Auditory Canal Atresia
F 6051183 5002465 11/01/2005 05/10/2006 Venlafaxine MD Drug Exposure During Pregnancy, Unevaluable Event
F 6056407 5515824 07/01/2005 11/14/2007 Effexor OT Depression Drug Exposure During Pregnancy, Premature Baby
M 6057969 5010990 04/01/2006 05/23/2006 Effexor XR OT Depression Coarctation of the Aorta, Drug Exposure During Pregnancy, Transposition of the Great Vessels, Ventricular Septal Defect
M 6057969 5030389 04/01/2006 06/14/2006 Effexor XR Depression Coarctation of the Aorta, Congenital Anomaly, Drug Exposure During Pregnancy, Transposition of the Great Vessels, Ventricular Septal Defect
M 6057969 5076347 04/01/2006 08/07/2006 Effexor XR OT Depression Coarctation of the Aorta, Drug Exposure During Pregnancy, Transposition of the Great Vessels, Ventricular Septal Defect
6058970 5010741 05/01/2006 05/23/2006 Effexor XR MD Apgar Score Low, Breech Presentation, Complication of Delivery, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Somnolence Neonatal
M 6058970 5027110 05/01/2006 06/12/2006 Effexor XR MD Apgar Score Low, Body Temperature Decreased, Bradycardia Neonatal, Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Floppy Infant, Grunting, Infantile Apnoeic Attack, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Oxygen Saturation Decreased, Pallor, Poor Weight Gain Neonatal, Sepsis Neonatal, Somnolence Neonatal
6061438 5013854 05/25/2006 Effexor XR OT Drug Exposure During Pregnancy, Poor Weight Gain Neonatal, Small for Dates Baby
6074336 5030571 06/14/2006 Effexor XR Depression Drug Exposure During Pregnancy, Foetal Growth Retardation
6074336 5475446 10/03/2007 Venlafaxine OT Depression Drug Exposure During Pregnancy, Foetal Growth Retardation, Unevaluable Event
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6075239 5030445 05/27/2003 06/14/2006 Effexor XR Major Depression Abdominal Distension, Caesarean Section, Depression, Disease Recurrence, Drug Exposure During Pregnancy, Irritability, Nausea, Oligohydramnios, Oral Intake Reduced, Premature Labour
M 6075856 5030803 01/19/2004 06/14/2006 Effexor XR Major Depression Caesarean Section, Drug Exposure During Pregnancy, Oligohydramnios, Premature Baby
M 6075856 5062135 01/19/2004 07/21/2006 Effexor XR Major Depression Caesarean Section, Drug Exposure During Pregnancy, Oligohydramnios, Premature Baby
6085914 5046894 06/07/2006 06/28/2006 Effexor XR Cleft Palate, Congenital Anomaly, Drug Exposure During Pregnancy, Low Set Ears
F 6085914 5064998 06/07/2006 07/26/2006 Effexor XR Depression Cleft Palate, Congenital Anomaly, Congenital Jaw Malformation, Drug Exposure During Pregnancy, Gene Mutation, Low Set Ears, Mandibulofacial Dysostosis
M 6092648 5056323 06/23/2006 07/17/2006 Effexor XR OT Depression Acoustic Stimulation Tests Abnormal, Drug Exposure During Pregnancy, Facial Paresis, Hemiparesis, Neonatal Disorder
F 6099180 5067199 11/14/2005 07/26/2006 Venlafaxine Anxiety, Depression, Panic Attack Drug Exposure During Pregnancy, Idiopathic Thrombocytopenic Purpura, Thrombocytopenia Neonatal
M 6109967 5077941 06/01/2006 08/08/2006 Venlafaxine Post-Traumatic Stress Disorder Drug Exposure During Pregnancy, Immature Respiratory System, Iron Deficiency Anaemia, Neonatal Disorder, Premature Baby
F 6125353 5092849 08/28/2006 Effexor Panic Disorder Apgar Score Low, Drug Exposure During Pregnancy, Dyskinesia Neonatal, Hypoglycaemia Neonatal, Hypotonia Neonatal, Neonatal Aspiration, Neonatal Respiratory Distress Syndrome, Poor Sucking Reflex
F 6138194 5108493 06/19/2006 09/13/2006 Effexor XR Caesarean Section, Drug Exposure During Pregnancy, Intra-Uterine Death
F 6138357 5111636 09/08/2006 09/20/2006 Effexor MD Depression Congenital Foot Malformation, Drug Exposure During Pregnancy, Finger Hypoplasia, Limb Malformation, Talipes
F 6140202 5110151 09/18/2006 Effexor OT Depression Caesarean Section, Drug Exposure Before Pregnancy, Placenta Praevia Haemorrhage, Premature Baby, Premature Labour, Vaginal Haemorrhage
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6141004 5189470 01/01/2003 12/18/2006 Effexor XR MD Depression Collapse of Lung, Drug Exposure During Pregnancy, Infantile Asthma, Neonatal Disorder, Neonatal Respiratory Failure, Pneumothorax, Premature Baby, Respiratory Disorder Neonatal, Respiratory Syncytial Virus Infection, Umbilical Cord Around Neck
6150979 5127869 10/10/2006 Effexor Cerebral Haemorrhage Foetal, Cerebral Palsy, Drug Exposure During Pregnancy
F 6162329 5135933 01/01/2006 10/19/2006 Effexor XR Convulsion Neonatal, Drug Exposure During Pregnancy, Nervousness
M 6180707 5158269 10/01/2005 11/17/2006 Effexor Conversion Disorder, Paraplegia Drug Exposure During Pregnancy, Talipes
M 6180767 5159250 03/30/2005 11/17/2006 Effexor XR OT Mental Disorder Congenital Intestinal Malformation, Drug Exposure During Pregnancy
F 6181118 5159164 02/11/2006 11/16/2006 Effexor XR Depression Congenital Tricuspid Valve Atresia, Drug Exposure During Pregnancy, Foetal Growth Retardation, Pulmonary Artery Stenosis Congenital, Ventricular Septal Defect
M 6205362 5179204 12/11/2006 Effexor XR MD Developmental Delay, Drug Exposure During Pregnancy, Motor Dysfunction, Muscular Weakness
F 6205885 5179103 01/01/2006 12/11/2006 Effexor Depression Agitation Neonatal, Convulsion Neonatal, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Grand Mal Convulsion, Irritability, Neonatal Disorder, Patent Ductus Arteriosus
F 6209723 5191432 01/01/2006 12/18/2006 Effexor XR CN Depression Caesarean Section, Drug Exposure During Pregnancy, Pregnancy Induced Hypertension
F 6209793 5189477 11/29/2006 12/18/2006 Effexor XR CN Depression Caesarean Section, Convulsion Neonatal, Drug Exposure During Pregnancy, Foetal Heart Rate Increased, Respiratory Disorder Neonatal
6211140 5191840 01/01/2003 12/18/2006 Effexor Depression Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
F 6213172 5194066 11/22/2005 12/22/2006 Effexor XR Depression Caesarean Section, Drug Exposure During Pregnancy, Foetal Growth Retardation, Placental Insufficiency, Premature Baby
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6214175 5196093 04/01/2006 12/26/2006 Effexor Cleft Palate, Congenital Anomaly, Drug Exposure During Pregnancy, Premature Baby
F 6214938 5196174 12/22/2006 Effexor Bradycardia Neonatal, Convulsion Neonatal, Drug Exposure During Pregnancy, Hypertension Neonatal, Neonatal Respiratory Depression
6221134 5206012 01/08/2007 Effexor Drug Exposure During Pregnancy, Limb Hypoplasia Congenital, Limb Reduction Defect
M 6223533 5210316 01/01/2007 01/11/2007 Effexor XR Apgar Score Low, Drug Exposure During Pregnancy, Dyskinesia Neonatal, Dyspnoea
6224327 5213408 01/01/2006 01/16/2007 Venlafaxine Anxiety Disorder, Depression, Panic Disorder Death Neonatal, Drug Exposure During Pregnancy, Injury Asphyxiation, Umbilical Cord Around Neck
F 6224327 5225861 10/28/2006 02/01/2007 Venlafaxine OT Anxiety Disorder Umbilical Cord Around Neck
M 6226382 5223662 07/25/2006 01/30/2007 Effexor XR OT Depression Cardiac Murmur, Life Support, Premature Baby
F 6226509 5217182 01/19/2007 01/23/2007 Effexor XR OT Depression Anxiety, Coordination Abnormal, Diplopia, Drug Exposure During Pregnancy, Dry Mouth, Eye Movement Disorder, Feeling Abnormal, Headache, Hyperhidrosis, Influenza Like Illness, Nausea, Nightmare, Paraesthesia, Vertigo, Vision Blurred
6228484 5217718 01/01/2005 01/19/2007 Effexor Drug Exposure During Pregnancy, Foetal Growth Retardation, Hydrocephalus, Psychomotor Skills Impaired
6228484 5232267 01/01/2005 02/07/2007 Effexor OT Drug Exposure During Pregnancy, Foetal Growth Retardation, Hydrocephalus, Psychomotor Skills Impaired
6228484 5670973 01/01/2005 03/18/2008 Effexor OT Drug Exposure During Pregnancy, Foetal Growth Retardation, Hydrocephalus, Psychomotor Skills Impaired
F 6228554 5225860 10/16/2006 02/01/2007 Effexor OT Abortion Spontaneous, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6229588 5227432 01/01/2006 02/02/2007 Venlafaxine CN Depression Drug Exposure During Pregnancy, Gestational Diabetes
F 6229845 5219182 11/01/2006 01/22/2007 Effexor XR Anxiety, Depression Drug Exposure During Pregnancy, Eye Infection, Neonatal Disorder, Weight Decrease Neonatal
M 6232679 5232270 07/01/2006 02/07/2007 11/01/2006 Effexor XR CN Anomaly of External Ear Congenital, Intra-Uterine Death, Limb Malformation, Low Set Ears, Skull Malformation, Transmission of Drug Via Semen, Umbilical Cord Abnormality
M 6234576 5234198 02/09/2007 Effexor XR MD Hypoplastic Left Heart Syndrome
M 6234576 5287729 12/09/2006 04/05/2007 12/09/2006 Effexor XR MD Postpartum Depression Hypoplastic Left Heart Syndrome, Multi-Organ Failure
M 6234576 5414820 12/09/2006 08/15/2007 12/09/2006 Effexor XR MD Postpartum Depression Hypoplastic Left Heart Syndrome, Multi-Organ Failure
F 6234793 5234424 03/01/2005 02/09/2007 Effexor XR OT Drug Exposure During Pregnancy, Placental Disorder
F 6234793 5287707 03/01/2005 04/05/2007 Effexor XR OT Postpartum Depression Blood Pressure Decreased, Cervix Dystocia, Drug Dependence, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Placental Disorder
F 6234933 5234532 01/01/2006 02/09/2007 Effexor XR MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Placental Disorder
F 6234933 5287730 01/01/2006 04/05/2007 Effexor XR MD Postpartum Depression Blood Pressure Decreased, Dependence, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Placental Disorder
F 6235010 5234609 12/29/2005 02/09/2007 Effexor XR OT Poor Weight Gain Neonatal, Small for Dates Baby
F 6235010 5286802 12/29/2005 04/04/2007 Effexor XR MD Postpartum Depression Poor Weight Gain Neonatal, Small for Dates Baby, Underweight
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6248084 5241241 12/06/2006 02/12/2007 12/09/2006 Effexor XR CN Postpartum Depression Congenital Anomaly, Drug Exposure During Pregnancy, Hypoplastic Left Heart Syndrome, Myocardial Infarction, Neonatal Multi-Organ Failure
6252314 5254336 01/11/2007 03/02/2007 Effexor XR MD Major Depression Foetal Heart Rate Decreased, Neonatal Anoxia
F 6252315 5254337 01/01/2006 03/02/2007 Effexor XR MD Major Depression Drug Exposure During Pregnancy, Pre-Eclampsia, Uterine Rupture
F 6254764 5256950 06/03/2006 03/07/2007 Effexor MD Abdominal Distension, Cardiac Murmur, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dyspnoea, Neonatal Hepatomegaly, Tremor Neonatal
F 6254764 5383912 06/03/2006 07/11/2007 Effexor MD Abdominal Distension, Cardiac Murmur, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dyspnoea, Tremor Neonatal
F 6254764 5424743 06/03/2006 08/24/2007 Effexor MD Abdominal Distension, Cardiac Murmur, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dyspnoea, Tremor Neonatal
F 6259143 5262607 03/12/2007 Venlafaxine OT Depression Drug Exposure During Pregnancy, Trisomy 18
F 6262117 5266001 09/14/2006 03/15/2007 Venlafaxine OT Depression Antepartum Haemorrhage, Cervical Incompetence, Drug Exposure During Pregnancy, Dysgeusia, Premature Labour, Tachycardia
F 6263154 5266940 06/01/2006 03/16/2007 03/03/2007 Effexor XR MD Anxiety Drug Exposure During Pregnancy, Intra-Uterine Death
6270708 5275820 03/26/2007 Effexor XR OT Cardiac Arrest Neonatal, Death Neonatal, Drug Exposure During Pregnancy, Heart Disease Congenital, Neonatal Respiratory Arrest
6272909 5278278 01/01/2006 03/28/2007 Effexor MD Cerebral Ventricle Dilatation, Drug Exposure During Pregnancy, Pyelectasia, Trisomy 21, Ultrasound Antenatal Screen Abnormal
6272909 5476677 01/01/2006 10/04/2007 05/01/2007 Effexor MD Drug Exposure During Pregnancy, Intra-Uterine Death, Trisomy 21
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6277629 5283782 06/19/2006 04/02/2007 Effexor XR OT Depression Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Respiratory Distress Syndrome
M 6279721 5286792 12/29/2006 04/04/2007 Effexor XR OT Depression Hyperbilirubinaemia Neonatal, Neonatal Respiratory Distress Syndrome, Premature Baby
F 6279731 5286803 01/01/2006 04/04/2007 Effexor XR OT Depression Drug Exposure During Pregnancy, Placenta Praevia
F 6284312 5279773 12/15/2006 Effexor XR MD Abortion Spontaneous, Drug Exposure During Pregnancy
6284375 5279780 12/15/2006 Effexor XR MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
F 6284862 5281960 12/15/2006 Effexor XR OT Depression Abortion Spontaneous, Convulsion, Drug Exposure During Pregnancy, Overdose
F 6284941 5281632 12/15/2006 Effexor XR OT Anxiety, Depression Abortion Spontaneous, Drug Exposure During Pregnancy
6287400 5295695 04/13/2007 Effexor XR MD Congenital Anomaly, Drug Exposure During Pregnancy, Feeding Disorder
6287400 5450278 09/12/2007 Effexor XR MD Congenital Anomaly, Drug Exposure During Pregnancy, Dysmorphism, Feeding Disorder, Motor Dysfunction
6287894 5296423 01/01/2007 04/13/2007 03/27/2007 Effexor XR MD Anxiety Abortion Induced, Asthenia, Drug Exposure During Pregnancy, Foetal Growth Retardation, Foetal Movements Decreased, Trisomy 21
6287894 5586129 01/01/2007 12/05/2007 Effexor XR MD Anxiety, Depression Asthenia, Foetal Growth Retardation, Foetal Movements Decreased, Trisomy 21
F 6288572 5297242 05/09/2006 04/16/2007 Effexor OT Convulsion, Drug Exposure During Pregnancy, Intentional Overdose, Intra-Uterine Death, Sinus Tachycardia
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6289515 5298618 08/31/2006 04/17/2007 Effexor OT Cyanosis Neonatal, Drug Exposure During Pregnancy, Erythrosis, Foetal Growth Retardation, Jaundice Neonatal, Polycythaemia, Premature Baby
F 6289515 5450277 08/31/2006 09/12/2007 Effexor XR OT Depression Cyanosis Neonatal, Drug Exposure During Pregnancy, Dysphagia, Erythrosis, Feeding Disorder Neonatal, Foetal Growth Retardation, Haemangioma of Skin, Jaundice Neonatal, Neonatal Disorder, Polycythaemia, Poor Sucking Reflex, Premature Baby
6291107 5300797 01/01/2006 04/18/2007 Effexor XR OT Coarctation of the Aorta, Drug Exposure During Pregnancy
6291107 5304708 01/01/2006 04/23/2007 Effexor XR OT Anxiety Coarctation of the Aorta, Drug Exposure During Pregnancy
F 6294331 5304737 04/23/2007 Effexor XR OT Depression Cleft Palate, Drug Exposure During Pregnancy
M 6294332 5304739 07/28/2006 04/23/2007 Effexor XR OT Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, High-Pitched Crying, Hyperreflexia, Hypertonia, Pyrexia
F 6297151 5308644 03/01/2007 04/26/2007 Effexor OT Depression Foetal Heart Rate Disorder
6320015 5334127 05/25/2007 Effexor XR OT Autism, Drug Exposure During Pregnancy
F 6320018 5334130 08/29/2006 05/25/2007 Venlafaxine MD Depression Drug Exposure During Pregnancy
6320031 5334153 05/25/2007 Effexor XR OT Congenital Cystic Kidney Disease, Drug Exposure During Pregnancy
M 6320059 5334222 01/01/2007 05/25/2007 Venlafaxine OT Depression Congenital Genital Malformation
F 6320198 5333108 05/09/2007 05/21/2007 Effexor XR MD Bipolar Disorder Drug Exposure During Pregnancy, Muscle Spasms, Neonatal Disorder, No Therapeutic Response
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6323373 5336701 05/09/2007 05/24/2007 Effexor XR MD Bipolar Disorder Drug Exposure During Pregnancy, Muscle Spasms, No Therapeutic Response
6327603 5347563 06/06/2007 Venlafaxine MD Abortion Induced, Congenital Central Nervous System Anomaly, Drug Exposure During Pregnancy
6327603 5406702 08/07/2007 Venlafaxine MD Anxiety Disorder Congenital Central Nervous System Anomaly, Drug Exposure During Pregnancy, Kyphosis Congenital
F 6330862 5353395 08/01/2006 06/12/2007 Effexor XR CN Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Hypertension, Paraesthesia
F 6331067 5353668 06/12/2007 Effexor XR CN Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
F 6331068 5353669 06/12/2007 Effexor XR CN Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
F 6331069 5353671 06/12/2007 Effexor XR CN Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
6343971 5372303 06/01/2007 06/27/2007 Trevilor MD Cleft Palate, Drug Exposure During Pregnancy
M 6343971 5459901 06/01/2007 09/19/2007 Venlafaxine MD Anxiety Disorder Caesarean Section, Cleft Palate, Drug Exposure During Pregnancy, Eye Disorder, Premature Baby
M 6343971 5468651 06/01/2007 09/26/2007 Venlafaxine MD Anxiety Disorder Cleft Palate, Drug Exposure During Pregnancy, Eye Disorder, Premature Baby
M 6345791 5374727 06/29/2007 Venlafaxine MD Drug Exposure During Pregnancy, Epilepsy
M 6345791 5498672 10/26/2007 Venlafaxine MD Anxiety Drug Exposure During Pregnancy, Epilepsy, Febrile Convulsion
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6347479 5376293 06/26/2007 07/02/2007 Trevilor OT Post-Traumatic Stress Disorder Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Infection
F 6350670 5379994 07/16/2005 07/06/2007 Effexor XR MD Panic Attack Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Formication, Suicidal Ideation, Tinnitus
F 6350670 5426324 07/16/2005 08/27/2007 Effexor XR MD Panic Attack Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Formication, Suicidal Ideation, Tinnitus
F 6353054 5382459 07/10/2006 07/10/2007 Effexor XR MD Depression Drug Exposure During Pregnancy
M 6354367 5383966 06/01/2007 07/11/2007 Effexor MD Apgar Score Abnormal, Foetal Heart Rate Abnormal, Small for Dates Baby
F 6361333 5390964 01/01/2006 07/19/2007 Effexor XR OT Depression Chondrodystrophy, Drug Exposure During Pregnancy, Foetal Growth Retardation
F 6361333 5399919 01/01/2006 07/30/2007 Effexor XR OT Depression Chondrodystrophy, Drug Exposure During Pregnancy, Foetal Growth Retardation, Premature Baby
6366577 5396462 07/25/2007 Venlafaxine MD Drug Exposure During Pregnancy, Neonatal Disorder
6366578 5396463 07/25/2007 Venlafaxine MD Drug Exposure During Pregnancy, Neonatal Disorder
6366590 5396486 07/25/2007 Venlafaxine MD Drug Exposure During Pregnancy, Neonatal Disorder
6366591 5396487 07/25/2007 Venlafaxine MD Drug Exposure During Pregnancy, Neonatal Disorder
6366592 5396488 07/25/2007 Venlafaxine MD Drug Exposure During Pregnancy, Neonatal Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6373917 5404247 08/02/2007 Effexor XR MD Panic Disorder Drug Exposure During Pregnancy, Thyroid Disorder
M 6373917 5443657 07/16/2007 09/05/2007 Effexor XR MD Panic Disorder Congenital Hypothyroidism, Drug Exposure During Pregnancy
F 6373963 5404310 05/09/2007 08/02/2007 Effexor XR OT Depression Convulsion Neonatal, Drug Withdrawal Syndrome Neonatal, Dyskinesia
F 6373975 5404330 08/30/2006 08/02/2007 Effexor XR OT Depression Caesarean Section, Drug Exposure During Pregnancy, Pregnancy Induced Hypertension
F 6373975 5465887 08/30/2006 09/24/2007 Effexor XR OT Depression Caesarean Section, Drug Exposure During Pregnancy, Pregnancy Induced Hypertension
F 6377110 5407347 08/07/2007 Venlafaxine OT Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Ectopic Pregnancy, Metrorrhagia
F 6388550 5422030 10/12/2006 08/22/2007 Effexor XR OT Depression Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Neonatal Candida Infection, Somnolence Neonatal
F 6391881 5426471 07/09/2007 08/27/2007 Effexor XR OT Depression Congenital Diaphragmatic Hernia
F 6395822 5432314 02/01/2006 08/31/2007 Effexor XR OT Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Ectopic Pregnancy
F 6413431 5452236 12/01/2006 09/14/2007 Effexor XR OT Depression Agitation Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Hypertonia Neonatal, Hypotonia Neonatal, Movement Disorder, Neonatal Hypoxia, Poor Sucking Reflex, Respiration Abnormal, Respiratory Rate Decreased, Somnolence Neonatal, Tremor Neonatal
F 6419741 5459103 04/11/2007 09/19/2007 Venlafaxine OT Anxiety Disorder Anaemia Neonatal, Cyanosis Neonatal, Drug Exposure During Pregnancy
M 6426607 5466782 08/01/2007 09/25/2007 Effexor XR OT Depression Drug Exposure During Pregnancy, Pulmonary Malformation
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6437381 5479266 01/01/2007 10/08/2007 Effexor XR MD Major Depression Drug Exposure During Pregnancy, Trisomy 21
F 6451921 5498638 11/01/2006 10/26/2007 Venlafaxine OT Depression Drug Exposure During Pregnancy, Polyhydramnios, Premature Rupture of Membranes
6452815 5499558 06/01/2007 10/26/2007 Venlafaxine MD Depression Bradycardia Neonatal, Cyanosis Neonatal, Foetal Macrosomia, Premature Baby, Screaming, Tremor Neonatal
F 6463754 5512239 01/01/2007 11/12/2007 Effexor XR OT Blood Pressure Diastolic Increased, Caesarean Section, Drug Exposure During Pregnancy, Proteinuria
F 6466718 5515823 06/01/2007 11/14/2007 Venlafaxine PH Affective Disorder Abortion Spontaneous, Blood Pressure Increased, Drug Exposure During Pregnancy, Ovarian Adenoma, Placental Disorder
F 6469361 5510933 11/29/2006 11/06/2007 Effexor XR Anxiety, Depression Cardio-Respiratory Arrest, Childhood Disintegrative Disorder, Convulsion, Drug Exposure During Pregnancy, Dysphagia, Eating Disorder, Eye Disorder, Poor Sucking Reflex, Respiratory Disorder Neonatal
6469522 5519015 01/01/2007 11/16/2007 Venlafaxine MD Obsessive Thoughts Foetal Growth Retardation, Localised Oedema
F 6473258 5523626 01/01/2007 11/21/2007 Effexor XR OT Depression Apgar Score Low, Drug Exposure During Pregnancy, Infantile Apnoeic Attack
F 6473258 5571083 11/01/2007 12/21/2007 Effexor XR OT Bipolar Disorder Apgar Score Low, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hypertonia Neonatal, Infantile Apnoeic Attack, Neonatal Disorder, Oxygen Saturation Decreased
6501538 5557780 01/01/2007 12/14/2007 Trevilor MD Agitation Neonatal, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Myoclonus
F 6507985 5564884 12/30/2006 12/18/2007 Effexor XR CN Panic Disorder Drug Exposure During Pregnancy, Intra-Uterine Death
F 6508856 5566021 11/24/2007 12/19/2007 Effexor XR OT Depression Abnormal Labour, Drug Exposure During Pregnancy, Uterine Injury
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6511413 5569547 11/04/2006 12/20/2007 05/02/2007 Effexor OT Bipolar I Disorder Brain Herniation, Cerebral Ventricle Dilatation, Delayed Fontanelle Closure, Drug Exposure During Pregnancy, Foetal Distress Syndrome, Foetal Growth Retardation, Hypoperfusion, Macrocephaly, Renal Aplasia, Spina Bifida, Talipes
M 6512177 5570534 09/29/2007 12/21/2007 Effexor XR MD Depression Drug Exposure During Pregnancy, Fallot's Tetralogy
F 6512289 5570689 11/04/2006 12/21/2007 Effexor OT Bipolar I Disorder Drug Exposure During Pregnancy, Necrosis Ischaemic, Placental Chorioangioma, Placental Disorder, Placental Infarction, Placental Necrosis
6524885 5588530 01/01/2007 01/11/2008 Effexor XR MD Drug Exposure During Pregnancy, Hypoglycaemia Neonatal
M 6553742 5627356 01/12/2008 02/15/2008 Effexor OT Depression Premature Baby
6554105 5627864 02/15/2008 Effexor XR MD Drug Exposure During Pregnancy, Dysmorphism, Stillbirth
M 6557004 5631995 02/20/2008 Effexor XR OT Developmental Delay, Drug Exposure During Pregnancy, Speech Disorder Developmental
M 6557722 5632837 02/25/2007 02/21/2008 Effexor OT Major Depression Hypospadias
6570735 5585828 12/05/2007 Effexor XR MD Convulsion Neonatal, Cyanosis Neonatal
F 6570767 5586244 01/01/2005 12/05/2007 Effexor XR Anxiety Drug Exposure During Pregnancy, Focal Segmental Glomerulosclerosis, Headache, Hypertension, Renal Impairment
F 6570771 5651832 01/17/2008 03/05/2008 Effexor MD Major Depression Abdominal Pain, Adnexa Uteri Mass
F 6570771 5671049 01/17/2008 03/18/2008 Effexor XR MD Major Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Ovarian Cyst
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6571929 5587380 01/01/2006 12/05/2007 Effexor XR OT Convulsion Neonatal, Drug Exposure During Pregnancy
F 6572104 5586489 12/05/2007 Effexor XR Depression Drug Exposure During Pregnancy
F 6587729 5671933 03/19/2008 Effexor OT Depression Congenital Foot Malformation
F 6587741 5671955 04/01/2007 03/19/2008 Effexor OT Depression Cerebral Ventricle Dilatation, Drug Exposure During Pregnancy, Foetal Growth Retardation
F 6587970 5586934 11/17/2006 12/05/2007 Effexor XR OT Depression, Dysthymic Disorder, Generalised Anxiety Disorder Respiratory Disorder Neonatal
F 6588014 5586488 12/05/2007 Effexor XR MD Anxiety Drug Exposure During Pregnancy
F 6588019 5586490 12/05/2007 Effexor XR Depression Drug Exposure During Pregnancy
F 6589814 5674977 01/01/2007 03/20/2008 Effexor OT Depression Drug Exposure During Pregnancy, Pre-Eclampsia
F 6589814 5675173 01/01/2007 03/20/2008 Effexor OT Depression Drug Exposure During Pregnancy, Pre-Eclampsia
M 6591368 5676661 01/07/2008 03/24/2008 Effexor OT Congenital Heart Valve Disorder, Drug Exposure During Pregnancy, Hypotonia Neonatal, Lethargy, Unresponsive To Stimuli
M 6591539 5676995 08/01/2006 03/24/2008 Effexor OT Drug Exposure During Pregnancy, Dysmorphism, Microcephaly, Premature Baby, Small for Dates Baby
M 6593351 5680110 01/01/2007 03/26/2008 02/24/2008 Effexor OT Congenital Musculoskeletal Anomaly, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6593351 5680582 01/01/2007 03/26/2008 Effexor OT Congenital Musculoskeletal Anomaly, Drug Exposure During Pregnancy
F 6597492 5684388 02/21/2008 03/28/2008 Trevilor MD Anxiety Drug Exposure During Pregnancy, Foetal Distress Syndrome
F 6598035 5684989 06/01/2007 03/28/2008 Trevilor OT Anxiety Drug Exposure During Pregnancy, Haemoglobin Decreased, Premature Labour, Premature Rupture of Membranes, Prolonged Labour, Uterine Hypotonus
0 Months M 3464790 4335650 04/14/2000 04/06/2004 Effexor MD Drug Withdrawal Syndrome Neonatal, Maternal Drugs Affecting Foetus
0 Months M 4148303 4369719 01/01/2003 05/28/2004 Effexor XR OT Depression Drug Exposure During Pregnancy, Talipes
0 Months M 4188546 4415335 06/15/2004 07/30/2004 Effexor XR Depression Caesarean Section, Cardiac Arrest Neonatal, Drug Exposure During Pregnancy, Neonatal Tachycardia
M 5215650 5671770 11/09/1994 02/27/2008 Effexor OT Depression Hernia Congenital, Intestinal Perforation
0 Months 5809874 4674377 03/04/2005 05/24/2005 Effexor XR OT Caesarean Section, Convulsion Neonatal, Drug Exposure During Pregnancy, Foetal Distress Syndrome, Nervous System Disorder
F 6209793 5737961 11/29/2006 05/14/2008 Effexor XR MD Depression Congenital Neurological Disorder, Convulsion Neonatal, Dysphagia, Feeding Disorder Neonatal, Foetal Heart Rate Increased, Hypertonia Neonatal, Respiratory Disorder Neonatal
F 6463754 5750353 01/01/2007 05/28/2008 Effexor XR OT Blood Pressure Diastolic Increased, Caesarean Section, Drug Exposure During Pregnancy, Proteinuria
M 6557004 5701021 04/10/2008 Effexor XR OT Developmental Delay, Drug Exposure During Pregnancy, Speech Disorder Developmental
F 6570771 5698023 01/04/2008 04/08/2008 Effexor XR MD Major Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Ovarian Cyst
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6587741 5766621 04/01/2007 06/12/2008 Effexor OT Depression Cerebral Ventricle Dilatation, Drug Exposure During Pregnancy, Foetal Growth Retardation
6607580 5695951 04/07/2008 Effexor OT Congenital Diaphragmatic Hernia, Drug Exposure During Pregnancy
M 6617366 5708604 07/05/2006 04/17/2008 Effexor OT Depression Aorta Hypoplasia, Drug Exposure During Pregnancy, Persistent Left Superior Vena Cava, Premature Baby, Radiation Exposure During Pregnancy
F 6618116 5709566 12/12/2007 04/18/2008 Venlafaxine CN Body Temperature Decreased, Premature Baby
M 6625021 5718569 06/01/2005 04/25/2008 Effexor XR CN Depression Abdominal Pain, Autism, Blood Bilirubin Increased, Drug Exposure During Pregnancy, Ear Infection, Feeding Disorder Neonatal, Hernia, Jaundice Neonatal, Musculoskeletal Stiffness, Neonatal Disorder, Pyrexia, Restlessness, Sleep Disorder, Sleep Terror, Speech Disorder, Underweight, Unevaluable Event
F 6627514 5721362 04/29/2008 Effexor OT Depression Drug Exposure During Pregnancy
F 6636721 5733106 01/01/2008 05/09/2008 Effexor MD Drug Exposure During Pregnancy
M 6636780 5733168 05/09/2008 Venlafaxine OT Depression Abnormal Palmar/Plantar Creases, Ear Malformation, Foetal Damage, Head Deformity
6636840 5733232 05/09/2008 Effexor OT Mental Disorder Congenital Diaphragmatic Anomaly, Neonatal Disorder
6636840 5737959 05/14/2008 Effexor OT Mental Disorder Congenital Diaphragmatic Hernia, Drug Exposure During Pregnancy
M 6644099 5743534 09/16/2003 05/20/2008 Effexor XR CN Cardiac Septal Defect, Drug Exposure During Pregnancy, Premature Baby
F 6645084 5744954 05/21/2008 Effexor MD Ataxia, Foetal Growth Retardation, Hypokinesia Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6655731 5756656 03/27/2008 06/03/2008 Effexor OT Depression Premature Baby, Small for Dates Baby
F 6658024 5759817 04/09/2008 06/05/2008 Effexor OT Depression Failure To Thrive, General Physical Health Deterioration, Hypokalaemia, Hyponatraemia, Urinary Retention
6658783 5760863 01/01/2008 06/06/2008 Effexor OT Depression Drug Exposure During Pregnancy, Transposition of the Great Vessels
M 6667313 5772057 06/13/2008 Venlafaxine OT Developmental Delay, Drug Exposure During Pregnancy
M 6670004 5775825 02/01/2007 06/17/2008 Effexor OT Depression Agitation Neonatal, Anotia, Bradycardia Neonatal, Cardiomyopathy Neonatal, Congenital Central Nervous System Anomaly, Congenital Neurological Disorder, Congenital Pharyngeal Anomaly, Drug Exposure During Pregnancy, Dysmorphism, Dysphagia, Extrapyramidal Disorder, Foetal Growth Retardation, Infantile Apnoeic Attack, Limb Malformation, Microcephaly, Microtia, Neonatal Respiratory Distress Syndrome, Poor Sucking Reflex, Premature Baby, Subdural Effusion, Trismus, Ventricular Septal Defect
1 Hours F 4193883 4426931 01/01/2001 08/11/2004 Effexor MD Depression Drug Exposure During Pregnancy, Myoclonus, Neonatal Apnoeic Attack, Neonatal Disorder
1 Hours F 4193883 4432424 01/01/2001 08/20/2004 Effexor MD Depression Caesarean Section, Cardiac Murmur, Congenital Mitral Valve Incompetence, Congenital Ventricular Septal Defect, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Screen Positive, Head Lag, Heart Rate Increased, Hypotonia Neonatal, Masked Facies, Myoclonus, Neonatal Apnoeic Attack, Subarachnoid Haemorrhage Neonatal, Transient Tachypnoea of the Newborn
1 Hours F 4193883 4434322 08/25/2004 Effexor MD Depression Blood Glucose Decreased, Caesarean Section, Cardiac Murmur, Chest X-Ray Abnormal, Congenital Mitral Valve Incompetence, Congenital Ventricular Septal Defect, CSF White Blood Cell Count Positive, Drug Exposure During Pregnancy, Head Lag, Heart Rate Abnormal, Heart Rate Increased, Hypotonia Neonatal, Myoclonus, Neonatal Apnoeic Attack, Neonatal Disorder, Red Blood Cells CSF Positive, Subarachnoid Haemorrhage Neonatal, Trisomy 21
12 Hours F 4004986 4333207 04/02/2004 Effexor Depression Blood PH Decreased, Cardio-Respiratory Distress, Drug Exposure During Pregnancy, Forceps Delivery, Neonatal Disorder, Premature Baby, Regurgitation of Food, Sedation
1 Day 4160926 4382223 06/16/2004 Effexor Depression Angiopathy, Blindness Congenital, Cerebral Atrophy Congenital, Developmental Delay, Drug Exposure During Pregnancy, Epilepsy Congenital
1 Day 4160926 4382346 06/16/2004 Effexor Depression Angiopathy, Blindness Congenital, Cerebral Atrophy Congenital, Congenital Anomaly, Developmental Delay, Drug Exposure During Pregnancy, Epilepsy Congenital
1 Day 4223065 4462429 08/10/2004 09/24/2004 Effexor MD Depression Apgar Score Low, Blood Lactic Acid Increased, Caesarean Section, Drug Exposure During Pregnancy, Hypotonia Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
1 Day M 5754507 4596184 02/03/2005 02/25/2005 Effexor XR Depression Convulsion Neonatal, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Electroencephalogram Abnormal, Hypothermia Neonatal, Nasal Flaring, Neonatal Apnoeic Attack, Neonatal Disorder, Neonatal Hypoxia, Oxygen Saturation Decreased, Transient Tachypnoea of the Newborn, Tremor Neonatal
1 Day 5759880 4606782 07/01/2004 01/16/2005 Effexor PH Anxiety, Depression Convulsion, Drug Exposure During Pregnancy, Musculoskeletal Stiffness, Tension
24 Hours F 5771031 4677419 05/26/2005 Effexor XR Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
1 Day M 5779305 4634422 11/22/2004 04/11/2005 Effexor Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Fever Neonatal, Neonatal Tachypnoea, Vomiting Neonatal
1 Day F 5791385 4650077 01/01/2004 04/28/2005 Effexor Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Hypotension, Neonatal Respiratory Failure
1 Day M 5811957 4678733 01/01/2004 05/31/2005 Effexor XR Drug Exposure During Pregnancy, Transient Tachypnoea of the Newborn
1 Day M 5934194 4708427 07/05/2005 Effexor Depression Cerebral Atrophy Congenital, Congenital Anomaly, Congenital Central Nervous System Anomaly, Congenital Hair Disorder, Congenital Nail Disorder, Drug Exposure During Pregnancy, Epilepsy, Facial Dysmorphism, Flat Feet, Growth Retardation, Karyotype Analysis Abnormal, Neonatal Disorder, Phalangeal Hypoplasia, Psychomotor Retardation, Skin Disorder
1 Day F 6099180 5065014 11/14/2005 07/26/2006 Venlafaxine Anxiety, Depression, Panic Attack Drug Exposure During Pregnancy, Idiopathic Thrombocytopenic Purpura, Neonatal Disorder
1 Day 6140196 5110150 09/18/2006 Effexor OT Depression Apgar Score Low, Bacteria Stool Identified, Blood PH Decreased, Caesarean Section, Drug Exposure During Pregnancy, Necrotising Enterocolitis Neonatal, Neonatal Respiratory Failure, Placenta Praevia, Premature Baby
1 Day M 6141004 5110549 01/01/2003 09/18/2006 Effexor XR CN Depression Collapse of Lung, Drug Exposure During Pregnancy, Infantile Asthma, Neonatal Respiratory Failure, Premature Baby, Respiratory Disorder Neonatal
1 Day F 6226284 5214485 10/17/2006 01/16/2007 Effexor XR CN Drug Exposure During Pregnancy, Premature Baby
2 Days F 4104939 4310414 01/01/2003 03/01/2004 Effexor XR Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Maternal Drugs Affecting Foetus, Neonatal Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
2 Days F 6012290 4947279 02/27/2006 03/13/2006 Effexor XR MD Drug Exposure During Pregnancy Agitation Neonatal, Drug Exposure During Pregnancy, Dyskinesia Neonatal
2 Days 6060680 5014536 05/25/2006 Effexor Depression Dehydration, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome Neonatal, Neonatal Disorder, Neonatal Tachypnoea, Poor Sucking Reflex
2 Days M 6149212 5124721 09/01/2006 10/06/2006 Venlafaxine Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Hypertonia, Nervousness, Tremor
2 Days M 6149212 5124741 09/01/2006 10/06/2006 Venlafaxine Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Nervousness
8 Days F 6135959 5106122 01/01/2005 09/11/2006 Effexor XR MD Anxiety, Depression, Panic Disorder Brain Damage, Cerebrovascular Accident, Convulsion Neonatal, Crying, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Hypokinesia Neonatal, Ischaemia, Neonatal Anoxia, Neonatal Disorder, Neonatal Respiratory Arrest
2 Weeks F 6471258 5521142 09/23/2007 11/19/2007 09/23/2007 Venlafaxine OT Schizophrenia Drug Exposure Via Breast Milk, Sudden Infant Death Syndrome
6 Weeks F 4173231 4397655 06/08/2004 07/13/2004 Venlafaxine Depression Bone Marrow Depression, Developmental Delay, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Pallor
6 Weeks F 4173231 4526382 06/08/2004 12/10/2004 Venlafaxine Depression Anaemia Neonatal, Bone Marrow Depression, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, Pallor, Small for Dates Baby
6 Weeks 4193769 4425601 08/10/2004 Effexor XR OT Coma, Sudden Infant Death Syndrome
6 Weeks 4193769 4444459 09/02/2004 Effexor XR MD Loss of Consciousness, Sudden Infant Death Syndrome
3 Months 5934741 4837017 11/21/2005 Effexor Depression Congenital Anomaly, Drug Exposure During Pregnancy, Growth Retardation, Haemangioma
3 Months 5934741 4839673 11/25/2005 Effexor Depression Congenital Anomaly, Drug Exposure During Pregnancy, Foetal Growth Retardation, Haemangioma Congenital
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
3 Months M 6119363 5087239 01/01/2005 08/21/2006 Effexor XR CN Drug Exposure Via Breast Milk, Multiple Fractures, Rib Fracture, Upper Limb Fracture
3 Months M 6119363 5096258 11/17/2005 08/30/2006 Effexor XR Postpartum Depression Drug Exposure Via Breast Milk, Multiple Fractures, Osteogenesis Imperfecta, Rib Fracture, Upper Limb Fracture
3 Months M 6119363 5133047 11/17/2005 10/17/2006 Effexor XR OT Anxiety, Postpartum Depression Child Abuse, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Irritability, Osteogenesis Imperfecta, Rib Fracture, Upper Limb Fracture
3 Months M 6119363 5134039 11/17/2005 10/19/2006 Effexor XR Anxiety, Postpartum Depression Child Abuse, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Irritability, Osteogenesis Imperfecta, Rib Fracture, Upper Limb Fracture
3 Months 6150989 5127873 01/01/2006 10/10/2006 Effexor XR Child Abuse, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Irritability, Rib Fracture
3 Months 6150989 5129936 01/01/2006 10/12/2006 Effexor XR Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Irritability, Rib Fracture, Victim of Child Abuse
6 Months 6245043 5246463 08/01/2006 02/26/2007 02/01/2007 Effexor XR OT Depression Drug Exposure Via Breast Milk, Sudden Infant Death Syndrome
33 Weeks M 6570746 5586235 07/01/2006 12/05/2007 Effexor XR Depression Premature Baby
10 Months 5779307 4711090 07/07/2005 Effexor XR OT Depression Drug Exposure During Pregnancy, Lymphocytic Leukaemia
4 Years M 6681270 5788511 06/26/2008 Effexor OT Abnormal Behaviour, Drug Exposure During Pregnancy
15 Years F 5798747 4658316 05/01/2004 05/09/2005 Effexor OT Caesarean Section, Drug Exposure During Pregnancy
15 Years F 5798747 4677742 05/01/2004 05/27/2005 Effexor Caesarean Section, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
15 Years F 5798747 4693606 05/01/2004 06/16/2005 Effexor Caesarean Section, Drug Exposure During Pregnancy
19 Years F 5740936 4576346 02/07/2005 Effexor Depressed Mood Caesarean Section, Drug Exposure During Pregnancy
19 Years F 5740936 4578626 11/23/2004 02/09/2005 Effexor Depressed Mood Caesarean Section, Drug Exposure During Pregnancy
19 Years F 5952938 4863963 01/01/2005 12/19/2005 Effexor XR Depression Caesarean Section, Drug Exposure During Pregnancy, Postpartum Haemorrhage
19 Years F 5952938 4866097 01/01/2005 12/21/2005 Effexor XR MD Depression Caesarean Section, Drug Exposure During Pregnancy, Postpartum Haemorrhage
19 Years F 5952938 4866863 01/01/2005 12/22/2005 Effexor XR OT Depression Caesarean Section, Drug Exposure During Pregnancy, Postpartum Haemorrhage
19 Years F 6136968 5103252 06/14/2005 09/08/2006 Effexor PH Depression Abortion Spontaneous Incomplete, Drug Exposure During Pregnancy, Intra-Uterine Death
19 Years F 6138316 5108663 09/15/2006 Venlafaxine MD Postpartum Depression Bipolar II Disorder, Brief Psychotic Disorder With Postpartum Onset, Insomnia, Intentional Overdose
20 Years F 4196969 4430014 11/01/2003 08/17/2004 Efectin Personality Disorder Abortion Spontaneous, Drug Exposure During Pregnancy, Placental Disorder
20 Years F 6068259 5024034 03/01/2006 06/07/2006 03/01/2006 Effexor XR MD Bipolar Disorder Acute Respiratory Distress Syndrome, Drug Exposure Before Pregnancy, Respiratory Failure
21 Years F 4169446 4394791 01/01/2004 07/07/2004 Effexor XR MD Depression Abnormal Behaviour, Aggression, Drug Exposure During Pregnancy, Overdose, Psychotic Disorder, Suicide Attempt, Treatment Noncompliance
21 Years F 4169446 4743348 01/01/2004 08/09/2005 Effexor XR MD Depression Aggression, Drug Exposure During Pregnancy, Overdose, Psychotic Disorder, Suicide Attempt, Treatment Noncompliance
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
21 Years F 5859264 4736471 06/18/2005 08/02/2005 Effexor OT Anxiety, Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
21 Years F 5859264 4737051 06/18/2005 08/04/2005 Effexor Anxiety, Depression Drug Withdrawal Syndrome, Insomnia, Malaise, Tremor
21 Years F 5859264 4738281 06/18/2005 08/03/2005 Effexor MD Anxiety, Depression Anxiety, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
21 Years F 5859264 4743654 06/18/2005 08/09/2005 Effexor Anxiety, Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
21 Years F 5859264 4749935 06/18/2005 08/22/2005 Effexor XR Anxiety, Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Malaise
21 Years F 5859264 4761365 06/18/2005 09/01/2005 Effexor XR Anxiety, Depression Anxiety, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Insomnia, Malaise, Tremor
21 Years F 5859264 4991196 06/18/2005 04/26/2006 Effexor XR Anxiety, Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Insomnia, Malaise, Tremor
21 Years F 5940077 4844617 10/27/2005 11/25/2005 Effexor XR CN Anxiety, Panic Attack, Prophylaxis Drug Exposure During Pregnancy, Insomnia, Prolonged Pregnancy
21 Years F 5940077 4853017 10/27/2005 12/12/2005 Effexor XR Anxiety, Panic Attack, Prophylaxis Caesarean Section, Convulsion, Drug Exposure During Pregnancy, Insomnia, Prolonged Pregnancy
21 Years F 5940077 4866849 10/27/2005 12/22/2005 Effexor XR Anxiety, Panic Attack, Prophylaxis Caesarean Section, Convulsion, Drug Exposure During Pregnancy, Insomnia, Prolonged Pregnancy, Tremor
22 Years F 6241242 5212783 07/28/2002 01/18/2007 Effexor OT Depression Disturbance In Attention, Drug Exposure During Pregnancy, Emotional Disorder, Hypertension, Premature Baby, Psychomotor Hyperactivity
23 Years F 5713788 4546053 02/17/2004 01/03/2005 Effexor XR MD Affective Disorder Drug Exposure During Pregnancy, Induced Labour, Postpartum Haemorrhage, Prolonged Labour
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
23 Years F 5879866 4766860 10/01/2004 09/09/2005 Effexor XR Postpartum Depression Anxiety, Drug Exposure During Pregnancy, Induced Labour, Pre-Eclampsia
23 Years F 5879866 4767803 10/01/2004 09/12/2005 Effexor XR Depression Anxiety, Drug Exposure During Pregnancy, Induced Labour, Pre-Eclampsia
23 Years F 5879866 4767804 10/01/2004 09/12/2005 Effexor XR Postpartum Depression Drug Exposure During Pregnancy, Induced Labour, Pre-Eclampsia
23 Years F 5879866 4866105 10/01/2004 12/21/2005 Effexor XR OT Major Depression Drug Exposure During Pregnancy, Pre-Eclampsia
23 Years F 6009120 4941623 06/09/2005 03/08/2006 Effexor Depression Abortion Missed, Drug Exposure During Pregnancy
23 Years F 6009120 4961732 06/09/2005 03/29/2006 Effexor Depression Abortion Missed, Drug Exposure During Pregnancy
23 Years F 6027783 4967493 01/01/2005 04/03/2006 Effexor XR MD Depression Abdominal Pain Upper, Acute Fatty Liver of Pregnancy, Alanine Aminotransferase Increased, Anorexia, Aspartate Aminotransferase Increased, Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspepsia, Ear Pain, Gestational Diabetes, Hepatic Enzyme Increased, Herpes Simplex, Nausea, Premature Baby, Premature Labour, Skin Lesion, Vulvovaginal Mycotic Infection
23 Years F 6027783 5013677 01/01/2005 05/25/2006 Effexor XR MD Depression Acute Fatty Liver of Pregnancy, Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspepsia, Ear Pain, Gestational Diabetes, Hepatic Enzyme Increased, Hepatic Steatosis, Herpes Simplex, Premature Labour, Vulvovaginal Mycotic Infection
23 Years F 6123383 5094837 08/28/2006 08/30/2006 Effexor XR CN Depression, Familial Risk Factor Drug Dependence, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Hot and Cold, Hunger, Hyperphagia, Impaired Work Ability, Mood Altered
24 Years F 4224716 4463050 01/01/2002 09/28/2004 Effexor XR OT Panic Attack Antepartum Haemorrhage, Bronchitis, Cervical Incompetence, Drug Exposure During Pregnancy, False Labour, Migraine, Pain, Pelvic Pain, Premature Labour, Sinusitis, Vaginal Haemorrhage
24 Years F 6139972 5110767 08/01/2006 09/19/2006 Effexor XR Depression Confusional State, Diarrhoea, Dizziness, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Hot and Cold, Headache, Hunger, Hyperhidrosis, Insomnia, Mood Altered, Nausea, Paraesthesia, Tremor, Vomiting
24 Years F 6234179 5224947 12/01/2004 01/26/2007 Effexor XR Drug Exposure During Pregnancy, Overdose
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
24 Years F 6284315 5279774 06/20/2005 12/15/2006 Effexor XR MD Anxiety, Post-Traumatic Stress Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Liver Function Test Abnormal
25 Years F 6392217 5427084 01/01/2007 08/28/2007 Effexor CN Postpartum Depression Activities of Daily Living Impaired, Condition Aggravated, Depression, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome
25 Years F 6392217 5482155 01/01/2007 10/11/2007 Effexor CN Postpartum Depression Activities of Daily Living Impaired, Condition Aggravated, Depression, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome, Mental Disorder, Tearfulness
25 Years F 4223674 4462810 06/01/2003 09/27/2004 Effexor XR Caesarean Section, Drug Exposure During Pregnancy, Respiratory Disorder
25 Years F 5778470 4633459 01/01/2004 04/12/2005 Effexor XR Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Hydronephrosis, Kidney Small, Limb Malformation
25 Years F 5778470 4845437 01/01/2004 11/25/2005 Effexor Congenital Hydronephrosis, Drug Exposure During Pregnancy, Finger Deformity, Heart Disease Congenital, Kidney Small, Limb Malformation, Ureteric Dilatation
25 Years F 5804355 4665977 04/22/2005 05/17/2005 Effexor XR CN Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Palpitations, Vomiting In Pregnancy
25 Years F 5890424 4780719 07/13/2005 09/26/2005 Effexor Depression Abortion Spontaneous, Drug Exposure During Pregnancy
25 Years F 5936053 4837295 01/01/2004 11/22/2005 Effexor XR Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Foetal Disorder, Foetal Heart Rate Decreased, Hydronephrosis, Kidney Small, Limb Malformation, Ureteric Dilatation
25 Years F 6392217 5708606 01/01/2007 04/17/2008 Effexor CN Postpartum Depression Activities of Daily Living Impaired, Condition Aggravated, Depression, Drug Effect Decreased, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Mental Disorder, Tearfulness
26 Years F 4128299 4338292 02/01/2004 04/09/2004 Effexor XR CN Depression Abnormal Dreams, Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Maternal Drugs Affecting Foetus
26 Years F 6135033 5103267 01/01/2004 09/08/2006 Effexor XR Abortion Spontaneous, Drug Exposure During Pregnancy, Infertility Female
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
26 Years F 6135033 5194518 01/01/2004 12/22/2006 Effexor XR Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Infertility
27 Years F 6559928 5636214 01/01/2007 02/25/2008 Effexor OT Depression Drug Exposure During Pregnancy, Foetal Disorder
27 Years F 4167192 4390283 06/30/2004 Trevilor MD Depression Caesarean Section, Drug Exposure During Pregnancy, Foetal Heart Rate Increased
27 Years F 5758260 4599309 05/01/2004 03/02/2005 Effexor OT Dissociative Identity Disorder Breast Discharge, Drug Exposure During Pregnancy
27 Years F 6109659 5076342 10/01/2005 08/07/2006 Venlafaxine MD Post-Traumatic Stress Disorder Drug Exposure During Pregnancy, Intra-Uterine Death, Premature Baby, Urinary Tract Infection
27 Years F 6159371 5154498 01/10/2005 11/14/2006 Effexor Depression Arthralgia, Blood Alkaline Phosphatase Increased, Caesarean Section, Constipation, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Faecaloma, Galactostasis, Headache, Hypotension, Infrequent Bowel Movements, Labour Complication, Lactation Disorder, Nipple Pain, Oedema Peripheral, Otitis Externa, Pain, Prolonged Labour, Rash, Sciatica, Skin Infection, Tinea Pedis, Upper Respiratory Tract Infection
27 Years F 6284161 5280202 01/01/2005 12/15/2006 Effexor XR OT Depression, Generalised Anxiety Disorder Abortion Missed, Drug Exposure During Pregnancy
27 Years F 6320452 5334884 01/01/2006 05/25/2007 Effexor MD Depression Abdominal Pain Upper, Drug Exposure During Pregnancy, Fatigue, Feeling of Despair, Nausea, Vomiting
27 Years F 6508170 5565183 01/01/2007 12/18/2007 Effexor XR CN Anxiety Anger, Crying, Disturbance In Attention, Drug Effect Decreased, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Obsessive-Compulsive Disorder, Paraesthesia, Suicidal Ideation
27 Years F 6570390 5586045 12/05/2007 Effexor XR PH Depression Abortion Spontaneous, Drug Exposure During Pregnancy
28 Years F 4144356 4360232 04/28/2004 05/13/2004 Effexor XR Depression Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy
28 Years F 4166532 4389052 01/01/2003 06/28/2004 Effexor XR MD Anxiety Abortion Spontaneous, Drug Exposure During Pregnancy, Sensation of Foreign Body
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
28 Years F 4181079 4408445 07/23/2004 Effexor XR Dysthymic Disorder, Generalised Anxiety Disorder Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
28 Years F 4208367 4444526 11/01/2001 09/02/2004 Effexor XR MD Depression, Postpartum Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Female Sexual Dysfunction, Paraesthesia, Paraesthesia Oral, Sensory Disturbance, Social Avoidant Behaviour, Unevaluable Event, Visual Disturbance
28 Years F 4211444 4445874 11/27/2003 09/07/2004 Effexor XR Depression Drug Exposure During Pregnancy, Pre-Eclampsia, Premature Baby
28 Years F 5840900 4713051 01/01/2003 07/12/2005 Trevilor Generalised Anxiety Disorder Abortion Spontaneous, Drug Exposure During Pregnancy
28 Years F 6224829 5215300 06/01/2006 01/16/2007 Effexor Depression Drug Exposure During Pregnancy, Intra-Uterine Death
28 Years F 6226285 5214497 08/01/2006 01/16/2007 Effexor XR CN Anxiety, Depression Drug Exposure During Pregnancy, Gestational Diabetes, Pregnancy Induced Hypertension, Premature Labour, Vomiting
28 Years F 6554262 5628082 01/01/2007 02/15/2008 Effexor OT Depression Drug Exposure During Pregnancy, Eclampsia
29 Years F 5711681 4537415 01/01/2003 12/16/2004 Effexor XR Depression Agitation, Confusional State, Coordination Abnormal, Dizziness, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Hypertension, Malaise, Tremor
29 Years F 5851013 4724389 07/21/2005 Effexor Depression Arthropathy, Caesarean Section, Drug Exposure During Pregnancy, Maternal Distress During Labour
29 Years F 5851013 4724390 07/21/2005 Effexor Depression Caesarean Section, Drug Exposure During Pregnancy, Maternal Distress During Labour
29 Years F 5927816 4830613 01/01/2005 11/15/2005 Effexor OT Delirium, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Hallucination, Multiple Drug Overdose Intentional, Suicide Attempt, Tachycardia
29 Years F 6008095 4938528 03/01/2004 03/02/2006 Effexor Drug Exposure During Pregnancy, Pre-Eclampsia, Stress
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
29 Years F 6056407 5008994 07/01/2005 05/19/2006 Effexor Depression Drug Exposure During Pregnancy, Premature Labour
29 Years F 6138194 5119915 06/19/2006 09/27/2006 Effexor XR Depression Caesarean Section, Drug Exposure During Pregnancy, Intra-Uterine Death
29 Years F 6138194 5121635 06/19/2006 10/03/2006 Effexor XR Depression Caesarean Section, Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Intra-Uterine Death
29 Years F 6159371 5131735 09/11/2006 10/16/2006 Effexor Depression Drug Exposure During Pregnancy, Labour Complication
30 Years F 4188535 4474200 01/07/2004 10/08/2004 Effexor XR MD Depression Drug Exposure During Pregnancy, Laboratory Test Abnormal, Oligohydramnios
30 Years F 5696120 4522816 02/01/2004 12/07/2004 Effexor Depression Blood Pressure Increased, Caesarean Section, Drug Exposure During Pregnancy, Eye Oedema, Headache, Oedema, Sinus Tachycardia, Visual Disturbance
30 Years F 5696120 4523946 02/01/2004 12/09/2004 Effexor Depression Blood Pressure Increased, Caesarean Section, Drug Exposure During Pregnancy, Pre-Eclampsia, Premature Baby, Sinus Tachycardia
30 Years F 5696120 4524773 02/01/2004 12/08/2004 Effexor Depression Caesarean Section, Drug Exposure During Pregnancy, Pre-Eclampsia, Sinus Tachycardia
30 Years F 5708061 4537693 05/01/2004 12/16/2004 Effexor XR Anxiety Abortion Spontaneous, Drug Exposure During Pregnancy
30 Years F 5807438 4672907 05/20/2004 05/23/2005 Effexor XR OT Caesarean Section, Drug Exposure During Pregnancy, Foetal Distress Syndrome
30 Years F 5824273 4690938 11/05/2004 06/10/2005 Venlafaxine Caesarean Section, Drug Exposure During Pregnancy, Haemorrhagic Diathesis, Haemorrhagic Disorder, Neonatal Disorder, Peripheral Oedema Neonatal
30 Years F 5824273 4692292 11/05/2004 06/14/2005 Venlafaxine Caesarean Section, Drug Exposure During Pregnancy, Haemorrhagic Diathesis, Oedema Peripheral
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
30 Years F 5826809 4693614 01/01/2005 06/16/2005 Effexor Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Suicidal Ideation
30 Years F 5826809 4743900 01/01/2005 08/09/2005 Effexor Depression Abortion Early, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Suicidal Ideation
30 Years F 5826809 4745282 01/01/2005 08/12/2005 Effexor Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Suicidal Ideation
30 Years F 5826809 4746539 01/01/2005 08/15/2005 Effexor OT Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Suicidal Ideation
30 Years F 5840160 4708365 01/01/2002 07/05/2005 Effexor XR Depression, Post-Traumatic Stress Disorder Caesarean Section, Dizziness, Drug Exposure During Pregnancy, Drug Ineffective, Hypertension, Nausea
30 Years F 5951497 4855548 01/01/2005 12/14/2005 Effexor XR Depression Caesarean Section, Delayed Delivery, Drug Exposure During Pregnancy
30 Years F 5951497 4861188 01/30/2005 12/16/2005 Effexor XR Depression Arrested Labour, Caesarean Section, Delayed Delivery, Drug Exposure During Pregnancy
30 Years F 5951497 4875721 01/30/2005 01/05/2006 Effexor XR Depression Caesarean Section, Delayed Delivery, Drug Exposure During Pregnancy, Failed Trial of Labour
30 Years F 6008473 5087232 07/01/2006 08/21/2006 Effexor XL Depression Disease Recurrence, Drug Exposure During Pregnancy, Postpartum Haemorrhage, Pyelonephritis, Urinary Tract Infection
30 Years F 6142398 5116978 01/01/2005 09/22/2006 Effexor OT Depression Caesarean Section, Drug Exposure During Pregnancy
31 Years F 4142424 4358602 03/30/2004 05/14/2004 Effexor XR Depression Caesarean Section, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Labour Complication
31 Years F 4142424 4360234 03/30/2004 05/13/2004 Effexor XR Depression Caesarean Section, Complications of Maternal Exposure To Therapeutic Drugs, Labour Complication, Maternal Drugs Affecting Foetus
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
31 Years F 4161086 4382350 06/16/2004 Effexor Angiopathy, Blindness Congenital, Cerebral Atrophy Congenital, Developmental Delay, Drug Exposure During Pregnancy, Epilepsy Congenital
31 Years F 4161086 4382351 06/16/2004 Effexor Depression Angiopathy, Drug Exposure During Pregnancy
31 Years F 5665160 4467063 01/01/2004 10/04/2004 Effexor XR MD Panic Attack Crying, Dizziness, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Abnormal, High Risk Pregnancy, Nausea, Placenta Praevia, Tinnitus, Treatment Noncompliance, Vaginal Haemorrhage, Vertigo
31 Years F 5665160 4574736 01/01/2004 02/04/2005 Effexor XR MD Panic Attack Antepartum Haemorrhage, Crying, Dizziness, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Abnormal, Nausea, Placenta Praevia, Tinnitus, Treatment Noncompliance, Vertigo
31 Years F 5669271 5026183 01/01/2003 06/07/2006 Effexor MD Drug Exposure During Pregnancy, Pregnancy Induced Hypertension, Pulmonary Oedema
31 Years F 5867145 4747537 07/02/2005 08/16/2005 Venlafaxine Drug Exposure During Pregnancy, Intentional Misuse, Overdose, Vomiting
31 Years F 5954016 4866456 01/01/2005 12/21/2005 Effexor Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Pre-Eclampsia
31 Years F 5954016 4867117 01/01/2005 12/21/2005 Effexor Disease Recurrence, Drug Exposure During Pregnancy, Pre-Eclampsia
31 Years F 5974570 4885565 04/15/2005 12/20/2005 Effexor XR MD Anxiety Abortion Spontaneous, Drug Exposure During Pregnancy
31 Years F 6230266 5219235 07/25/2006 01/22/2007 Effexor XR Depression Caesarean Section, Drug Exposure During Pregnancy, Pre-Eclampsia, Premature Separation of Placenta
31 Years F 6285213 5279938 03/01/2006 12/15/2006 Effexor XR Anxiety, Depression Abortion Spontaneous, Drug Exposure During Pregnancy
31 Years F 6285215 5279945 05/01/2006 12/15/2006 Effexor XR Anxiety, Depression Abortion Spontaneous, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
31 Years F 6331330 5354380 03/10/2007 06/12/2007 Effexor MD Depression Drug Exposure During Pregnancy, Postpartum Haemorrhage, Uterine Atony
31 Years F 6487077 5541544 09/01/2007 12/10/2007 Effexor XR CN Depression Dehydration, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Abnormal, Headache, Impaired Driving Ability, Impaired Work Ability, Memory Impairment, Nausea, Weight Decreased
32 Years F 4025535 4382462 01/01/2003 06/17/2004 Effexor Complications of Maternal Exposure To Therapeutic Drugs, Gestational Diabetes
32 Years F 4025535 4384730 01/01/2003 06/21/2004 Effexor Drug Exposure During Pregnancy
32 Years F 4025535 4384782 01/01/2003 06/21/2004 Effexor Drug Exposure During Pregnancy, Gestational Diabetes
32 Years F 4173768 4398982 01/01/2003 07/12/2004 Effexor XR OT Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Uterine Infection
32 Years F 4209872 4446101 02/01/2003 09/07/2004 Effexor XR OT Depression, Eating Disorder Abortion Missed, Abortion Spontaneous, Drug Exposure During Pregnancy
32 Years F 5731064 4567278 01/01/2004 01/27/2005 Effexor XR OT Abortion Spontaneous, Anxiety, Drug Exposure During Pregnancy, Intentional Misuse, Treatment Noncompliance
33 Years F 6370172 5400321 04/01/2007 07/30/2007 Effexor XR MD Depression Anxiety, Condition Aggravated, Depression, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Sleep Disorder, Suicidal Ideation
33 Years F 4086950 4285513 01/01/2003 01/30/2004 Effexor XR OT Depression, Eating Disorder Abortion Missed, Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Maternal Drugs Affecting Foetus
33 Years F 4167205 4390345 08/01/2003 06/30/2004 Trevilor MD Depression Caesarean Section, Complications of Maternal Exposure To Therapeutic Drugs, Premature Rupture of Membranes
33 Years F 5669223 4474083 01/01/2004 10/08/2004 Effexor XR PH Drug Exposure During Pregnancy, Hepatic Failure, Pre-Eclampsia, Pregnancy Induced Hypertension
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
33 Years F 5707050 4537558 01/01/2003 12/16/2004 Effexor XR Depression Anxiety, Chest Pain, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Abnormal, Palpitations, Paraesthesia, Platelet Count Decreased, Sensory Disturbance, Uterine Disorder, Uterine Haemorrhage
33 Years F 5836880 4707239 07/01/2004 07/01/2005 Effexor Depression, Schizoaffective Disorder Blood Pressure Increased, Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes
33 Years F 5836880 4711159 07/01/2004 07/08/2005 Effexor XR OT Depression, Schizoaffective Disorder Blood Pressure Increased, Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes
33 Years F 5836880 4714269 07/01/2004 07/12/2005 Effexor XR Depression, Schizoaffective Disorder Blood Pressure Increased, Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes
33 Years F 5836880 4716659 01/01/2004 07/14/2005 Effexor XR OT Depression, Schizoaffective Disorder Blood Pressure Increased, Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes
33 Years F 5836880 4816433 01/01/2004 10/28/2005 Effexor XR OT Depression, Schizoaffective Disorder Blood Pressure Increased, Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes
33 Years F 5953795 5154490 01/01/2005 11/14/2006 Effexor Bipolar Disorder Abortion Spontaneous, Drug Exposure During Pregnancy, Intra-Uterine Death
33 Years F 5965761 4881298 01/01/2005 01/12/2006 Effexor XR MD Depression, Post-Traumatic Stress Disorder Anger, Depression, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Flashback, Impaired Work Ability, Irritability, Mood Swings, Nightmare, Panic Attack
33 Years F 5965761 4914377 01/01/2005 02/13/2006 Effexor XR MD Post-Traumatic Stress Disorder Agitation, Anger, Complication of Pregnancy, Depression, Drug Abuser, Drug Exposure During Pregnancy, Fatigue, Flashback, Gestational Diabetes, Impaired Work Ability, Irritability, Malaise, Mood Swings, Nightmare, Panic Attack, Premature Rupture of Membranes, Psychomotor Skills Impaired
34 Years F 4068419 4269834 01/01/2003 01/12/2004 Effexor XR Bipolar Disorder, Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Medication Error, Suicide Attempt
34 Years F 5728272 4562452 01/01/2004 01/21/2005 Effexor Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Vaginal Haemorrhage
34 Years F 5728272 4587959 01/01/2004 02/15/2005 Effexor OT Depression Abortion Spontaneous, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
34 Years M 5895974 4787309 03/01/2004 10/03/2005 Effexor XR Depression, Mood Altered Abortion Spontaneous, Drug Dose Omission, Drug Withdrawal Syndrome, Ejaculation Delayed, Erectile Dysfunction, Somnolence, Transmission of Drug Via Semen
34 Years F 5951398 4855517 12/01/2004 12/14/2005 Effexor XR MD Depression Breech Presentation, Caesarean Section, Drug Dependence, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Failed Trial of Labour
35 Years F 4224168 4462878 01/01/2004 09/27/2004 Effexor OT Depression Caesarean Section, Drug Exposure During Pregnancy, Drug Ineffective, Retroplacental Haematoma, Vomiting
35 Years F 4224168 4464534 01/01/2004 09/29/2004 Effexor Depression Caesarean Section, Drug Exposure During Pregnancy, Drug Ineffective, Retroplacental Haematoma, Vomiting
35 Years F 5948777 4853104 01/01/2003 12/12/2005 Effexor Depression Alpha 1 Foetoprotein Decreased, Drug Exposure During Pregnancy, Intra-Uterine Death, Oligohydramnios, Ultrasound Antenatal Screen Abnormal
35 Years F 5951096 4854941 01/13/2005 12/13/2005 Effexor XR Anxiety, Depression Drug Exposure During Pregnancy, Premature Labour
35 Years F 6214320 5196106 11/01/2006 12/26/2006 Effexor XR Depression Drug Exposure During Pregnancy, Drug Interaction
35 Years F 6680088 5786968 03/16/2008 06/25/2008 Effexor MD Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Uterine Disorder
36 Years F 3776200 5063094 06/20/2001 07/24/2006 Effexor Drug Exposure Before Pregnancy, Homicide, Incorrect Dose Administered
36 Years F 5753994 4596034 07/01/2004 02/25/2005 Effexor Depression Abortion Induced, Drug Exposure During Pregnancy, Encephalocele, Foetal Disorder
36 Years F 6319535 5333737 12/01/2006 05/24/2007 Venlafaxine OT Depression Blood Cholesterol Increased, Drug Exposure During Pregnancy, Pre-Eclampsia
37 Years F 6328690 5341754 04/20/2007 05/29/2007 04/20/2007 Effexor XR CN Bipolar I Disorder Abdominal Pain Lower, Abortion Spontaneous, Anxiety, Breast Enlargement, Breast Tenderness, Cardiac Arrest, Cervix Disorder, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Foetal Disorder, Insomnia, Intra-Uterine Death, Nightmare, Palpitations, Paraesthesia, Post Procedural Haemorrhage, Vaginal Haemorrhage, Vomiting In Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
37 Years F 6334110 5358469 07/01/2006 06/15/2007 Effexor MD Drug Exposure During Pregnancy, Obstetrical Pulmonary Embolism, Pre-Eclampsia, Uterine Haemorrhage
37 Years F 6334110 5632838 07/01/2006 02/21/2008 Effexor OT Depression Drug Exposure During Pregnancy, Obstetrical Pulmonary Embolism, Pre-Eclampsia, Uterine Haemorrhage
37 Years F 6334110 5642788 07/01/2006 02/28/2008 Effexor OT Depression Drug Exposure During Pregnancy, Obstetrical Pulmonary Embolism, Pre-Eclampsia, Uterine Haemorrhage
37 Years F 6354366 5383965 09/29/2006 07/11/2007 Effexor MD Depression Arrested Labour, Delayed Delivery, Drug Exposure During Pregnancy
37 Years F 6103174 5067560 05/01/2005 07/27/2006 Effexor XR Generalised Anxiety Disorder, Panic Attack Abortion Spontaneous, Constipation, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Menstrual Disorder, Metrorrhagia, Nausea, Paraesthesia, Tremor, Vertigo, Vomiting
37 Years F 6103174 5084823 05/01/2005 08/15/2006 Effexor XR Generalised Anxiety Disorder, Panic Attack Constipation, Drug Withdrawal Syndrome, Menstrual Disorder, Metrorrhagia, Nausea, Paraesthesia, Tremor, Vertigo, Vomiting
37 Years F 6103174 5084826 05/01/2005 08/15/2006 Effexor XR Generalised Anxiety Disorder, Panic Attack Constipation, Drug Withdrawal Syndrome, Menstrual Disorder, Metrorrhagia, Nausea, Paraesthesia, Tremor, Vertigo, Vomiting
37 Years F 6141526 5113515 11/01/2005 09/20/2006 Venlafaxine Depression Caesarean Section, Drug Exposure During Pregnancy, Haemorrhage, Placenta Praevia, Premature Baby, Premature Separation of Placenta
37 Years F 6612461 5702336 03/01/2007 04/11/2008 Venlafaxine MD Depression Dehydration, Dizziness, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Hyperhidrosis, Insomnia, Intra-Uterine Death, Nausea, Palpitations
37 Years F 6634695 5730774 02/01/2006 05/07/2008 Venlafaxine OT Depression Drug Exposure During Pregnancy, Polyhydramnios, Unstable Foetal Lie
38 Years F 5905652 4801085 01/01/2005 10/11/2005 Effexor Abortion Spontaneous, Drug Exposure During Pregnancy
38 Years F 5941024 4893286 08/01/2005 01/24/2006 Effexor XR OT Depression Abortion Spontaneous, Depression, Disease Recurrence, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Intra-Uterine Death, Therapy Non-Responder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
38 Years F 5943011 4848111 03/01/2005 12/06/2005 Effexor Bipolar Disorder Drug Exposure During Pregnancy, Uterine Leiomyoma
38 Years F 5943011 4848584 03/01/2005 12/06/2005 Effexor Bipolar Disorder Drug Exposure During Pregnancy, Premature Labour, Uterine Leiomyoma
38 Years F 6050298 5000147 04/01/2003 05/10/2006 Effexor XR Depression Abortion Spontaneous, Drug Exposure During Pregnancy
38 Years F 6050298 5133112 04/01/2003 10/18/2006 Effexor XR Depression Abortion Spontaneous, Drug Exposure During Pregnancy
38 Years F 6210058 5191358 01/01/2006 12/19/2006 Effexor Abortion Spontaneous, Drug Exposure During Pregnancy
38 Years F 6284954 5281633 02/01/2006 12/15/2006 Effexor XR MD Panic Attack Abortion Spontaneous, Drug Exposure During Pregnancy
39 Years F 4159211 4380978 03/10/2004 06/14/2004 Effexor Depression Drug Exposure During Pregnancy, Ectopic Pregnancy
39 Years F 6051318 5002575 01/01/2004 05/10/2006 Effexor XR MD Depression Abortion Spontaneous, Drug Exposure During Pregnancy
39 Years F 6051318 5134048 01/01/2004 10/19/2006 Effexor XR Depression Abortion Spontaneous, Drug Exposure Before Pregnancy
39 Years F 6075239 5063675 07/24/2006 Effexor XR Major Depression Abdominal Distension, Drug Exposure During Pregnancy, Irritability, Nausea, Oligohydramnios, Oral Intake Reduced
40 Years F 5664690 4465450 03/26/2004 09/30/2004 Effexor XR Depression Abortion Spontaneous, Chorioamnionitis, Condition Aggravated, Depression, Drug Exposure During Pregnancy, Retroplacental Haematoma
40 Years F 5731257 4650901 11/01/2004 04/29/2005 Effexor Abortion Spontaneous, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
40 Years F 5731257 4652704 11/01/2004 05/02/2005 Effexor Abortion Spontaneous, Drug Exposure During Pregnancy
40 Years F 6058570 5010883 01/01/2005 05/23/2006 Effexor XR MD Breech Delivery, Complication of Delivery, Drug Exposure During Pregnancy
40 Years F 6058570 5027366 01/01/2005 06/09/2006 Effexor XR MD Beta Haemolytic Streptococcal Infection, Breech Delivery, Caesarean Section, Complication of Delivery, Drug Exposure During Pregnancy
41 Years F 5848141 4720889 07/20/2005 Effexor XR OT Depression Abortion Spontaneous, Drug Exposure During Pregnancy
41 Years F 5848141 4746677 08/15/2005 Effexor XR OT Depression Abortion Spontaneous, Drug Exposure During Pregnancy
41 Years F 6030019 4970756 01/01/2005 04/06/2006 Effexor Bipolar I Disorder Caesarean Section, Drug Exposure During Pregnancy, Failed Induction of Labour
41 Years F 6047147 4994192 02/28/2005 05/03/2006 Effexor XR OT Depression Drug Exposure During Pregnancy, Premature Baby, Retained Placenta or Membranes
43 Years F 6569068 5636032 01/14/2008 02/20/2008 Effexor XR PH Depression Abortion Spontaneous, Drug Exposure During Pregnancy
43 Years F 5706406 4537481 01/01/2003 12/16/2004 Effexor XR Depression Abortion Spontaneous, Drug Exposure During Pregnancy
43 Years F 5722468 4555414 01/18/2005 Effexor XR OT Premenstrual Syndrome Abortion Spontaneous, Altered Visual Depth Perception, Anger, Arthralgia, Crying, Depression, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome, Fear, Feeling Abnormal, Hypoaesthesia, Lethargy, Loss of Libido, Mood Swings, Myalgia, Nerve Injury, Nervous System Disorder, Nightmare, Panic Attack, Road Traffic Accident, Weight Increased
47 Years F 5775942 4628180 10/26/2004 04/01/2005 Effexor Aggression, Agitation, Depressive Delusion, Hypothyroidism, Postpartum Hypopituitarism
96 Males 254 Females 432 Cases (Gender was not reported for 82 Cases) 647 Individual Safety Reports

This is a list of all Primary Suspect Drugs reported in the Detail Table

Efectin (venlafaxine), Effexor (venlafaxine), Effexor XR (venlafaxine), Trevilor (venlafaxine), Venlafaxine (venlafaxine)

These are the Adverse Reactions culled from the Individual Safety Reports in the Detail Table

Abdominal Distension, Abdominal Pain, Abdominal Pain Lower, Abdominal Pain Upper, Abnormal Behaviour, Abnormal Dreams, Abnormal Labour, Abnormal Palmar/Plantar Creases, Abortion Early, Abortion Induced, Abortion Missed, Abortion Spontaneous, Abortion Spontaneous Incomplete, Acoustic Stimulation Tests Abnormal, Activities of Daily Living Impaired, Acute Fatty Liver of Pregnancy, Acute Respiratory Distress Syndrome, Adactyly, Adenomatous Polyposis Coli, Adnexa Uteri Mass, Aggression, Agitation, Agitation Neonatal, Alanine Aminotransferase Increased, Alpha 1 Foetoprotein Decreased, Altered Visual Depth Perception, Anaemia Neonatal, Anencephaly, Anger, Angiopathy, Ankyloglossia Congenital, Anomaly of External Ear Congenital, Anorectal Agenesis, Anorectal Disorder, Anorexia, Anotia, Antepartum Haemorrhage, Antidepressant Drug Clearance Increased, Anxiety, Aorta Hypoplasia, Apgar Score Abnormal, Apgar Score Low, Areflexia, Arrested Labour, Arthralgia, Arthropathy, Artificial Rupture of Membranes, Aspartate Aminotransferase Increased, Aspiration, Asthenia, Asthenopia, Ataxia, Atrial Septal Defect, Attention Deficit Hyperactivity Disorder, Autism, Bacteria Stool Identified, Bacterial Infection, Base Excess Negative, Beta Haemolytic Streptococcal Infection, Bipolar II Disorder, Birth Trauma, Blindness Congenital, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Blood Calcium Abnormal, Blood Calcium Increased, Blood Cholesterol Increased, Blood Culture Positive, Blood Glucose Decreased, Blood Lactic Acid Increased, Blood PH Decreased, Blood Pressure Decreased, Blood Pressure Diastolic Increased, Blood Pressure Increased, Body Temperature Decreased, Bone Marrow Depression, Bradycardia Foetal, Bradycardia Neonatal, Brain Damage, Brain Herniation, Brain Malformation, Breast Discharge, Breast Enlargement, Breast Tenderness, Breath Holding, Breech Delivery, Breech Presentation, Brief Psychotic Disorder With Postpartum Onset, Bronchitis, Bronchomalacia, Caesarean Section, Cardiac Arrest, Cardiac Arrest Neonatal, Cardiac Murmur, Cardiac Septal Defect, Cardiomyopathy Neonatal, Cardio-Respiratory Arrest, Cardio-Respiratory Arrest Neonatal, Cardio-Respiratory Distress, Catheter Related Complication, Central Nervous System Function Test Abnormal, Cerebral Atrophy Congenital, Cerebral Cyst, Cerebral Disorder, Cerebral Haemorrhage, Cerebral Haemorrhage Foetal, Cerebral Haemorrhage Neonatal, Cerebral Palsy, Cerebral Ventricle Dilatation, Cerebrovascular Accident, Cervical Incompetence, Cervix Disorder, Cervix Dystocia, Chest Pain, Chest X-Ray Abnormal, Child Abuse, Childhood Disintegrative Disorder, Chondrodystrophy, Chorioamnionitis, Chromosome Abnormality, Cleft Lip and Palate, Cleft Palate, Coarctation of the Aorta, Collapse of Lung, Coma, Communication Disorder, Complication of Delivery, Complication of Pregnancy, Complications of Maternal Exposure To Therapeutic Drugs, Condition Aggravated, Confusional State, Congenital Anomalies of Ear Ossicles, Congenital Anomaly, Congenital Bladder Anomaly, Congenital Brain Damage, Congenital Cardiac Septal Defect, Congenital Central Nervous System Anomaly, Congenital Cerebellar Agenesis, Congenital Cerebral Cyst, Congenital Cystic Kidney Disease, Congenital Diaphragmatic Anomaly, Congenital Diaphragmatic Hernia, Congenital Ectopic Bladder, Congenital Floppy Infant, Congenital Foot Malformation, Congenital Genital Malformation, Congenital Hair Disorder, Congenital Hand Malformation, Congenital Heart Valve Disorder, Congenital Hydronephrosis, Congenital Hypothyroidism, Congenital Infection, Congenital Intestinal Malformation, Congenital Jaw Malformation, Congenital Mitral Valve Incompetence, Congenital Musculoskeletal Anomaly, Congenital Myopathy, Congenital Nail Disorder, Congenital Neurological Disorder, Congenital Nose Malformation, Congenital Oral Malformation, Congenital Pharyngeal Anomaly, Congenital Pulmonary Hypertension, Congenital Pulmonary Valve Disorder, Congenital Renal Cyst, Congenital Tongue Anomaly, Congenital Torticollis, Congenital Tricuspid Valve Atresia, Congenital Ureteric Anomaly, Congenital Ventricular Septal Defect, Constipation, Convulsion, Convulsion Neonatal, Coordination Abnormal, Crying, CSF White Blood Cell Count Positive, Cyanosis Neonatal, Death Neonatal, Dehydration, Delayed Delivery, Delayed Fontanelle Closure, Delirium, Dependence, Depressed Level of Consciousness, Depression, Depressive Delusion, Developmental Delay, Dextrocardia, Diaphragmatic Disorder, Diarrhoea, Diarrhoea Neonatal, Diplopia, Disease Recurrence, Dissociation, Disturbance In Attention, Disturbance In Social Behaviour, Dizziness, Drug Abuser, Drug Clearance Increased, Drug Dependence, Drug Dose Omission, Drug Effect Decreased, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Drug Interaction, Drug Screen Positive, Drug Toxicity, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Dry Mouth, Dysgeusia, Dyskinesia, Dyskinesia Neonatal, Dysmorphism, Dyspepsia, Dysphagia, Dyspnoea, Dystrophia Myotonica, Ear Infection, Ear Malformation, Ear Pain, Eating Disorder, Ebstein's Anomaly, Eclampsia, Ectopic Pregnancy, Ejaculation Delayed, Electrocardiogram T Wave Abnormal, Electroconvulsive Therapy, Electroencephalogram Abnormal, Emotional Disorder, Encephalocele, Encephalopathy Neonatal, Epilepsy, Epilepsy Congenital, Erectile Dysfunction, Erythrosis, Excitability, Exomphalos, External Auditory Canal Atresia, Extrapyramidal Disorder, Eye Disorder, Eye Infection, Eye Movement Disorder, Eye Oedema, Facial Dysmorphism, Facial Paresis, Facioscapulohumeral Muscular Dystrophy, Faecaloma, Failed Induction of Labour, Failed Trial of Labour, Failure To Thrive, Fallot's Tetralogy, False Labour, Fatigue, Fear, Febrile Convulsion, Feeding Disorder, Feeding Disorder Neonatal, Feeding Disorder of Infancy or Early Childhood, Feeding Problem In Child, Feeding Problem In Newborn, Feeling Abnormal, Feeling Hot and Cold, Feeling Jittery, Feeling of Despair, Female Sexual Dysfunction, Fever Neonatal, Finger Deformity, Finger Hypoplasia, Flashback, Flat Feet, Floppy Infant, Focal Segmental Glomerulosclerosis, Foetal Arrhythmia, Foetal Cardiac Disorder, Foetal Cystic Hygroma, Foetal Damage, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Heart Rate Abnormal, Foetal Heart Rate Decreased, Foetal Heart Rate Disorder, Foetal Heart Rate Increased, Foetal Macrosomia, Foetal Malformation, Foetal Movements Decreased, Forceps Delivery, Formication, Gait Disturbance, Galactostasis, Gastrooesophageal Reflux Disease, Gastroschisis, Gene Mutation, General Physical Health Deterioration, Gestational Diabetes, Grand Mal Convulsion, Growth Retardation, Grunting, Haemangioma, Haemangioma Congenital, Haemangioma of Skin, Haematocrit Decreased, Haemoglobin Decreased, Haemorrhage, Haemorrhagic Diathesis, Haemorrhagic Disorder, Hallucination, Hand Deformity, Head Deformity, Head Lag, Headache, Heart Disease Congenital, Heart Rate Abnormal, Heart Rate Increased, Hemiparesis, Hepatic Enzyme Increased, Hepatic Failure, Hepatic Steatosis, Hernia, Hernia Congenital, Herpes Simplex, High Arched Palate, High Risk Pregnancy, High-Pitched Crying, Hip Dysplasia, Homicide, Horner's Syndrome, Hospitalisation, Hunger, Hydrocele, Hydrocephalus, Hydronephrosis, Hyperacusis, Hyperaesthesia, Hyperbilirubinaemia Neonatal, Hyperemesis Gravidarum, Hyperexplexia, Hyperhidrosis, Hyperphagia, Hyperreflexia, Hypertension, Hypertension Neonatal, Hypertonia, Hypertonia Neonatal, Hypoaesthesia, Hypochondroplasia, Hypoglycaemia Neonatal, Hypokalaemia, Hypokinesia, Hypokinesia Neonatal, Hyponatraemia, Hypoperfusion, Hypoplastic Left Heart Syndrome, Hyporeflexia, Hypospadias, Hypotension, Hypothermia Neonatal, Hypothyroidism, Hypotonia Neonatal, Hypotonic-Hyporesponsive Episode, Idiopathic Thrombocytopenic Purpura, Immature Respiratory System, Impaired Driving Ability, Impaired Work Ability, Inborn Error of Metabolism, Incorrect Dose Administered, Induced Labour, Infantile Apnoeic Attack, Infantile Asthma, Infection, Infertility, Infertility Female, Influenza Like Illness, Infrequent Bowel Movements, Injury Asphyxiation, Insomnia, Intentional Misuse, Intentional Overdose, Intestinal Perforation, Intestinal Polyp, Intra-Uterine Death, Iron Deficiency Anaemia, Irritability, Ischaemia, Jaundice Neonatal, Joint Hyperextension, Karyotype Analysis Abnormal, Kidney Malformation, Kidney Small, Klebsiella Infection, Kyphosis Congenital, Laboratory Test Abnormal, Labour Complication, Lactation Disorder, Large for Dates Baby, Laryngomalacia, Lethargy, Life Support, Limb Hypoplasia Congenital, Limb Malformation, Limb Reduction Defect, Liver Function Test Abnormal, Localised Oedema, Loss of Consciousness, Loss of Libido, Low Set Ears, Lymphocytic Leukaemia, Macrocephaly, Malaise, Malnutrition, Mandibulofacial Dysostosis, Masked Facies, Mastication Disorder, Maternal Distress During Labour, Maternal Drugs Affecting Foetus, Meconium In Amniotic Fluid, Medication Error, Memory Impairment, Meningocele, Meningomyelocele, Menstrual Disorder, Mental Disorder, Metrorrhagia, Microcephaly, Microglossia, Micrognathia, Microphthalmos, Microtia, Migraine, Moaning, Mood Altered, Mood Swings, Motor Dysfunction, Movement Disorder, Multi-Organ Failure, Multiple Congenital Abnormalities, Multiple Drug Overdose Intentional, Multiple Fractures, Multiple Injuries, Muscle Contractions Involuntary, Muscle Rigidity, Muscle Spasms, Muscle Twitching, Muscular Dystrophy, Muscular Weakness, Musculoskeletal Stiffness, Myalgia, Myocardial Infarction, Myoclonus, Nasal Flaring, Nausea, Necrosis Ischaemic, Necrotising Enterocolitis Neonatal, Neonatal Anoxia, Neonatal Apnoeic Attack, Neonatal Aspiration, Neonatal Candida Infection, Neonatal Disorder, Neonatal Hepatomegaly, Neonatal Hyponatraemia, Neonatal Hypotension, Neonatal Hypoxia, Neonatal Infection, Neonatal Multi-Organ Failure, Neonatal Pneumonia, Neonatal Respiratory Arrest, Neonatal Respiratory Depression, Neonatal Respiratory Distress Syndrome, Neonatal Respiratory Failure, Neonatal Tachycardia, Neonatal Tachypnoea, Nerve Injury, Nervous System Disorder, Nervousness, Neutropenia Neonatal, Night Sweats, Nightmare, Nipple Pain, No Therapeutic Response, Obsessive-Compulsive Disorder, Obstetrical Pulmonary Embolism, Oedema, Oedema Peripheral, Oligohydramnios, Oral Candidiasis, Oral Intake Reduced, Osteogenesis Imperfecta, Osteopenia, Otitis Externa, Ovarian Adenoma, Ovarian Cyst, Overdose, Oxygen Saturation Decreased, Pain, Palatal Disorder, Pallor, Palpitations, Panic Attack, Paraesthesia, Paraesthesia Oral, Patent Ductus Arteriosus, Pathological Fracture, Pelvic Pain, Peripheral Oedema Neonatal, Persistent Left Superior Vena Cava, PH Body Fluid Abnormal, Phalangeal Hypoplasia, Photophobia, Placenta Praevia, Placenta Praevia Haemorrhage, Placental Chorioangioma, Placental Disorder, Placental Infarction, Placental Insufficiency, Placental Necrosis, Platelet Count Decreased, Pneumonia Aspiration, Pneumothorax, Poland's Syndrome, Polycythaemia, Polydactyly, Polyhydramnios, Polytraumatism, Poor Sucking Reflex, Poor Weight Gain Neonatal, Post Procedural Haemorrhage, Postpartum Haemorrhage, Postpartum Hypopituitarism, Potter's Syndrome, Pre-Eclampsia, Pregnancy Induced Hypertension, Premature Baby, Premature Labour, Premature Rupture of Membranes, Premature Separation of Placenta, Prolonged Labour, Prolonged Pregnancy, Proteinuria, Psychomotor Hyperactivity, Psychomotor Retardation, Psychomotor Skills Impaired, Psychotic Disorder, Pulmonary Artery Atresia, Pulmonary Artery Stenosis Congenital, Pulmonary Malformation, Pulmonary Oedema, Pulmonary Oedema Neonatal, Pulmonary Valve Stenosis Congenital, Pyelectasia, Pyelonephritis, Pyrexia, Radiation Exposure During Pregnancy, Rash, Rash Pruritic, Rebound Effect, Red Blood Cells CSF Positive, Reflexes Abnormal, Regurgitation of Food, Renal Agenesis, Renal Aplasia, Renal Impairment, Respiration Abnormal, Respiratory Depression, Respiratory Disorder, Respiratory Disorder Neonatal, Respiratory Failure, Respiratory Rate Decreased, Respiratory Rate Increased, Respiratory Syncytial Virus Infection, Restlessness, Resuscitation, Retained Placenta or Membranes, Retroplacental Haematoma, Rib Deformity, Rib Fracture, Road Traffic Accident, Sciatica, Screaming, Sedation, Self Mutilation, Sensation of Foreign Body, Sensory Disturbance, Sensory Integrative Dysfunction, Sepsis Neonatal, Shoulder Dystocia, Sinus Tachycardia, Sinusitis, Skin Disorder, Skin Hypoplasia, Skin Infection, Skin Lesion, Skull Fracture, Skull Malformation, Sleep Apnoea Syndrome, Sleep Disorder, Sleep Terror, Small for Dates Baby, Snoring, Social Avoidant Behaviour, Somnolence, Somnolence Neonatal, Speech Disorder, Speech Disorder Developmental, Spina Bifida, Staphylococcal Sepsis, Status Epilepticus, Stillbirth, Stress, Subarachnoid Haemorrhage Neonatal, Subdural Effusion, Sudden Infant Death Syndrome, Suicidal Ideation, Suicide Attempt, Syndactyly, Tachycardia, Tachycardia Foetal, Talipes, Tearfulness, Tension, Testicular Torsion, Therapeutic Response Unexpected, Therapy Non-Responder, Thrombocytopenia Neonatal, Thyroid Disorder, Tinea Pedis, Tinnitus, Tongue Disorder, Tracheomalacia, Transient Tachypnoea of the Newborn, Transmission of Drug Via Semen, Transposition of the Great Vessels, Treatment Noncompliance, Tremor, Tremor Neonatal, Trismus, Trisomy 18, Trisomy 21, Ultrasound Antenatal Screen Abnormal, Ultrasound Skull Abnormal, Umbilical Cord Abnormality, Umbilical Cord Around Neck, Underweight, Unevaluable Event, Unresponsive To Stimuli, Unstable Foetal Lie, Upper Limb Fracture, Upper Respiratory Tract Infection, Ureteric Dilatation, Urinary Retention, Urinary Tract Infection, Uterine Atony, Uterine Contractions During Pregnancy, Uterine Disorder, Uterine Haemorrhage, Uterine Hypotonus, Uterine Infection, Uterine Injury, Uterine Leiomyoma, Uterine Rupture, Vaginal Haemorrhage, Ventricular Internal Diameter Abnormal, Ventricular Septal Defect, Vertigo, Victim of Child Abuse, Vision Blurred, Visual Disturbance, Vomiting, Vomiting In Pregnancy, Vomiting Neonatal, Vomiting Projectile, Vulvovaginal Mycotic Infection, Weight Decrease Neonatal, Weight Decreased, Weight Increased, White Blood Cell Count Decreased

Definitions
  
Abortion Spontaneous Miscarriage means loss of an embryo or fetus before the 20th week of pregnancy. Most miscarriages occur during the first 14 weeks of pregnancy. The medical term for miscarriage is spontaneous abortion.
  
Anomaly Something that deviates from what is standard, normal or expected (Congenital Anomaly, Congenital Bladder Anomaly, Congenital Central Nervous System Anomaly, Congenital Musculoskeletal Anomaly, Congenital Tongue Anomaly).
  
Apgar Score A system of assessing the general physical condition of a newborn infant based on a rating of 0, 1, or 2 for five criteria: heart rate, respiration, muscle tone, skin color, and response to stimuli. The five scores are added together, with a perfect score being 10. (After Virginia Apgar (1909–1974), American physician)
  
Asthenia Loss or lack of bodily strength; weakness; debility.
  
Bradycardia Slowness of heart rate.
  
Cerebral Atrophy Congenital Cerebral atrophy is a common feature of many of the diseases that affect the brain. Atrophy of any tissue means loss of cells. In brain tissue, atrophy describes a loss of neurons and the connections between them. Atrophy can be generalized, which means that all of the brain has shrunk; or it can be focal, affecting only a limited area of the brain and resulting in a decrease of the functions that area of the brain controls. If the cerebral hemispheres (the two lobes of the brain that form the cerebrum) are affected, conscious thought and voluntary processes may be impaired.
  
Cerebral Cyst The brain contains pockets or spaces called ventricles with a spongy layer of cells and blood vessels called the choroid plexus. This is in the middle of the fetal brain. The choroid plexus has the important function of producing a fluid called cerebrospinal fluid. The fluid produced by the cells of the choroid plexus fills the ventricles and then flows around the brain and the spinal cord to provide a cushion of fluid around these structures.
Choroid plexus cysts (CPCs) occur within this structure and come from fluid trapped within this spongy layer of cells, much like a soap bubble or a blister. CPCs are often called "soft signs" or fetal ultrasound "markers" because some studies have found a weak association between CPCs and fetal chromosome abnormalities.
  
Cerebral Palsy Cerebral palsy (CP) is the term used for a group of nonprogressive disorders of movement and posture caused by abnormal development of, or damage to, motor control centers of the brain. CP is caused by events before, during, or after birth.
Voluntary movement (walking, grasping, chewing, etc.) is primarily accomplished using muscles that are attached to bones, known as the skeletal muscles. Control of the skeletal muscles originates in the cerebral cortex, the largest portion of the brain. Palsy means paralysis, but may also be used to describe uncontrolled muscle movement. Therefore, cerebral palsy encompasses any disorder of abnormal movement and paralysis caused by abnormal function of the cerebral cortex.
  
Cervical Incompetence A condition in which a pregnant woman's cervix begins to dilate (widen) and efface (thin) before her pregnancy has reached term. Cervical incompetence is a cause of miscarriage and preterm birth in the second and third trimesters.
  
Chondrodystrophy A disturbance that affects the development of the cartilage of the long bones ... resulting in arrested growth of the long bones.
  
Chromosome Abnormality Chromosome abnormalities usually occur when there is an error in cell division.
  
Cleft Palate A congenital fissure in the roof of the mouth, resulting from incomplete fusion of the palate during embryonic development.
  
Coarctation of the Aorta A defect that develops in the fetus in which there is a narrowing of the aortic arch, the main blood artery that delivers blood from the left ventricle of the heart to the rest of the body.
  
Congenital A physical abnormality that is present at birth.
  
Congenital Anomaly Medical term for a birth defect which is a physical abnormality that is present at birth; they are also called congenital abnormalities. When multiple birth defects occur together and have a similar cause, they are called syndromes (e.g. Drug Withdrawal Syndrome Neonatal).
  
Cyanosis Neonatal Cyanosis is a physical sign causing bluish discoloration of the skin and mucous membranes. Cyanosis is caused by a lack of oxygen in the blood. It is seen in infants at birth as a result of heart defects, respiratory distress syndrome, or lung and breathing problems.
  
Drug Withdrawal Syndrome Neonatal Refers to the characteristic signs and symptoms that appear when a drug that causes physical dependence is regularly used for a long time and then suddenly discontinued or decreased in dosage. Also known as abstinence syndrome. A group of unpleasant symptoms produced by the abrupt termination of drug taking. These symptoms, commonly called withdrawal symptoms, include anxiety, muscle weakness, nausea, vomiting, tremor, and a rapid heart beat.
  
Dyskinesia An impairment in the ability to control movements, characterized by spasmodic or repetitive motions or lack of coordination.
  
Dysmorphism An anatomical malformation.
  
Dyspnoea Difficulty in breathing, often associated with lung or heart disease and resulting in shortness of breath. Also called air hunger.
  
Ectopic Pregnancy In an ectopic pregnancy, the fertilized egg implants in a location outside the uterus and tries to develop there. The word ectopic means "in an abnormal place or position." The most common site is the fallopian tube, the tube that normally carries eggs from the ovary to the uterus. However, ectopic pregnancy can also occur in the ovary, the abdomen, and the cervical canal (the opening from the uterus to the vaginal canal). The phrases tubal pregnancy, ovarian pregnancy, cervical pregnancy, and abdominal pregnancy refer to the specific area of an ectopic pregnancy.
  
Encephalocele Hernia (bulge or protrusion) of the brain through a congenital or traumatic opening in the cranium.
  
Feeding Disorder Neonatal An inability to eat sufficiently, a continual need to consume abnormal items of food or substances lacking nutrients, or frequent vomiting episodes without any indications of a gastrointestinal infection.
  
Gastrooesophageal Reflux Disease A chronic condition (GERD) in which the lower esophageal sphincter allows gastric acids to reflux into the esophagus, causing heartburn, acid indigestion, and possible injury to the esophageal lining.
  
Gestational Diabetes Gestational diabetes is a condition that occurs during pregnancy. Like other forms of diabetes, gestational diabetes involves a defect in the way the body processes and uses sugars (glucose) in the diet.
In diabetes, blood levels of glucose remain abnormally high. In many forms of diabetes, this is because the pancreas does not produce enough insulin.
In gestational diabetes, the pancreas is not at fault. Instead, the problem is in the placenta. During pregnancy, the placenta provides the baby with nourishment. It also produces a number of hormones that interfere with the body's usual response to insulin. This condition is referred to as "insulin resistance." Most pregnant women do not suffer from gestational diabetes, because the pancreas works to produce extra quantities of insulin in order to compensate for insulin resistance. However, when a woman's pancreas cannot produce enough extra insulin, blood levels of glucose stay abnormally high, and the woman is considered to have gestational diabetes.
  
Hydronephrosis Hydronephrosis is the swelling of the kidneys when urine flow is obstructed in any of part of the urinary tract.
  
Hypertonia Extreme tension of the muscles or arteries.
  
Hypoglycemia The condition called hypoglycemia is literally translated as low blood sugar. Hypoglycemia occurs when blood sugar (or blood glucose) concentrations fall below a level necessary to properly support the body's need for energy and stability throughout its cells.
  
Hypoplastic Left Heart Syndrome (Also known as HLHS), is a rare congenital heart defect in which the left side of the heart is severely underdeveloped. In babies with HLHS, the aorta and left ventricle are very small, and the aortic and mitral valves are either too small to allow sufficient blood flow or are atretic (closed) altogether. As blood returns from the lungs to the left atrium, it must pass through an atrial septal defect to the right side of the heart.

In a healthy human, the left side of the heart receives oxygen-rich blood from the lungs and pumps it out to the rest of the body; with these structures underdeveloped, they cannot circulate blood to other organs, and the right ventricle must pump blood to both the lungs, as it would normally, and to the rest of the body, a situation which cannot be sustained for long.

In cases of HLHS, the right side of the heart often must pump blood to the body through a patent ductus arteriosus. As the ductus arteriosus closes a few days after birth, blood flow is severely restricted and eventually cut off, leading to dangerously low circulation and eventually to shock.
  
Hypotonia Decease of normal tonicity (normal firmness or functional readiness in body tissues or organs) or tension.
  
Infantile Apnoeic Attack Apnoea is a temporary absence or cessation of breathing.
  
Intestinal Perforation A hole in the intestinal wall.
  
Meningocele A moderately severe form of spina bifida in which the meninges protrude, causing a bulge under the skin.
  
Neonatal Respiratory Distress Syndrome Respiratory distress syndrome (RDS) of the newborn, also known as infant RDS, is an acute lung disease present at birth, which usually affects premature babies. Layers of tissue called hyaline membranes keep the oxygen that is breathed in from passing into the blood. The lungs are said to be "airless." Without treatment, the infant will die within a few days after birth.
  
Neonatal Tachypnoea Abnormally fast or deep respiration, which results in the loss of carbon dioxide from the blood, thereby causing a fall in blood pressure, tingling of the extremities, and sometimes fainting.
  
Oligohydramnios A deficiency in the amount of amniotic fluid.
  
Osteogenesis Imperfecta Osteogenesis imperfecta (OI) is a group of genetic diseases of collagen in which the bones are formed improperly, making them fragile and prone to breaking.
  
Palor Extreme or unnatural paleness.
  
Paraesthesia A skin sensation, such as burning, prickling, itching, or tingling, with no apparent physical cause.
  
Patent Ductus Arteriosus Patent ductus arteriosus (PDA) is a heart defect that occurs when the ductus arteriosus (the temporary fetal blood vessel that connects the aorta and the pulmonary artery) does not close at birth.
In some infants, the ductus arteriosus remains open (or patent) and the resulting heart defect is known as patent ductus arteriosus
  
Placenta Praevia Placenta previa is a condition that occurs during pregnancy when the placenta is abnormally placed, and partially or totally covers the cervix.
  
Polydactyly The condition of having supernumerary (more than 10) fingers or toes.
  
Pre-Eclampsia Abnormal state of pregnancy characterized by hypertension and fluid retention and albuminuria (the presence of albumin in the urine, sometimes indicating kidney disease); if untreated, can lead to eclampsia (coma and convulsions before, during, or shortly after childbirth, characterized by edema, hypertension, and proteinuria).
  
Spina Bifida A serious birth abnormality in which the spinal cord is malformed and lacks its usual protective skeletal and soft tissue coverings.
Spina bifida may appear in the body midline anywhere from the neck to the buttocks. In its most severe form, termed spinal rachischisis, the entire spinal canal is open, exposing the spinal cord and nerves. More commonly, the abnormality appears as a localized mass on the back that is covered by skin or by the meninges, the three-layered membrane that envelopes the spinal cord. Spina bifida is usually readily apparent at birth because of the malformation of the back and paralysis below the level of the abnormality.
  
Sudden Infant Death Syndrome Sudden infant death syndrome (SIDS) is the unexplained death without warning of an apparently healthy infant, usually during sleep.
  
Talipes Clubfoot is a condition in which one or both feet are twisted into an abnormal position at birth. The condition is also known as talipes.
  
Trisomy 21 Down syndrome is the most common cause of mental retardation and malformation in a newborn. It occurs because of the presence of an extra chromosome. The extra chromosome in Down syndrome is labeled number 21. For this reason, the existence of three such chromosomes is sometimes referred to as Trisomy 21.
  
Ventricular Septal Defect A ventricular septal defect is a hole in the wall of the heart (septum) that separates the left lower chamber (left ventricle) from the right lower chamber (right ventricle). The hole allows blood to flow from the left ventricle to the right ventricle instead of entering the aorta for distribution throughout the body. Ventricular septal defect is one of a group of heart problems found in newborn babies that are collectively called congenital heart disease.
  


Top 20 Adverse Reactions
Adverse Reaction Cases
Drug Exposure During Pregnancy 386
Premature Baby 61
Caesarean Section 55
Neonatal Disorder 51
Abortion Spontaneous 51
Drug Withdrawal Syndrome 36
Drug Withdrawal Syndrome Neonatal 28
Congenital Anomaly 28
Drug Exposure Via Breast Milk 19
Intra-Uterine Death 18
Foetal Growth Retardation 17
Hypotonia Neonatal 16
Feeding Disorder Neonatal 15
Convulsion Neonatal 15
Agitation Neonatal 15
Poor Sucking Reflex 13
Maternal Drugs Affecting Foetus 13
Pre-Eclampsia 12
Neonatal Respiratory Distress Syndrome 12
Premature Labour 11


MedWatch Reporting by Consumers

MedWatch is the Food and Drug Administration's program for reporting any undesirable experience associated with the use of a medical product. If you think you or someone in your family has experienced an adverse reaction from taking Venlafaxine and it has not been reported to the FDA, see this page for instructions on reporting the adverse event through your doctor or directly to the FDA using an online form.

A May 2006 USA Today article states that "drug companies are required to file any reports they have to the FDA, but consumers and doctors report such events on a voluntary basis. Studies suggest the FDA's Adverse Events Reporting System database captures only 1% to 10% of drug-induced side effects and deaths, "maybe even less than 1%," says clinical pharmacologist Alastair J.J. Wood, an associate dean at Vanderbilt Medical School in Nashville. So the real number of cases is almost certainly much higher".