Citalopram - 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
M 4035498 4332618 09/10/2003 03/30/2004 Cipramil OT Panic Attack Base Excess Negative, Blood Sodium Increased, Congenital Hand Malformation, Congenital Hydrocephalus, Feeding Problem In Newborn, Maternal Drugs Affecting Foetus, Protein Urine Present, Somnolence, Synovitis
M 4035498 5538375 09/10/2003 12/05/2007 Citalopram OT Panic Attack Congenital Hand Malformation, Congenital Hydrocephalus, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Protein Urine, Synovitis
M 4074663 4276834 10/01/2003 01/20/2004 Celexa MD Depression Cleft Lip, Cleft Palate, Drug Exposure During Pregnancy
M 4074663 4418049 10/01/2003 08/03/2004 Celexa MD Depression Cleft Lip and Palate, Drug Exposure During Pregnancy
M 4104623 4313000 01/26/2004 03/05/2004 Citalopram PH Depression Anaemia, Failure To Thrive, Hyponatraemia, Weight Decreased
4134792 4348466 04/23/2004 Celexa MD Depression Congenital Anomaly of Inner Ear, Deafness Congenital, Maternal Drugs Affecting Foetus, Spinal Disorder, Vascular Anomaly
M 4148585 4365944 03/25/2004 05/20/2004 Cipramil OT Drug Exposure During Pregnancy, Dyspnoea, Hypertonia Neonatal, Hypopnoea, Irritability, Neonatal Apnoeic Attack, Tremor Neonatal
M 4148585 4375833 03/25/2004 06/07/2004 Citalopram Apgar Score Low, Bloody Discharge, Drug Exposure During Pregnancy, Dyspnoea, Hypertonia Neonatal, Hypopnoea, Irritability, Neonatal Apnoeic Attack, Neonatal Disorder, Tremor Neonatal
M 4148585 4380002 03/25/2004 06/14/2004 Citalopram Apnoea, Dyspnoea, Hypopnoea, Hypotonia Neonatal, Irritability, Maternal Drugs Affecting Foetus, Respiratory Depth Decreased, Respiratory Rate Decreased, Tremor
M 4159057 4379305 05/01/2004 06/14/2004 Celexa MD Anxiety, Depression Clonus, Drug Exposure During Pregnancy, Fever Neonatal, Neonatal Disorder
M 4159057 4418051 05/09/2004 08/03/2004 Celexa MD Anxiety, Depression Clonus, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, Pyrexia, Tremor Neonatal
M 4160075 4381574 06/15/2004 Celexa MD Cleft Lip and Palate, Drug Exposure During Pregnancy, Failure To Thrive
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
4167393 4390710 06/30/2004 Celexa MD Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome
M 4182821 4411420 06/14/2004 07/27/2004 Citalopram PH Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dyskinesia, Hypotonia Neonatal, Neonatal Respiratory Distress Syndrome, Premature Baby
M 4182821 4432253 06/14/2004 08/20/2004 Citalopram OT Depression Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dyskinesia Neonatal, Hypotonia Neonatal, Neonatal Respiratory Distress Syndrome, Premature Baby
F 4195416 4427572 08/12/2004 Citalopram OT Abortion Spontaneous, Drug Exposure During Pregnancy, Stress Symptoms
M 4201505 4433463 08/04/2002 08/24/2004 Citalopram OT Panic Attack Breech Presentation, Diaphragmatic Hernia, Drug Exposure During Pregnancy, Intestinal Transposition
F 4213429 4449428 09/14/2004 Citalopram OT Depression Abortion Spontaneous, Drug Exposure During Pregnancy
4222980 4462053 05/12/2004 09/24/2004 Celexa MD Depression Amniocentesis Abnormal, Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy, Hip Dysplasia, Jaundice Neonatal, Neonatal Disorder
M 4222980 4612409 05/17/2004 03/16/2005 Celexa MD Depression Amniotic Fluid Volume Decreased, Breech Presentation, Caesarean Section, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Foetal Growth Retardation, Foetal Heart Rate Decreased, Hip Dysplasia, Jaundice Neonatal, Ultrasound Scan Abnormal
M 5654667 4480458 10/06/2004 10/18/2004 Celexa MD Anxiety Drug Exposure During Pregnancy, Hypertonia Neonatal, Hypotonia Neonatal, Neonatal Disorder, Posturing
5658869 4488269 10/01/2004 10/26/2004 Celexa MD Anxiety, Depression Drug Exposure During Pregnancy, Heart Disease Congenital, Limb Reduction Defect
5658869 4503284 10/01/2004 11/12/2004 Celexa MD Anxiety, Depression Caesarean Section, Drug Exposure During Pregnancy, Fallot's Tetralogy, Phalangeal Hypoplasia
M 5684788 4505389 08/16/2004 11/16/2004 Citalopram OT Caesarean Section, Drug Exposure During Pregnancy, Hypertonia Neonatal, Irritability, Musculoskeletal Stiffness, Neonatal Apnoeic Attack, Neonatal Disorder, Neonatal Respiratory Depression
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5692632 4518151 01/01/2002 11/30/2004 Celexa CN Drug Exposure During Pregnancy Blood Glucose Increased, Drug Exposure During Pregnancy, Pulmonary Oedema Neonatal
5754861 4596457 02/28/2005 Citalopram MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
5754907 4596452 02/28/2005 Citalopram MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
M 5768876 4616050 03/17/2003 03/21/2005 Cipramil OT Congenital Anomaly, Congenital Arterial Malformation, Drug Exposure During Pregnancy, Poland's Syndrome
5825657 4692102 06/14/2005 Celexa MD Congenital Anomaly, Drug Exposure During Pregnancy
M 5830991 4702790 05/31/2005 06/28/2005 Celexa MD Caesarean Section, Drug Exposure During Pregnancy, Feeding Problem In Newborn, Neonatal Hypoxia, Neonatal Tachypnoea
F 5839317 4710736 07/07/2005 Akarin PH Depression Premature Labour, Premature Rupture of Membranes
F 5839317 4746639 08/15/2005 Akarin OT Depression Drug Exposure During Pregnancy, Premature Labour, Premature Rupture of Membranes
M 5844795 4710733 04/05/2005 07/07/2005 Akarin PH Depression Apgar Score Low, Convulsion Neonatal, Dacryocystitis Infective, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Encephalitis Post Varicella, Hypocalcaemia, Neonatal Asphyxia, Neonatal Candida Infection, Ophthalmia Neonatorum, Oral Candidiasis, Premature Baby
M 5844795 4724861 04/05/2005 07/22/2005 Akarin OT Depression Acidosis, Convulsion Neonatal, Dacryocystitis Infective, Drug Exposure During Pregnancy, Encephalitis Post Varicella, Hypocalcaemia, Neonatal Asphyxia, Neonatal Disorder, Ophthalmia Neonatorum, Oral Candidiasis, Premature Baby, Psychomotor Hyperactivity
M 5844795 4746650 04/05/2005 08/15/2005 Akarin OT Depression Acidosis, Apgar Score Low, Convulsion Neonatal, Dacryocystitis Infective, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypocalcaemia, Hypotonia Neonatal, Neonatal Asphyxia, Ophthalmia Neonatorum, Oral Candidiasis, Premature Baby, Premature Rupture of Membranes
M 5866540 4747929 04/08/2005 08/16/2005 Celexa CN Depression Caesarean Section, Drug Exposure During Pregnancy, Immature Respiratory System, Infantile Colic, 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
M 5886706 4778180 05/02/2005 09/23/2005 Citalopram PH Depression, Post-Traumatic Stress Disorder Abortion Induced, Asthenia, Confusional State, Diarrhoea, Drug Ineffective, Headache, Influenza, Irritability, Malaise, Musculoskeletal Stiffness, Myalgia, Nausea, Neck Pain, Pain, Vomiting
F 5917502 4816729 10/24/2005 10/31/2005 Celexa OT Caesarean Section, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Feeling Jittery, Foetal Cardiac Disorder, Hypoglycaemia Neonatal, Neonatal Disorder
M 5918152 4811856 06/22/2004 10/26/2005 Celexa CN Panic Attack Blood Cortisol Decreased, Drug Exposure During Pregnancy, Premature Baby
M 5918152 4855131 06/22/2004 12/14/2005 Celexa MD Panic Attack Blood Cortisol Decreased, Drug Exposure During Pregnancy, Neonatal Disorder, Premature Baby
F 5918180 4811697 08/15/2005 10/25/2005 Celexa CN Depression Apgar Score Low, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Flatulence, Meconium In Amniotic Fluid, Neonatal Candida Infection, Respiratory Disorder Neonatal, Somnolence Neonatal
F 5918180 4872011 08/15/2005 12/30/2005 Celexa CN Depression Apgar Score Low, Candidiasis, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Eructation, Flatulence, Meconium In Amniotic Fluid, Neonatal Disorder, Respiration Abnormal, Respiratory Disorder Neonatal, Somnolence Neonatal
F 5918180 4959995 08/15/2005 03/27/2006 Celexa MD Depression Apgar Score Low, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Labour Complication, Meconium In Amniotic Fluid, Neonatal Respiratory Depression, Postmature Baby, Precipitate Labour
F 5951339 4855595 12/14/2005 Citalopram MD Panic Disorder Acute Psychosis, Antidepressant Drug Level Decreased, Completed Suicide, Drug Exposure During Pregnancy
M 5957800 4871268 09/06/2005 12/29/2005 Celexa OT Convulsion Neonatal, Drug Exposure During Pregnancy, Grand Mal Convulsion
M 5957800 4880374 09/06/2005 01/11/2006 Celexa OT Convulsion Neonatal, Drug Exposure During Pregnancy
5969913 4885933 11/15/2005 01/17/2006 Citalopram Congenital Pulmonary Valve Atresia, Drug Exposure During Pregnancy, Ventricular Septal Defect
F 5970271 4886604 01/19/2006 Citalopram Depression Drug Exposure During Pregnancy, Stillbirth
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5970274 4886606 01/19/2006 Citalopram Depression Drug Exposure During Pregnancy, Exomphalos, Hernia Congenital, Inguinal Hernia, Umbilical Hernia
5976117 4893357 01/24/2006 Citalopram MD Brachial Plexopathy, Congenital Anomaly, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Tachypnoea
M 5976117 4899936 01/31/2006 Citalopram MD Apgar Score Low, Brachial Plexopathy, Drug Exposure During Pregnancy, Hypotonia Neonatal, Transient Tachypnoea of the Newborn
F 5984528 4903436 10/24/2005 02/06/2006 Celexa PH Agitation Neonatal, Blood Glucose Abnormal, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Temperature Regulation Disorder
F 5989945 4907903 02/08/2006 Citalopram OT Postpartum Depression Developmental Delay, Drug Exposure During Pregnancy, Head Deformity, Synostosis
M 6004043 4937125 10/29/2005 03/07/2006 Celexa MD Anxiety, Depression Apgar Score Low, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Disorder, Neonatal Hypoxia, Neonatal Tachypnoea
F 6019158 4953788 01/01/2005 03/21/2006 Celexa MD Apgar Score Low, Coombs Test Positive, C-Reactive Protein Increased, Crying, Drug Exposure During Pregnancy, Haematocrit Decreased, Hypotonia Neonatal, Jaundice Neonatal, Maternal Condition Affecting Foetus, Neonatal Aspiration, Neonatal Pneumonia, Neonatal Tachypnoea, Poor Peripheral Circulation
F 6019158 4963004 01/01/2005 03/31/2006 Celexa MD Apgar Score Low, Coombs Test Positive, Drug Exposure During Pregnancy, Hypotonia Neonatal, Jaundice Neonatal, Mean Arterial Pressure Decreased, Neonatal Aspiration, Neonatal Disorder, Neonatal Pneumonia, Neonatal Respiratory Depression, Neonatal Tachypnoea, Peripheral Vascular Disorder
F 6019158 5078570 01/01/2005 08/08/2006 Celexa MD Apgar Score Low, Cardiovascular Disorder, Coombs Test Positive, Depression, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hypotonia Neonatal, Inspiratory Capacity Decreased, Jaundice Neonatal, Maternal Drugs Affecting Foetus, Mean Arterial Pressure Decreased, Neonatal Respiratory Depression, Neonatal Tachypnoea, Pneumonia Aspiration, White Blood Cell Count Increased
M 6026609 4927978 02/23/2006 Akarin OT Drug Exposure During Pregnancy, Polydactyly
F 6035640 4978052 03/23/2006 04/14/2006 Sepram OT Drug Exposure During Pregnancy, Dyspnoea, Haemoglobin Increased, Neonatal Infection, Patent Ductus Arteriosus, Platelet Count Decreased, Respiratory Disorder Neonatal, White Blood Cell Count Decreased
F 6035640 4995861 03/23/2006 05/04/2006 Citalopram OT Drug Exposure During Pregnancy, Haematocrit Decreased, Haemoglobin Decreased, Infantile Apnoeic Attack, Patent Ductus Arteriosus, Platelet Count Increased, Premature Baby, White Blood Cell Count Increased
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6047077 4994218 05/03/2006 Cipramil OT Drug Exposure During Pregnancy, Premature Baby
M 6047077 5008915 04/17/2006 05/18/2006 Cipramil OT Congenital Scoliosis, Congenital Spinal Fusion, Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome, Patent Ductus Arteriosus, Premature Baby, Sepsis Neonatal
M 6047077 5015064 04/17/2006 05/30/2006 Cipramil OT Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome, Patent Ductus Arteriosus, Premature Baby, Sepsis Neonatal
6094830 5060979 07/20/2006 Citalopram PH Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Hypotonia Neonatal, Respiratory Disorder Neonatal, Sleep Disorder
F 6102742 5067548 07/27/2006 Citalopram Depression Drug Exposure During Pregnancy, Heart Disease Congenital
F 6102742 5071847 08/01/2006 Citalopram Depression Drug Exposure During Pregnancy, Heart Disease Congenital
F 6102742 5072873 08/02/2006 Citalopram OT Depression Drug Exposure During Pregnancy, Heart Disease Congenital
F 6114353 5082971 07/14/2006 08/14/2006 Citalopram Depression Anal Atresia, Drug Exposure During Pregnancy, Premature Baby
F 6114353 5096534 07/14/2006 08/30/2006 Citalopram OT Depression Anal Atresia, Drug Exposure During Pregnancy, Premature Baby
6125432 5093433 08/29/2006 Citalopram Congenital Anomaly, Drug Exposure During Pregnancy
F 6130030 5097917 05/09/2004 09/05/2006 Celexa MD Depression Congenital Anomaly, Drug Exposure During Pregnancy, Fallot's Tetralogy
F 6142696 5116938 08/07/2006 09/25/2006 Citalopram Crying, Drug Exposure During Pregnancy, Dystonia, Feeling Abnormal, Small for Dates 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 6142696 5130092 08/07/2006 10/13/2006 Citalopram OT Crying, Drug Exposure During Pregnancy, Dystonia, Feeling Abnormal, Neonatal Disorder, Small for Dates Baby
M 6145681 5120550 10/02/2006 Citalopram OT Drug Exposure During Pregnancy, Hyperbilirubinaemia Neonatal, Premature Baby
F 6149581 5126057 02/20/2006 10/10/2006 Celexa OT Depression Abortion Induced, Anophthalmos, Congenital Anomaly, Congenital Eye Disorder, Drug Exposure During Pregnancy, Head Circumference Abnormal
M 6164381 5139801 09/02/2003 10/25/2006 06/06/2004 Celexa LW Acute Respiratory Failure, Atrial Septal Defect, Brain Damage, Bronchopulmonary Dysplasia, Caesarean Section, Cerebral Palsy, Chronic Respiratory Failure, Congenital Anomaly, Convulsion, Drug Exposure During Pregnancy, Optic Nerve Hypoplasia, Pneumonia, Pulmonary Hypertension, Ventricular Septal Defect
M 6164381 5165116 09/02/2003 11/24/2006 06/06/2004 Celexa LW Abdominal Distension, Acute Respiratory Failure, Agitation, Apgar Score Low, Aspiration, Atelectasis, Atrial Septal Defect, Bacterial Infection, Base Excess Decreased, Blood Alkaline Phosphatase Increased, Blood PH Decreased, Bradycardia Neonatal, Brain Damage, Bronchial Obstruction, Bronchopulmonary Dysplasia, Caesarean Section, Cardiac Arrest, Cardiomegaly, Cephalhaematoma, Cerebral Palsy, Chromosome Abnormality, Chronic Respiratory Failure, Congenital Central Nervous System Anomaly, Convulsion Neonatal, Coordination Abnormal, Cor Pulmonale, Cyanosis Neonatal, Developmental Delay, Drug Exposure During Pregnancy, Dysmorphism, Eye Rolling, Feeling Cold, Fluid Overload, Foetal Distress Syndrome, Frequent Bowel Movements, Gastrooesophageal Reflux Disease, General Physical Health Deterioration, Haematocrit Decreased, Hydronephrosis, Hyperbilirubinaemia Neonatal, Hypercapnia, Hypotonia, Hypoxia, Increased Bronchial Secretion, Lethargy, Livedo Reticularis, Loss of Consciousness, Low Set Ears, Memory Impairment, Mental Retardation Severity Unspecified, Neonatal Disorder, Neonatal Hepatomegaly, Neonatal Pneumonia, Neonatal Respiratory Distress Syndrome, Neonatal Respiratory Failure, Oedema, Ophthalmia Neonatorum, Optic Nerve Hypoplasia, Oxygen Saturation Decreased, Persistent Foetal Circulation, Prothrombin Time Prolonged, Pulmonary Oedema Neonatal, Pulse Absent, Pupillary Reflex Impaired, Rash Pustular, Respiratory Acidosis, Respiratory Arrest, Right Ventricular Systolic Pressure, Sepsis Neonatal, Sinus Tachycardia, Sputum Abnormal, Supraventricular Extrasystoles, Tachycardia Foetal, Tricuspid Valve Incompetence, Ventricular Septal Defect
M 6175116 5152504 11/09/2006 Citalopram OT Drug Use for Unknown Indication Apgar Score Low, Drug Exposure During Pregnancy, Gastrointestinal Malformation
6189594 5165190 11/24/2006 Citalopram OT Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Foetal Disorder, Infantile Spasms
F 6227519 5216827 05/04/2005 01/19/2007 Celexa MD Drug Exposure During Pregnancy, Premature Baby
M 6241976 5232364 01/13/2007 02/05/2007 Citalopram OT Drug Exposure During Pregnancy, Hydrocele
F 6258850 5249278 01/01/2001 02/23/2007 Citalopram Abortion Induced, Appetite Disorder, Completed Suicide, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Irritability, Overdose, Tearfulness, Weight Fluctuation
F 6258850 5292630 01/01/2001 04/04/2007 Citalopram Abortion Induced, Apathy, Appetite Disorder, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Intentional Overdose, Irritability, Mental Disorder, Suicide Attempt, Tearfulness, Weight Fluctuation
F 6258945 5248910 02/23/2007 Citalopram Abortion Induced, Apathy, Appetite Disorder, Completed Suicide, Drug Withdrawal Syndrome, Emotional Distress, Irritability, Overdose, Tearfulness, Weight Fluctuation
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6292744 5292632 09/19/2006 04/04/2007 Citalopram Depression Amniotic Cavity Disorder, Drug Exposure During Pregnancy, Foetal Malformation, Inflammation, Intra-Uterine Death, Placental Disorder
F 6292744 5383144 09/19/2006 07/05/2007 Citalopram OT Depression Chorioamnionitis, Drug Exposure During Pregnancy, Intra-Uterine Death, Placental Disorder, Skull Malformation
F 6302493 5306047 04/17/2007 Citalopram OT Drug Exposure During Pregnancy, Poland's Syndrome
F 6307828 5314196 04/25/2007 Citalopram MD Congenital Anomaly, Drug Exposure During Pregnancy, Facial Paresis
M 6334136 5348462 03/14/2007 06/05/2007 Citalopram Drug Exposure During Pregnancy, Hydronephrosis, Neonatal Disorder, Pyelectasia, Rhesus Antibodies Positive
M 6334136 5473150 03/14/2007 09/27/2007 Citalopram Drug Exposure During Pregnancy, Hydronephrosis, Pyelectasia, Vesicoureteric Reflux
6363136 5389794 02/02/2007 07/13/2007 Citalopram Cerebral Haemorrhage Neonatal, Drug Exposure During Pregnancy, Premature Baby
6363136 5390010 02/02/2007 07/13/2007 Citalopram OT Cerebral Haemorrhage Neonatal, Drug Exposure During Pregnancy, Premature Baby
M 6363136 5446081 02/02/2007 09/04/2007 Citalopram OT Cerebral Haemorrhage Neonatal, Drug Exposure During Pregnancy, Premature Baby
6369160 5397296 07/23/2007 Citalopram Drug Exposure During Pregnancy, Foetal Growth Retardation
F 6371067 5399964 07/25/2007 Citalopram OT Abortion Induced, Drug Exposure During Pregnancy
M 6374840 5402035 05/23/2007 07/27/2007 Citalopram OT Drug Exposure During Pregnancy Apnoea, Asthenia, Drug Exposure During Pregnancy, Pallor
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6376765 5404092 05/23/2007 07/31/2007 Citalopram OT Asthenia, Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Neonatal Disorder, Pallor
F 6379050 5407004 08/01/2007 Citalopram Transmission of Drug Via Semen Acquired Epileptic Aphasia, Drug Exposure During Pregnancy, Transmission of Drug Via Semen
M 6379606 5406787 05/23/2007 08/02/2007 Citalopram OT Apnoea, Asthenia, Drug Exposure During Pregnancy, Neonatal Disorder, Pallor
M 6379606 5526181 05/23/2007 11/20/2007 Citalopram OT Amniorrhoea, Apgar Score Low, Apnoea, Asthenia, Blood Bilirubin Increased, C-Reactive Protein Increased, Drug Exposure During Pregnancy, Hypotonia Neonatal, Infantile Apnoeic Attack, Neonatal Disorder, Pallor, Premature Baby
6406466 5429857 08/27/2007 Citalopram Cleft Lip and Palate, Drug Exposure During Pregnancy
6406967 5430392 08/28/2007 Citalopram Drug Exposure During Pregnancy Cleft Lip and Palate, Drug Exposure During Pregnancy
6410595 5442918 08/30/2007 Citalopram Cleft Lip and Palate, Drug Exposure During Pregnancy
6414103 5447592 09/05/2007 Citalopram Depression Cleft Lip, Cleft Palate, Drug Exposure During Pregnancy
F 6414402 5446077 09/04/2007 Citalopram OT Depression Drug Exposure During Pregnancy
F 6440674 5475916 10/01/2007 Celexa Apgar Score Low, Drug Exposure During Pregnancy, Meconium Increased, Somnolence Neonatal
6474407 5518319 11/13/2007 Citalopram PH Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18
6474407 5530430 11/27/2007 Citalopram Drug Exposure During Pregnancy Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6475049 5519150 11/14/2007 Citalopram Drug Exposure During Pregnancy, Trisomy 18
6475049 5530433 11/27/2007 Citalopram Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18
6475956 5522851 11/15/2007 Citalopram Depression Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18
6476845 5523272 11/16/2007 Citalopram OT Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18
6477965 5524809 11/16/2007 Citalopram Depression Drug Exposure During Pregnancy, Trisomy 18
M 6483560 5528109 09/10/2003 11/23/2007 Citalopram OT Panic Attack Congenital Hand Malformation, Congenital Hydrocephalus, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Synovitis
F 6483972 5530391 09/30/2007 11/27/2007 Citalopram OT Drug Use for Unknown Indication Drug Exposure During Pregnancy, Neonatal Respiratory Depression
6484629 5530418 11/27/2007 Citalopram OT Depression Drug Exposure During Pregnancy, Trisomy 18
F 6490456 5532151 09/30/2007 11/28/2007 Citalopram OT Drug Exposure During Pregnancy, Neonatal Respiratory Depression
F 6506357 5537008 12/04/2007 Citalopram Depression Drug Exposure During Pregnancy, Premature Labour
6506358 5536999 12/04/2007 Citalopram Drug Exposure During Pregnancy, Premature Baby
F 6510517 5552419 12/10/2007 Citalopram 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
6510591 5552430 12/10/2007 Citalopram OT Abortion Spontaneous, Drug Exposure During Pregnancy
M 6511564 5550872 10/18/2003 12/10/2007 Citalopram OT Ammonia Increased, Culture Urine Positive, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Escherichia Infection, Feeding Disorder Neonatal, Maternal Condition Affecting Foetus, Protein Urine Present, Red Blood Cells Urine, Uterine Infection, White Blood Cells Urine
F 6513306 5552426 12/10/2007 Citalopram OT Depression Drug Exposure During Pregnancy, Intra-Uterine Death
M 6513746 5590827 01/10/2008 Citalopram MD Abscess, Anomaly of External Ear Congenital, Congenital Eyelid Malformation, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Disorder, Perianal Abscess, Prominent Epicanthal Folds, Visual Acuity Reduced, Visual Disturbance
F 6514086 5557371 07/31/2006 12/11/2007 08/10/2006 Citalopram PH Depression Drug Exposure During Pregnancy, Premature Baby, Sepsis Neonatal
M 6520468 5576138 12/26/2007 Citalopram CN Drug Exposure During Pregnancy, Hydrocele
6538991 5589480 11/25/2007 01/09/2008 Citalopram Drug Exposure During Pregnancy, Drug Ineffective, Premature Labour
6538991 5599627 11/25/2007 01/18/2008 Citalopram OT Drug Exposure During Pregnancy, Premature Baby
6538991 5613397 11/25/2007 01/29/2008 Citalopram Drug Exposure During Pregnancy, Premature Baby
F 6604728 5679864 03/24/2008 Citalopram CN Drug Exposure During Pregnancy, Premature Labour
0 Days M 4074663 4443542 10/01/2003 09/01/2004 Celexa MD Depression Apgar Score Low, Cleft Lip and Palate, Drug Exposure During Pregnancy
0 Days 4092070 4293376 02/10/2004 Celexa MD Depression Maternal Drugs Affecting Foetus, Multiple Congenital Abnormalities
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
0 Days M 4134792 4507351 11/18/2004 Celexa MD Depression Arnold-Chiari Malformation, Congenital Anomaly of Inner Ear, Congenital Atrial Septal Defect, Congenital Cardiovascular Anomaly, Congenital Elevation of Scapula, Congenital Torticollis, Deafness Congenital, Deafness Unilateral, Drug Exposure During Pregnancy, Spine Malformation
0 Days F 4148585 4386273 03/25/2004 06/22/2004 Cipramil Agitation Neonatal, Apgar Score Low, Drug Exposure During Pregnancy, Feeling Jittery, Hypotonia Neonatal, Irritability, Neonatal Apnoeic Attack, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Poor Sucking Reflex, Tremor Neonatal, Vacuum Extractor Delivery
0 Days F 4211025 4446922 07/26/2004 09/08/2004 Citalopram Depression Congenital Ventricular Septal Defect, Drug Exposure During Pregnancy
0 Days M 4222980 4511901 05/17/2004 11/23/2004 Celexa MD Depression Amniotic Fluid Volume Decreased, Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy, Foetal Growth Retardation, Hip Dysplasia, Jaundice Neonatal, Neonatal Disorder, Small for Dates Baby
0 Days F 5658869 4577015 10/06/2004 02/08/2005 Celexa Anxiety, Depression Caesarean Section, Drug Exposure During Pregnancy, Fallot's Tetralogy, Limb Malformation, Placenta Praevia, Placental Insufficiency
0 Days M 5667865 4471956 12/01/2003 10/07/2004 Citalopram OT Panic Disorder Blood Bilirubin Increased, Feeding Problem In Newborn, Jaundice Neonatal, Neonatal Disorder
0 Days M 5710155 4541905 09/20/2004 12/27/2004 Citalopram PH Cardiac Murmur, Drug Exposure During Pregnancy, Heart Disease Congenital
0 Days 5731094 4565915 01/28/2005 Citalopram PH Depression Camptodactyly Congenital, Congenital Anomaly, Congenital Hand Malformation, Congenital Pulmonary Hypertension, Drug Exposure During Pregnancy, Foetal Movements Decreased, Joint Hyperextension, Polyhydramnios, Premature Baby
0 Days 5755143 4596464 02/28/2005 Citalopram MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
0 Days 5755958 4596445 02/28/2005 Citalopram MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
0 Days 5755967 4596449 02/28/2005 Citalopram MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
0 Days 5755974 4596453 02/28/2005 Citalopram MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
0 Days 5755977 4596456 02/28/2005 Citalopram MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
0 Days M 5798380 4659271 01/23/2004 05/10/2005 Citalopram OT Drug Exposure During Pregnancy, Pierre Robin Syndrome
0 Days M 5800139 4661119 01/12/2004 05/11/2005 Citalopram OT Congenital Central Nervous System Anomaly, Congenital Eye Disorder, Corneal Disorder, Drug Exposure During Pregnancy, Haemangioma Congenital, Microphthalmos
F 6604728 5701188 04/07/2008 Citalopram OT Drug Exposure During Pregnancy, Premature Labour
F 6604728 5739699 05/13/2008 Citalopram Depressive Symptom Depression, Drug Exposure During Pregnancy, Premature Labour
F 6609429 5736314 05/08/2008 Akarin Abnormal Faeces, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Maternal Drugs Affecting Foetus, Neonatal Tachycardia, Psychomotor Hyperactivity, Respiratory Rate Increased, Restlessness, Tremor Neonatal
F 6624314 5705910 07/02/2002 04/11/2008 Cipramil OT Drug Exposure During Pregnancy, Duane's Syndrome, Strabismus Congenital
6648547 5736931 05/09/2008 Citalopram Abortion Induced, Maternal Drugs Affecting Foetus, Multiple Congenital Abnormalities
6649397 5738005 05/09/2008 Citalopram Depression Abortion Induced, Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus, Multiple Congenital Abnormalities
M 6650110 5736837 02/22/2008 05/08/2008 Citalopram Caesarean Section, Diarrhoea Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Maternal Drugs Affecting Foetus, Premature Baby
6650262 5739582 05/13/2008 Citalopram Abortion Induced, Drug Exposure During Pregnancy, Multiple Congenital Abnormalities
M 6657757 5748898 05/22/2008 Celexa OT Drug Use for Unknown Indication Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Maternal Drugs Affecting Foetus, Opisthotonus, Red Blood Cells CSF Positive
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6661296 5753464 05/27/2008 Citalopram MD Drug Exposure During Pregnancy, Drug Interaction, Drug Withdrawal Syndrome Neonatal, Extrapyramidal Disorder, Grunting, Hypertonia, Maternal Drugs Affecting Foetus, Metabolic Acidosis, Neonatal Respiratory Distress Syndrome
F 6663112 5755185 01/01/2007 05/28/2008 Celexa MD Caesarean Section, Jaundice Neonatal, Maternal Drugs Affecting Foetus, Talipes
F 6663112 5756367 01/01/2007 05/29/2008 Celexa MD Jaundice Neonatal, Maternal Drugs Affecting Foetus, Talipes
F 6664912 5757203 05/29/2008 Citalopram Drug Exposure During Pregnancy Drug Interaction, Drug Withdrawal Syndrome Neonatal, Electroencephalogram Abnormal, Extrapyramidal Disorder, Maternal Drugs Affecting Foetus, Metabolic Acidosis, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Premature Baby, Respiratory Disorder Neonatal, Small for Dates Baby
F 6676025 5769008 06/10/2008 Citalopram MD Drug Exposure During Pregnancy Apgar Score Low, Autonomic Nervous System Imbalance, Drug Interaction, Drug Withdrawal Syndrome Neonatal, Electroencephalogram Abnormal, Extrapyramidal Disorder, Maternal Drugs Affecting Foetus, Metabolic Acidosis, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Premature Baby, Pupillary Reflex Impaired
1 Hours F 6125469 5093458 08/28/2006 Citalopram Agitation Neonatal, Apgar Score Low, Bradycardia Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Growth Retardation, Neonatal Asphyxia, Premature Baby
1 Hours F 6125469 5107777 09/14/2006 Citalopram Agitation Neonatal, Apgar Score Low, Bradycardia Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Growth Retardation, Neonatal Asphyxia, Neonatal Disorder, Oligohydramnios, Premature Baby, Premature Rupture of Membranes
1 Day M 5731094 4727698 09/08/2004 07/27/2005 09/21/2004 Citalopram Depression Areflexia, Caesarean Section, Camptodactyly Congenital, Cerebral Haemorrhage, Cholestasis, Cleft Palate, Congenital Multiplex Arthrogryposis, Drug Exposure During Pregnancy, Foetal Disorder, Foetal Distress Syndrome, Gastrointestinal Motility Disorder, Hand Deformity, Hip Dysplasia, Hypokinesia Neonatal, Hypoxia, Ischaemia, Joint Hyperextension, Muscular Dystrophy, Muscular Weakness, Myasthenic Syndrome, Mydriasis, Polyhydramnios, Premature Baby, Pulmonary Hypertension
1 Day M 5731094 4758951 09/08/2004 08/26/2005 09/21/2004 Citalopram OT Depression Aids Related Complex, Akinesia, Amniocentesis Abnormal, Apgar Score Low, Areflexia, Arthropathy, Blood PH Decreased, Caesarean Section, Camptodactyly Congenital, Cerebral Haemorrhage Neonatal, Cerebrovascular Disorder, Combined Immunodeficiency, Congenital Hand Malformation, Congenital Multiplex Arthrogryposis, Death Neonatal, Deformity Thorax, Drug Exposure During Pregnancy, Foetal Disorder, Foetal Distress Syndrome, Gastrointestinal Motility Disorder, Haemoglobin Increased, Hip Dysplasia, Hypokinesia Neonatal, Ischaemia, Joint Hyperextension, Mydriasis, Myopathy, Neonatal Cholestasis, Neonatal Hypoxia, Neuromyopathy, Obstructive Airways Disorder, Oculocephalogyric Reflex Absent, Palatal Disorder, PCO2 Decreased, PO2 Decreased, Polyhydramnios, Premature Baby, Pulmonary Hypertension
1 Day M 5731094 4759161 09/08/2004 08/31/2005 09/21/2004 Citalopram PH Depression Akinesia, Amniocentesis Abnormal, Apgar Score Low, Areflexia, Blood PH Decreased, Caesarean Section, Camptodactyly Congenital, Cerebral Haemorrhage, Cholestasis, Congenital Multiplex Arthrogryposis, Congenital Neurological Disorder, Congenital Oral Malformation, Congenital Pulmonary Hypertension, Death Neonatal, Deformity Thorax, Drug Exposure During Pregnancy, Feeding Tube Complication, Gastrointestinal Motility Disorder, Haemoglobin Increased, Hand Deformity, Hip Dysplasia, Hypokinesia Neonatal, Immobile, Ischaemia, Joint Hyperextension, Mydriasis, Myopathy, Neonatal Hypoxia, Obstruction, Polyhydramnios, Premature Baby
1 Day M 5731094 4785157 09/08/2004 09/28/2005 09/21/2004 Citalopram OT Depression Akinesia, Amniocentesis Abnormal, Apgar Score Low, Blood PH Decreased, Camptodactyly Congenital, Cerebral Haemorrhage, Cholestasis, Congenital Multiplex Arthrogryposis, Death Neonatal, Drug Exposure During Pregnancy, Foetal Disorder, Gastrointestinal Motility Disorder, Hand Deformity, Hip Dysplasia, Hyporeflexia, Hypoxia, Immobile, Ischaemia, Joint Hyperextension, Loss of Proprioception, Mydriasis, Myopathy, Palatal Disorder, PCO2 Decreased, PO2 Decreased, Polyhydramnios, Premature Baby, Pulmonary Hypertension, Respiratory Tract Malformation, Small for Dates Baby
1 Day F 5850779 4724507 07/21/2005 Celexa 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
1 Day F 5850786 4724523 07/21/2005 Celexa Crying, Depersonalisation, Drug Exposure During Pregnancy, Neonatal Disorder
1 Day F 5850786 4726488 07/26/2005 Celexa Crying, Depersonalisation, Drug Exposure During Pregnancy, Neonatal Disorder
1 Day M 5859865 4736978 07/12/2005 08/04/2005 Citalopram OT Panic Disorder Apgar Score Low, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hyperthermia, Hypotonia Neonatal, Irritability, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Respiratory Disorder Neonatal, Tremor Neonatal
1 Day M 5859865 4865793 07/12/2005 12/20/2005 Citalopram PH Apgar Score Low, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Hypotonia Neonatal, Irritability, Neonatal Asphyxia, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Regurgitation of Food, Tremor Neonatal
1 Day M 6600947 5677141 03/18/2008 Citalopram Agitation, Crying, Drug Exposure During Pregnancy, Hypoventilation, Infantile Apnoeic Attack, Neonatal Respiratory Distress Syndrome, Premature Baby
1 Day F 6604726 5701189 03/07/2008 04/07/2008 Citalopram OT Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Premature Baby, Skin Discolouration
1 Day F 6604726 5739584 03/07/2008 05/13/2008 Citalopram Drug Exposure Via Breast Milk, Infantile Apnoeic Attack, Maternal Drugs Affecting Foetus, Premature Baby
2 Days M 6650110 5762094 03/22/2008 06/04/2008 Citalopram OT Caesarean Section, Diarrhoea Neonatal, Drug Withdrawal Syndrome Neonatal, Maternal Drugs Affecting Foetus, Premature Baby
2 Days M 6650110 5766477 03/22/2008 06/06/2008 Citalopram PH Caesarean Section, Diarrhoea Neonatal, Drug Withdrawal Syndrome Neonatal, Maternal Drugs Affecting Foetus, Premature Baby
4 Days 6604726 5679863 03/24/2008 Citalopram CN Apnoea, Drug Exposure During Pregnancy, Premature Baby
4 Days 6604726 5692875 04/01/2008 Citalopram Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Premature Baby
5 Days F 6514086 5574067 08/05/2006 12/21/2007 08/10/2006 Citalopram Depression Death Neonatal, Drug Exposure During Pregnancy, Premature Baby, Premature Rupture of Membranes, Sepsis Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
5 Days F 6514086 5574088 08/05/2006 12/21/2007 08/10/2006 Seropram Depression Drug Exposure During Pregnancy, Premature Baby, Sepsis Neonatal
7 Days F 4211020 4446921 07/19/2004 09/08/2004 Citalopram Drug Exposure During Pregnancy, Fever Neonatal, Haemorrhage Intracranial, Hydrocephalus, Neonatal Disorder, Thrombocythaemia
7 Days F 4211020 4544797 07/19/2004 12/30/2004 Citalopram OT Cerebral Haemorrhage Neonatal, Drug Exposure During Pregnancy, Fever Neonatal, Hydrocephalus, Meningorrhagia, Neonatal Disorder, Neonatal Infection, Thrombocythaemia
7 Days F 4211020 4553262 07/19/2004 01/13/2005 Citalopram OT Cerebral Haemorrhage Neonatal, Congenital Hydrocephalus, Drug Exposure During Pregnancy, Fever Neonatal, Neonatal Disorder, Neonatal Infection, Thrombocythaemia
7 Days F 4211020 4883385 07/19/2004 01/13/2006 Citalopram Drug Exposure Before Pregnancy, Fever Neonatal, Haemorrhage Intracranial, Hydrocephalus, Infection, Meningorrhagia, Neonatal Disorder, Thrombocythaemia
2 Months F 6138342 5108655 05/04/2006 09/15/2006 05/04/2006 Celexa Drug Exposure During Pregnancy, Sudden Infant Death Syndrome
3 Months F 6513746 5557438 12/11/2007 Citalopram MD Abscess, Anomaly of External Ear Congenital, Congenital Eyelid Malformation, Drug Exposure During Pregnancy, Visual Acuity Reduced
3 Months F 4144693 4363638 02/15/2004 05/24/2004 02/15/2004 Citalopram CN Depression Abnormal Behaviour, Brain Damage, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Eye Redness, Eye Rolling, Feeling Cold, Hypotonia, Movement Disorder, Screaming, Sedation, Somnolence, Staring
4 Months 4134785 4348465 04/01/2004 04/23/2004 Celexa PH Drug Exposure Via Breast Milk, Maternal Drugs Affecting Foetus, Rash, Splenomegaly, White Blood Cell Count Decreased
4 Months 4134785 4446761 04/01/2004 09/10/2004 Celexa PH Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Rash, Splenomegaly, White Blood Cell Count Decreased
6 Months M 5783124 4639213 04/18/2005 Citalopram OT Abdominal Pain, Anorexia, Crying, Drug Exposure Via Breast Milk, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Insomnia, Weight Decreased
6 Months M 6189594 5178912 09/01/2006 12/11/2006 Citalopram OT Depression Drug Exposure During Pregnancy, Infantile Spasms
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
9 Months F 6091233 5054514 07/14/2006 Citalopram OT Panic Disorder With Agoraphobia Chromosome Abnormality, Congenital Anomaly, Convulsion, Lissencephaly, Transmission of Drug Via Semen
9 Months F 6091233 5104215 09/11/2006 Seropram OT Panic Disorder With Agoraphobia Chromosomal Deletion, Congenital Anomaly, Convulsion, Lissencephaly, Transmission of Drug Via Semen
39 Weeks M 6689682 5786759 03/14/2007 06/18/2008 Citalopram Panic Disorder Congenital Hydronephrosis, Maternal Drugs Affecting Foetus, Neonatal Disorder, Pyelocaliectasis
1 Year M 4115344 4323149 04/01/2002 03/22/2004 Celexa CN Depression Autism, Maternal Drugs Affecting Foetus, Pervasive Developmental Disorder, Premature Baby
1 Year F 5827210 4698300 05/01/2003 06/21/2005 Citalopram OT Diabetes Mellitus, Drug Exposure During Pregnancy
2 Years F 6609429 5688132 03/27/2008 Akarin OT Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Neonatal Disorder, Neonatal Tachycardia, Restlessness, Tremor Neonatal
3 Years F 6518592 5382662 07/03/2007 Celexa OT Depression Autism, Breech Delivery, Drug Exposure During Pregnancy, Macrocephaly
4 Years F 5827210 4692932 05/01/2005 06/15/2005 Citalopram Diabetes Mellitus, Drug Exposure During Pregnancy
100 Years F 6151680 5128262 07/12/2006 10/11/2006 Seropram OT Apgar Score Low, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Growth Retardation, Hypertonia Neonatal, Neonatal Respiratory Distress Syndrome
13 Years 6065223 5019195 05/31/2006 Celexa OT Aspiration, Death Neonatal, Drug Exposure During Pregnancy, Neonatal Aspiration
22 Years F 6192005 5147655 05/23/2006 09/15/2006 Celexa CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Intentional Overdose, Nausea, Vomiting
22 Years F 6192005 5486265 05/23/2006 09/17/2007 Celexa CN Drug Exposure During Pregnancy, Intentional Overdose, Nausea, Vomiting
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
22 Years F 6390299 5420837 08/16/2007 Citalopram Depression Cleft Lip and Palate, Drug Exposure During Pregnancy
25 Years F 6035531 4977889 03/19/2006 04/14/2006 Citalopram OT Panic Disorder Amniocentesis Abnormal, Drug Exposure During Pregnancy, Dyspnoea, Haemoglobin Increased, Hyperaemia, Neonatal Disorder, Neonatal Infection, Patent Ductus Arteriosus, Platelet Count Decreased, Premature Baby, White Blood Cell Count Decreased
25 Years F 6035531 4995814 03/19/2006 05/04/2006 Citalopram OT Panic Disorder Drug Exposure During Pregnancy, Haematocrit Increased, Haemoglobin Decreased, Infection, Platelet Count Increased, Premature Labour
25 Years F 6167085 5141875 10/27/2006 Citalopram OT Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Intra-Uterine Death
26 Years F 6481467 5528421 11/21/2007 Citalopram Depression Amniorrhoea, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Mental Disorder, Premature Baby
26 Years F 6600862 5677412 03/18/2008 Citalopram OT Caesarean Section, Drug Exposure During Pregnancy, Postmature Baby
26 Years F 5918149 4811853 10/12/2003 10/26/2005 Celexa CN Panic Attack Drug Exposure During Pregnancy, Premature Labour
26 Years F 5918149 4847164 10/12/2003 12/05/2005 Celexa CN Panic Attack Drug Exposure During Pregnancy, Premature Labour
26 Years F 6144823 5117812 09/26/2006 Citalopram Agitation, Akathisia, Anhedonia, Asthenia, Bipolar II Disorder, Crying, Disease Recurrence, Disturbance In Attention, Dysphoria, Homicidal Ideation, Hypomania, Insomnia, Irritability, Major Depression, Marital Problem, Obsessive Thoughts, Postpartum Depression, Restlessness, Thinking Abnormal
27 Years F 6529883 5589493 11/25/2007 01/09/2008 Citalopram Depression Drug Exposure Before Pregnancy, Drug Ineffective, Premature Labour
27 Years F 6529883 5600985 11/25/2007 01/18/2008 Citalopram OT Depression Drug Exposure During Pregnancy, Drug Ineffective, Premature Labour
27 Years F 6529883 5613398 11/25/2007 01/29/2008 Citalopram Depression Drug Exposure During Pregnancy, Premature Labour
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
27 Years F 5771198 4620882 01/01/2004 03/25/2005 Celexa Drug Exposure During Pregnancy, Haemorrhage, Umbilical Cord Abnormality
27 Years F 5771198 4678779 01/01/2004 05/31/2005 Celexa OT Bleeding Peripartum, Drug Exposure During Pregnancy, Premature Separation of Placenta
27 Years F 5771198 4694916 01/01/2004 06/17/2005 Celexa OT Antepartum Haemorrhage, Drug Exposure During Pregnancy, Haemorrhage, Placental Disorder, Umbilical Cord Abnormality
27 Years F 5918176 4811696 11/04/2004 10/25/2005 Celexa CN Depression Candidiasis, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Emotional Disorder, Euphoric Mood, Feeling Abnormal, Galactostasis, Haemorrhage, Nausea, Nephrolithiasis, Nipple Pain, Prolonged Labour, Vaginal Haemorrhage
27 Years F 5918176 4872020 11/04/2004 12/30/2005 Celexa CN Depression Abnormal Behaviour, Amenorrhoea, Anxiety, Bipolar Disorder, Candidiasis, Complication of Pregnancy, Condition Aggravated, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Euphoric Mood, False Labour, Galactostasis, Haemorrhage, Labour Pain, Mania, Nausea, Nephrolithiasis, Nipple Disorder, Nipple Pain, Panic Attack, Paraesthesia, Paranoia, Postpartum Depression, Postpartum Haemorrhage, Thinking Abnormal
27 Years F 5918176 4885803 11/04/2004 01/17/2006 Celexa MD Depression Anxiety, Bipolar II Disorder, Condition Aggravated, Crying, Depression, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Emotional Distress, Euphoric Mood, False Labour, Galactostasis, Haemorrhage, Inadequate Analgesia, Induced Labour, Mania, Nausea, Nephrolithiasis, Nipple Disorder, Nipple Pain, Obsessive-Compulsive Disorder, Pain, Panic Attack, Paraesthesia, Paranoia, Postpartum Depression, Postpartum Haemorrhage, Vaginal Haemorrhage
27 Years F 5918176 4960000 11/04/2004 03/27/2006 Celexa MD Depression Anxiety, Bipolar II Disorder, Breast Haemorrhage, Calculus Urinary, Candidiasis, Crying, Drug Exposure During Pregnancy, Drug Ineffective, Euphoric Mood, Fatigue, Galactostasis, Hydronephrosis, Mania, Nausea, Nephrolithiasis, Nipple Disorder, Nipple Pain, Pain, Panic Attack, Paraesthesia, Paranoia, Postpartum Depression, Postpartum Haemorrhage, Streptococcal Serology Positive, Vaginal Haemorrhage
27 Years F 5926606 4825149 11/09/2005 Citalopram OT Depression Abortion Induced, Cystic Lymphangioma, Drug Exposure During Pregnancy, Trisomy 21
28 Years F 4222981 4462056 09/24/2004 Celexa MD Depression Amniocentesis Abnormal, Breech Delivery, Caesarean Section, Headache, Insomnia
28 Years F 4222981 4511899 09/01/2003 11/23/2004 Celexa MD Depression Amniotic Fluid Volume Decreased, Breast Mass, Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy, Foetal Growth Retardation, Headache, Insomnia
28 Years F 4222981 4612408 09/01/2003 03/16/2005 Celexa MD Depression Amniotic Fluid Volume Decreased, Beta Haemolytic Streptococcal Infection, Breech Presentation, Caesarean Section, Haematocrit Decreased, Headache, Insomnia, Post Procedural Complication
28 Years F 5692635 4518152 01/01/2002 11/30/2004 Celexa CN Depression Abortion Spontaneous, Blood Glucose Increased, Caesarean Section, Drug Exposure During Pregnancy, Labour Induction
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 5928800 4831224 12/01/2004 11/16/2005 Celexa MD Postpartum Depression Diarrhoea, Drug Exposure During Pregnancy, Post Procedural Hypothyroidism, Thyroidectomy, Vertigo
28 Years F 5928800 4877695 12/01/2004 01/09/2006 Celexa MD Postpartum Depression Diarrhoea, Drug Exposure During Pregnancy, Post Procedural Hypothyroidism, Road Traffic Accident, Thyroid Gland Cancer, Vertigo
28 Years F 5928800 4905559 12/01/2004 02/03/2006 Celexa MD Postpartum Depression Anaemia, Caesarean Section, Diarrhoea, Drug Exposure During Pregnancy, Hypothyroidism, Road Traffic Accident, Thyroid Gland Cancer, Vertigo
28 Years F 5928800 4915685 12/01/2004 02/14/2006 Celexa MD Postpartum Depression Caesarean Section, Diarrhoea, Drug Exposure During Pregnancy, Foetal Distress Syndrome, Hypothyroidism, Thyroid Gland Cancer, Umbilical Cord Around Neck, Vertigo
28 Years F 6114017 5081342 09/06/2005 08/11/2006 Celexa MD Depression Arrested Labour, Caesarean Section, Cephalo-Pelvic Disproportion, Complication of Pregnancy, Drug Exposure During Pregnancy, Gestational Diabetes, Weight Increased
29 Years F 4116649 4323719 12/01/2002 03/23/2004 Cipramil PH Depression Abortion Spontaneous, Caesarean Section, Complications of Maternal Exposure To Therapeutic Drugs, Foetal Malposition, Maternal Drugs Affecting Foetus
29 Years F 4116649 4337681 12/01/2002 04/08/2004 Cipramil Depression Abortion Spontaneous, Caesarean Section, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Foetal Malposition, Maternal Drugs Affecting Foetus
29 Years F 6141807 5114623 04/01/2005 09/21/2006 Citalopram Depression Abortion Induced, Drug Dose Omission, Drug Exposure During Pregnancy
29 Years F 6168974 5144628 10/31/2006 Citalopram OT Depression Caesarean Section, Drug Exposure During Pregnancy
30 Years F 5687962 4510259 01/01/2002 11/19/2004 Citalopram OT Depression Antepartum Haemorrhage, Drug Exposure During Pregnancy, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Infection, Intra-Uterine Death, Neonatal Aspiration, Placental Insufficiency, Pleural Haemorrhage, Umbilical Cord Abnormality, Umbilical Cord Around Neck
30 Years F 5695403 4522799 01/01/2002 12/08/2004 Citalopram OT Depression Drug Exposure During Pregnancy, Intra-Uterine Death, Placental Disorder, Uterine Contractions During Pregnancy, Vaginal Haemorrhage
30 Years F 5704847 4532081 05/01/2004 12/17/2004 Cipramil Depression Drug Exposure During Pregnancy, Gestational Diabetes
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 5704847 4621382 05/01/2004 03/25/2005 Cipramil OT Depression Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes
30 Years F 5865545 4747046 10/19/2004 08/15/2005 Celexa CN Depression Back Pain, Caesarean Section, Dehydration, Drug Exposure During Pregnancy, Drug Ineffective, Kidney Infection, Nausea, Premature Labour, Vomiting
30 Years F 3922549 5343626 01/01/2001 05/31/2007 Cipramil OT Depression Cholestasis, Drug Exposure During Pregnancy
30 Years F 6252650 5244847 02/16/2007 Citalopram Depression Drug Exposure During Pregnancy, Intra-Uterine Death
30 Years F 6252650 5281136 03/23/2007 Citalopram OT Depression Drug Exposure During Pregnancy, Stillbirth
30 Years F 6252650 5290349 04/02/2007 Citalopram OT Depression Drug Exposure During Pregnancy, Intra-Uterine Death
30 Years F 6356185 5382685 07/03/2007 Celexa OT Premenstrual Syndrome Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Metrorrhagia, Nausea, Progesterone Decreased, Vomiting
31 Years F 5921607 4819965 08/25/2005 11/02/2005 Citalopram OT Congenital Central Nervous System Anomaly, Congenital Hydrocephalus, Drug Exposure During Pregnancy
31 Years F 5921607 4942905 08/25/2005 03/09/2006 Citalopram OT Abortion Induced, Cleft Lip and Palate, Congenital Central Nervous System Anomaly, Congenital Hydrocephalus, Drug Exposure Before Pregnancy, Hypoxia, Macrocephaly, Placental Disorder
31 Years F 5953750 4866823 12/22/2005 Citalopram OT Drug Exposure During Pregnancy, Intra-Uterine Death
31 Years F 6227520 5216828 09/07/2004 01/19/2007 Celexa MD Anxiety, Depression Drug Exposure During Pregnancy, Haemorrhoids, Premature Labour, Sinusitis
31 Years F 6422727 5449784 09/06/2006 09/10/2007 Citalopram OT Depression Abortion Induced, 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
32 Years F 5658874 4488271 01/01/2004 10/26/2004 Celexa MD Anxiety, Depression Cystocele, Drug Exposure During Pregnancy, Placenta Praevia
32 Years F 5658874 4503281 01/01/2004 11/12/2004 Celexa MD Anxiety, Depression Caesarean Section, Cystocele, Drug Exposure During Pregnancy, Placenta Praevia
32 Years F 5658874 4577036 12/31/2003 02/08/2005 Celexa MD Anxiety, Depression Caesarean Section, Cervix Disorder, Cystocele, Drug Exposure During Pregnancy, Placenta Praevia, Placental Insufficiency, Post Procedural Pain, Sinusitis
32 Years F 6114354 5082973 08/14/2006 Citalopram Depression Congenital Anomaly, Drug Exposure During Pregnancy, Foetal Disorder, Hydrocephalus, Intracranial Aneurysm
32 Years F 6114354 5147138 11/03/2006 Citalopram OT Depression Congenital Hydrocephalus, Drug Exposure During Pregnancy, Intracranial Aneurysm
33 Years F 6049490 5557373 01/29/2006 12/11/2007 Citalopram PH Depression Drug Exposure During Pregnancy, Premature Rupture of Membranes, Sepsis Neonatal
33 Years F 6049490 5574065 01/29/2006 12/12/2007 Citalopram Depression Drug Exposure During Pregnancy, Premature Labour, Premature Rupture of Membranes
33 Years F 6049490 5574086 01/29/2006 12/21/2007 Seropram Depression Drug Exposure During Pregnancy, Premature Rupture of Membranes, Sepsis
33 Years F 6227025 5216515 01/01/2005 01/18/2007 Citalopram OT Conduct Disorder, Depression Drug Exposure During Pregnancy, Polyhydramnios, Premature Baby
33 Years F 6045161 4990938 10/14/2005 04/28/2006 Celexa MD Obsessive-Compulsive Disorder Caesarean Section, Drug Exposure During Pregnancy, Labour Complication
33 Years F 6049490 4998545 01/29/2006 05/08/2006 Citalopram OT Depression Depression, Drug Exposure During Pregnancy
33 Years F 6067821 5022543 06/05/2006 Citalopram Depression Drug Exposure During Pregnancy, Ectopic Pregnancy
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 6209154 5188511 07/01/2006 12/14/2006 Celexa MD Depression Abortion Incomplete, Contusion, Drug Exposure During Pregnancy, Overdose, Physical Assault
33 Years F 6630664 5725458 05/01/2008 Citalopram OT Depression Multiple Congenital Abnormalities
33 Years F 6648187 5733181 05/07/2008 Citalopram OT Depression Abortion Induced, Drug Exposure During Pregnancy, Multiple Congenital Abnormalities
33 Years F 6649262 5738052 04/03/2008 05/08/2008 Citalopram Depression Abortion Induced, Drug Exposure During Pregnancy, Multiple Congenital Abnormalities
33 Years F 6651626 5740107 05/13/2008 Citalopram OT Depression Abortion Induced, Congenital Anomaly, Maternal Drugs Affecting Foetus
33 Years F 6651818 5739952 05/13/2008 Citalopram Depression Abortion Induced, Drug Exposure During Pregnancy
34 Years F 5762620 4607722 01/01/2004 03/09/2005 Seropram Depression Congenital Anomaly, Drug Exposure During Pregnancy, Microphthalmos
34 Years F 5990197 4907893 02/08/2006 Citalopram OT Major Depression Drug Exposure During Pregnancy, Premature Labour
34 Years F 5990197 4920847 01/12/2006 02/17/2006 Citalopram PH Major Depression Drug Exposure During Pregnancy, Premature Labour, Uterine Contractions Abnormal
34 Years F 6147541 5119993 09/29/2006 Citalopram OT Drug Exposure During Pregnancy, Premature Labour
35 Years F 6096154 5060067 07/19/2006 Citalopram PH Drug Exposure During Pregnancy, Heart Disease Congenital
35 Years F 6096154 5094494 08/29/2006 Seropram Drug Exposure During Pregnancy, Migraine
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
35 Years F 6213429 5193626 12/21/2006 Citalopram MD Depression Bradykinesia, Coordination Abnormal, Depressed Mood, Depression, Disturbance In Attention, Dizziness, Drug Toxicity, Drug Withdrawal Syndrome, Electric Shock, Emotional Disorder, Fatigue, Feeling Abnormal, Heart Rate Irregular, Hyperhidrosis, Hypokinesia, Insomnia, Memory Impairment, Muscle Spasms, Muscle Twitching, Musculoskeletal Stiffness, Nervous System Disorder, Pain In Extremity, Paraesthesia, Premature Baby, Psychomotor Retardation, Respiratory Tract Infection, Sleep Disorder, Somnolence, Thinking Abnormal
35 Years F 6213429 5196540 12/27/2006 Citalopram MD Depression Bradykinesia, Coordination Abnormal, Depressed Mood, Disturbance In Attention, Dizziness, Drug Toxicity, Drug Withdrawal Syndrome, Emotional Disorder, Feeling Abnormal, Heart Rate Increased, Heart Rate Irregular, Insomnia, Memory Impairment, Muscle Spasms, Musculoskeletal Stiffness, Nervous System Disorder, Pain In Extremity, Paraesthesia, Psychomotor Retardation, Sleep Disorder, Somnolence
35 Years F 6650112 5736840 06/26/2007 05/08/2008 Citalopram PH Depression Caesarean Section, Drug Exposure During Pregnancy
35 Years F 6650112 5762093 06/26/2007 06/04/2008 Citalopram OT Depression Caesarean Section, Drug Exposure During Pregnancy, Premature Labour
35 Years F 6650112 5766478 06/26/2007 06/06/2008 Citalopram Depression Caesarean Section, Drug Exposure During Pregnancy
36 Years F 5936429 4837296 12/31/2004 11/22/2005 Citalopram OT Depression Caesarean Section, Drug Exposure During Pregnancy, Fear
36 Years F 6216415 5199518 10/02/2006 12/29/2006 Citalopram OT Depression Anaemia, Anosmia, Drug Exposure During Pregnancy, Epistaxis
36 Years F 6216415 5222880 10/02/2006 01/24/2007 Citalopram Depression Anaemia, Drug Exposure During Pregnancy, Epistaxis
37 Years F 6288181 5285133 01/01/2006 03/28/2007 Citalopram PH Depression Abortion Spontaneous, Drug Exposure Before Pregnancy
37 Years F 6356841 5383153 07/05/2007 Citalopram Depression Agitation, Anxiety, Drug Exposure During Pregnancy, Drug Interaction, Drug Withdrawal Syndrome, Dystonia, Hyperemesis Gravidarum, Self-Injurious Ideation
37 Years F 6356841 5392852 06/18/2007 Citalopram Depression Agitation, Anxiety, Cyclothymic Disorder, Drug Exposure During Pregnancy, Drug Interaction, Dystonia, Hyperemesis Gravidarum
37 Years F 6412582 5443315 08/31/2007 Citalopram OT Abortion Induced, Amniotic Fluid Volume Increased, Breast Malformation, Congenital Muscle Absence, Congenital Scoliosis, Drug Exposure During Pregnancy, Echography Abnormal, Motor Neurone Disease, Multiple Congenital Abnormalities, Oedema Peripheral, Pectus Excavatum, Pterygium, Retrognathia, Spine Malformation
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 5917366 4810387 12/27/2004 10/24/2005 Citalopram Anxiety Drug Exposure During Pregnancy, Intentional Overdose, Pregnancy Induced Hypertension
37 Years F 6356841 5714817 04/21/2008 Citalopram Depression Agitation, Anxiety, Drug Exposure During Pregnancy, Drug Interaction, Drug Withdrawal Syndrome, Dystonia, Hyperemesis Gravidarum, Suicidal Ideation
38 Years F 5731092 4565914 01/28/2005 Citalopram PH Depression Drug Exposure During Pregnancy, Polyhydramnios, Premature Baby
38 Years F 5731092 4758425 08/26/2005 Citalopram OT Depression Caesarean Section, Drug Exposure During Pregnancy, Nausea, Polyhydramnios, Premature Labour, Vomiting
38 Years F 5731092 4759162 08/31/2005 Citalopram PH Depression Caesarean Section, Complication of Pregnancy, Drug Exposure During Pregnancy, Nausea, Polyhydramnios, Premature Labour, Vomiting In Pregnancy
38 Years F 5852295 4727700 07/27/2005 Citalopram Depression Caesarean Section, Drug Exposure During Pregnancy, Nausea, Polyhydramnios, Premature Labour, Vomiting
38 Years F 5865002 4747558 08/10/2005 08/17/2005 Citalopram CN Depression Abortion Spontaneous, Drug Exposure During Pregnancy
38 Years F 6041671 4988325 04/25/2006 Citalopram OT Depression Congenital Anomaly, Congenital Aortic Atresia, Drug Exposure During Pregnancy
38 Years F 6041671 5009812 05/22/2006 Citalopram OT Depression Drug Exposure During Pregnancy
38 Years F 6685292 5776262 01/01/2007 06/16/2008 Citalopram OT Depression Abortion Spontaneous, Amenorrhoea, Drug Exposure During Pregnancy, Intra-Uterine Death
38 Years F 6452587 5486017 10/12/2007 Citalopram OT Depression Abortion Induced, Drug Exposure During Pregnancy, Intra-Uterine Death
40 Years F 6036536 4979110 04/18/2006 Citalopram 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
41 Years F 6137795 5243085 02/13/2007 Citalopram OT Anxiety Disorder Drug Exposure During Pregnancy, Premature Labour
41 Years F 6137795 5367695 06/19/2007 Citalopram OT Anxiety, Anxiety Disorder Drug Exposure During Pregnancy, Neonatal Disorder, Premature Labour, Screaming
41 Years F 6475050 5519164 11/14/2007 Citalopram Depression Abortion, Drug Exposure During Pregnancy
41 Years F 6475050 5530428 11/27/2007 Citalopram Depression Abortion Induced, Drug Exposure During Pregnancy
41 Years F 6476850 5523278 11/16/2007 Citalopram OT Depression Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18
41 Years F 6476853 5523279 11/16/2007 Citalopram OT Depression Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18
41 Years F 6478248 5525461 11/19/2007 Citalopram Depression Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18
41 Years F 6478248 5532152 11/28/2007 Citalopram OT Depression Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18
41 Years F 6478253 5525466 11/19/2007 Citalopram Depression Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18
41 Years F 6478253 5531628 11/28/2007 Citalopram OT Depression Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18
41 Years F 6510538 5552421 12/10/2007 Citalopram OT Depression Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18
41 Years F 6137795 5106256 09/12/2006 Citalopram OT Anxiety Disorder Drug Exposure During Pregnancy, Premature Labour, Tocolysis
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
41 Years F 6137795 5154551 11/13/2006 Citalopram OT Anxiety Disorder Drug Exposure During Pregnancy, Premature Labour
46 Years F 6126444 5093457 07/25/2006 08/28/2006 Citalopram Caesarean Section, Drug Exposure During Pregnancy, Oligohydramnios, Premature Labour
46 Years F 6126444 5107776 07/25/2006 09/14/2006 Seropram Caesarean Section, Drug Exposure During Pregnancy, Infection, Oligohydramnios, Premature Labour, Prolonged Labour
43 Males 121 Females 204 Cases (Gender was not reported for 40 Cases) 315 Individual Safety Reports

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

Akarin (citalopram), Celexa (citalopram), Cipramil (citalopram), Citalopram (citalopram), Sepram (citalopram), Seropram (citalopram)

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

Abdominal Distension, Abdominal Pain, Abnormal Behaviour, Abnormal Faeces, Abortion, Abortion Incomplete, Abortion Induced, Abortion Spontaneous, Abscess, Acidosis, Acquired Epileptic Aphasia, Acute Psychosis, Acute Respiratory Failure, Agitation, Agitation Neonatal, Aids Related Complex, Akathisia, Akinesia, Amenorrhoea, Ammonia Increased, Amniocentesis Abnormal, Amniorrhoea, Amniotic Cavity Disorder, Amniotic Fluid Volume Decreased, Amniotic Fluid Volume Increased, Anaemia, Anal Atresia, Anhedonia, Anomaly of External Ear Congenital, Anophthalmos, Anorexia, Anosmia, Antepartum Haemorrhage, Antidepressant Drug Level Decreased, Anxiety, Apathy, Apgar Score Low, Apnoea, Appetite Disorder, Areflexia, Arnold-Chiari Malformation, Arrested Labour, Arthropathy, Aspiration, Asthenia, Atelectasis, Atrial Septal Defect, Autism, Autonomic Nervous System Imbalance, Back Pain, Bacterial Infection, Base Excess Decreased, Base Excess Negative, Beta Haemolytic Streptococcal Infection, Bipolar Disorder, Bipolar II Disorder, Bleeding Peripartum, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Blood Cortisol Decreased, Blood Glucose Abnormal, Blood Glucose Increased, Blood PH Decreased, Blood Sodium Increased, Bloody Discharge, Brachial Plexopathy, Bradycardia Neonatal, Bradykinesia, Brain Damage, Breast Haemorrhage, Breast Malformation, Breast Mass, Breech Delivery, Breech Presentation, Bronchial Obstruction, Bronchopulmonary Dysplasia, Caesarean Section, Calculus Urinary, Camptodactyly Congenital, Candidiasis, Cardiac Arrest, Cardiac Murmur, Cardiomegaly, Cardiovascular Disorder, Cephalhaematoma, Cephalo-Pelvic Disproportion, Cerebral Haemorrhage, Cerebral Haemorrhage Neonatal, Cerebral Palsy, Cerebrovascular Disorder, Cervix Disorder, Cholestasis, Chorioamnionitis, Chromosomal Deletion, Chromosome Abnormality, Chronic Respiratory Failure, Cleft Lip, Cleft Lip and Palate, Cleft Palate, Clonus, Combined Immunodeficiency, Completed Suicide, Complication of Pregnancy, Complications of Maternal Exposure To Therapeutic Drugs, Condition Aggravated, Confusional State, Congenital Anomaly, Congenital Anomaly of Inner Ear, Congenital Aortic Atresia, Congenital Arterial Malformation, Congenital Atrial Septal Defect, Congenital Cardiovascular Anomaly, Congenital Central Nervous System Anomaly, Congenital Elevation of Scapula, Congenital Eye Disorder, Congenital Eyelid Malformation, Congenital Hand Malformation, Congenital Hydrocephalus, Congenital Hydronephrosis, Congenital Multiplex Arthrogryposis, Congenital Muscle Absence, Congenital Neurological Disorder, Congenital Oral Malformation, Congenital Pulmonary Hypertension, Congenital Pulmonary Valve Atresia, Congenital Scoliosis, Congenital Spinal Fusion, Congenital Torticollis, Congenital Ventricular Septal Defect, Contusion, C-Reactive Protein Increased, Convulsion, Convulsion Neonatal, Coombs Test Positive, Coordination Abnormal, Cor Pulmonale, Corneal Disorder, Crying, Culture Urine Positive, Cyanosis Neonatal, Cyclothymic Disorder, Cystic Lymphangioma, Cystocele, Dacryocystitis Infective, Deafness Congenital, Deafness Unilateral, Death Neonatal, Deformity Thorax, Dehydration, Depersonalisation, Depressed Mood, Depression, Developmental Delay, Diabetes Mellitus, Diaphragmatic Hernia, Diarrhoea, Diarrhoea Neonatal, Disease Recurrence, Disturbance In Attention, Dizziness, Drug Dose Omission, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Drug Interaction, Drug Toxicity, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Duane's Syndrome, Dyskinesia, Dyskinesia Neonatal, Dysmorphism, Dysphoria, Dyspnoea, Dystonia, Echography Abnormal, Ectopic Pregnancy, Electric Shock, Electroencephalogram Abnormal, Emotional Disorder, Emotional Distress, Encephalitis Post Varicella, Epistaxis, Eructation, Escherichia Infection, Euphoric Mood, Exomphalos, Extrapyramidal Disorder, Eye Redness, Eye Rolling, Facial Paresis, Failure To Thrive, Fallot's Tetralogy, False Labour, Fatigue, Fear, Feeding Disorder Neonatal, Feeding Problem In Newborn, Feeding Tube Complication, Feeling Abnormal, Feeling Cold, Feeling Jittery, Fever Neonatal, Flatulence, Fluid Overload, Foetal Cardiac Disorder, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Heart Rate Decreased, Foetal Malformation, Foetal Malposition, Foetal Movements Decreased, Frequent Bowel Movements, Galactostasis, Gastrointestinal Disorder, Gastrointestinal Malformation, Gastrointestinal Motility Disorder, Gastrooesophageal Reflux Disease, General Physical Health Deterioration, Gestational Diabetes, Grand Mal Convulsion, Growth Retardation, Grunting, Haemangioma Congenital, Haematocrit Decreased, Haematocrit Increased, Haemoglobin Decreased, Haemoglobin Increased, Haemorrhage, Haemorrhage Intracranial, Haemorrhoids, Hand Deformity, Head Circumference Abnormal, Head Deformity, Headache, Heart Disease Congenital, Heart Rate Increased, Heart Rate Irregular, Hernia Congenital, Hip Dysplasia, Homicidal Ideation, Hydrocele, Hydrocephalus, Hydronephrosis, Hyperaemia, Hyperbilirubinaemia Neonatal, Hypercapnia, Hyperemesis Gravidarum, Hyperhidrosis, Hyperthermia, Hypertonia, Hypertonia Neonatal, Hypocalcaemia, Hypoglycaemia Neonatal, Hypokinesia, Hypokinesia Neonatal, Hypomania, Hyponatraemia, Hypopnoea, Hyporeflexia, Hypothyroidism, Hypotonia, Hypotonia Neonatal, Hypoventilation, Hypoxia, Immature Respiratory System, Immobile, Inadequate Analgesia, Increased Bronchial Secretion, Induced Labour, Infantile Apnoeic Attack, Infantile Colic, Infantile Spasms, Infection, Inflammation, Influenza, Inguinal Hernia, Insomnia, Inspiratory Capacity Decreased, Intentional Overdose, Intestinal Transposition, Intracranial Aneurysm, Intra-Uterine Death, Irritability, Ischaemia, Jaundice Neonatal, Joint Hyperextension, Kidney Infection, Labour Complication, Labour Induction, Labour Pain, Lethargy, Limb Malformation, Limb Reduction Defect, Lissencephaly, Livedo Reticularis, Loss of Consciousness, Loss of Proprioception, Low Set Ears, Macrocephaly, Major Depression, Malaise, Mania, Marital Problem, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Mean Arterial Pressure Decreased, Meconium In Amniotic Fluid, Meconium Increased, Memory Impairment, Meningorrhagia, Mental Disorder, Mental Retardation Severity Unspecified, Metabolic Acidosis, Metrorrhagia, Microphthalmos, Migraine, Motor Neurone Disease, Movement Disorder, Multiple Congenital Abnormalities, Muscle Spasms, Muscle Twitching, Muscular Dystrophy, Muscular Weakness, Musculoskeletal Stiffness, Myalgia, Myasthenic Syndrome, Mydriasis, Myopathy, Nausea, Neck Pain, Neonatal Apnoeic Attack, Neonatal Asphyxia, Neonatal Aspiration, Neonatal Candida Infection, Neonatal Cholestasis, Neonatal Disorder, Neonatal Hepatomegaly, Neonatal Hypoxia, Neonatal Infection, Neonatal Pneumonia, Neonatal Respiratory Depression, Neonatal Respiratory Distress Syndrome, Neonatal Respiratory Failure, Neonatal Tachycardia, Neonatal Tachypnoea, Nephrolithiasis, Nervous System Disorder, Neuromyopathy, Nipple Disorder, Nipple Pain, Obsessive Thoughts, Obsessive-Compulsive Disorder, Obstruction, Obstructive Airways Disorder, Oculocephalogyric Reflex Absent, Oedema, Oedema Peripheral, Oligohydramnios, Ophthalmia Neonatorum, Opisthotonus, Optic Nerve Hypoplasia, Oral Candidiasis, Overdose, Oxygen Saturation Decreased, Pain, Pain In Extremity, Palatal Disorder, Pallor, Panic Attack, Paraesthesia, Paranoia, Patent Ductus Arteriosus, PCO2 Decreased, Pectus Excavatum, Perianal Abscess, Peripheral Vascular Disorder, Persistent Foetal Circulation, Pervasive Developmental Disorder, Phalangeal Hypoplasia, Physical Assault, Pierre Robin Syndrome, Placenta Praevia, Placental Disorder, Placental Insufficiency, Platelet Count Decreased, Platelet Count Increased, Pleural Haemorrhage, Pneumonia, Pneumonia Aspiration, PO2 Decreased, Poland's Syndrome, Polydactyly, Polyhydramnios, Poor Peripheral Circulation, Poor Sucking Reflex, Post Procedural Complication, Post Procedural Hypothyroidism, Post Procedural Pain, Postmature Baby, Postpartum Depression, Postpartum Haemorrhage, Posturing, Precipitate Labour, Pregnancy Induced Hypertension, Premature Baby, Premature Labour, Premature Rupture of Membranes, Premature Separation of Placenta, Progesterone Decreased, Prolonged Labour, Prominent Epicanthal Folds, Protein Urine, Protein Urine Present, Prothrombin Time Prolonged, Psychomotor Hyperactivity, Psychomotor Retardation, Pterygium, Pulmonary Hypertension, Pulmonary Oedema Neonatal, Pulse Absent, Pupillary Reflex Impaired, Pyelectasia, Pyelocaliectasis, Pyrexia, Rash, Rash Pustular, Red Blood Cells CSF Positive, Red Blood Cells Urine, Regurgitation of Food, Respiration Abnormal, Respiratory Acidosis, Respiratory Arrest, Respiratory Depth Decreased, Respiratory Disorder Neonatal, Respiratory Rate Decreased, Respiratory Rate Increased, Respiratory Tract Infection, Respiratory Tract Malformation, Restlessness, Retrognathia, Rhesus Antibodies Positive, Right Ventricular Systolic Pressure, Road Traffic Accident, Screaming, Sedation, Self-Injurious Ideation, Sepsis, Sepsis Neonatal, Sinus Tachycardia, Sinusitis, Skin Discolouration, Skull Malformation, Sleep Disorder, Small for Dates Baby, Somnolence, Somnolence Neonatal, Spinal Disorder, Spine Malformation, Splenomegaly, Sputum Abnormal, Staring, Stillbirth, Strabismus Congenital, Streptococcal Serology Positive, Stress Symptoms, Sudden Infant Death Syndrome, Suicidal Ideation, Suicide Attempt, Supraventricular Extrasystoles, Synostosis, Synovitis, Tachycardia Foetal, Talipes, Tearfulness, Temperature Regulation Disorder, Thinking Abnormal, Thrombocythaemia, Thyroid Gland Cancer, Thyroidectomy, Tocolysis, Transient Tachypnoea of the Newborn, Transmission of Drug Via Semen, Tremor, Tremor Neonatal, Tricuspid Valve Incompetence, Trisomy 18, Trisomy 21, Ultrasound Scan Abnormal, Umbilical Cord Abnormality, Umbilical Cord Around Neck, Umbilical Hernia, Uterine Contractions Abnormal, Uterine Contractions During Pregnancy, Uterine Infection, Vacuum Extractor Delivery, Vaginal Haemorrhage, Vascular Anomaly, Ventricular Septal Defect, Vertigo, Vesicoureteric Reflux, Visual Acuity Reduced, Visual Disturbance, Vomiting, Vomiting In Pregnancy, Weight Decreased, Weight Fluctuation, Weight Increased, White Blood Cell Count Decreased, White Blood Cell Count Increased, White Blood Cells Urine

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.
  
Akinesia Loss of normal motor function, resulting in impaired muscle movement.
  
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)
  
Anal Atresia The anus is either not present or it is in the wrong place.
  
Anophthalmos A congenital absence of all tissues of the eyes.
  
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)
  
Areflexia The absence of reflexes.
  
Arnold-Chiari Malformation Arnold-Chiari malformation is a rare genetic disorder in which parts of the brain are formed abnormally. Malformations may occur in the lower portion of the brain (cerebellum) or in the brain stem.
  
Atelectasis Atelectasis is a collapse of lung tissue affecting part or all of one lung. This condition prevents normal oxygen absoption to healthy tissues.
  
Atrial Septal Defect An atrial septal defect is an abnormal opening in the wall separating the left and right upper changers (atria) of the heart.
  
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. Foetal Distress Syndrome, Neonatal Respiratory Distress Syndrome, Pierre Robin Syndrome).
  
Congenital Aortic Atresia The congenital absence of the normal valvular orifice into the aorta.
  
Congenital Atrial Septal Defect An abnormal opening in the wall separating the left and right upper chambers (atria) of the heart.
  
Congenital Hydrocephalus Hydrocephalus is an abnormal expansion of cavities (ventricles) within the brain that is caused by the accumulation of cerebrospinal fluid.
  
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.
  
Dyspnoea Difficulty in breathing, often associated with lung or heart disease and resulting in shortness of breath. Also called air hunger.
  
Fallot's Tetralogy A congenital malformation of the heart characterized by a defect in the ventricular septum, misplacement of the origin of the aorta, narrowing of the pulmonary artery, and enlargement of the right ventricle.
  
Foetal Distress Syndrome An abnormal condition of a fetus during gestation or at the time of delivery, marked by altered heart rate or rhythm and leading to compromised blood flow or changes in blood chemistry.
  
Hydronephrosis Hydronephrosis is the swelling of the kidneys when urine flow is obstructed in any of part of the urinary tract. Swelling of the ureter, which always accompanies hydronephrosis, is called hydroureter. Hydronephrosis implies that a ureter and the renal pelvis (the connection of the ureter to the kidney) are overfilled with urine.
  
Hypercapnia A condition marked by an unusually high concentration of carbon dioxide in the blood as a result of hypoventilation (abnormally slow and shallow respiration).
  
Hypertonia Neonatal Hypertonia is a condition marked by an abnormal increase in the tightness of muscle tone and a reduced ability of a muscle to stretch (i.e. an increased stiffness).
  
Hypotonia Neonatal Hypotonia is a condition of abnormally low muscle tone (the amount of tension or resistance to movement in a muscle), often involving reduced muscle strength. Hypotonia is not a specific medical disorder, but a potential manifestation of many different diseases and disorders that affect motor nerve control by the brain or muscle strength.
  
Hypoxia Deficiency in the amount of oxygen reaching body tissues.
  
Microphthalmia Microphthalmia refers to an abnormally small eye. Microphthalmia results from a developmental defect after formation of the optic vesicle. The developmental abnormality causes the optic vesicle to fold inwards, resulting in the formation of a cyst. The cyst will progressively swell from birth, and it may be situated along the optic nerve. The cyst may also be situated along other important eye structures.
  
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.
  
Persistent Foetal Circulation The circulation of blood in the foetus is somewhat different from that of the baby after birth. This transition from foetal to neonatal circulation is one of the major physiologic changes after delivery. Before birth, the lungs are collapsed and the blood pressure in the lungs is quite high. This results in a very low blood flow through the lungs. After delivery, the lungs expand and the blood pressure in the lungs decreases.
In some babies, although the lungs expand the blood vessels in the lungs remain constricted resulting in persistently high blood pressure in the lungs. This reduces the amount of blood that the infant can pump through the lungs. This decreased blood flow through the lungs after birth is called persistent foetal circulation because it is a persistence of the pattern of blood flow normally seen prior to birth during the foetal period.
  
Pierre Robin Syndrome Pierre Robin Syndrome (PRS) is a congenital condition of facial abnormalities in humans. As PRS is not caused by a single defect gene, it is not a genetic syndrome, but rather a chain of certain developmental malformations, one entailing the next.
  
Pierre Robin Syndrome Pierre Robin Syndrome (PRS) is a congenital condition of facial abnormalities in humans. As PRS is not caused by a single defect gene, it is not a genetic syndrome, but rather a chain of certain developmental malformations, one entailing the next. [images]
  
Pulmonary Hypertension Pulmonary hypertension is a rare lung disorder characterized by increased pressure in the pulmonary artery. The pulmonary artery carries oxygen-poor blood from the lower chamber on the right side of the heart (right ventricle) to the lungs where it picks up oxygen ... the disorder results in thickening of the pulmonary arteries and narrowing of these blood vessels. In response, the right side of the heart works harder to move the blood through these arteries and it becomes enlarged. Eventually overworking the right side of the heart may lead to right-sided heart failure, resulting in death.
  
Trisomy A condition in which an extra copy of a chromosome is present in the cell nuclei, causing developmental abnormalities.
  
Trisomy 18 Edwards' syndrome is caused by an extra (third) copy of chromosome 18. The extra chromosome is lethal for most babies born with this condition. It causes major physical abnormalities and severe mental retardation. Very few children afflicted with this syndrome survive beyond the first year.
  
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. This blood recycles through the lungs before returning to the left ventricle. This results in less oxygenated blood reaching the body. If the hole is sufficiently large, the lack of oxygen being delivered to the body can cause severe problems, including heart failure and breathlessness.
  
Williams Syndrome Typical facial features seen in children with Williams syndrome include a wide mouth with full lips, a small chin, and a short, slightly upturned nose. Children with blue or green eyes often times show a starburst pattern in the colored part (iris) of the eyes. An unusual narrowing of the aorta called supravalvular aortic stenosis is often present, and hernias are often seen in the inguinal area of the abdomen. The blood vessels and abdominal wall often show weakness or altered development. Muscle tone is typically low, and children are often on the low end of birth weight, with relatively poor weight gain and growth in their early years.


Top 20 Adverse Reactions
Adverse Reaction Cases
Drug Exposure During Pregnancy 185
Neonatal Disorder 29
Caesarean Section 28
Abortion Induced 28
Premature Baby 27
Maternal Drugs Affecting Foetus 20
Drug Withdrawal Syndrome Neonatal 18
Premature Labour 17
Apgar Score Low 16
Congenital Anomaly 14
Drug Exposure Via Breast Milk 12
Trisomy 18 11
Neonatal Respiratory Distress Syndrome 11
Hypotonia Neonatal 11
Convulsion Neonatal 11
Abortion Spontaneous 11
Intra-Uterine Death 9
Multiple Congenital Abnormalities 8
Nausea 7
Irritability 7


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 Citalopram 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".