Sertraline - 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
4029187 4279756 01/23/2004 Zoloft MD Anxiety, Depression Maternal Drugs Affecting Foetus, Talipes
F 4029187 4439802 08/31/2004 Zoloft MD Anxiety, Depression Drug Exposure During Pregnancy, Talipes
M 4072673 4274585 01/15/2004 Lustral Ill-Defined Disorder Cleft Palate, Maternal Drugs Affecting Foetus
M 4079383 4279593 01/01/2003 01/23/2004 Zoloft Depression Developmental Delay, Maternal Drugs Affecting Foetus, Premature Baby
M 4079383 4320442 01/01/2003 03/17/2004 Zoloft Depression Developmental Delay, Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus, Premature Baby
4091275 4290905 02/09/2004 Sertraline Depression Cleft Palate, Maternal Drugs Affecting Foetus
4091288 4290304 02/09/2004 Zoloft PH Ill-Defined Disorder Craniosynostosis, Maternal Drugs Affecting Foetus, Neonatal Disorder, Sedation
M 4096798 4299537 01/22/2004 02/17/2004 01/24/2004 Sertraline MD Depression Complications of Maternal Exposure To Therapeutic Drugs, Congenital Diaphragmatic Anomaly, Death Neonatal, Maternal Drugs Affecting Foetus
F 4104019 4309452 03/01/2003 03/01/2004 Zoloft CN Anxiety Abortion Spontaneous, Anxiety, Complications of Maternal Exposure To Therapeutic Drugs, Insomnia, Maternal Drugs Affecting Foetus
4115647 4323764 03/23/2004 Sertraline PH Ill-Defined Disorder Congenital Pulmonary Hypertension, Maternal Drugs Affecting Foetus
M 4116429 4325035 06/10/2001 03/26/2004 Zoloft CN Depression Abnormal Behaviour, Convulsion, Developmental Coordination Disorder, Drug Withdrawal Syndrome, Failure To Thrive, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Hypersensitivity, Respiratory Disorder, Sleep Disorder, Speech Disorder Developmental
F 4132230 4343822 04/19/2004 Zoloft MD Ill-Defined Disorder Complications of Maternal Exposure To Therapeutic Drugs, Intra-Uterine Death, 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
F 4141045 4357105 05/07/2004 Zoloft CN Ill-Defined Disorder Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Maternal Drugs Affecting Foetus
F 4146108 4362205 05/17/2004 Zoloft Depression Abdominal Pain Upper, Abortion Spontaneous, Anorexia, Complications of Maternal Exposure To Therapeutic Drugs, Diarrhoea, Insomnia, Maternal Drugs Affecting Foetus, Tremor
F 4149822 4366950 05/24/2004 Zoloft MD Depression Abnormal Labour, Caesarean Section, Drug Exposure During Pregnancy
F 4152267 4369731 01/01/2001 05/28/2004 Zoloft Depression Blood Pressure Decreased, Bruxism, Cardiac Failure Congestive, Cardiomyopathy, Drug Exposure During Pregnancy, Tooth Injury, Treatment Noncompliance
F 4160344 4381536 06/16/2004 Zoloft MD Anxiety Apgar Score Low, Blood PH Decreased, Congenital Nystagmus, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Disorder, Oxygen Saturation Decreased, Premature Baby, Respiration Abnormal, Sleep Study Abnormal
M 4164173 4386979 06/23/2004 Sertraline MD Ill-Defined Disorder Drug Exposure During Pregnancy, Hypertonia Neonatal, Hypopnoea, Neonatal Disorder, Neonatal Respiratory Acidosis, Premature Baby
M 4164173 4681058 06/01/2005 Sertraline MD Drug Exposure During Pregnancy, Drug Toxicity, Drug Withdrawal Syndrome, Encephalopathy Neonatal, Hypertonia Neonatal, Neonatal Respiratory Acidosis, Neonatal Respiratory Distress Syndrome, Poisoning, Premature Baby
F 4169345 4394826 07/07/2004 Zoloft PH Depression Complications of Maternal Exposure To Therapeutic Drugs, Condition Aggravated, Depression, Vomiting
4171854 4396018 06/25/2004 07/08/2004 Zoloft MD Ill-Defined Disorder Drug Exposure Via Breast Milk, Hypotonia
F 4173942 4398380 03/10/2004 07/12/2004 Zoloft CN Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Eye Movement Disorder, Neonatal Disorder
F 4173942 4432758 08/20/2004 Zoloft Ill-Defined Disorder Congenital Nystagmus, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Eye Movement Disorder, Neonatal Disorder
M 4173949 4398702 07/12/2004 Sertraline MD Ill-Defined Disorder Drug Exposure During Pregnancy, Talipes
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 4173949 4424117 08/09/2004 Sertraline MD Ill-Defined Disorder Drug Exposure During Pregnancy, Talipes
M 4181059 4408247 07/22/2004 Sertraline MD Depression Double Outlet Right Ventricle, Drug Exposure During Pregnancy
4190892 4420032 01/01/2004 08/04/2004 Zoloft MD Ill-Defined Disorder Congenital Absence of Cranial Vault, Maternal Drugs Affecting Foetus
4190892 4433757 01/01/2004 08/25/2004 Zoloft MD Depression Abortion Induced, Anencephaly, Congenital Anomaly, Drug Exposure During Pregnancy
4192193 4423383 08/06/2004 Zoloft MD Stress Symptoms Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypersensitivity, Hypoglycaemia Neonatal, Neonatal Apnoeic Attack, Neonatal Disorder, Unresponsive To Pain Stimuli
4194581 4415350 06/30/2004 Zoloft Ill-Defined Disorder Drug Withdrawal Syndrome Neonatal
4199961 4432602 08/20/2004 Zoloft PH Ill-Defined Disorder Drug Exposure During Pregnancy, Foetal Heart Rate Decreased
4199961 4462199 09/24/2004 Zoloft PH Ill-Defined Disorder Drug Exposure During Pregnancy, Foetal Heart Rate Decreased
4206205 4438718 08/30/2004 Zoloft MD Ill-Defined Disorder Death Neonatal, Drug Exposure During Pregnancy
4206205 4467352 10/04/2004 Zoloft MD Ill-Defined Disorder Death Neonatal, Drug Exposure During Pregnancy, Foetal Disorder, Renal Disorder
M 4215277 4451661 12/24/2003 09/15/2004 Lustral MD Depression Suicidal Drug Withdrawal Syndrome, Hypotonia, Maternal Drugs Affecting Foetus, Restlessness, Shock, Tremor Neonatal
F 4219244 4456694 09/21/2004 Zoloft MD Ill-Defined Disorder 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
F 4221482 4457742 09/22/2004 Sertraline PH Ill-Defined Disorder Drug Exposure During Pregnancy, Foetal Growth Retardation, Oligohydramnios
M 5665142 4467035 10/04/2004 Zoloft Mental Disorder Anger, Autism, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspnoea, Feeling Abnormal, Growth Retardation, Hypersensitivity, Mental Retardation Severity Unspecified, Mentally Late Developer, Movement Disorder, Nasopharyngitis, Neonatal Disorder
M 5691385 4515499 11/26/2004 Zoloft OT Depression Breech Presentation, Caesarean Section, Congenital Macrocephaly, Drug Exposure During Pregnancy
M 5691385 4551622 01/11/2005 Zoloft OT Depression Breech Presentation, Caesarean Section, Chromosome Abnormality, Congenital Anomaly, Drug Exposure During Pregnancy, Macrocephaly
5691595 4517000 11/30/2004 Zoloft MD Ill-Defined Disorder Caesarean Section, Drug Exposure During Pregnancy, Stillbirth
F 5703047 4530585 01/01/2004 12/16/2004 Lustral OT Depression Convulsion, Drug Exposure Via Breast Milk, Epilepsy
F 5708736 4539759 12/22/2004 Zoloft OT Ill-Defined Disorder Drug Exposure During Pregnancy, Premature Labour, Vaginal Haemorrhage
F 5708809 4539805 12/22/2004 Zoloft OT Ill-Defined Disorder Bed Rest, Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy, Premature Baby, Vaginal Haemorrhage
5730126 4565038 01/26/2005 Sertraline OT Depression Abortion Induced, Drug Exposure During Pregnancy, Hypoplastic Left Heart Syndrome
M 5741859 4576819 01/01/2004 02/07/2005 Zoloft Blood Bilirubin Increased, Caesarean Section, Coombs Direct Test Positive, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Flatulence, Large for Dates Baby, Transfusion Reaction
M 5741859 4596856 01/01/2004 02/28/2005 Zoloft MD Ill-Defined Disorder Amniotic Fluid Volume Increased, Blood Bilirubin Increased, Blood Pressure Increased, Caesarean Section, Coombs Test Positive, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Flatulence, Pre-Eclampsia, Premature Rupture of Membranes, Transfusion Reaction, Weight Decreased
F 5743853 4579166 08/30/2002 02/08/2005 Zoloft OT 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
5748451 4586492 02/14/2005 Zoloft MD Ill-Defined Disorder Drug Exposure During Pregnancy, Foetal Heart Rate, Pulmonary Artery Atresia, Transposition of the Great Vessels, Univentricular Heart
M 5748451 4775029 09/20/2005 Zoloft MD Ill-Defined Disorder Abortion Induced, Congenital Pulmonary Valve Atresia, Drug Exposure During Pregnancy, Heart Disease Congenital, Pulmonary Artery Atresia, Transposition of the Great Vessels, Univentricular Heart, Ventricular Hypoplasia
F 5757417 4598861 01/01/2004 03/01/2005 Zoloft MD Depression Abortion Induced, Caudal Regression Syndrome, Drug Exposure During Pregnancy
5757417 4651028 01/01/2004 04/29/2005 Zoloft MD Abortion Induced, Caudal Regression Syndrome, Drug Exposure During Pregnancy
5764329 4607006 03/10/2005 Zoloft MD Ill-Defined Disorder Drug Exposure During Pregnancy, Dyspnoea, Haematocrit Decreased, Neonatal Disorder, Snoring
M 5764329 4665299 05/17/2005 Zoloft MD Drug Exposure During Pregnancy, Haematocrit Decreased, Neonatal Disorder, Respiratory Disorder Neonatal, Snoring
5769351 4618147 03/22/2005 Zoloft MD Ill-Defined Disorder Drug Exposure During Pregnancy, Limb Reduction Defect
5769351 4672914 03/08/2005 05/23/2005 Zoloft MD Congenital Hand Malformation, Drug Exposure During Pregnancy
5773767 4627281 01/01/2004 03/31/2005 Zoloft MD Ill-Defined Disorder Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Heart Disease Congenital
5783410 4640448 04/19/2005 Zoloft MD Congenital Anomaly, Drug Exposure During Pregnancy
F 5808187 4672764 05/23/2005 Sertraline MD Agitation Neonatal, Blood Pressure Increased, Drug Exposure During Pregnancy, Feeling Jittery, Hypoglycaemia, Inappropriate Antidiuretic Hormone Secretion, Jaundice Neonatal, Large for Dates Baby, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Opisthotonus, Premature Baby, Serotonin Syndrome
M 5808310 4672755 01/01/2004 05/23/2005 12/12/2004 Zoloft MD Coarctation of the Aorta, Drug Exposure During Pregnancy, Shock, 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 5812212 4678867 02/08/2003 05/31/2005 Zoloft MD Abdominal Pain, Autism Spectrum Disorder, Caesarean Section, Drug Exposure During Pregnancy, Neonatal Disorder, Small for Dates Baby
F 5812267 4678849 05/31/2005 Zoloft MD Caesarean Section, Drug Exposure During Pregnancy, Infertility, Laboratory Test Interference, Metrorrhagia
M 5817786 4681897 06/02/2005 Sertraline PH Ankyloglossia Congenital, Drug Exposure During Pregnancy
M 5821030 4686440 06/06/2005 Zoloft MD Drug Exposure During Pregnancy, Talipes
F 5829949 4698499 06/22/2005 Zoloft CN Abortion Spontaneous, Agitation, Bipolar Disorder, Caesarean Section, Depression, Drug Exposure During Pregnancy, Feeling Abnormal, Hallucination (Auditory), Hyperphagia, Hypersomnia, Intentional Self-Injury, Laceration, Mood Swings, Premature Labour, Psychomotor Hyperactivity, Suicidal Ideation, Suicide Attempt, Weight Decreased, Weight Increased
F 5837336 4713165 07/01/2005 Zoloft Anxiety, Depression Affective Disorder, Anxiety, Drug Exposure During Pregnancy, Drug Ineffective, Haematoma, Haemorrhage, Insomnia, Panic Attack, Weight Increased
5837384 4713143 07/01/2005 Zoloft PH Ill-Defined Disorder Blood Glucose Abnormal, Drug Exposure During Pregnancy
M 5847805 4720539 05/01/2002 07/19/2005 Zoloft Ill-Defined Disorder Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy
F 5875780 4759815 09/30/2005 08/31/2005 Zoloft CN Depression, Obsessive-Compulsive Disorder Anger, Divorced, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Hearing Impaired, Hot Flush, Lethargy, Nightmare, Overweight, Paraesthesia, Visual Disturbance
5889761 4779487 09/23/2005 Zoloft Ill-Defined Disorder Congenital Anomaly, Drug Exposure During Pregnancy
M 5890907 4854906 05/19/2003 12/13/2005 Zoloft MD Ill-Defined Disorder Apgar Score Low, Body Temperature Increased, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, Respiratory Disorder Neonatal
M 5890907 4855574 05/19/2003 12/14/2005 Zoloft MD Ill-Defined Disorder Apgar Score Low, Body Temperature Increased, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspnoea, Respiratory Disorder Neonatal, 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 5898138 4788078 10/03/2005 Zoloft OT Anxiety Disorder Drug Exposure During Pregnancy, Fallot's Tetralogy
F 5898138 4796751 10/07/2005 Zoloft OT Anxiety Disorder Drug Exposure During Pregnancy, Fallot's Tetralogy
M 5906784 4801462 09/01/2005 10/11/2005 Zoloft PH Ill-Defined Disorder Caesarean Section, Drug Exposure During Pregnancy, Inappropriate Antidiuretic Hormone Secretion, Irritability, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Transient Tachypnoea of the Newborn, Urine Output Decreased
M 5906784 4835875 09/01/2005 11/18/2005 Zoloft PH Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Inappropriate Antidiuretic Hormone Secretion, Irritability, Neonatal Respiratory Distress Syndrome, Transient Tachypnoea of the Newborn, Urine Output Decreased
5923839 4823689 11/07/2005 Sertraline OT Ill-Defined Disorder Abortion Induced, Brain Malformation, Congenital Anomaly, Congenital Central Nervous System Anomaly, Drug Exposure During Pregnancy
F 5939541 4845459 11/25/2005 Lustral MD Ill-Defined Disorder Drug Exposure During Pregnancy, Ectopic Pregnancy
F 5939541 4847636 12/05/2005 Sertraline MD Ill-Defined Disorder Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy
F 5939541 4871702 12/30/2005 Lustral MD Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy, Treatment Noncompliance
F 5940968 4846166 12/01/2005 Sertraline MD Obsessive-Compulsive Disorder Abortion Spontaneous, Congenital Anomaly, Drug Exposure During Pregnancy
5940978 4846213 12/01/2005 Sertraline MD Ill-Defined Disorder Abortion, Congenital Anomaly, Drug Exposure During Pregnancy
5940978 4911957 09/01/2005 02/13/2006 Sertraline MD Ill-Defined Disorder Abortion Spontaneous, Congenital Anomaly, Drug Exposure During Pregnancy
F 5953854 4866747 01/01/2005 12/21/2005 Zoloft MD Ill-Defined Disorder Caesarean Section, Drug Exposure During Pregnancy, Premature Baby, 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 5954808 4866630 01/01/2005 12/22/2005 Zoloft MD Ill-Defined Disorder Caesarean Section, Drug Exposure During Pregnancy, Hellp Syndrome, Pre-Eclampsia, Premature Baby, Small for Dates Baby
F 5954808 4903425 01/01/2005 02/03/2006 Zoloft MD Ill-Defined Disorder Caesarean Section, Drug Exposure During Pregnancy, Hellp Syndrome, Pre-Eclampsia, Premature Baby, Small for Dates Baby
F 5961056 4874852 01/04/2006 Sertraline OT Coarctation of the Aorta, Drug Exposure During Pregnancy
F 5962022 5195424 01/01/2000 12/29/2006 Zoloft CN Depression Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Crying, Decreased Appetite, Depression, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain In Extremity, Phobia, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Suicide Attempt, Tachycardia, Tremor, Vaginal Infection, Weight Decreased
F 5962022 5226451 01/01/2000 02/01/2007 Zoloft CN Depression Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Breast Pain, Crying, Decreased Appetite, Depression, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain In Extremity, Phobia, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Suicide Attempt, Tachycardia, Tremor, Vaginal Infection, Weight Decreased
F 5962022 5237992 01/01/2000 02/14/2007 Zoloft CN Depression Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Breast Pain, Confusional State, Crying, Decreased Appetite, Depression, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain In Extremity, Phobia, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased
F 5962022 5267677 01/01/1999 03/16/2007 Zoloft CN Depression Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Breast Pain, Confusional State, Crying, Decreased Appetite, Depression, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, Weight Increased
F 5962022 5279491 01/01/1999 03/28/2007 Zoloft CN Depression Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Blood Prolactin Increased, Breast Pain, Confusional State, Crying, Decreased Appetite, Depression, Dizziness, Drug Ineffective, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Rhinitis, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Stress, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, Weight Increased
F 5962022 5289846 01/01/1999 04/06/2007 Zoloft CN Depression Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Blood Prolactin Increased, Breast Pain, Confusional State, Crying, Decreased Appetite, Depression, Dizziness, Drug Ineffective, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Rhinitis, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Stress, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, Weight Increased
F 5962022 5352908 01/01/1999 06/11/2007 Zoloft CN Depression Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Blood Prolactin Increased, Breast Pain, Confusional State, Constipation, Crying, Decreased Appetite, Depression, Dizziness, Drug Ineffective, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Premenstrual Syndrome, Rhinitis, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Stress, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, Weight Increased
F 5962022 5398991 01/01/1999 07/27/2007 Zoloft CN Depression Abdominal Pain, Abortion, Agitation, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Blood Prolactin Increased, Breast Pain, Confusional State, Constipation, Crying, Decreased Appetite, Depression, Dizziness, Drug Ineffective, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Premenstrual Syndrome, Rhinitis, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Stress, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, Weight Increased
F 5962022 5406203 01/01/1999 08/06/2007 Zoloft CN Depression Abdominal Pain, Abortion, Agitation, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Blood Prolactin Increased, Breast Pain, Confusional State, Constipation, Crying, Decreased Appetite, Depression, Dizziness, Drug Ineffective, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Premenstrual Syndrome, Rhinitis, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Stress, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, Weight Increased
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5962022 5411492 01/01/1999 08/10/2007 Zoloft CN Depression Abdominal Pain, Abortion, Agitation, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Blood Prolactin Increased, Breast Pain, Confusional State, Constipation, Crying, Decreased Appetite, Depression, Dizziness, Drug Ineffective, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hunger, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Premenstrual Syndrome, Rhinitis, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Stress, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, Weight Increased
5976331 4893368 01/24/2006 Sertraline OT Ill-Defined Disorder Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy
5976331 4915701 02/13/2006 Sertraline OT Ill-Defined Disorder Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy
5976463 4895571 01/25/2006 Sertraline OT Ill-Defined Disorder Congenital Anomaly, Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy
5976463 4915699 02/13/2006 Sertraline OT Ill-Defined Disorder Congenital Anomaly, Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy
F 5980471 4905986 05/01/1997 02/06/2006 Zoloft Depression, Obsessive-Compulsive Disorder Abortion Induced, Abortion Spontaneous, Aggression, Arthritis, Bronchitis, Burning Sensation, Caesarean Section, Drug Exposure During Pregnancy, Drug Intolerance, Economic Problem, Ectopic Pregnancy, Ectopic Pregnancy Termination, Inflammation, Irritable Bowel Syndrome, Laceration, Movement Disorder, Multiple Allergies, Pneumonia, Postpartum Depression, Skin Burning Sensation
F 5982314 4898724 05/01/1996 01/31/2006 Zoloft Depression Drug Exposure During Pregnancy, Jaundice Neonatal, Neonatal Aspiration, Neonatal Hypoxia
F 5982428 4898726 01/31/2006 Zoloft Depression Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome, Premature Baby
5982430 4898727 05/01/2002 01/31/2006 06/01/2002 Zoloft Depression Abortion Spontaneous, Drug Exposure Before Pregnancy, Foetal Heart Rate Abnormal
M 5982437 4898728 01/01/2003 01/31/2006 Zoloft Depression Birth Trauma, Caesarean Section, Contusion, Drug Exposure During Pregnancy, Foetal Heart Rate Decreased, Head Injury, Jaundice Neonatal, Psychomotor Hyperactivity
5985812 4901363 02/02/2006 Zoloft OT Ill-Defined Disorder Drug Exposure During Pregnancy, Heart Disease Congenital
5985812 4931342 02/28/2006 Zoloft OT Ill-Defined Disorder Congenital Pulmonary Hypertension, Drug Exposure During Pregnancy, Transposition of the Great Vessels
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5987973 4903719 04/13/2005 02/02/2006 Zoloft MD Depression Congenital Foot Malformation, Drug Exposure During Pregnancy
F 5988300 4910686 02/08/2006 Zoloft MD Depression Amniotic Fluid Volume Decreased, Death Neonatal, Drug Exposure During Pregnancy, Pulmonary Hypoplasia, Renal Aplasia
5993043 4914129 02/10/2006 Zoloft MD Ill-Defined Disorder Congenital Anomaly, Drug Exposure During Pregnancy
M 5997647 4919120 10/01/2004 02/16/2006 Zoloft OT Ill-Defined Disorder Abdominal Pain, Anorectal Disorder, Ano-Rectal Stenosis, Cardiac Murmur, Dacryostenosis Congenital, Drug Exposure During Pregnancy, Foetal Disorder, Gastrooesophageal Reflux Disease, Liver Disorder, Neonatal Disorder, Renal Disorder, Ultrasound Antenatal Screen Abnormal, Vomiting Neonatal
M 5999313 4923537 02/21/2006 Zoloft Ill-Defined Disorder Drug Exposure During Pregnancy, Premature Baby
5999314 4923538 02/21/2006 Zoloft Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Ineffective, Premature Baby
F 5999316 4923539 02/21/2006 Zoloft Ill-Defined Disorder Blindness, Cerebral Haemorrhage Neonatal, Cerebral Palsy, Cerebrovascular Accident, Choking, Congenital Anomaly, Congenital Central Nervous System Anomaly, Convulsion Neonatal, Developmental Delay, Drug Exposure During Pregnancy, Foetal Disorder, Neonatal Disorder, Paralysis, Premature Baby
F 5999322 4923543 02/21/2006 Zoloft Depression Abortion Spontaneous, Benign Hydatidiform Mole, Drug Exposure During Pregnancy, Drug Ineffective
6004426 4931423 02/28/2006 Sertraline Ill-Defined Disorder Drug Exposure During Pregnancy, Neonatal Respiratory Failure, Persistent Foetal Circulation
6004426 4935162 03/02/2006 Sertraline Ill-Defined Disorder Drug Exposure During Pregnancy, Neonatal Respiratory Failure
M 6012204 4947470 03/13/2006 Zoloft Ill-Defined Disorder Caesarean Section, Drug Dependence, Drug Exposure During Pregnancy, Hypothermia Neonatal, Neonatal Complications of Substance Abuse, Neonatal Disorder, Obstetric Procedure Complication, Placenta Praevia, Premature Baby, Small for Dates Baby, Weight Decrease Neonatal
F 6017790 4952799 03/20/2006 Zoloft Ill-Defined Disorder Back Pain, Cardiac Failure Congestive, Condition Aggravated, Crying, Drug Exposure During Pregnancy, Emotional Disorder, False Labour, Fluid Overload, Fluid Retention
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6017866 4952879 03/20/2006 Zoloft Ill-Defined Disorder Adenotonsillectomy, Clavicle Fracture, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hypersensitivity, Mood Altered, Nasopharyngitis, Neonatal Disorder
6025552 4963873 03/30/2006 Zoloft OT Ill-Defined Disorder Drug Exposure During Pregnancy, Muscle Rigidity
6028166 4968167 04/05/2006 Zoloft MD Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Muscle Spasms, Myoclonus, Premature Baby
F 6030534 4971758 04/06/2006 Sertraline Ill-Defined Disorder Drug Toxicity, Drug Withdrawal Syndrome Neonatal, Electroencephalogram Abnormal, Feeling Jittery, Irritability, Myoclonus, Opisthotonus, Tardive Dyskinesia
F 6030534 4978204 04/17/2006 Sertraline MD Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Electroencephalogram Abnormal
M 6032090 4973917 04/10/2006 Sertraline MD Depression Abdominal Pain, Adenocarcinoma, Back Pain, Cognitive Disorder, Coma, Compression Fracture, Drug Interaction, Drug Level Increased, Drug Toxicity, Drug Withdrawal Syndrome, Failure To Thrive, Gastrooesophageal Cancer, Hallucination, Laboratory Test Interference, Malnutrition, Myoclonus, Osteoporosis, Pain, Respiratory Depression, Schizophrenia (Paranoid Type)
6032118 4974597 12/01/2004 04/10/2006 Zoloft Ill-Defined Disorder Drug Exposure During Pregnancy, Premature Baby
M 6032118 4978933 01/01/2005 04/17/2006 Zoloft Ill-Defined Disorder Depression, Drug Exposure During Pregnancy, Eclampsia, Gestational Diabetes, Pre-Eclampsia, Premature Labour
6036577 4980890 04/18/2006 Zoloft MD Ill-Defined Disorder Drug Exposure During Pregnancy, Speech Disorder Developmental
6036577 5021750 06/05/2006 Zoloft MD Ill-Defined Disorder Drug Exposure During Pregnancy, Speech Disorder Developmental
F 6050909 5000500 05/01/2006 Zoloft PH Ill-Defined Disorder Drug Exposure During Pregnancy, High Risk Pregnancy
6052121 5003389 05/11/2006 Sertraline OT Depression Drug Exposure During Pregnancy, Trisomy 13
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6059314 5012114 05/24/2006 Zoloft Bipolar I Disorder Crying, Depressed Mood, Drug Exposure During Pregnancy, Feeling Abnormal, Irritability, Post-Traumatic Stress Disorder, Uterine Leiomyoma
6062602 5018180 02/16/2006 05/30/2006 Zoloft MD Ill-Defined Disorder Drug Exposure During Pregnancy, Trisomy 21
F 6068239 5025988 06/12/2006 Zoloft CN Drug Exposure During Pregnancy
F 6071696 5027296 06/08/2006 Zoloft MD Affective Disorder, Bulimia Nervosa Appendicectomy, Drug Exposure During Pregnancy
F 6074637 5030049 06/14/2006 Zoloft MD Anxiety Disorder, Major Depression Caesarean Section, Drug Dependence, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Respiratory Distress Syndrome, Pericardial Effusion
F 6074728 5030328 06/15/2006 Zoloft MD Ill-Defined Disorder Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Disorder, Neonatal Respiratory Distress Syndrome, Pericardial Effusion
F 6082098 5046659 06/26/2006 07/07/2006 Zoloft CN Obsessive-Compulsive Disorder Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Tremor Neonatal
F 6094262 5060200 01/01/2006 07/20/2006 Zoloft Depression Anxiety, Drug Exposure During Pregnancy, Heart Rate Increased, Mental Disorder
F 6094262 5087111 01/01/2006 08/21/2006 Zoloft Depression Anxiety, Drug Exposure During Pregnancy, Heart Rate Increased, Mental Disorder
6097216 5062325 07/21/2006 Zoloft OT Depression Alpha 1 Foetoprotein Amniotic Fluid Increased, Drug Exposure During Pregnancy, Foetal Disorder, Microcephaly, Restlessness, Schizophrenia (Paranoid Type), Spinal Deformity
6097216 5170577 12/05/2006 Zoloft OT Depression Alpha 1 Foetoprotein Increased, Drug Exposure During Pregnancy, Microcephaly, Spine Malformation
F 6119624 5087490 08/21/2006 Zoloft Drug Use for Unknown Indication Depersonalisation, Drug Exposure Before Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6127279 5096582 08/30/2006 Zoloft MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Polydactyly
M 6127279 5109788 09/15/2006 Zoloft MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Polydactyly
F 6130557 5100783 09/06/2006 Zoloft Drug Use for Unknown Indication Caesarean Section, Drug Exposure During Pregnancy, Placenta Praevia
F 6130557 5100902 09/06/2006 Zoloft Drug Use for Unknown Indication Caesarean Section, Drug Exposure During Pregnancy, Placenta Praevia, Treatment Noncompliance, Wrong Technique In Drug Usage Process
M 6132419 5102426 08/01/2006 09/07/2006 Sertraline MD Drug Use for Unknown Indication Circulatory Failure Neonatal, Cyanosis Neonatal, Drug Exposure During Pregnancy, Neonatal Disorder, Pulmonary Hypertension
M 6138425 5107885 05/15/2006 09/15/2006 05/15/2006 Zoloft Pelvic Pain Death Neonatal, Drug Exposure During Pregnancy, Premature Baby
M 6141471 5115370 09/22/2006 Sertraline MD Depression Apgar Score Low, Drug Exposure During Pregnancy, Transient Tachypnoea of the Newborn
F 6141550 5115354 09/22/2006 Zoloft MD Abortion Spontaneous, Anxiety, Drug Exposure During Pregnancy
F 6150456 5126474 10/10/2006 Zoloft Postpartum Depression Drug Exposure During Pregnancy
F 6151008 5127963 10/10/2006 Sertraline OT Depression Anaemia, Drug Exposure During Pregnancy, Haemorrhage, Labour Complication, Premature Baby
6161631 5143671 11/03/2006 Sertraline Drug Exposure During Pregnancy, Fallot's Tetralogy
M 6161913 5135563 09/25/2005 10/20/2006 Zoloft OT Depression Drug Exposure During Pregnancy, Pulmonary Hypoplasia, Renal Aplasia
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6161913 5149947 09/25/2005 11/08/2006 09/25/2005 Zoloft OT Depression Anal Atresia, Congenital Great Vessel Anomaly, Death Neonatal, Drug Exposure During Pregnancy, Pulmonary Hypoplasia, Renal Aplasia, Ventricular Septal Defect
M 6163094 5136637 10/23/2006 Zoloft Developmental Delay, Drug Exposure Via Breast Milk
6177271 5154390 11/14/2006 Sertraline OT Drug Exposure During Pregnancy, Heart Disease Congenital
6177271 5154428 11/14/2006 Sertraline OT Congenital Anomaly, Drug Exposure During Pregnancy, Multiple Cardiac Defects
6177454 5154422 11/14/2006 Sertraline OT Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital
6177454 5155632 11/14/2006 Sertraline OT Drug Exposure During Pregnancy, Fallot's Tetralogy
F 6180068 5157791 11/16/2006 Zoloft Depression Drug Exposure During Pregnancy, Uterine Contractions Abnormal
M 6188507 5167682 04/01/2006 12/01/2006 Zoloft Depression, Obsessive-Compulsive Disorder, Post-Traumatic Stress Disorder Cleft Lip, Congenital Anomaly, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy
F 6205538 5179886 12/11/2006 11/19/2006 Sertraline MD Depression Apgar Score Low, Brain Damage, Caesarean Section, Drug Exposure During Pregnancy, Encephalitis, Neonatal Asphyxia, Neonatal Disorder, Placenta Praevia
F 6205863 5195390 01/17/2004 12/29/2006 01/17/2004 Zoloft CN Panic Attack Drug Exposure During Pregnancy, Stillbirth
F 6205867 5195394 12/19/2006 12/29/2006 Zoloft CN Panic Attack Dizziness, Drug Exposure During Pregnancy, Fall, Nausea
F 6207748 5189934 12/15/2006 Zoloft Depression, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, Somnolence 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 6216358 5209695 01/01/2006 01/16/2007 Lustral MD Depression Drug Exposure During Pregnancy, Postpartum Depression, Weight Increased
F 6216358 5213797 01/01/2006 01/19/2007 Lustral MD Depression Postpartum Depression, Weight Increased
M 6219032 5213781 03/01/2005 01/19/2007 Zoloft OT Dysthymic Disorder Dental Caries, Drug Exposure During Pregnancy, Enamel Anomaly, Tooth Disorder
M 6220152 5215038 10/03/2006 01/22/2007 Zoloft MD Choking, Cyanosis, Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Jaundice Neonatal, Retching, Vomiting
M 6237091 5224759 01/23/2007 01/29/2007 Zoloft MD Depression Congenital Anomaly, Drug Exposure During Pregnancy, Polydactyly, Syndactyly
6238139 5227169 01/30/2007 Sertraline Drug Use for Unknown Indication Cleft Palate, Drug Exposure During Pregnancy
6241009 5230775 02/02/2007 Sertraline Cleft Lip and Palate, Drug Exposure During Pregnancy
F 6244433 5245702 10/01/2006 02/23/2007 Zoloft CN Anxiety Abortion Spontaneous
6255718 5258146 03/07/2007 Sertraline Cleft Lip, Cleft Palate
6255733 5258153 03/07/2007 Sertraline Cleft Lip, Cleft Palate, Congenital Anomaly, Drug Exposure During Pregnancy
F 6258271 5261149 11/03/2006 03/09/2007 Zoloft MD Affective Disorder Arrested Labour
F 6259897 5254889 02/19/2007 03/02/2007 Zoloft MD Anxiety, Depression Cerebral Cyst, Congenital Central Nervous System Anomaly, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Polydactyly, Tremor
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6260279 5264063 03/13/2007 Sertraline Cleft Lip, Cleft Palate, Drug Exposure During Pregnancy
F 6262816 5266609 12/01/2006 03/15/2007 Zoloft MD Depression Coarctation of the Aorta, Drug Exposure During Pregnancy, Neonatal Aspiration, Pyloric Stenosis
F 6262825 5266618 11/01/2006 03/15/2007 Zoloft MD Depression Drug Exposure During Pregnancy, Urinary Tract Infection
6274536 5271848 01/01/2006 03/16/2007 Sertraline Cleft Lip and Palate, Drug Exposure During Pregnancy
F 6293093 5303494 01/01/2006 04/20/2007 01/21/2007 Zoloft MD Drug Exposure During Pregnancy, Muscle Twitching, Sudden Death
F 6293184 5303574 04/10/2006 04/20/2007 Zoloft OT Drug Exposure During Pregnancy, Foetal Distress Syndrome, Placental Disorder
F 6293184 5344472 04/10/2006 06/04/2007 Zoloft OT Drug Exposure During Pregnancy, Foetal Distress Syndrome, Placental Disorder
F 6293184 5588039 04/10/2006 01/11/2008 Zoloft OT Caesarean Section, Drug Exposure During Pregnancy, Foetal Distress Syndrome, Placental Disorder, Premature Labour, Retroplacental Haematoma
F 6293365 5303756 04/20/2007 Zoloft OT Ill-Defined Disorder Drug Exposure During Pregnancy, Pulmonary Hypertension, Transposition of the Great Vessels
F 6293365 5310838 04/28/2007 Zoloft OT Ill-Defined Disorder Developmental Delay, Drug Exposure During Pregnancy, Pulmonary Hypertension, Transposition of the Great Vessels
M 6299193 5310832 01/01/2006 04/28/2007 Zoloft MD Congenital Absence of Bile Ducts, Drug Exposure During Pregnancy, Nausea
6300964 5312758 04/30/2007 Sertraline Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Laryngomalacia, Muscle Spasms, Tremor
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6300965 5312759 04/30/2007 Sertraline Choking, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Hypersensitivity, Hypervigilance, Irritability
F 6301858 5313961 05/01/2007 11/19/2006 Lustral CN Depression Congenital Brain Damage, Drug Exposure During Pregnancy, Encephalitis, Neonatal Asphyxia
6303154 5315333 05/02/2007 Sertraline Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Laryngomalacia, Muscle Spasms, Tremor
M 6303165 5315341 05/02/2007 Sertraline Drug Exposure During Pregnancy, Neurodevelopmental Disorder
M 6305289 5317339 05/04/2007 Sertraline Drug Exposure During Pregnancy, Myotonia
6305291 5317341 05/04/2007 Sertraline Choking, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Hypersensitivity, Hypervigilance, Irritability
6305972 5318342 05/07/2007 Zoloft CN Drug Exposure During Pregnancy, Foetal Growth Retardation
M 6312796 5319707 05/03/2007 Sertraline Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Limb Malformation
M 6317201 5324409 05/09/2007 Sertraline OT Drug Exposure During Pregnancy, Limb Malformation
M 6317568 5320884 05/04/2007 Sertraline Drug Exposure During Pregnancy, Limb Malformation
M 6319832 5334065 04/17/2007 05/24/2007 Sertraline OT Convulsion, Drug Exposure During Pregnancy, Dyskinesia, Grunting, Hypervigilance, Tachypnoea, Tremor
M 6320026 5328229 05/14/2007 Sertraline Drug Exposure During Pregnancy Congenital 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
F 6324792 5342734 06/01/2007 Sertraline OT Depression Cardiac Septal Defect, Congenital Anomaly, Drug Exposure During Pregnancy
M 6324897 5342833 01/01/2003 06/01/2007 05/05/2005 Zoloft LW Cardiac Disorder, Congenital Anomaly, Drug Exposure During Pregnancy
M 6325376 5332175 05/21/2007 Sertraline Drug Exposure During Pregnancy Congenital Neurological Disorder, Drug Exposure During Pregnancy, Maternal Alcohol Use, Maternal Use of Illicit Drugs
F 6329220 5339386 04/16/2007 05/25/2007 Sertraline Depression Caesarean Section, Drug Exposure During Pregnancy, Polyhydramnios
M 6331022 5341715 04/17/2007 05/30/2007 Sertraline MD Depression Bradycardia Neonatal, Caesarean Section, Convulsion Neonatal, Drug Exposure During Pregnancy, Dyskinesia Neonatal, Grunting, Hypervigilance, Neonatal Disorder, Neonatal Tachypnoea, Oxygen Saturation Decreased, Tremor Neonatal
F 6332545 5356258 06/12/2007 Zoloft CN Blood Pressure Decreased, Stillbirth, Syncope Vasovagal
F 6333045 5346658 06/04/2007 Sertraline Depression Cardiac Septal Defect, Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy
F 6336104 5353028 06/06/2007 Sertraline Drug Exposure During Pregnancy Cardiac Septal Defect, Congenital Anomaly, Drug Exposure During Pregnancy
F 6336243 5352182 06/06/2007 Sertraline OT Depression Cardiac Septal Defect, Congenital Anomaly
F 6336456 5346738 06/04/2007 Sertraline Drug Exposure During Pregnancy Cardiac Septal Defect, Drug Exposure During Pregnancy, Multiple Congenital Abnormalities
M 6343509 5339402 04/17/2007 05/25/2007 Sertraline Depression Caesarean Section, Convulsion Neonatal, Drug Exposure During Pregnancy, Grunting, Hypervigilance, Movement Disorder, Neonatal Disorder, Neonatal Tachypnoea, Polyhydramnios, Tremor Neonatal
F 6344681 5357409 06/12/2007 Sertraline Depression Cardiac Septal Defect, Congenital 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 6347579 5376413 01/01/2006 07/02/2007 Zoloft MD Apnoea, Convulsion, Cyanosis, Drug Exposure During Pregnancy, Hypertonia, Intercostal Retraction, Muscle Twitching, Nystagmus
6348681 5377702 07/03/2007 Sertraline Neural Tube Defect
M 6349437 5372618 06/26/2007 Sertraline OT Caesarean Section, Drug Exposure During Pregnancy, Premature Baby
6355011 5384787 07/11/2007 Sertraline Craniosynostosis, Drug Exposure During Pregnancy
6355015 5384798 07/11/2007 Sertraline Neural Tube Defect
M 6357039 5386931 01/01/2006 07/13/2007 Zoloft OT Depression Convulsion, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspnoea
M 6357096 5386977 07/13/2007 Zoloft PH Blood Magnesium Decreased, Drug Exposure During Pregnancy, Hypocalcaemia, Pulmonary Hypertension
M 6357096 5443782 01/01/2007 09/05/2007 Zoloft MD Depression Blood Magnesium Decreased, Drug Exposure During Pregnancy, Hypocalcaemia, Pulmonary Hypertension
F 6362551 5390511 07/12/2007 Sertraline Depression Cardiac Septal Defect, Congenital Anomaly, Drug Exposure During Pregnancy
6367112 5397099 07/25/2007 Sertraline OT Depression Congenital Anomaly, Drug Exposure During Pregnancy
F 6370470 5400697 07/30/2007 Sertraline MD Depression Congenital Anomaly, Heart Disease Congenital, Transmission of Drug Via Semen
6370787 5400171 07/25/2007 Sertraline Congenital Anomaly, Drug Exposure During Pregnancy, Lower Limb Deformity, Upper Limb Deformity
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6370875 5400120 07/25/2007 Sertraline Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Limb Deformity, Multiple Congenital Abnormalities
6375913 5402760 07/27/2007 Sertraline Depression Congenital Anomaly, Congenital Hand Malformation, Drug Exposure During Pregnancy
6376522 5400142 07/25/2007 Sertraline Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Limb Malformation
F 6376976 5381404 06/29/2007 Zoloft Drug Use for Unknown Indication Drug Exposure During Pregnancy, Respiratory Distress
6377487 5381376 06/29/2007 Zoloft MD Ill-Defined Disorder Drug Exposure During Pregnancy, Respiratory Disorder Neonatal
6381107 5407052 08/03/2007 Sertraline Depression Congenital Anomaly, Drug Exposure During Pregnancy
6385727 5413302 08/10/2007 Sertraline OT Depression Congenital Anomaly, Drug Exposure During Pregnancy, Limb Reduction Defect
6391885 5426494 01/01/2007 08/27/2007 Daxid MD Drug Exposure During Pregnancy, Movement Disorder, Neonatal Disorder
6394045 5430070 08/29/2007 06/04/2007 Zoloft MD Congenital Tricuspid Valve Atresia, Drug Exposure During Pregnancy
6394045 5505564 11/02/2007 06/04/2007 Zoloft MD Congenital Tricuspid Valve Atresia, Drug Exposure During Pregnancy
6407696 5445166 06/26/2006 09/06/2007 Zoloft OT Depression Alpha 1 Foetoprotein Increased, Drug Exposure During Pregnancy, Microcephaly, Spine Malformation
M 6407698 5445169 01/01/2005 09/06/2007 Zoloft MD Drug Exposure During Pregnancy, Hypertension, Respiratory Rate Increased
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6408795 5446586 01/01/2006 09/07/2007 Zoloft CN Postpartum Depression Cyanosis, Drug Exposure During Pregnancy, Neonatal Disorder, Vocal Cord Paresis
F 6408795 5530942 01/01/2006 11/30/2007 Zoloft MD Postpartum Depression Cyanosis, Drug Exposure During Pregnancy, Feeding Disorder of Infancy or Early Childhood, Neonatal Disorder, Pyloric Stenosis, Thermal Burn, Vocal Cord Paresis
6408858 5446699 01/01/2005 09/07/2007 Zoloft MD Cyanosis, Death, Drug Exposure During Pregnancy
F 6413211 5451802 09/13/2007 Zoloft MD Depression Postpartum Depression
M 6438640 5477089 10/03/2007 Zoloft Anxiety, Depression, Obsessive-Compulsive Disorder, Trichotillomania Cardiac Disorder, Cardiac Perforation, Cardiac Valve Disease, Drug Exposure During Pregnancy, Heart Valve Incompetence
6438680 5469259 09/24/2007 Sertraline OT Drug Exposure During Pregnancy Cleft Lip and Palate, Drug Exposure During Pregnancy
M 6438993 5470535 09/27/2007 05/05/2005 Zoloft Adrenal Disorder Aortic Stenosis, Atrial Septal Defect, Bicuspid Aortic Valve, Cleft Palate, Congenital Arterial Malformation, Congenital Pulmonary Hypertension, DiGeorge's Syndrome, Drug Exposure During Pregnancy, Gastrointestinal Disorder, Persistent Foetal Circulation, Ventricular Septal Defect
F 6441549 5484589 10/12/2007 Sertraline MD Depression Stillbirth, Vaginal Haemorrhage
F 6441549 5511748 04/14/2007 11/09/2007 Sertraline MD Depression Antiphospholipid Syndrome, Stillbirth, Vaginal Haemorrhage
6460634 5508048 04/14/2007 11/06/2007 Sertraline OT Depression Stillbirth, Vaginal Haemorrhage
F 6469170 5518608 01/01/1999 11/15/2007 Zoloft CN Abortion Spontaneous
M 6470958 5520759 11/19/2007 Zoloft LW Aortic Stenosis, Cardiac Septal Defect, Collapse of Lung, Drug Exposure During Pregnancy, Dysphagia, Persistent Foetal Circulation
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6470959 5520761 11/19/2007 Zoloft LW Atrial Septal Defect, Drug Exposure During Pregnancy
F 6470960 5520762 11/19/2007 Zoloft LW Depression Drug Exposure During Pregnancy, Takayasu's Arteritis
M 6470963 5520765 01/01/1999 11/19/2007 Zoloft LW Drug Exposure During Pregnancy, Hypoplastic Right Heart Syndrome
F 6470968 5520770 03/01/2005 11/19/2007 Zoloft LW Atrial Septal Defect, Cardiac Murmur, Drug Exposure During Pregnancy, Ventricular Septal Defect, Weight Gain Poor
M 6471531 5521439 11/19/2007 Zoloft LW Arterial Disorder, Drug Exposure During Pregnancy
F 6471532 5521440 11/19/2007 Zoloft LW Coarctation of the Aorta, Drug Exposure During Pregnancy, Ventricular Septal Defect
6471535 5521442 01/01/2001 11/19/2007 Zoloft LW Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome, Persistent Foetal Circulation
F 6471536 5521443 11/19/2007 Zoloft LW Depression Aortic Valve Stenosis, Cardiac Failure, Drug Exposure During Pregnancy
M 6471537 5521444 01/01/2000 11/19/2007 Zoloft LW Depression Complement Factor C4, Developmental Delay, Drug Exposure During Pregnancy, Pulmonary Valve Stenosis, Single Functional Kidney
M 6472581 5522639 11/20/2007 Zoloft LW Asthma, Developmental Delay, Drug Exposure During Pregnancy, Fallot's Tetralogy, Grand Mal Convulsion
F 6473253 5523619 01/01/2006 11/21/2007 Zoloft CN Body Temperature Increased, Cyanosis, Discomfort, Drug Exposure During Pregnancy, Dysphagia, Dyspnoea, Hypertension, Hypoplastic Right Heart Syndrome, Influenza Like Illness, Irritability, Laryngeal Stenosis, Psychomotor Skills Impaired, Speech Disorder Developmental, Transposition of the Great Vessels, Univentricular Heart
F 6473253 5526353 01/01/2006 11/27/2007 Zoloft CN Body Temperature Increased, Cyanosis, Discomfort, Drug Exposure During Pregnancy, Dysphagia, Dyspnoea, Hypertension, Hypoplastic Right Heart Syndrome, Influenza Like Illness, Irritability, Laryngeal Stenosis, Psychomotor Skills Impaired, Speech Disorder Developmental, Transposition of the Great Vessels, Univentricular Heart
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6473563 5524143 11/21/2007 Zoloft LW Drug Exposure During Pregnancy, Post-Traumatic Stress Disorder, Ventricular Septal Defect
F 6473566 5524146 11/21/2007 Zoloft LW Anomalous Pulmonary Venous Connection, Drug Exposure During Pregnancy, Post Procedural Complication, Ventricular Septal Defect
F 6473568 5524149 11/21/2007 Zoloft LW Aortic Stenosis, Developmental Delay, Drug Exposure During Pregnancy, Exomphalos
F 6473667 5524297 11/21/2007 Zoloft LW Drug Exposure During Pregnancy, Ebstein's Anomaly
M 6473668 5524298 11/21/2007 Zoloft LW Drug Exposure During Pregnancy, Transposition of the Great Vessels
M 6473669 5524299 11/21/2007 Zoloft LW Drug Exposure During Pregnancy, Limb Reduction Defect
M 6473670 5524300 11/21/2007 Zoloft LW Drug Exposure During Pregnancy, Heart Valve Incompetence, Transposition of the Great Vessels, Ventricular Septal Defect
F 6473672 5524302 01/01/2006 11/21/2007 Zoloft CN Atrial Septal Defect, Drug Exposure During Pregnancy, Patent Ductus Arteriosus, Ventricular Septal Defect
F 6473673 5524303 11/21/2007 Zoloft CN Atrial Septal Defect, Drug Exposure During Pregnancy
F 6473675 5524305 01/01/2005 11/21/2007 Zoloft CN Cardiac Failure, Coarctation of the Aorta, Developmental Delay, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Organ Failure, Vocal Cord Paralysis
M 6473677 5524307 11/21/2007 Zoloft LW Drug Exposure During Pregnancy, Dyspnoea, Fallot's Tetralogy, Laryngeal Stenosis
F 6496046 5551770 11/16/2007 12/12/2007 Zoloft PH Abortion Spontaneous, Menorrhagia
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6518173 5579809 01/02/2008 Zoloft MD Abortion Spontaneous
F 6518173 5599322 01/22/2008 Zoloft MD Abortion Spontaneous, Drug Exposure During Pregnancy
F 6524930 5588595 01/11/2008 Zoloft CN Depression Abortion Induced, Intra-Uterine Death
F 6526665 5590689 01/01/2005 01/14/2008 Zoloft CN Schizoaffective Disorder Abdominal Pain Upper, Cholecystectomy, Endometriosis, Joint Dislocation, Mania, Migraine, Ovarian Cyst, Pre-Eclampsia, Vomiting
M 6533315 5600654 01/23/2008 Zoloft CN Developmental Delay, Drug Exposure During Pregnancy
M 6533315 5628501 02/15/2008 Zoloft CN Developmental Delay, Drug Exposure During Pregnancy
M 6533315 5639339 02/26/2008 Zoloft CN Developmental Delay, Drug Exposure During Pregnancy
M 6533316 5600655 01/23/2008 Zoloft CN Developmental Delay, Drug Exposure During Pregnancy
M 6533316 5628455 02/15/2008 Zoloft CN Developmental Delay, Drug Exposure During Pregnancy
M 6533316 5639337 02/26/2008 Zoloft CN Developmental Delay, Drug Exposure During Pregnancy
F 6533341 5600702 09/25/2007 01/23/2008 Zoloft OT Bradycardia Neonatal, Drug Exposure During Pregnancy
6536879 5605208 01/01/2006 01/28/2008 Zoloft PH Apnoea, Drug Exposure During Pregnancy, Hypotonia, Oxygen Saturation Decreased, Vomiting
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6539702 5608828 03/17/2007 01/31/2008 03/17/2007 Sertraline MD Panic Disorder Death Neonatal, Hypotonia Neonatal
F 6549012 5620961 08/02/2007 02/08/2008 Zoloft MD Depression Drug Exposure During Pregnancy, Haemangioma, Patent Ductus Arteriosus
F 6554631 5635365 08/01/2006 02/22/2008 Sertraline MD Depression Diabetes Insipidus, Drug Exposure During Pregnancy, Jaundice Neonatal
F 6602391 5689501 02/15/2008 03/31/2008 Serlain MD Anxiety Disorder Abortion Spontaneous
0 Days M 3967126 4382202 06/15/2004 Zoloft MD Depression Blood Glucose Decreased, Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Hyperreflexia, Neonatal Disorder, Neonatal Tachypnoea, Reflexes Abnormal
0 Days M 4145779 4360946 05/17/2004 Zoloft MD Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hyperventilation, Laryngomalacia, Neonatal Disorder, Tardive Dyskinesia
0 Days F 5829568 4698486 01/01/2003 06/22/2005 Zoloft Caesarean Section, Drug Exposure During Pregnancy, Neonatal Aspiration, Premature Baby, Umbilical Cord Around Neck
M 6470958 5786332 06/07/2006 06/24/2008 Zoloft CN Postpartum Depression Aortic Valve Stenosis, Arthritis, Blood Pressure Systolic Decreased, Bone Disorder, Cardiac Septal Defect, Collapse of Lung, Congenital Heart Valve Disorder, Developmental Delay, Drug Exposure During Pregnancy, Dysphagia, Ear Infection, Eczema, Feeding Disorder of Infancy or Early Childhood, Hypothalamo-Pituitary Disorder, Lethargy, Patent Ductus Arteriosus, Persistent Foetal Circulation, Pneumonia, Respiratory Distress, Walking Disability
M 6470959 5786339 03/29/2001 06/24/2008 Zoloft CN Depression Atrial Septal Defect, Developmental Delay, Drug Exposure During Pregnancy, Ear Infection, Ear Malformation, Failure To Thrive, Foetal Growth Retardation, Head Deformity, Hydronephrosis, Hypospadias, Respiratory Disorder, Talipes, Umbilical Cord Abnormality, Ventricular Septal Defect, Weight Gain Poor
F 6470960 5782276 06/23/2008 Zoloft LW Depression Angiopathy, Drug Exposure During Pregnancy, Laryngeal Stenosis, Respiratory Distress, Takayasu's Arteritis, Underweight
F 6470968 5786364 03/01/2005 06/24/2008 Zoloft CN Anxiety Atrial Septal Defect, Cardiac Murmur, Drug Exposure During Pregnancy, Ventricular Septal Defect, Weight Gain Poor
M 6471531 5786334 04/24/2003 06/24/2008 Zoloft LW Depression Arterial Disorder, Dehydration, Drug Exposure During Pregnancy, Hypoxia, Neonatal Aspiration, Pneumonia Bacterial, Respiratory Distress, Vasoconstriction, Viral Infection
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6471532 5786341 04/01/2005 06/24/2008 Zoloft LW Depression Aortic Elongation, Bicuspid Aortic Valve, Coarctation of the Aorta, Drug Exposure During Pregnancy, Scar, Ventricular Septal Defect
M 6471535 5786360 01/01/2001 06/24/2008 Zoloft LW Depression Asthma, Cognitive Disorder, Collapse of Lung, Developmental Delay, Drug Exposure During Pregnancy, Failure To Thrive, Feeding Disorder Neonatal, Food Allergy, Gastric Disorder, Neonatal Respiratory Distress Syndrome, Persistent Foetal Circulation, Tachycardia, Weight Decreased
F 6471536 5786357 01/01/2004 06/24/2008 Zoloft LW Depression Aortic Valve Stenosis, Cardiac Failure, Cardiac Murmur, Cardiomegaly, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Pneumonia
M 6471537 5786356 01/01/2000 06/24/2008 Zoloft LW Depression Arthropathy, Atrial Septal Defect, Cardiac Murmur, Complement Factor C4 Decreased, Cyanosis, Developmental Delay, Dizziness, Drug Exposure During Pregnancy, Dyspepsia, Ear Infection, Headache, Hypertension, Hypertrophy, Myoclonic Epilepsy, Palpitations, Pulmonary Valve Stenosis, Single Functional Kidney, Sleep Apnoea Syndrome, Syncope, Thalassaemia, Urinary Tract Infection
M 6472581 5786359 06/24/2008 Zoloft LW Asthma, Developmental Delay, Drug Exposure During Pregnancy, Fallot's Tetralogy, Grand Mal Convulsion, Pulmonary Artery Atresia, Respiratory Distress
F 6473253 5786333 01/01/2006 06/24/2008 Zoloft LW Postpartum Depression Aortic Disorder, Body Temperature Increased, Cyanosis, Discomfort, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Dysphagia, Dyspnoea, Hypertension, Hypoplastic Right Heart Syndrome, Influenza Like Illness, Irritability, Laryngeal Stenosis, Psychomotor Skills Impaired, Pulmonary Valve Stenosis, Speech Disorder Developmental, Transposition of the Great Vessels, Ventricular Septal Defect
F 6473563 5786232 06/24/2008 Zoloft LW Tension Headache Drug Exposure During Pregnancy, Post-Traumatic Stress Disorder, Ventricular Septal Defect
F 6473566 5786363 07/02/2005 06/24/2008 Zoloft LW Postpartum Depression Anomalous Pulmonary Venous Connection, Croup Infectious, Drug Exposure During Pregnancy, Ear Infection, Nasopharyngitis, Post Procedural Complication, Respiratory Tract Infection, Ventricular Septal Defect
F 6473568 5786361 03/01/2006 06/24/2008 Zoloft LW Depression Aortic Stenosis, Developmental Delay, Drug Exposure During Pregnancy, Exomphalos, Lung Disorder, Mitral Valve Prolapse, Scar
M 6473669 5782279 08/24/2000 06/23/2008 Zoloft LW Depression Drug Exposure During Pregnancy, Limb Reduction Defect, Scoliosis, Tooth Disorder, Torticollis
F 6473673 5782281 09/15/1999 06/23/2008 Zoloft CN Depression Atrial Septal Defect, Dental Caries, Drug Exposure During Pregnancy, Ear Infection, Enamel Anomaly, Migraine
F 6473675 5786436 01/01/2005 06/24/2008 Zoloft LW Depression Cardiac Failure, Cardiac Septal Defect, Coarctation of the Aorta, Developmental Delay, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Organ Failure, Vocal Cord Paralysis
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6473677 5786337 12/02/2005 06/24/2008 Zoloft CN Postpartum Depression Caesarean Section, Cardiac Murmur, Deafness, Developmental Delay, Drug Exposure During Pregnancy, Dyspnoea, Fallot's Tetralogy, Gastrooesophageal Reflux Disease, Laryngeal Stenosis, Vocal Cord Disorder, Weight Gain Poor
F 6549012 5710198 08/02/2007 04/18/2008 Zoloft MD Depression Drug Exposure During Pregnancy, Haemangioma, Patent Ductus Arteriosus
6605627 5693977 04/03/2008 Zoloft MD Congenital Anomaly, Drug Exposure During Pregnancy
F 6606594 5695131 03/10/2008 04/04/2008 Zoloft MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia, Neonatal Asphyxia, Tremor
F 6606594 5705982 03/10/2008 04/15/2008 Zoloft MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia, Neonatal Asphyxia, Tremor
F 6612937 5703087 04/11/2008 Lustral MD Bipolar Disorder Arrested Labour, Malaise, Prolonged Labour
F 6613483 5697925 08/31/2006 04/04/2008 Zoloft Anxiety Atrial Septal Defect, Drug Exposure During Pregnancy, Pulmonary Valve Stenosis
M 6614556 5705033 01/01/2004 04/14/2008 Zoloft CN Depression Asthma, Drug Exposure During Pregnancy, Dyspnoea, Gastroenteritis Eosinophilic, Premature Baby
6616405 5707654 04/16/2008 11/30/2004 Zoloft CN Drug Exposure During Pregnancy, Foetal Distress Syndrome, Persistent Foetal Circulation, Umbilical Cord Around Neck
M 6624961 5718465 04/25/2008 Zoloft MD Panic Disorder Drug Exposure During Pregnancy, Hypospadias
F 6625123 5718729 04/25/2008 Zoloft MD Panic Disorder Drug Exposure During Pregnancy, Urinary Tract Disorder
6625128 5718734 04/25/2008 Sertraline PH Convulsion, Drug Exposure During Pregnancy, Eye Rolling, Muscle Twitching, 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
M 6629360 5723522 04/30/2008 Sertraline OT Depression Abnormal Palmar/Plantar Creases, Ear Malformation, Foetal Damage, Head Deformity, Polyhydramnios
6631056 5725887 05/02/2008 Sertraline OT Depression Abnormal Palmar/Plantar Creases, Ear Malformation, Foetal Damage, Head Deformity, Polyhydramnios
M 6634711 5730805 05/07/2008 Sertraline OT Depression Abnormal Palmar/Plantar Creases, Ear Malformation, Foetal Damage, Head Deformity, Polyhydramnios
6635155 5731292 05/08/2008 Sertraline OT Convulsion, Drug Exposure During Pregnancy, Eye Rolling, Muscle Twitching, Small for Dates Baby
F 6635833 5732130 08/28/2007 05/08/2008 Sertraline MD Depression Abortion Spontaneous
F 6637437 5734030 01/01/2007 05/09/2008 Lustral MD Depression Abortion Spontaneous, Drug Exposure During Pregnancy
M 6645185 5731283 05/05/2008 Sertraline Depression Abnormal Palmar/Plantar Creases, Ear Malformation, Foetal Damage, Head Deformity, Maternal Drugs Affecting Foetus, Polyhydramnios
M 6645185 5736924 05/09/2008 Sertraline Depression Abnormal Palmar/Plantar Creases, Ear Malformation, Foetal Malformation, Head Deformity, Maternal Drugs Affecting Foetus, Polyhydramnios
M 6645326 5731272 05/05/2008 Sertraline Abnormal Palmar/Plantar Creases, Caesarean Section, Drug Exposure During Pregnancy, Ear Malformation, Foetal Damage, Head Deformity, Maternal Drugs Affecting Foetus, Polyhydramnios, Unstable Foetal Lie
M 6646894 5732526 05/06/2008 Sertraline Drug Exposure During Pregnancy Abnormal Palmar/Plantar Creases, Caesarean Section, Drug Exposure During Pregnancy, Ear Malformation, Foetal Damage, Head Deformity, Oblique Presentation, Polyhydramnios
M 6646894 5738012 05/09/2008 Sertraline Drug Exposure During Pregnancy Abnormal Palmar/Plantar Creases, Caesarean Section, Drug Exposure During Pregnancy, Ear Malformation, Foetal Damage, Head Deformity, Maternal Drugs Affecting Foetus, Multiple Congenital Abnormalities, Oblique Presentation, Polyhydramnios
6647495 5744929 08/28/2007 05/21/2008 Sertraline OT Anxiety Abortion Spontaneous
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6652267 5752755 04/13/2007 05/29/2008 Zoloft OT Anxiety Abortion Spontaneous, Drug Exposure During Pregnancy
6652465 5741427 05/14/2008 Sertraline Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Eye Rolling, Maternal Drugs Affecting Foetus, Muscle Twitching, Partial Seizures, Small for Dates Baby
6653025 5742526 05/15/2008 Sertraline Drug Use for Unknown Indication Convulsion Neonatal, Eye Rolling, Maternal Drugs Affecting Foetus, Muscle Twitching, Neonatal Disorder, Small for Dates Baby
6653025 5744912 05/16/2008 Sertraline Drug Use for Unknown Indication Convulsion, Drug Exposure During Pregnancy, Eye Rolling, Maternal Drugs Affecting Foetus, Muscle Twitching, Small for Dates Baby
6653025 5744914 05/16/2008 Sertraline Drug Use for Unknown Indication Convulsion, Drug Exposure During Pregnancy, Eye Rolling, Maternal Drugs Affecting Foetus, Muscle Twitching, Small for Dates Baby
6653035 5742552 05/15/2008 Sertraline OT Convulsion Neonatal, Eye Rolling, Maternal Drugs Affecting Foetus, Muscle Twitching, Neonatal Disorder, Small for Dates Baby
M 6653992 5744041 05/16/2008 Sertraline OT Depression Abnormal Palmar/Plantar Creases, Caesarean Section, Ear Malformation, Head Deformity, Maternal Drugs Affecting Foetus, Polyhydramnios, Unstable Foetal Lie
6654587 5743792 04/08/2008 05/16/2008 Sertraline Eye Rolling, Maternal Drugs Affecting Foetus, Muscle Twitching, Partial Seizures, Small for Dates Baby
M 6654856 5743810 07/01/2005 05/16/2008 Sertraline Depression Abnormal Palmar/Plantar Creases, Caesarean Section, Congenital Anomaly, Ear Malformation, Head Deformity, Maternal Drugs Affecting Foetus, Polyhydramnios, Unstable Foetal Lie
F 6662662 5766101 01/23/2007 06/11/2008 Zoloft MD Depression Drug Exposure During Pregnancy, Intra-Uterine Death
M 6675623 5782394 06/23/2008 Zoloft LW Depression Cerebral Haemorrhage, Convulsion, Developmental Delay, Drug Exposure During Pregnancy, Kidney Enlargement, Persistent Foetal Circulation, Pneumonia
F 6675777 5782565 09/06/2003 06/23/2008 Zoloft CN Anxiety Cardiac Murmur, Drug Exposure During Pregnancy, Supravalvular Aortic Stenosis
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6676049 5782590 01/01/1998 06/24/2008 Zoloft LW Anxiety Anal Atresia, Constipation, Crying, Drug Exposure During Pregnancy, Flatulence
F 6679509 5786435 06/24/2008 06/17/1998 Zoloft LW Depression Congenital Diaphragmatic Hernia, Dextrocardia, Drug Exposure During Pregnancy, Respiratory Distress
M 6679510 5786437 06/24/2008 Zoloft LW Anxiety Asplenia, Drug Exposure During Pregnancy, Heart Disease Congenital, Hypertension, Phaeochromocytoma, Pulmonary Artery Atresia, Transposition of the Great Vessels
F 6679545 5786477 11/26/2006 06/24/2008 Zoloft LW Congenital Pulmonary Valve Atresia, Drug Exposure During Pregnancy, Fallot's Tetralogy, Patent Ductus Arteriosus
F 6679623 5786574 08/17/2005 06/24/2008 Zoloft LW Depression Abdominal Pain, Cleft Lip and Palate, Constipation, Craniosynostosis, Drug Exposure During Pregnancy, Ear Infection, Fine Motor Delay, Gastrooesophageal Reflux Disease, Mild Mental Retardation, Mixed Receptive-Expressive Language Disorder, Perinatal Brain Damage, Weight Gain Poor
M 6679624 5786575 04/21/2007 06/24/2008 Zoloft LW Panic Attack Cardiac Murmur, Drug Exposure During Pregnancy, Patent Ductus Arteriosus, Pulmonary Valve Stenosis
F 6679625 5786576 01/02/2002 06/24/2008 Zoloft LW Depression Atrial Septal Defect, Cyanosis, Drug Exposure During Pregnancy, Hypertension, Patent Ductus Arteriosus, Pleural Effusion, Pulmonary Valve Stenosis, Tricuspid Valve Incompetence, Ventricular Septal Defect, Wound Infection
M 6679626 5786577 06/24/2008 Zoloft LW Depression Bradycardia Foetal, Cephalhaematoma, Craniosynostosis, Developmental Delay, Drug Exposure During Pregnancy, Head Deformity, Movement Disorder, Nervousness, Premature Baby, Respiratory Distress
M 6679627 5786578 04/20/2004 06/24/2008 Sertraline LW Depression Drug Exposure During Pregnancy, Pulmonary Artery Atresia, Pulmonary Hypertension, Pulmonary Valve Stenosis, Tricuspid Valve Disease, Ventricular Septal Defect
M 6679630 5786580 06/24/2008 Zoloft LW Depression Drug Exposure During Pregnancy, Fallot's Tetralogy, Lung Disorder
F 6679631 5786581 01/07/2004 06/24/2008 Zoloft LW Depression Congenital Anomaly, Drug Exposure During Pregnancy, Renal Cyst, Renal Impairment
F 6679632 5786582 06/24/2008 Zoloft CN Aortic Disorder, Cerebellar Hypoplasia, Congenital Central Nervous System Anomaly, Congenital Pulmonary Hypertension, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Hypothalamo-Pituitary Disorder, Nervous System Disorder, Patent Ductus Arteriosus, Spine Malformation, 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 6679633 5786583 06/24/2008 Zoloft LW Coarctation of the Aorta, Drug Exposure During Pregnancy, Mitral Valve Disease, Pulmonary Hypertension, Respiratory Distress
F 6679650 5786596 09/01/2006 06/24/2008 Zoloft LW Generalised Anxiety Disorder Atrial Septal Defect, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Jaundice, Lethargy, Pulmonary Valve Stenosis, Unresponsive To Stimuli
F 6679651 5786597 06/24/2008 Zoloft LW Panic Disorder Atrial Septal Defect, Drug Exposure During Pregnancy, Patent Ductus Arteriosus, Pulmonary Hypertension, Ventricular Septal Defect
M 6679652 5786598 01/01/2005 06/24/2008 Zoloft LW Depression Congenital Arterial Malformation, Drug Exposure During Pregnancy, Jaundice Neonatal, Pulmonary Valve Incompetence
F 6679653 5786599 06/24/2008 Zoloft LW Atrial Septal Defect, Coarctation of the Aorta, Drug Exposure During Pregnancy, Ventricular Septal Defect
F 6679655 5786601 03/31/2004 06/24/2008 04/16/2004 Zoloft LW Depression Aortic Valve Stenosis, Atrial Septal Defect, Atrioventricular Septal Defect, Cardiac Murmur, Drug Exposure During Pregnancy, Hepatic Congestion, Lung Disorder, Mitral Valve Hypoplasia, Multiple Congenital Abnormalities, Patent Ductus Arteriosus, Persistent Foetal Circulation, Renal Tubular Necrosis, Right Ventricular Hypertrophy
M 6679656 5786602 06/11/2006 06/24/2008 Zoloft CN Anomaly of External Ear Congenital, Craniosynostosis, Drug Exposure During Pregnancy
M 6679657 5786603 06/16/2006 06/24/2008 Zoloft LW Aortic Valve Incompetence, Atrial Septal Defect, Auricular Swelling, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Heart Disease Congenital, Respiratory Distress, Transposition of the Great Vessels, Ventricular Septal Defect
M 6679677 5786610 06/01/2007 06/24/2008 Zoloft LW Premenstrual Syndrome Collapse of Lung, Drug Exposure During Pregnancy, Ear Infection, Post Procedural Complication, Transposition of the Great Vessels
M 6679678 5786611 06/16/2005 06/24/2008 Zoloft LW Depression Atrial Septal Defect, Drug Exposure During Pregnancy, Hypoplastic Left Heart Syndrome, Mitral Valve Incompetence, Renal Impairment
F 6679679 5786613 06/24/2008 Zoloft LW Obsessive-Compulsive Disorder Cardiac Valve Disease, Drug Exposure During Pregnancy, Lung Disorder, Persistent Foetal Circulation, Plasminogen Activator Inhibitor
M 6679681 5786614 02/27/1998 06/24/2008 Zoloft CN Abdominal Pain, Asthma, Attention Deficit/Hyperactivity Disorder, Drug Exposure During Pregnancy, Pulmonary Hypertension, Respiratory Disorder, Respiratory Tract Infection, Skin Discolouration
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6679709 5786629 09/06/2006 06/24/2008 Zoloft LW Postpartum Depression Cardiac Arrest, Congenital Oesophageal Web, Drug Exposure During Pregnancy, Eczema, Fallot's Tetralogy, Gastrointestinal Malformation, Haematochezia, Hypokinesia, Jaundice, Otitis Media, Respiratory Tract Infection, Speech Disorder
F 6686031 5794225 06/27/2008 Zoloft LW Congenital Anomaly, Drug Exposure During Pregnancy
F 6686039 5794234 06/27/2008 Zoloft LW Congenital Anomaly, Drug Exposure During Pregnancy
1 Hours M 6360092 5386143 06/27/2007 07/11/2007 Zoloft MD Depression Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeling Jittery, Hyperreflexia, Hypertonia, Hypoglycaemia Neonatal, Hypomagnesaemia, Irritability, Neonatal Disorder
14 Hours M 6329239 5339441 01/01/2007 05/25/2007 Sertraline Bradycardia Neonatal, Caesarean Section, Convulsion, Convulsion Neonatal, Drug Exposure During Pregnancy, Dyskinesia Neonatal, Grunting, Hypervigilance, Neonatal Disorder, Neonatal Tachypnoea, Oxygen Saturation Decreased, Posture Abnormal, Tremor Neonatal
14 Hours M 6330851 5341700 04/17/2007 05/30/2007 Sertraline Drug Exposure During Pregnancy Caesarean Section, Convulsion Neonatal, Drug Exposure During Pregnancy, Dyskinesia Neonatal, Grunting, Hypervigilance, Neonatal Disorder, Neonatal Tachypnoea, Tremor Neonatal
14 Hours M 6519681 5339441 05/25/2007 Sertraline OT Bradycardia Neonatal, Caesarean Section, Convulsion, Convulsion Neonatal, Drug Exposure During Pregnancy, Dyskinesia Neonatal, Grunting, Hypervigilance, Neonatal Disorder, Neonatal Tachypnoea, Oxygen Saturation Decreased, Posture Abnormal, Tremor Neonatal
1 Day M 4135868 4350168 03/14/2004 04/26/2004 Zoloft MD Depression Drug Withdrawal Syndrome Neonatal, Maternal Drugs Affecting Foetus
1 Day M 4164053 4386180 06/22/2004 Zoloft MD Ill-Defined Disorder Body Temperature Decreased, Bradycardia, Cerebral Haemorrhage Neonatal, Cerebral Ventricle Dilatation, Drug Exposure During Pregnancy, Heart Rate Increased, Indirect Infection Transmission, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Premature Baby, Respiratory Rate Increased, Small for Dates Baby
1 Day M 4164053 4517077 11/30/2004 Zoloft MD Ill-Defined Disorder Body Temperature Decreased, Bradycardia Neonatal, Cerebral Haemorrhage Neonatal, Cerebral Ventricle Dilatation, Cyanosis Neonatal, Drug Exposure During Pregnancy, Foetal Disorder, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Premature Baby, Unwanted Pregnancy, Vertical Infection Transmission
1 Day F 5820115 4686967 06/06/2005 Zoloft MD Arrhythmia Neonatal, Blood Glucose Decreased, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, Neonatal Tachycardia, Oxygen Saturation Decreased, Premature Baby, Supraventricular Tachycardia
1 Day F 5890877 4781137 11/22/2003 09/26/2005 Zoloft MD Ill-Defined Disorder Congenital Nose Malformation, Congenital Nystagmus, Developmental Coordination Disorder, Drug Exposure During Pregnancy, Eye Movement Disorder, Fallot's Tetralogy, Hypertelorism of Orbit, Neonatal Disorder, Skull Malformation, Strabismus Congenital, Vascular Anomaly
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 5953854 4899301 10/17/2005 01/31/2006 Zoloft MD Ill-Defined Disorder Caesarean Section, Diarrhoea, Drug Exposure During Pregnancy, Premature Baby, Small for Dates Baby
1 Day F 5981216 4899760 12/01/2005 01/31/2006 01/18/2006 Zoloft Ill-Defined Disorder Drug Exposure During Pregnancy, Premature Baby, Respiratory Disorder Neonatal
1 Day F 5981216 4983107 12/01/2005 04/20/2006 01/18/2006 Zoloft MD Ill-Defined Disorder Apgar Score Low, Chorioamnionitis, Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Funisitis, Lung Disorder, Patent Ductus Arteriosus, Placental Disorder, Premature Baby
1 Day F 6252769 5243595 03/12/2000 02/20/2007 Zoloft OT Anxiety, Depression Congenital Central Nervous System Anomaly, Convulsion, Drug Exposure During Pregnancy
1 Day F 6375644 5400226 03/06/2006 07/27/2007 Zoloft Postpartum Depression Drug Exposure During Pregnancy, Fatigue, Fine Motor Delay, Personality Disorder, Speech Disorder Developmental, Transposition of the Great Vessels, Ventricular Hypoplasia
1 Day F 6466835 5509912 09/23/2004 11/07/2007 Zoloft CN Obsessive-Compulsive Disorder Drug Exposure During Pregnancy, Hypopituitarism, Patent Ductus Arteriosus, Persistent Foetal Circulation, Ventricular Septal Defect
1 Day M 6608055 5690115 09/06/2006 03/31/2008 Zoloft Depression Colonic Obstruction, Drug Exposure During Pregnancy, Fallot's Tetralogy, Foetal Heart Rate Decreased
2 Days M 5918671 4818974 04/10/2004 11/02/2005 Zoloft Postpartum Depression, Prophylaxis Drug Exposure During Pregnancy, Hypoplastic Left Heart Syndrome
3 Days F 5710733 4546117 10/08/2004 01/05/2005 Sertraline PH Depression Caesarean Section, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome Neonatal, Dyskinesia Neonatal, Failed Induction of Labour, Muscle Twitching, Neonatal Disorder, Tonic Clonic Movements, Tremor Neonatal
3 Days F 6554631 5628724 02/15/2008 Sertraline MD Depression Diabetes Insipidus, Drug Exposure During Pregnancy, Jaundice Neonatal
4 Days M 4149832 4366953 05/06/2004 05/24/2004 Zoloft MD Depression Agitation Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Fever Neonatal, Lethargy, Neonatal Disorder, Rash Neonatal
4 Days F 6028166 4998520 01/01/2005 05/08/2006 Zoloft MD Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Muscle Spasms, Myoclonus, 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
4 Days F 6028166 4999954 01/01/2005 05/01/2006 Zoloft MD Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Muscle Spasms, Myoclonus, Premature Baby
5 Days M 6220152 5178811 10/06/2006 12/08/2006 Zoloft MD Choking, Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Jaundice Neonatal, Neonatal Disorder, Retching, Sinusitis
12 Days M 5664881 4466398 01/01/2004 09/30/2004 Zoloft Anxiety Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Heart Rate Increased, Insomnia, Medication Error, Muscle Twitching, Neonatal Disorder, Postmature Baby, Respiratory Rate Increased
13 Days F 5785166 4641079 03/15/2005 04/19/2005 03/28/2005 Zoloft CN Cleft Lip and Palate, Congenital Anomaly, Deformity, Drug Exposure During Pregnancy, Dysphagia, Ebstein's Anomaly, Horseshoe Kidney, Neonatal Disorder, Nervous System Disorder, Poor Sucking Reflex, Pulmonary Oedema Neonatal, Ventricular Septal Defect
19 Days F 6541643 5611365 08/22/2007 02/01/2008 Lustral OT Cleft Palate, Dehydration, Drug Exposure During Pregnancy, Irritability, Ventricular Septal Defect, Weight Decreased
19 Days F 6541643 5623485 08/22/2007 02/12/2008 Lustral OT Cleft Palate, Dehydration, Irritability, Ventricular Septal Defect, Weight Decreased
19 Days F 6593112 5663890 03/11/2008 Sertraline OT Cardiac Murmur, Dehydration, Drug Exposure During Pregnancy, Hypotonia Neonatal, Ill-Defined Disorder, Irritability, Lipoatrophy, Neonatal Disorder, Weight Decrease Neonatal
2 Months M 6518905 5580713 07/01/2007 01/03/2008 Zoloft OT Depression Agitation, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal
2 Months M 6518905 5587356 07/01/2007 01/10/2008 Zoloft OT Depression Agitation, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal
4 Months M 5890907 4781149 09/23/2005 Zoloft Ill-Defined Disorder Body Temperature Increased, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Unevaluable Event
4 Months M 5890907 4781593 09/27/2005 Zoloft Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspnoea, Neonatal Disorder, Pyrexia
23 Weeks M 6498847 5534361 11/30/2007 Sertraline 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
6 Months 6330596 5352890 06/11/2007 Zoloft MD Body Height Below Normal, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Gastrooesophageal Reflux Disease, Weight Gain Poor
6 Months M 6330596 5389504 01/01/2006 07/17/2007 Zoloft MD Depression Body Height Below Normal, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Weight Gain Poor
1 Year M 6271062 5276314 03/26/2007 Zoloft MD Autism Spectrum Disorder, Drug Exposure During Pregnancy
2 Years M 6078995 5037096 06/23/2006 Zoloft CN Depression Cerebral Disorder, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Paresis, Presbyopia, Strabismus, Upper Respiratory Tract Infection
2 Years M 6078995 5145917 01/01/2003 11/02/2006 Zoloft Depression Cerebral Palsy, Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus
4 Years M 4035258 4277662 09/01/2003 01/21/2004 Zoloft Anxiety Drug Exposure Via Breast Milk, Maternal Drugs Affecting Foetus, Sensory Integrative Dysfunction
4 Years M 4035258 4280256 09/01/2003 01/26/2004 Zoloft Anxiety Autism, Maternal Drugs Affecting Foetus, Sensory Integrative Dysfunction
16 Years F 5837042 4713102 07/01/2005 Zoloft OT Anxiety Depression, Drug Exposure During Pregnancy, Intentional Misuse, Overdose, Suicide Attempt
17 Years F 5983557 4899947 01/18/2006 01/31/2006 Zoloft Depression Abdominal Pain Upper, Drug Exposure During Pregnancy, Premature Labour
17 Years F 5983557 4919329 01/18/2006 02/16/2006 Zoloft Depression Abdominal Pain Upper, Drug Exposure During Pregnancy, Premature Baby
17 Years F 5983557 4983041 11/14/2005 04/20/2006 Zoloft MD Depression Abdominal Pain Upper, Chorioamnionitis, Drug Exposure During Pregnancy, Funisitis, Nausea, Placental Disorder, Premature Labour, Urine Ketone Body Present, Vomiting, Weight Decreased
18 Years F 6055317 5007885 05/17/2006 Zoloft MD Major Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Suicidal Ideation
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
19 Years F 4219244 4500891 08/31/2004 11/09/2004 Zoloft MD Abnormal Behaviour, Impulse-Control Disorder Abnormal Behaviour, Drug Exposure During Pregnancy, Impulse-Control Disorder, Refusal of Treatment By Patient, Stillbirth
20 Years F 6202184 5170599 03/01/2006 12/05/2006 Zoloft OT Schizophrenia Condition Aggravated, Drug Exposure During Pregnancy, Schizophrenia
20 Years F 6349436 5372616 03/20/2007 06/26/2007 Sertraline MD Depression Caesarean Section, Drug Exposure During Pregnancy, Hyperemesis Gravidarum, Premature Labour
21 Years F 6068971 5022073 04/01/2006 06/05/2006 Sertraline OT Anxiety Abortion Spontaneous, Drug Exposure During Pregnancy
23 Years F 5872665 4757711 01/01/2000 08/30/2005 Zoloft Bipolar Disorder, Bipolar I Disorder, Depression Anxiety, Bipolar I Disorder, Condition Aggravated, Dizziness, Dyskinesia, Eyelid Ptosis, Haemorrhage, Insomnia, Nausea, Somnolence, Suicide Attempt, Tremor
23 Years F 5872665 4771042 01/01/2000 09/14/2005 Zoloft Depression Aggression, Anorexia, Anxiety, Crying, Depression, Disease Recurrence, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Galactorrhoea, Haemorrhage, Headache, Hormone Level Abnormal, Insomnia, Musculoskeletal Pain, Nausea, Somnolence, Suicide Attempt, Tremor, Vaginal Haemorrhage, Weight Decreased
23 Years F 5872665 4804683 01/01/2000 10/17/2005 Zoloft Bipolar Disorder, Bipolar I Disorder, Depression Abortion, Alcoholism, Amenorrhoea, Anorexia, Anxiety, Condition Aggravated, Crying, Depression, Disease Recurrence, Dizziness, Drug Exposure During Pregnancy, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Galactorrhoea, Haemorrhage, Headache, Hormone Level Abnormal, Insomnia, Irritability, Nausea, Skin Discolouration, Somnolence, Suicide Attempt, Tachycardia, Tremor, Vaginal Haemorrhage, Weight Decreased
23 Years F 5872665 4823510 11/07/2005 Zoloft Depression Abdominal Pain, Abortion Induced, Aggression, Alcoholism, Amenorrhoea, Anorexia, Anxiety, Bipolar Disorder, Condition Aggravated, Crying, Depression, Disease Recurrence, Dizziness, Drug Exposure During Pregnancy, Euphoric Mood, Eyelid Ptosis, Galactorrhoea, Haemorrhage, Headache, Hypothyroidism, Insomnia, Irritability, Movement Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Somnolence, Suicide Attempt, Tachycardia, Treatment Noncompliance, Tremor, Uterine Haemorrhage, Vaginal Haemorrhage, Vaginal Infection, Weight Decreased
23 Years F 5872665 4830570 11/15/2005 Zoloft Bipolar Disorder, Bipolar I Disorder, Depression Abdominal Pain, Abortion, Aggression, Agonal Rhythm, Alcoholism, Anorexia, Anxiety, Bacterial Infection, Bipolar Disorder, Condition Aggravated, Crying, Depression, Disease Recurrence, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Facial Palsy, Galactorrhoea, Haemorrhage, Headache, Herpes Virus Infection, Hypothyroidism, Insomnia, Irritability, Menorrhagia, Mood Altered, Musculoskeletal Pain, Nausea, Neck Pain, Skin Discolouration, Somnolence, Suicide Attempt, Tachycardia, Tremor, Uterine Haemorrhage, Vaginal Haemorrhage, Vaginal Infection, Vaginitis Bacterial, Weight Decreased
23 Years F 5872665 4847658 12/05/2005 Zoloft Bipolar Disorder, Bipolar I Disorder, Depression Abdominal Pain, Abortion, Aggression, Alcoholism, Anorexia, Anxiety, Bipolar I Disorder, Condition Aggravated, Crying, Decreased Appetite, Depression, Dizziness, Euphoric Mood, Eyelid Ptosis, Feeling Abnormal, Flatulence, Galactorrhoea, Genital Infection Bacterial, Headache, Hormone Level Abnormal, Hypothyroidism, Insomnia, Irritability, Memory Impairment, Menorrhagia, Menstrual Disorder, Menstruation Irregular, Mood Altered, Movement Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Seborrhoeic Dermatitis, Skin Discolouration, Somnolence, Suicide Attempt, Tachycardia, Tremor, Uterine Haemorrhage, Vaginal Haemorrhage, Vaginal Infection, Weight Decreased
23 Years F 5962022 4877642 01/09/2006 Zoloft CN Depression Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anorexia, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Depression, Disease Recurrence, Dizziness, Drug Dose Omission, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Flatulence, Galactorrhoea, Haemorrhage, Headache, Hormone Level Abnormal, Insomnia, Mania, Menstruation Irregular, Mood Altered, Musculoskeletal Pain, Nausea, Rash Macular, Seborrhoeic Dermatitis, Serratia Infection, Somnolence, Suicide Attempt, Tachycardia, Tremor, Uterine Haemorrhage, Vaginal Haemorrhage, Vaginal Infection, Vaginitis Bacterial, Weight Decreased
23 Years F 5962022 4885813 01/17/2006 Zoloft Bipolar Disorder, Bipolar I Disorder, Depression Abdominal Pain, Abortion, Agitation, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Condition Aggravated, Crying, Decreased Appetite, Depression, Dizziness, Drug Dose Omission, Euphoric Mood, Eyelid Ptosis, Feeling Abnormal, Flatulence, Galactorrhoea, Haemorrhagic Disorder, Headache, Insomnia, Irritability, Mania, Menstruation Irregular, Mood Altered, Movement Disorder, Nausea, Neck Pain, Seborrhoeic Dermatitis, Skin Striae, Somnolence, Suicide Attempt, Tachycardia, Tremor, Vaginal Haemorrhage, Vaginitis Bacterial, Weight Decreased
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 5962022 4996150 05/04/2006 Zoloft CN Bipolar Disorder, Bipolar I Disorder, Depression Abortion, Aggression, Agitation, Alcoholism, Amenorrhoea, Amnesia, Anorexia, Anxiety, Blood Pressure Decreased, Crying, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Galactorrhoea, Headache, Hormone Level Abnormal, Inappropriate Schedule of Drug Administration, Influenza Like Illness, Insomnia, Irritability, Menstruation Irregular, Mood Altered, Nausea, Neck Pain, Seborrhoeic Dermatitis, Sinusitis, Somnolence, Suicide Attempt, Tachycardia, Treatment Noncompliance, Tremor, Vaginal Haemorrhage, Weight Decreased
23 Years F 6051517 5003668 05/15/2006 Zoloft Depression Abortion, Alcoholism, Amnesia, Anorexia, Anxiety, Bacterial Infection, Bipolar Disorder, Blood Pressure Decreased, Depression, Dizziness, Drug Exposure During Pregnancy, Euphoric Mood, Eyelid Ptosis, Galactorrhoea, Headache, Hypoaesthesia, Hypothyroidism, Influenza, Irritability, Mania, Musculoskeletal Pain, Nausea, Seborrhoeic Dermatitis, Sinusitis, Somnolence, Suicide Attempt, Tachycardia, Tremor, Uterine Haemorrhage, Vaginal Disorder, Vaginal Haemorrhage, Weight Decreased
23 Years F 6051517 5049123 07/06/2006 Zoloft Bipolar Disorder, Bipolar I Disorder, Depression Abdominal Pain, Abortion, Aggression, Agitation, Alcoholism, Amenorrhoea, Amnesia, Anorexia, Anxiety, Bacterial Infection, Blood Pressure Decreased, Condition Aggravated, Depression, Disease Recurrence, Dizziness, Drug Exposure During Pregnancy, Dyskinesia, Euphoric Mood, Eye Disorder, Eyelid Ptosis, Flatulence, Galactorrhoea, Headache, Hormone Level Abnormal, Hypoaesthesia, Hypoaesthesia Facial, Hypothyroidism, Influenza, Insomnia, Irritability, Mania, Menstruation Irregular, Mood Altered, Nausea, Pain, Seborrhoeic Dermatitis, Sinusitis, Skin Discolouration, Somnolence, Suicide Attempt, Tachycardia, Tremor, Vaginal Haemorrhage, Vaginal Infection, Weight Decreased
23 Years F 6124800 5091541 07/29/2006 08/24/2006 Zoloft MD Drug Use for Unknown Indication Caesarean Section, Drug Exposure During Pregnancy, Pancreatitis Acute
23 Years F 6155531 5131684 07/29/2006 10/16/2006 Zoloft MD Caesarean Section, Drug Exposure During Pregnancy, Pancreatitis Acute
24 Years F 5693729 4519265 06/01/2004 12/01/2004 Zoloft MD Postpartum Depression Drug Exposure During Pregnancy, Uterine Contractions During Pregnancy
24 Years F 6171690 5147398 11/06/2006 Zoloft CN Anxiety, Depression Blood Cholesterol Increased, Drug Exposure During Pregnancy, Fatigue, Injury, Memory Impairment, Ventriculo-Peritoneal Shunt, Weight Increased
24 Years F 6444156 5485583 10/02/2007 10/11/2007 Zoloft CN Anxiety Abortion Spontaneous, Drug Exposure During Pregnancy
24 Years F 6466114 5507320 02/01/2006 11/02/2007 Sertraline Depression Drug Exposure During Pregnancy
24 Years F 6468500 5509580 02/01/2006 11/06/2007 Sertraline Depression Drug Exposure During Pregnancy
24 Years F 6470457 5513528 02/01/2006 11/08/2007 Sertraline OT Depression Drug Exposure During Pregnancy
24 Years F 6470457 5612192 02/01/2006 01/28/2008 Sertraline Depression 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
24 Years F 6472141 5512811 02/01/2006 11/08/2007 Sertraline Depression Drug Exposure During Pregnancy
24 Years F 6684398 5776997 01/01/2007 06/16/2008 Sertraline OT Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus
25 Years F 6521489 5578266 12/27/2007 Sertraline Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy
25 Years F 6521489 5580027 12/28/2007 Sertraline OT Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy
25 Years F 6521489 5613444 01/29/2008 Sertraline OT Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy
25 Years F 6522402 5581177 12/27/2007 Sertraline Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy
25 Years F 6523154 5580192 12/28/2007 Sertraline Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy
25 Years F 6549133 5621060 01/18/2008 02/08/2008 Zoloft MD Panic Attack Abortion
25 Years F 6549133 5628514 01/18/2008 02/15/2008 Zoloft MD Panic Attack Abortion
25 Years F 6032120 4974599 12/01/2004 04/10/2006 Zoloft Depression Depression, Drug Exposure During Pregnancy, Eclampsia, Gestational Diabetes, Pre-Eclampsia, Premature Baby
26 Years F 6481228 5530338 03/01/2005 11/27/2007 Zoloft Obsessive-Compulsive Disorder Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy
26 Years F 5657464 4486436 07/16/2004 10/26/2004 Zoloft CN Anxiety Adjustment Disorder, Fear, Homicidal Ideation, Postpartum Depression, Psychotic Disorder, Suicidal Ideation, Thyroiditis
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 5710456 4541828 01/01/2004 12/27/2004 Zoloft MD Depression Antepartum Haemorrhage, Anxiety, Arrested Labour, Caesarean Section, Drug Exposure During Pregnancy, Placenta Praevia, Umbilical Cord Around Neck, Weight Increased
26 Years F 6138203 5112883 09/01/2006 09/21/2006 Sertraline OT Dehydration, Diarrhoea, Drug Exposure During Pregnancy, Headache, Therapeutic Response Unexpected With Drug Substitution
27 Years F 6059314 5030599 06/15/2006 Zoloft Bipolar I Disorder Crying, Depressed Mood, Drug Exposure Before Pregnancy, Feeling Abnormal, Irritability, Mood Altered, Post-Traumatic Stress Disorder, Uterine Leiomyoma
28 Years F 4131352 4342388 03/01/2004 04/16/2004 Zoloft Anxiety Complications of Maternal Exposure To Therapeutic Drugs, Intra-Uterine Death, Maternal Drugs Affecting Foetus
28 Years F 4131352 4360018 03/01/2004 05/13/2004 Zoloft MD Anxiety Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Maternal Drugs Affecting Foetus
28 Years F 4156847 4375996 06/07/2004 Sertraline PH Obsessive-Compulsive Disorder Abortion Spontaneous, Maternal Drugs Affecting Foetus
28 Years F 4161076 4382172 01/01/2002 06/15/2004 Zoloft OT Depression Drug Dependence, Drug Effect Decreased, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Emotional Distress, Nausea
28 Years F 5693327 4517772 11/13/2004 11/30/2004 Zoloft MD Depression Caesarean Section, Drug Exposure During Pregnancy, Stillbirth
28 Years F 5906034 4802057 10/11/2005 Zoloft PH Ill-Defined Disorder Caesarean Section, Drug Exposure During Pregnancy
28 Years F 5906034 4835877 09/13/2005 11/18/2005 Zoloft PH Depression Caesarean Section, Drug Exposure During Pregnancy
28 Years F 5940968 4916755 11/02/2005 02/14/2006 Sertraline MD Obsessive-Compulsive Disorder Abortion Spontaneous, Drug Exposure During Pregnancy
28 Years F 6600980 5674789 03/19/2008 01/12/2008 Zoloft Insomnia Completed Suicide, Depression, 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
29 Years F 6531530 5592901 01/14/2008 Zoloft CN Developmental Delay, Drug Exposure During Pregnancy, Dyspraxia, Sensory Integrative Dysfunction
29 Years F 3642770 4332404 12/01/2000 04/01/2004 Zoloft Depression Complications of Maternal Exposure To Therapeutic Drugs, Intra-Uterine Death, Maternal Drugs Affecting Foetus
29 Years F 4159927 4381198 06/16/2004 Zoloft MD Anxiety Beta Haemolytic Streptococcal Infection, Complications of Maternal Exposure To Therapeutic Drugs, Premature Rupture of Membranes
29 Years F 4201465 4433755 01/01/2004 08/25/2004 Zoloft MD Depression Abortion Induced, Drug Exposure During Pregnancy
29 Years F 5847803 4720538 07/19/2005 Zoloft Panic Attack, Social Phobia Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes
30 Years F 4161222 4382251 06/15/2004 Zoloft MD Depression Beta Haemolytic Streptococcal Infection, Caesarean Section, Drug Exposure During Pregnancy, Vaginal Infection
30 Years F 5693801 4515663 06/10/2003 11/26/2004 Zoloft OT Depression Breech Delivery, Caesarean Section, Complications of Maternal Exposure To Therapeutic Drugs, Congenital Macrocephaly, Maternal Drugs Affecting Foetus
30 Years F 5960868 4875056 12/06/2005 01/04/2006 Sertraline MD Ill-Defined Disorder Caesarean Section, Drug Exposure During Pregnancy
30 Years F 5974374 4890813 01/23/2006 Zoloft Anxiety, Migraine Caesarean Section, Drug Exposure During Pregnancy, Pain, Rheumatoid Factor Increased
30 Years F 6025518 4963652 02/04/2006 03/30/2006 Sertraline OT Depression Abortion Missed, Drug Exposure During Pregnancy
30 Years F 6125205 5096888 05/15/2004 09/01/2006 Zoloft OT Postpartum Depression Abnormal Behaviour, Amnesia, Attention Deficit Hyperactivity Disorder, Bipolar Disorder, Condition Aggravated, Depression, Drug Exposure Before Pregnancy, Hormone Level Abnormal, Ill-Defined Disorder, Imprisonment, Mania, Panic Attack, Personality Change, Thyroid Disorder
31 Years F 5829949 4719518 07/19/2005 Zoloft MD Postpartum Depression Abortion Spontaneous, Bipolar Disorder, Caesarean Section, Chlamydial Infection, Depression, Drug Exposure During Pregnancy, Feeling Abnormal, Hallucination (Auditory), Laceration, Mood Swings, Oral Intake Reduced, Psychomotor Hyperactivity, Somnolence, Suicidal Ideation, Suicide Attempt, Weight Decreased, Weight Increased
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 6643311 5742447 08/28/2007 05/19/2008 Sertraline MD Anxiety Abortion Spontaneous
31 Years F 6659304 5753049 08/28/2007 05/27/2008 Sertraline Drug Use for Unknown Indication Abortion Spontaneous, Drug Exposure During Pregnancy
31 Years F 6660692 5753386 08/28/2007 05/27/2008 Sertraline Anxiety, Drug Exposure During Pregnancy Abortion Spontaneous, Drug Exposure During Pregnancy
31 Years F 6661416 5755509 08/28/2007 05/28/2008 Sertraline MD Anxiety, Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus
31 Years F 6663068 5753418 08/28/2007 05/27/2008 Sertraline Anxiety, Depression Abortion Spontaneous, Drug Exposure During Pregnancy
31 Years F 6684413 5777009 08/28/2007 06/16/2008 Sertraline Anxiety, Depression Abortion Spontaneous, Drug Exposure During Pregnancy
32 Years F 5728802 4564161 08/01/2004 01/26/2005 Lustral OT Depression Depression, Drug Exposure During Pregnancy, Drug Tolerance Decreased, Ectopic Pregnancy
32 Years F 5808436 4674029 05/25/2005 Sertraline MD Drug Exposure During Pregnancy, Premature Labour
32 Years F 5846987 4718864 07/19/2005 Gladem MD Depression Abortion Early, Drug Exposure During Pregnancy, Ectopic Pregnancy
32 Years F 6090079 5053208 07/12/2006 Sertraline OT Major Depression Decreased Appetite, Drug Exposure During Pregnancy, Oral Intake Reduced, Weight Gain Poor
32 Years F 6145615 5120242 01/17/2006 09/28/2006 Zoloft MD Depression Abortion Missed, Drug Exposure During Pregnancy
32 Years F 6187346 5164627 11/03/2006 11/24/2006 Zoloft MD Affective Disorder 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
33 Years F 5684967 4507390 01/01/2004 11/18/2004 Zoloft MD Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Paraesthesia, Sensory Loss, Swelling Face
33 Years F 5773820 4627072 03/31/2005 Zoloft MD Ill-Defined Disorder Abortion Spontaneous, Drug Exposure During Pregnancy, Unwanted Pregnancy
33 Years F 5812680 4678929 07/01/2004 05/31/2005 Zoloft PH Aggression, Drug Exposure During Pregnancy, Nausea, Vomiting
33 Years F 6021868 4957779 03/24/2006 Zoloft MD Ill-Defined Disorder Drug Exposure During Pregnancy, Intra-Uterine Death
33 Years F 6021868 4988993 04/25/2006 Zoloft MD Ill-Defined Disorder Abortion Spontaneous, Drug Exposure During Pregnancy, Foetal Heart Rate Abnormal
33 Years F 6052218 5003343 02/24/2006 05/12/2006 Zoloft OT Obsessive-Compulsive Disorder Caesarean Section, Drug Exposure During Pregnancy
33 Years F 6141550 5131806 10/16/2006 Zoloft MD Abortion Spontaneous, Anxiety, Drug Exposure During Pregnancy
34 Years F 5907032 4816400 02/09/2000 10/28/2005 Tresleen MD Anxiety, Depression Assisted Fertilisation, Drug Exposure During Pregnancy, Hypothyroidism
35 Years F 4088934 4287086 09/01/2003 02/05/2004 Zoloft Depression Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Ectopic Pregnancy, Haemorrhage, Laboratory Test Abnormal, Maternal Drugs Affecting Foetus, Obsessive Thoughts, Progesterone Decreased
35 Years F 4088934 4304327 09/01/2003 02/24/2004 Zoloft Depression Abortion Spontaneous, Blood Human Chorionic Gonadotropin Decreased, Complications of Maternal Exposure To Therapeutic Drugs, Ectopic Pregnancy, Maternal Drugs Affecting Foetus, Progesterone Decreased
35 Years F 4148186 4365328 01/01/2003 05/20/2004 Zoloft MD Anxiety, Depression Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy
36 Years F 5650690 4476497 10/12/2004 Zoloft OT Depression Anaemia, Caesarean Section, Depression, Dizziness, Drug Exposure During Pregnancy, Hypoaesthesia, Urinary Tract Infection, Uterine Leiomyoma
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
36 Years F 5650690 4494980 11/03/2004 Zoloft OT Depression Abdominal Pain, Anaemia, Caesarean Section, Dizziness, Hypoaesthesia, Sensation of Pressure, Urinary Tract Infection, Uterine Leiomyoma
36 Years F 5741846 4576818 10/25/2004 02/07/2005 Zoloft Depression Amniotic Fluid Volume Increased, Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Glycosylated Haemoglobin Decreased, Pre-Eclampsia, Premature Labour, Premature Rupture of Membranes
36 Years F 5741846 4620605 10/25/2004 03/24/2005 Zoloft MD Depression Amniotic Fluid Volume Increased, Caesarean Section, Drug Exposure During Pregnancy, Fluid Retention, Glycosylated Haemoglobin Increased, High Risk Pregnancy, Pre-Eclampsia, Premature Labour, Weight Decreased
36 Years F 5948522 4851808 01/01/2005 12/09/2005 Zoloft Schizoaffective Disorder Disease Recurrence, Drug Exposure During Pregnancy, Mania, Pre-Eclampsia, Weight Increased
36 Years F 6012195 4947467 05/01/2004 03/13/2006 Zoloft Depression Caesarean Section, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome, Feeling Abnormal, Insomnia, Nausea, Neuralgia, Obstetric Procedure Complication, Pain, Placenta Praevia, Premature Labour, Tremor, Weight Increased
36 Years F 6229794 5227777 02/02/2007 Zoloft MD Abortion Spontaneous
36 Years F 6229794 5267669 03/16/2007 Zoloft MD Major Depression Abortion Spontaneous, Drug Exposure During Pregnancy
36 Years F 6265283 5256922 12/19/2003 03/05/2007 Zoloft OT Depression, Postpartum Depression Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Ventricular Septal Defect
36 Years F 6491711 5546857 01/01/2000 12/11/2007 Zoloft OT Drug Exposure During Pregnancy, Synostosis
36 Years F 6511888 5570240 09/01/2007 12/20/2007 Zoloft MD Depression Drug Ineffective, Postpartum Haemorrhage
37 Years F 6464140 5506142 04/14/2007 11/01/2007 Sertraline Depression Drug Exposure During Pregnancy, Premature Labour, Stillbirth, Vaginal Haemorrhage
37 Years F 6465744 5507490 04/14/2007 11/02/2007 Sertraline MD Depression Antepartum Haemorrhage, Drug Exposure During Pregnancy, Premature Baby, Rubella, Stillbirth
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 6466224 5507322 11/02/2007 Sertraline Depression Stillbirth, Vaginal Haemorrhage
37 Years F 6466224 5512563 11/07/2007 Sertraline OT Depression Drug Exposure During Pregnancy, Stillbirth, Vaginal Haemorrhage
37 Years F 6469579 5511088 11/07/2007 Sertraline Depression Drug Exposure During Pregnancy, Stillbirth, Vaginal Haemorrhage
37 Years F 6469607 5511059 04/14/2007 11/07/2007 Sertraline Depression Drug Exposure During Pregnancy, Rubella Antibody Positive, Stillbirth, Vaginal Haemorrhage
37 Years F 6498857 5534362 04/14/2007 11/30/2007 Sertraline Depression Drug Exposure During Pregnancy, Premature Baby, Rubella Antibody Positive, Stillbirth, Vaginal Haemorrhage
37 Years F 4225168 4463861 05/10/2004 09/29/2004 Zoloft MD Depression Abortion Missed, Depression, Drug Exposure During Pregnancy
37 Years F 5840305 4712375 12/01/2004 07/11/2005 Zoloft Ill-Defined Disorder Drug Exposure During Pregnancy, Pre-Eclampsia, Premature Labour, Stillbirth
37 Years F 5876562 4764063 01/01/2005 09/06/2005 Zoloft Ill-Defined Disorder Caesarean Section, Drug Exposure During Pregnancy, Insomnia, Road Traffic Accident, Stress, Surgery, Vertigo
37 Years F 5876562 4789640 01/01/2005 10/04/2005 Zoloft Depression Drug Ineffective, Hypersomnia, Limb Operation, Oligomenorrhoea, Road Traffic Accident, Sinusitis, Stress, Vertigo
37 Years F 5981214 4899758 01/31/2006 Zoloft Depression Caesarean Section, Drug Exposure During Pregnancy, Menstrual Disorder, Metrorrhagia, Migraine, Ovarian Cyst, Pain, Panic Attack, Umbilical Cord Around Neck, Uterine Cyst, Uterine Leiomyoma, Vomiting In Pregnancy
37 Years F 6132133 5103144 08/01/2006 09/08/2006 Zoloft Depression Abortion Spontaneous, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
37 Years F 6207593 5179885 12/11/2006 Sertraline MD Anxiety, Depression, Panic Reaction Blood Pressure Increased, Caesarean Section, Drug Ineffective, Placenta Praevia, 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
37 Years F 6659609 5749248 01/08/2007 05/21/2008 07/25/2007 Zoloft OT Depression Drug Exposure During Pregnancy
38 Years F 6534542 5601838 06/07/2007 01/24/2008 Zoloft MD Depression Intra-Uterine Death
38 Years F 5907032 4803689 10/14/2005 Tresleen MD Anxiety Autoimmune Thyroiditis, Drug Exposure During Pregnancy
38 Years F 6180007 5157947 02/01/2006 11/16/2006 Zoloft CN Depression, Panic Disorder Abdominal Pain Lower, Amnesia, Anxiety, Confusional State, Crying, Disturbance In Attention, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Ineffective, Emotional Disorder, Feeling Abnormal, Ill-Defined Disorder, Impaired Driving Ability, Judgement Impaired, Major Depression, Malaise, Muscle Twitching, Nervous System Disorder, Optic Neuritis, Pain, Photophobia, Postpartum Depression, Suicidal Ideation, Vision Blurred, Visual Disturbance, Weight Decreased
40 Years F 5865696 4748517 08/17/2005 08/18/2005 Zoloft CN Anxiety, Depression Crying, Depression, Disorientation, Dizziness, Drug Dose Omission, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Abnormal, Hallucination (Auditory), Insomnia, Irritability, Mental Disorder, Tinnitus
40 Years F 6124649 5092504 08/28/2006 Zoloft Depression Anxiety, Diarrhoea, Drug Exposure During Pregnancy, Dyskinesia, Memory Impairment, Ovarian Cancer, Tremor
41 Years F 4152267 4417291 01/01/2001 08/02/2004 Zoloft OT Depression Blood Pressure Decreased, Bruxism, Cardiac Failure Congestive, Cardiomyopathy, Drug Exposure During Pregnancy, Fatigue, Glucose Tolerance Impaired, Tooth Fracture
42 Years F 5697930 4523140 10/24/2004 12/08/2004 Zoloft MD Ill-Defined Disorder Abortion Spontaneous, Drug Exposure During Pregnancy, Pyrexia
42 Years F 5798649 4658525 01/01/2005 05/09/2005 Zoloft MD Abortion Spontaneous, Contusion, Drug Exposure During Pregnancy, Haemorrhage
103 Males 226 Females 410 Cases (Gender was not reported for 81 Cases) 537 Individual Safety Reports

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

Daxid (sertraline), Gladem (sertraline), Lustral (sertraline), Serlain (sertraline), Sertraline (sertraline), Tresleen (sertraline), Zoloft (sertraline)

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

Abdominal Pain, Abdominal Pain Lower, Abdominal Pain Upper, Abnormal Behaviour, Abnormal Labour, Abnormal Palmar/Plantar Creases, Abortion, Abortion Early, Abortion Induced, Abortion Missed, Abortion Spontaneous, Adenocarcinoma, Adenotonsillectomy, Adjustment Disorder, Affective Disorder, Aggression, Agitation, Agitation Neonatal, Agonal Rhythm, Alcoholism, Alpha 1 Foetoprotein Amniotic Fluid Increased, Alpha 1 Foetoprotein Increased, Amenorrhoea, Amnesia, Amniotic Fluid Volume Decreased, Amniotic Fluid Volume Increased, Anaemia, Anal Atresia, Anencephaly, Anger, Angiopathy, Ankyloglossia Congenital, Anomalous Pulmonary Venous Connection, Anomaly of External Ear Congenital, Anorectal Disorder, Ano-Rectal Stenosis, Anorexia, Antepartum Haemorrhage, Antiphospholipid Syndrome, Anxiety, Aortic Disorder, Aortic Elongation, Aortic Stenosis, Aortic Valve Incompetence, Aortic Valve Stenosis, Apgar Score Low, Apnoea, Appendicectomy, Arrested Labour, Arrhythmia Neonatal, Arterial Disorder, Arthritis, Arthropathy, Asplenia, Assisted Fertilisation, Asthma, Atrial Septal Defect, Atrioventricular Septal Defect, Attention Deficit Hyperactivity Disorder, Attention Deficit/Hyperactivity Disorder, Auricular Swelling, Autism, Autism Spectrum Disorder, Autoimmune Thyroiditis, Back Pain, Bacterial Infection, Bed Rest, Benign Hydatidiform Mole, Beta Haemolytic Streptococcal Infection, Bicuspid Aortic Valve, Bipolar Disorder, Bipolar I Disorder, Birth Trauma, Blindness, Blood Bilirubin Increased, Blood Cholesterol Increased, Blood Glucose Abnormal, Blood Glucose Decreased, Blood Human Chorionic Gonadotropin Decreased, Blood Magnesium Decreased, Blood PH Decreased, Blood Pressure Decreased, Blood Pressure Increased, Blood Pressure Systolic Decreased, Blood Prolactin Increased, Body Height Below Normal, Body Temperature Decreased, Body Temperature Increased, Bone Disorder, Bradycardia, Bradycardia Foetal, Bradycardia Neonatal, Brain Damage, Brain Malformation, Breast Pain, Breech Delivery, Breech Presentation, Bronchitis, Bruxism, Burning Sensation, Caesarean Section, Cardiac Arrest, Cardiac Disorder, Cardiac Failure, Cardiac Failure Congestive, Cardiac Murmur, Cardiac Perforation, Cardiac Septal Defect, Cardiac Valve Disease, Cardiomegaly, Cardiomyopathy, Caudal Regression Syndrome, Cephalhaematoma, Cerebellar Hypoplasia, Cerebral Cyst, Cerebral Disorder, Cerebral Haemorrhage, Cerebral Haemorrhage Neonatal, Cerebral Palsy, Cerebral Ventricle Dilatation, Cerebrovascular Accident, Chlamydial Infection, Choking, Cholecystectomy, Chorioamnionitis, Chromosome Abnormality, Circulatory Failure Neonatal, Clavicle Fracture, Cleft Lip, Cleft Lip and Palate, Cleft Palate, Coarctation of the Aorta, Cognitive Disorder, Collapse of Lung, Colonic Obstruction, Coma, Complement Factor C4, Complement Factor C4 Decreased, Completed Suicide, Complications of Maternal Exposure To Therapeutic Drugs, Compression Fracture, Condition Aggravated, Confusional State, Congenital Absence of Bile Ducts, Congenital Absence of Cranial Vault, Congenital Anomaly, Congenital Arterial Malformation, Congenital Brain Damage, Congenital Cardiovascular Anomaly, Congenital Central Nervous System Anomaly, Congenital Diaphragmatic Anomaly, Congenital Diaphragmatic Hernia, Congenital Foot Malformation, Congenital Great Vessel Anomaly, Congenital Hand Malformation, Congenital Heart Valve Disorder, Congenital Macrocephaly, Congenital Neurological Disorder, Congenital Nose Malformation, Congenital Nystagmus, Congenital Oesophageal Web, Congenital Pulmonary Hypertension, Congenital Pulmonary Valve Atresia, Congenital Tricuspid Valve Atresia, Constipation, Contusion, Convulsion, Convulsion Neonatal, Coombs Direct Test Positive, Coombs Test Positive, Craniosynostosis, Croup Infectious, Crying, Cyanosis, Cyanosis Neonatal, Dacryostenosis Congenital, Deafness, Death, Death Neonatal, Decreased Appetite, Deformity, Dehydration, Dental Caries, Depersonalisation, Depressed Mood, Depression, Developmental Coordination Disorder, Developmental Delay, Dextrocardia, Diabetes Insipidus, Diarrhoea, DiGeorge's Syndrome, Discomfort, Disease Recurrence, Disorientation, Disturbance In Attention, Divorced, Dizziness, Double Outlet Right Ventricle, 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 Intolerance, Drug Level Increased, Drug Tolerance Decreased, Drug Toxicity, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Dyskinesia, Dyskinesia Neonatal, Dyspepsia, Dysphagia, Dyspnoea, Dyspraxia, Ear Infection, Ear Malformation, Ebstein's Anomaly, Eclampsia, Economic Problem, Ectopic Pregnancy, Ectopic Pregnancy Termination, Eczema, Electroencephalogram Abnormal, Emotional Disorder, Emotional Distress, Enamel Anomaly, Encephalitis, Encephalopathy Neonatal, Endometriosis, Epilepsy, Euphoric Mood, Exomphalos, Eye Disorder, Eye Movement Disorder, Eye Rolling, Eyelid Ptosis, Facial Palsy, Failed Induction of Labour, Failure To Thrive, Fall, Fallot's Tetralogy, False Labour, Fatigue, Fear, Feeding Disorder Neonatal, Feeding Disorder of Infancy or Early Childhood, Feeling Abnormal, Feeling Jittery, Fever Neonatal, Fine Motor Delay, Flatulence, Fluid Overload, Fluid Retention, Foetal Cardiac Disorder, Foetal Damage, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Heart Rate, Foetal Heart Rate Abnormal, Foetal Heart Rate Decreased, Foetal Malformation, Food Allergy, Formication, Funisitis, Galactorrhoea, Gastric Disorder, Gastroenteritis Eosinophilic, Gastrointestinal Disorder, Gastrointestinal Malformation, Gastrooesophageal Cancer, Gastrooesophageal Reflux Disease, Genital Infection Bacterial, Gestational Diabetes, Glucose Tolerance Impaired, Glycosylated Haemoglobin Decreased, Glycosylated Haemoglobin Increased, Grand Mal Convulsion, Grip Strength Decreased, Growth Retardation, Grunting, Haemangioma, Haematochezia, Haematocrit Decreased, Haematoma, Haemorrhage, Haemorrhagic Disorder, Hallucination, Hallucination (Auditory), Head Deformity, Head Injury, Headache, Hearing Impaired, Heart Disease Congenital, Heart Rate Increased, Heart Valve Incompetence, Hellp Syndrome, Hepatic Congestion, Herpes Virus Infection, High Risk Pregnancy, Homicidal Ideation, Hormone Level Abnormal, Horseshoe Kidney, Hot Flush, Hunger, Hydronephrosis, Hyperemesis Gravidarum, Hyperphagia, Hyperreflexia, Hypersensitivity, Hypersomnia, Hypertelorism of Orbit, Hypertension, Hypertonia, Hypertonia Neonatal, Hypertrophy, Hyperventilation, Hypervigilance, Hypoaesthesia, Hypoaesthesia Facial, Hypocalcaemia, Hypoglycaemia, Hypoglycaemia Neonatal, Hypokinesia, Hypomagnesaemia, Hypopituitarism, Hypoplastic Left Heart Syndrome, Hypoplastic Right Heart Syndrome, Hypopnoea, Hypospadias, Hypothalamo-Pituitary Disorder, Hypothermia Neonatal, Hypothyroidism, Hypotonia, Hypotonia Neonatal, Hypoxia, Ill-Defined Disorder, Impaired Driving Ability, Imprisonment, Impulse-Control Disorder, Inappropriate Antidiuretic Hormone Secretion, Inappropriate Schedule of Drug Administration, Indirect Infection Transmission, Infantile Apnoeic Attack, Infertility, Inflammation, Influenza, Influenza Like Illness, Injury, Insomnia, Intentional Misuse, Intentional Self-Injury, Intercostal Retraction, Intra-Uterine Death, Irritability, Irritable Bowel Syndrome, Jaundice, Jaundice Neonatal, Joint Dislocation, Judgement Impaired, Kidney Enlargement, Laboratory Test Abnormal, Laboratory Test Interference, Labour Complication, Laceration, Large for Dates Baby, Laryngeal Stenosis, Laryngomalacia, Lethargy, Limb Deformity, Limb Malformation, Limb Operation, Limb Reduction Defect, Lipoatrophy, Liver Disorder, Lower Limb Deformity, Lung Disorder, Macrocephaly, Major Depression, Malaise, Malnutrition, Mania, Maternal Alcohol Use, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Maternal Use of Illicit Drugs, Medication Error, Memory Impairment, Menorrhagia, Menstrual Disorder, Menstruation Irregular, Mental Disorder, Mental Retardation Severity Unspecified, Mentally Late Developer, Metrorrhagia, Microcephaly, Migraine, Mild Mental Retardation, Mitral Valve Disease, Mitral Valve Hypoplasia, Mitral Valve Incompetence, Mitral Valve Prolapse, Mixed Receptive-Expressive Language Disorder, Mood Altered, Mood Swings, Movement Disorder, Multiple Allergies, Multiple Cardiac Defects, Multiple Congenital Abnormalities, Muscle Rigidity, Muscle Spasms, Muscle Twitching, Musculoskeletal Pain, Myoclonic Epilepsy, Myoclonus, Myotonia, Nasopharyngitis, Nausea, Neck Pain, Neonatal Apnoeic Attack, Neonatal Asphyxia, Neonatal Aspiration, Neonatal Complications of Substance Abuse, Neonatal Disorder, Neonatal Hypoxia, Neonatal Respiratory Acidosis, Neonatal Respiratory Distress Syndrome, Neonatal Respiratory Failure, Neonatal Tachycardia, Neonatal Tachypnoea, Nervous System Disorder, Nervousness, Neural Tube Defect, Neuralgia, Neurodevelopmental Disorder, Nightmare, Nystagmus, Oblique Presentation, Obsessive Thoughts, Obstetric Procedure Complication, Oligohydramnios, Oligomenorrhoea, Opisthotonus, Optic Neuritis, Oral Intake Reduced, Organ Failure, Osteoporosis, Otitis Media, Ovarian Cancer, Ovarian Cyst, Overdose, Overweight, Oxygen Saturation Decreased, Pain, Pain In Extremity, Palpitations, Pancreatitis Acute, Panic Attack, Paraesthesia, Paralysis, Paresis, Partial Seizures, Patent Ductus Arteriosus, Pericardial Effusion, Perinatal Brain Damage, Persistent Foetal Circulation, Personality Change, Personality Disorder, Phaeochromocytoma, Phobia, Photophobia, Placenta Praevia, Placental Disorder, Plasminogen Activator Inhibitor, Pleural Effusion, Pneumonia, Pneumonia Bacterial, Poisoning, Polydactyly, Polyhydramnios, Poor Sucking Reflex, Post Procedural Complication, Postmature Baby, Postpartum Depression, Postpartum Haemorrhage, Post-Traumatic Stress Disorder, Posture Abnormal, Pre-Eclampsia, Premature Baby, Premature Labour, Premature Rupture of Membranes, Premenstrual Syndrome, Presbyopia, Progesterone Decreased, Prolonged Labour, Psychomotor Hyperactivity, Psychomotor Skills Impaired, Psychotic Disorder, Pulmonary Artery Atresia, Pulmonary Hypertension, Pulmonary Hypoplasia, Pulmonary Oedema Neonatal, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Pyloric Stenosis, Pyrexia, Rash Macular, Rash Neonatal, Reflexes Abnormal, Refusal of Treatment By Patient, Renal Aplasia, Renal Cyst, Renal Disorder, Renal Impairment, Renal Tubular Necrosis, Respiration Abnormal, Respiratory Depression, Respiratory Disorder, Respiratory Disorder Neonatal, Respiratory Distress, Respiratory Rate Increased, Respiratory Tract Infection, Restlessness, Retching, Retroplacental Haematoma, Rheumatoid Factor Increased, Rhinitis, Right Ventricular Hypertrophy, Road Traffic Accident, Rubella, Rubella Antibody Positive, Scar, Schizophrenia, Schizophrenia (Paranoid Type), Scoliosis, Seborrhoeic Dermatitis, Sedation, Sensation of Pressure, Sensory Integrative Dysfunction, Sensory Loss, Serotonin Syndrome, Serratia Infection, Shock, Single Functional Kidney, Sinusitis, Skin Burning Sensation, Skin Discolouration, Skin Lesion, Skin Striae, Skull Malformation, Sleep Apnoea Syndrome, Sleep Disorder, Sleep Study Abnormal, Small for Dates Baby, Snoring, Somnolence, Somnolence Neonatal, Speech Disorder, Speech Disorder Developmental, Spinal Deformity, Spine Malformation, Stillbirth, Strabismus, Strabismus Congenital, Stress, Sudden Death, Suicidal Ideation, Suicide Attempt, Supravalvular Aortic Stenosis, Supraventricular Tachycardia, Surgery, Swelling Face, Syncope, Syncope Vasovagal, Syndactyly, Synostosis, Tachycardia, Tachypnoea, Takayasu's Arteritis, Talipes, Tardive Dyskinesia, Tendonitis, Thalassaemia, Therapeutic Response Unexpected With Drug Substitution, Thermal Burn, Thyroid Disorder, Thyroiditis, Tinnitus, Tonic Clonic Movements, Tooth Disorder, Tooth Fracture, Tooth Injury, Torticollis, Transfusion Reaction, Transient Tachypnoea of the Newborn, Transmission of Drug Via Semen, Transposition of the Great Vessels, Treatment Noncompliance, Tremor, Tremor Neonatal, Tricuspid Valve Disease, Tricuspid Valve Incompetence, Trisomy 13, Trisomy 21, Ultrasound Antenatal Screen Abnormal, Umbilical Cord Abnormality, Umbilical Cord Around Neck, Underweight, Unevaluable Event, Univentricular Heart, Unresponsive To Pain Stimuli, Unresponsive To Stimuli, Unstable Foetal Lie, Unwanted Pregnancy, Upper Limb Deformity, Upper Respiratory Tract Infection, Urinary Tract Disorder, Urinary Tract Infection, Urine Ketone Body Present, Urine Output Decreased, Uterine Contractions Abnormal, Uterine Contractions During Pregnancy, Uterine Cyst, Uterine Haemorrhage, Uterine Leiomyoma, Vaginal Disorder, Vaginal Haemorrhage, Vaginal Infection, Vaginitis Bacterial, Vascular Anomaly, Vasoconstriction, Ventricular Hypoplasia, Ventricular Septal Defect, Ventriculo-Peritoneal Shunt, Vertical Infection Transmission, Vertigo, Viral Infection, Vision Blurred, Visual Disturbance, Vocal Cord Disorder, Vocal Cord Paralysis, Vocal Cord Paresis, Vomiting, Vomiting In Pregnancy, Vomiting Neonatal, Walking Disability, Weight Decrease Neonatal, Weight Decreased, Weight Gain Poor, Weight Increased, Wound Infection, Wrong Technique In Drug Usage Process

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.
  
Anal Atresia The anus is either not present or it is in the wrong place.
  
Anencephaly Congenital absence of most of the brain and spinal cord.
  
Ankyloglossia Congenital A congenital anomaly in which the mucous membrane under the tongue is too short limiting the mobility of the tongue.
  
Atrial Septal Defect An atrial septal defect (ASD), a congenital defect, occurs when there is an opening in the atrial septum, or dividing wall between the two upper chambers of the heart, known as the right and left atria.

Normally, oxygen-poor (blue) blood returns to the right atrium from the body, travels to the right ventricle, then is pumped into the lungs where it receives oxygen. Oxygen-rich (red) blood returns to the left atrium from the lungs, passes into the left ventricle, then is pumped out to the body through the aorta.

An atrial septal defect allows oxygen-rich (red) blood to pass from the left atrium through the opening in the septum, and then mix with oxygen-poor (blue) blood in the right atrium.

This heart defect can cause lung problems if not repaired. When blood passes through the ASD from the left atrium to the right atrium, a larger volume of blood than normal must be handled by the right side of the heart, causing the right side to become overworked and enlarged. Extra blood then passes through the pulmonary artery into the lungs, causing higher pressure than normal in the blood vessels in the lungs, a condition known as pulmonary hypertension.
  
Congenital A physical abnormality that is present at birth.
  
Digeorge's Syndrome DiGeorge syndrome (also called congenital thymic hypoplasia, or third and fourth pharyngeal pouch syndrome) is a birth defect that is caused by an abnormal chromosome and affects the baby's immune system. The syndrome is marked by absence or underdevelopment of the thymus and parathyroid glands.
DiGeorge syndrome is sometimes described as one of the "CATCH 22" disorders, so named because of their characteristics — cardiac defects, abnormal facial features, thymus underdevelopment, cleft palate, and hypocalcemia — caused by a deletion of several genes in chromosome 22. The specific facial features associated with DiGeorge syndrome include low-set ears, wide-set eyes, a small jaw, and a short groove in the upper lip.
  
Dyspnoea Difficulty in breathing, often associated with lung or heart disease and resulting in shortness of breath. Also called air hunger.
  
Ebstein's Anomaly Congenital downward displacement of the tricuspid valve into the right ventricle.
  
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.
  
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.
  
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.
  
Hypoplastic Right Heart Syndrome (HRHS) refers to underdevelopment of the right sided structures of the heart. These defects cause inadequate blood flow to the lungs and thus, a blue or cyanotic infant. The major problem is pulmonary valve atresia (absence). This valve normally opens and closes to let blood flow to the pulmonary artery. Secondary problems include a very small (hypoplastic) right ventricle (lower chamber which normally pumps blood to the lungs); a small tricuspid valve (this valve allows blood to flow into the right ventricle) and a small (hypoplastic) pulmonary artery. Also, the blood flow into the coronary arteries may be abnormal causing damage to the heart muscle.
  
Neonatal Asphyxia A condition in which an extreme decrease in the concentration of oxygen in the body accompanied by an increase in the concentration of carbon dioxide leads to loss of consciousness or death.
  
Neural Tube Defect Any of various congenital defects of the brain and spinal cord, such as spina bifida, resulting from incomplete closing of the neural tube in an embryo.
  
Nystagmus Rhythmic, oscillating motions of the eyes are called nystagmus. The to-and-fro motion is generally involuntary. Vertical nystagmus occurs much less frequently than horizontal nystagmus and is often, but not necessarily, a sign of serious brain damage. Nystagmus can be a normal physiological response or a result of a pathologic problem. ulation refers to a medical method of testing their connections to the brain, and therefore to the eyes. Cold or warm water flushed into the ear canal will generate motion signals from the inner ear. The eyes will respond to this signal with nystagmus if the pathways are intact.
  
Opisthotonus A condition, caused by a tetanic spasm of the back muscles, in which the trunk is arched forward while the head and lower limbs are bent backward.
  
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.
  
Pulmonary Hypertension From WebMD article:Babies whose mothers took antidepressant drugs in the second half of pregnancy are six times more likely to have a rare but dangerous lung ailment, a new study suggests.
One study isn't proof. But it's strong evidence that taking SSRI antidepressants -- such as Prozac, Zoloft, and Paxil -- carries an extra risk during pregnancy.
The risk is that the babies will have PPHN: persistent pulmonary hypertension of the newborn. Only one or two in a thousand babies get this, but it's very serious. It kills about one in 10 babies who get it. In moderately severe cases, half the survivors suffer hearing loss or brain damage.
  
Tardive Dyskinesia Tardive dyskinesia is a mostly irreversible neurological disorder of involuntary movements caused by longterm use of antipsychotic or neuroleptic drugs.
When these drugs are used long term, tardive dyskinesia (TD) can result. About 20 percent of people taking antipsychotic drugs for more then one year become affected by TD. The prevalence of TD tends to be highest among elderly patients and among women.
  
Transposition of the Great Vessels In transposition of the great arteries (TGA), the aorta and pulmonary artery are reversed. The aorta receives the oxygen-poor blood from the right ventricle, but it's carried back to the body without receiving more oxygen. Likewise, the pulmonary artery receives the oxygen-rich blood from the left ventricle but carries it back to the lungs.
  
Trisomy 13 Patau syndrome, also called trisomy 13, is a congenital (present at birth) disorder associated with the presence of an extra copy of chromosome 13. The extra chromosome 13 causes numerous physical and mental abnormalities, especially heart defects.
  
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 346
Caesarean Section 56
Neonatal Disorder 39
Abortion Spontaneous 39
Congenital Anomaly 33
Maternal Drugs Affecting Foetus 30
Premature Baby 27
Ventricular Septal Defect 21
Drug Withdrawal Syndrome Neonatal 17
Drug Exposure Via Breast Milk 17
Developmental Delay 17
Stillbirth 15
Irritability 15
Depression 15
Atrial Septal Defect 14
Vaginal Haemorrhage 13
Premature Labour 12
Convulsion 12
Complications of Maternal Exposure To Therapeutic Drugs 12
Tremor 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 Sertraline 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".