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Index of reports
> Cases with Maternal Exposure Timing Unspecified (602)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Zoloft (Sertraline) where reactions include maternal exposure timing unspecified. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 602 Next >>
Possible Zoloft side effects in 6 year old
Reported by a pharmacist from United States on 2012-08-27
Patient: 6 year old
Reactions: Maternal Exposure Timing Unspecified, Convulsion
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-08-27
Patient: male, weighing 2.4 kg (5.3 pounds)
Reactions: Head LAG, Dysmorphism, Congenital Central Nervous System Anomaly, Bundle Branch Block Right, Micrognathia, Tricuspid Valve Incompetence, Hypospadias, Cerebral Haemorrhage, Cardiomegaly, Cerebral Ischaemia, Patent Ductus Arteriosus, Congenital Anomaly, Pulmonary Vascular Disorder, Congenital Nose Malformation, Mitral Valve Prolapse, Pulmonary Valve Stenosis, Arachnodactyly, Maternal Exposure Timing Unspecified, Convulsion, Digeorge's Syndrome, Fallot's Tetralogy, Otitis Media, Aortic Valve Incompetence, Inguinal Hernia, Double Outlet Right Ventricle, Right Ventricular Hypertrophy, Failure To Thrive, Small FOR Dates Baby, Neck Deformity, Right Aortic Arch, Atrial Septal Defect, Speech Disorder Developmental, Motor Dysfunction, Pachygyria, Penile Torsion, Ventricular Septal Defect, Cognitive Disorder, Pulmonary Artery Atresia, Pulmonary Valve Incompetence, Respiratory Failure, Shwachman-Diamond Syndrome, Mitral Valve Incompetence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zoloft
Dosage: 50 unknown units, unk
Start date: 2004-03-01
Zoloft
Dosage: 50 mg, half tablet per day
Indication: Depression
Start date: 2003-05-21
Other drugs received by patient: Albuterol; Multi-Vitamins; Diphenhydramine; Prednisone
Possible Zoloft side effects in 5 year old
Reported by a pharmacist from United States on 2012-08-27
Patient: 5 year old
Reactions: Maternal Exposure Timing Unspecified, Convulsion
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-08-27
Patient: male, weighing 3.4 kg (7.4 pounds)
Reactions: Atrial Septal Defect, Neonatal Respiratory Distress Syndrome, Pulmonary Valve Stenosis, Hypertension Neonatal, Ventricular Septal Defect, Right Ventricle Outflow Tract Obstruction, Maternal Exposure Timing Unspecified, Pulmonary Artery Atresia, Fallot's Tetralogy, Congenital Anomaly, Sepsis Neonatal, Pneumothorax, Heart Disease Congenital, Pneumopericardium
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Zoloft
Dosage: 100mg half dose (1/2) daily
Start date: 2000-12-12
Zoloft
Dosage: one and half dose daily
Start date: 2001-01-02
Zoloft
Dosage: half dose of 100 mg and then increased to one and half dose daily
Start date: 2002-03-06
Other drugs received by patient: Multi-Vitamins; Ceflex
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-08-27
Patient: male
Reactions: Multiple Cardiac Defects, Maternal Exposure Timing Unspecified
Adverse event resulted in: death
Drug(s) suspected as cause:
Sertraline Hydrochloride
Indication: Depression
Sertraline Hydrochloride
Dosage: unk
Indication: Anxiety
Sertraline Hydrochloride
Indication: Affective Disorder
Zoloft
Indication: Affective Disorder
Zoloft
Indication: Depression
Zoloft
Dosage: unk
Indication: Anxiety
Possible Zoloft side effects in female
Reported by a lawyer from United States on 2012-08-27
Patient: female, weighing 2.9 kg (6.4 pounds)
Reactions: Atrial Septal Defect, Aortic Stenosis, Left Ventricular Hypertrophy, Ventricular Septal Defect, Tricuspid Valve Incompetence, Maternal Exposure Timing Unspecified, Transposition of THE Great Vessels, Pulmonary Artery Stenosis Congenital, Pulmonary Oedema Neonatal, Atelectasis Neonatal, Right Atrial Dilatation, Mitral Valve Incompetence, Heart Disease Congenital
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zoloft
Indication: Depression
Zoloft
Dosage: 50 mg, 1x/day
Indication: Anxiety
Start date: 2003-10-23
Zoloft
Indication: Affective Disorder
Other drugs received by patient: Ferrous Fumarate; Promethazine; Multi-Vitamins; Zyrtec; Vitamin B6; Folic Acid; Promethazine; Robitussin A-C / OLD Form /; Amoxil
Possible Zoloft side effects in female
Reported by a lawyer from United States on 2012-08-14
Patient: female
Reactions: Congenital Anomaly, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-08-14
Patient: male, weighing 2.4 kg (5.3 pounds)
Reactions: Head LAG, Dysmorphism, Congenital Central Nervous System Anomaly, Micrognathia, Bundle Branch Block Right, Tricuspid Valve Incompetence, Hypospadias, Cerebral Haemorrhage, Cerebral Ischaemia, Cardiomegaly, Patent Ductus Arteriosus, Congenital Anomaly, Pulmonary Vascular Disorder, Congenital Nose Malformation, Mitral Valve Prolapse, Pulmonary Valve Stenosis, Arachnodactyly, Maternal Exposure Timing Unspecified, Convulsion, Digeorge's Syndrome, Fallot's Tetralogy, Otitis Media, Aortic Valve Incompetence, Inguinal Hernia, Double Outlet Right Ventricle, Failure To Thrive, Right Ventricular Hypertrophy, Small FOR Dates Baby, Neck Deformity, Right Aortic Arch, Atrial Septal Defect, Speech Disorder Developmental, Pachygyria, Motor Dysfunction, Penile Torsion, Ventricular Septal Defect, Cognitive Disorder, Pulmonary Valve Incompetence, Pulmonary Artery Atresia, Respiratory Failure, Shwachman-Diamond Syndrome, Mitral Valve Incompetence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zoloft
Dosage: 50 unknown units, unk
Start date: 2004-03-01
Zoloft
Dosage: 50 mg, half tablet per day
Indication: Depression
Start date: 2003-05-21
Other drugs received by patient: Multi-Vitamins; Albuterol; Diphenhydramine; Prednisone
Possible Zoloft side effects in 3 year old male
Reported by a consumer/non-health professional from Denmark on 2012-08-08
Patient: 3 year old male
Reactions: Incontinence, Speech Disorder Developmental, Tongue Disorder, Maternal Exposure Timing Unspecified
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Zoloft
Other drugs received by patient: Selexid; Clotrimazole; Sulfametizol; Imadrax; Pentrexyl; Selexid
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-08-07
Patient: male, weighing 3.3 kg (7.3 pounds)
Reactions: Double Outlet Right Ventricle, Congenital Pulmonary Valve Disorder, Aorta Hypoplasia, Aortic Stenosis, Tricuspid Valve Incompetence, Jaundice Neonatal, Transposition of THE Great Vessels, Cardiomegaly, Patent Ductus Arteriosus, Cardiac Failure Congestive, Congenital Coronary Artery Malformation, Coarctation of THE Aorta, Atrial Septal Defect, Premature Baby, Univentricular Heart, Ventricular Septal Defect, Maternal Exposure Timing Unspecified, Congenital Pulmonary Hypertension, Pulmonary Valve Incompetence, Congenital Pulmonary Artery Anomaly, Mitral Valve Incompetence, Feeding Disorder Neonatal, Aortic Valve Incompetence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zoloft
Dosage: 75 mg, 1x/day
Indication: Anxiety
Start date: 2009-03-18
Zoloft
Dosage: 100 mg, 1x/day
Indication: Depression
Start date: 2009-07-01
End date: 2009-11-01
Zoloft
Dosage: 50 mg, 1x/day
Start date: 2010-04-22
Other drugs received by patient: Sertraline; Sertraline; Sertraline; Sertraline; Multi-Vitamins
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-08-03
Patient: male, weighing 2.4 kg (5.3 pounds)
Reactions: Head LAG, Dysmorphism, Congenital Central Nervous System Anomaly, Micrognathia, Bundle Branch Block Right, Tricuspid Valve Incompetence, Hypospadias, Cardiomegaly, Cerebral Haemorrhage, Cerebral Ischaemia, Patent Ductus Arteriosus, Congenital Anomaly, Pulmonary Vascular Disorder, Mitral Valve Prolapse, Congenital Nose Malformation, Pulmonary Valve Stenosis, Arachnodactyly, Maternal Exposure Timing Unspecified, Convulsion, Digeorge's Syndrome, Fallot's Tetralogy, Otitis Media, Aortic Valve Incompetence, Inguinal Hernia, Double Outlet Right Ventricle, Right Ventricular Hypertrophy, Failure To Thrive, Small FOR Dates Baby, Neck Deformity, Right Aortic Arch, Atrial Septal Defect, Speech Disorder Developmental, Pachygyria, Motor Dysfunction, Penile Torsion, Cognitive Disorder, Ventricular Septal Defect, Pulmonary Artery Atresia, Pulmonary Valve Incompetence, Shwachman-Diamond Syndrome, Respiratory Failure, Mitral Valve Incompetence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zoloft
Dosage: 50 unknown units, unk
Start date: 2004-03-01
Zoloft
Dosage: 50 mg, half tablet per day
Indication: Depression
Start date: 2003-05-21
Other drugs received by patient: Prednisone; Diphenhydramine; Albuterol; Multi-Vitamins
Possible Zoloft side effects in 3 month old male
Reported by a physician from Japan on 2012-08-01
Patient: 3 month old male, weighing 6.1 kg (13.4 pounds)
Reactions: Rhabdomyolysis, Exposure During Breast Feeding, Hepatic Failure, Maternal Exposure Timing Unspecified
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Depas
Dosage: unk
Start date: 2012-02-01
End date: 2012-03-20
Depas
Dosage: unk
Start date: 2012-03-01
Zoloft
Dosage: unk
Start date: 2012-02-01
End date: 2012-03-20
Zoloft
Dosage: unk
Start date: 2012-03-01
Possible Zoloft side effects in female
Reported by a lawyer from United States on 2012-07-31
Patient: female, weighing 2.9 kg (6.4 pounds)
Reactions: Weight Gain Poor, Atrial Septal Defect, Dilatation Ventricular, Pulmonary Valve Stenosis, Univentricular Heart, Ventricular Septal Defect, Congenital Scoliosis, Maternal Exposure Timing Unspecified, Transposition of THE Great Vessels, Cardiomegaly, Ventricular Hypertrophy, Left Atrial Dilatation, Spleen Malformation, Truncus Arteriosus Persistent, Atrioventricular Septal Defect
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zoloft
Other drugs received by patient: Phenobarbital; Colace; Tylenol (Caplet); Synthroid
Possible Zoloft side effects in female
Reported by a lawyer from United States on 2012-07-26
Patient: female, weighing 3.7 kg (8.1 pounds)
Reactions: Foetal Cardiac Disorder, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Zoloft
Dosage: 50 mg, 1x/day
Indication: Anxiety
Zoloft
Dosage: 25 mg, 1x/day
Start date: 2006-07-09
Other drugs received by patient: Thyroid TAB; Multi-Vitamins; Tylenol W / Codeine NO. 4; Thyroid TAB; Thyroid TAB
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-07-25
Patient: male, weighing 2.4 kg (5.3 pounds)
Reactions: Head LAG, Dysmorphism, Congenital Central Nervous System Anomaly, Bundle Branch Block Right, Micrognathia, Tricuspid Valve Incompetence, Hypospadias, Cerebral Ischaemia, Cerebral Haemorrhage, Cardiomegaly, Patent Ductus Arteriosus, Congenital Anomaly, Pulmonary Vascular Disorder, Mitral Valve Prolapse, Congenital Nose Malformation, Pulmonary Valve Stenosis, Arachnodactyly, Maternal Exposure Timing Unspecified, Convulsion, Digeorge's Syndrome, Fallot's Tetralogy, Otitis Media, Aortic Valve Incompetence, Inguinal Hernia, Double Outlet Right Ventricle, Right Ventricular Hypertrophy, Failure To Thrive, Small FOR Dates Baby, Neck Deformity, Right Aortic Arch, Atrial Septal Defect, Speech Disorder Developmental, Motor Dysfunction, Pachygyria, Penile Torsion, Ventricular Septal Defect, Cognitive Disorder, Pulmonary Artery Atresia, Pulmonary Valve Incompetence, Respiratory Failure, Shwachman-Diamond Syndrome, Mitral Valve Incompetence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zoloft
Dosage: 50 mg, half tablet per day
Indication: Depression
Start date: 2003-05-21
Zoloft
Dosage: 50 unknown units, unk
Start date: 2004-03-01
Other drugs received by patient: Multi-Vitamins; Albuterol; Diphenhydramine; Prednisone
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-07-25
Patient: male, weighing 3.1 kg (6.8 pounds)
Reactions: Atrial Septal Defect, Neonatal Respiratory Distress Syndrome, Congenital Naevus, Supraventricular Tachycardia, Jaundice Neonatal, Exomphalos, Maternal Exposure Timing Unspecified, Foetal Growth Restriction, Cyanosis, Patent Ductus Arteriosus, Sepsis Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zoloft
Dosage: 50 mg, every day
Indication: Anxiety
Start date: 2005-12-13
Zoloft
Dosage: 25 mg, 1x/day
Indication: Depression
Start date: 2006-07-09
Zoloft
Indication: Affective Disorder
Other drugs received by patient: Multi-Vitamins; Tramadol; Thyroid TAB; Tylenol W / Codeine NO. 4; Thyroid TAB; Tylenol W / Codeine NO. 4; Thyroid TAB; Tramadol; Vitamin B6; Lyrica; Tylenol W / Codeine NO. 4; Zofran ODT
Possible Zoloft side effects in female
Reported by a lawyer from United States on 2012-07-23
Patient: female
Reactions: Heart Disease Congenital, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in female
Reported by a lawyer from United States on 2012-07-23
Patient: female
Reactions: Heart Disease Congenital, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-07-23
Patient: male
Reactions: Heart Disease Congenital, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in
Reported by a lawyer from United States on 2012-07-23
Patient:
Reactions: Congenital Anomaly, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Zoloft
Dosage: unk
Indication: Anxiety
Zoloft
Indication: Affective Disorder
Zoloft
Indication: Depression
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-07-23
Patient: male
Reactions: Heart Disease Congenital, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-07-23
Patient: male
Reactions: Talipes, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in female
Reported by a lawyer from United States on 2012-07-23
Patient: female
Reactions: Heart Disease Congenital, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-07-23
Patient: male
Reactions: Craniosynostosis, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in female
Reported by a lawyer from United States on 2012-07-20
Patient: female
Reactions: Cleft Palate, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in female
Reported by a lawyer from United States on 2012-07-20
Patient: female
Reactions: Heart Disease Congenital, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in female
Reported by a lawyer from United States on 2012-07-20
Patient: female
Reactions: Cleft Palate, Congenital Spinal Cord Anomaly, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-07-20
Patient: male
Reactions: Craniosynostosis, Congenital Spinal Cord Anomaly, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-07-20
Patient: male
Reactions: Heart Disease Congenital, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
Possible Zoloft side effects in male
Reported by a lawyer from United States on 2012-07-20
Patient: male
Reactions: Heart Disease Congenital, Maternal Exposure Timing Unspecified
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zoloft
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