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Zoloft (Sertraline) - Congenital Anomaly - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Congenital Anomaly (131)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Zoloft (Sertraline) where reactions include congenital anomaly. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 131   Next >>

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 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 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 male

Reported by a lawyer from United States on 2012-08-03

Patient: male, weighing 2.0 kg (4.4 pounds)

Reactions: Pulmonary Hypertension, Foetal Exposure During Pregnancy, Jaundice Neonatal, Tricuspid Valve Incompetence, Oesophageal Stenosis, Cardiomegaly, Lymphadenitis, Cardiac Septal Defect, Cyanosis, Upper Respiratory Tract Infection, Congenital Anomaly, Takayasu's Arteritis, Tachypnoea, Pulmonary Oedema, Bronchiolitis, Congenital Coronary Artery Malformation, Atrial Septal Defect, Cellulitis, Cardiac Murmur, Haematuria, Ventricular Septal Defect, Acute Sinusitis, Otitis Media

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Zoloft

Other drugs received by patient: Gynazole; Chromagen Forte



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 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

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 female

Reported by a lawyer from United States on 2012-07-17

Patient: female, weighing 4.0 kg (8.8 pounds)

Reactions: Syringomyelia, Tricuspid Valve Incompetence, Spina Bifida Occulta, Female Genital Tract Fistula, Conus Medullaris Syndrome, Maternal Exposure Timing Unspecified, Persistent Cloaca, Patent Ductus Arteriosus, Mitral Valve Incompetence, Congenital Anomaly, Caudal Regression Syndrome, Anal Atresia, Aortic Valve Incompetence, Vacterl Syndrome, Vesicoureteric Reflux

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Sertraline Hydrochloride
    Dosage: 100 mg, 1x/day
    Indication: Depression
    Start date: 2006-01-01

Zoloft
    Dosage: 100 mg, 1x/day
    Indication: Depression
    Start date: 2005-06-13

Other drugs received by patient: Percocet



Possible Zoloft side effects in male

Reported by a lawyer from United States on 2012-07-10

Patient: male

Reactions: Atrial Septal Defect, Neonatal Respiratory Distress Syndrome, Pulmonary Valve Stenosis, Ventricular Septal Defect, Maternal Exposure Timing Unspecified, Right Ventricle Outflow Tract Obstruction, Pulmonary Artery Atresia, Fallot's Tetralogy, Congenital Anomaly, Heart Disease Congenital

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: half dose of 100 mg and then increased to one and half dose daily
    Start date: 2002-03-06

Zoloft
    Dosage: one and half dose daily
    Start date: 2001-01-02



Possible Zoloft side effects in female

Reported by a lawyer from United States on 2012-07-06

Patient: female, weighing 4.0 kg (8.8 pounds)

Reactions: Syringomyelia, Tricuspid Valve Incompetence, Female Genital Tract Fistula, Conus Medullaris Syndrome, Persistent Cloaca, Maternal Exposure Timing Unspecified, Congenital Anomaly, Patent Ductus Arteriosus, Mitral Valve Incompetence, Caudal Regression Syndrome, Anal Atresia, Vacterl Syndrome, Aortic Valve Incompetence, Vesicoureteric Reflux

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Sertraline Hydrochloride
    Dosage: 100 mg one tablet daily
    Indication: Depression
    Start date: 2006-01-01

Zoloft
    Dosage: 100 mg one tablet daily
    Indication: Depression
    Start date: 2005-06-13

Other drugs received by patient: Percocet



Possible Zoloft side effects in male

Reported by a lawyer from United States on 2012-07-03

Patient: male

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 2012-06-29

Patient: male, weighing 23.7 kg (52.1 pounds)

Reactions: Bicuspid Aortic Valve, Congenital Anomaly, Maternal Exposure Timing Unspecified, Coarctation of THE Aorta

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in male

Reported by a lawyer from United States on 2012-06-29

Patient: male, weighing 3.5 kg (7.8 pounds)

Reactions: HIP Dysplasia, Jaundice Neonatal, Maternal Exposure Timing Unspecified, Limb Malformation, Limb Deformity, Congenital Anomaly, Talipes, Heart Disease Congenital

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 2012-06-29

Patient: male

Reactions: Pulmonary Vein Stenosis, Atrial Septal Defect, Congenital Pulmonary Hypertension, Respiratory Failure, Congenital Anomaly, Bronchopulmonary Dysplasia, Maternal Exposure Timing Unspecified

Adverse event resulted in: death

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in female

Reported by a lawyer from United States on 2012-06-28

Patient: female

Reactions: Congenital Anomaly, Heart Disease Congenital, Maternal Exposure Timing Unspecified

Adverse event resulted in: life threatening event

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



Possible Zoloft side effects in female

Reported by a lawyer from United States on 2012-06-28

Patient: female

Reactions: Congenital Anomaly, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in

Reported by a lawyer from United States on 2012-06-27

Patient:

Reactions: Congenital Anomaly, Maternal Exposure Timing Unspecified

Adverse event resulted in: death

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in

Reported by a lawyer from United States on 2012-06-27

Patient:

Reactions: Congenital Anomaly, Maternal Exposure Timing Unspecified, Limb Malformation

Adverse event resulted in: death

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in

Reported by a lawyer from United States on 2012-06-27

Patient:

Reactions: Congenital Anomaly, Maternal Exposure Timing Unspecified

Adverse event resulted in: death

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in

Reported by a lawyer from United States on 2012-06-27

Patient:

Reactions: Learning Disability, Congenital Anomaly, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in

Reported by a lawyer from United States on 2012-06-27

Patient:

Reactions: Congenital Anomaly, Maternal Exposure Timing Unspecified

Adverse event resulted in: death

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in

Reported by a lawyer from United States on 2012-06-27

Patient:

Reactions: Congenital Anomaly, Heart Disease Congenital, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in

Reported by a lawyer from United States on 2012-06-26

Patient:

Reactions: Learning Disability, Congenital Anomaly, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in

Reported by a lawyer from United States on 2012-06-26

Patient:

Reactions: Congenital Anomaly, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in

Reported by a lawyer from United States on 2012-06-26

Patient:

Reactions: Congenital Anomaly, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in

Reported by a lawyer from United States on 2012-06-26

Patient:

Reactions: Congenital Anomaly, Maternal Exposure Timing Unspecified

Adverse event resulted in: death

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in

Reported by a lawyer from United States on 2012-06-26

Patient:

Reactions: Congenital Anomaly, Maternal Exposure Timing Unspecified, Liver Disorder

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in

Reported by a lawyer from United States on 2012-06-26

Patient:

Reactions: Congenital Anomaly, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in female

Reported by a lawyer from United States on 2012-06-25

Patient: female

Reactions: Congenital Anomaly, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Zoloft



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