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Index of reports
> Cases with Ventricular Septal Defect (24)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Paxil CR (Paroxetine) where reactions include ventricular septal defect. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Paxil CR side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: male, weighing 2.2 kg (4.8 pounds)
Reactions: Atrial Septal Defect, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Congenital Aortic Valve Incompetence, Coarctation of THE Aorta
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paroxetine HCL
Indication: Depression
Paxil
Dosage: 20mg per day
Indication: Depression
Start date: 2004-03-30
Paxil CR
Indication: Depression
Other drugs received by patient: Zantac; Reglan; Tylenol; Fioricet; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Iron Sulfatethiamin Compound TAB
Possible Paxil CR side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: male
Reactions: Trisomy 21, Atrial Septal Defect, Syndactyly, Bicuspid Aortic Valve, Foetal Exposure During Pregnancy, Tricuspid Valve Incompetence, Ventricular Septal Defect
Drug(s) suspected as cause:
Paxil
Indication: Product Used FOR Unknown Indication
Paroxetine HCL
Dosage: 20mg unknown
Indication: Product Used FOR Unknown Indication
Paxil CR
Dosage: 25mg unknown
Indication: Product Used FOR Unknown Indication
Possible Paxil CR side effects in male
Reported by a physician from United States on 2012-08-21
Patient: male
Reactions: Mitral Valve Incompetence, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Tricuspid Valve Incompetence, Aortic Valve Prolapse
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Indication: Anxiety
Paxil
Dosage: 30mg per day
Indication: Depression
Other drugs received by patient: Vitamin TAB; Norvasc; Lotrel; Insulin
Possible Paxil CR side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-16
Patient: male, weighing 2.2 kg (4.8 pounds)
Reactions: Atrial Septal Defect, Caesarean Section, Premature Baby, Aortic Stenosis, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Congenital Aortic Valve Incompetence, Coarctation of THE Aorta
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paroxetine HCL
Indication: Depression
Paxil
Dosage: 20mg per day
Indication: Depression
Start date: 2004-03-30
Paxil CR
Indication: Depression
Other drugs received by patient: Iron Sulfatethiamin Compound TAB; Acetaminophen; Reglan; Zantac; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Fioricet
Possible Paxil CR side effects in female
Reported by a physician from United States on 2012-06-04
Patient: female
Reactions: Atrial Septal Defect, Foetal Exposure During Pregnancy, Patent Ductus Arteriosus, Ventricular Septal Defect
Drug(s) suspected as cause:
Paxil CR
Other drugs received by patient: Topamax; Excedrin (Migraine); Acetaminophen; Clonidine
Possible Paxil CR side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-31
Patient: male, weighing 3.1 kg (6.8 pounds)
Reactions: Foetal Exposure During Pregnancy, Ventricular Septal Defect
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in female
Reported by a lawyer from United States on 2012-05-14
Patient: female, weighing 3.5 kg (7.7 pounds)
Reactions: Atrial Septal Defect, Congenital Tricuspid Valve Atresia, Fallot's Tetralogy, Pulmonary Valve Stenosis, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Cardiac Failure Congestive
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Other drugs received by patient: Diazepam; Hydrochlorothiazide
Possible Paxil CR side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-10
Patient: female
Reactions: Pulmonary Artery Stenosis Congenital, Atrial Septal Defect, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Cardiac Failure Congestive
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Indication: Depression
Paxil
Dosage: 20mg per day
Indication: Depression
Start date: 1996-02-01
End date: 1999-01-01
Other drugs received by patient: Multi-Vitamins
Possible Paxil CR side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-09
Patient: male, weighing 2.2 kg (4.8 pounds)
Reactions: Atrial Septal Defect, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Congenital Aortic Valve Incompetence, Coarctation of THE Aorta
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Indication: Depression
Paroxetine HCL
Indication: Depression
Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Iron Sulfatethiamin Compound TAB; Fioricet; Reglan; Acetaminophen; Zantac
Possible Paxil CR side effects in male
Reported by a lawyer from United States on 2012-05-07
Patient: male
Reactions: Trisomy 21, Atrial Septal Defect, Hypoplastic Left Heart Syndrome, Foetal Exposure During Pregnancy, Patent Ductus Arteriosus, Ventricular Septal Defect, Cardiac Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Dosage: 20mg per day
Indication: Product Used FOR Unknown Indication
Paxil CR
Dosage: 25mg unknown
Indication: Product Used FOR Unknown Indication
Start date: 2002-11-11
End date: 2003-10-07
Other drugs received by patient: Multi-Vitamins; Albuterol; Prevacid; Advair Diskus 100 / 50; Imitrex; Risperdal; Tylenol (Caplet); Ultram; Skelaxin; Amoxicillin
Possible Paxil CR side effects in male
Reported by a physician from United States on 2012-05-07
Patient: male
Reactions: Multiple Congenital Abnormalities, Foetal Exposure During Pregnancy, Renal Dysplasia, Scrotal Disorder, Hypospadias, Pulmonary Artery Stenosis Congenital, Adjustment Disorder, Congenital Anomaly, Patent Ductus Arteriosus, Cloacal Exstrophy, Atrial Septal Defect, Cardiac Murmur, Supraventricular Tachycardia, Intestinal Malrotation, Ventricular Septal Defect, Anxiety, Congenital Bladder Anomaly, Anal Atresia, Penis Disorder, Depressed Mood, Attention Deficit / Hyperactivity Disorder, Vesicoureteric Reflux
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Indication: Depression
Start date: 2002-08-20
Paxil
Dosage: 35mg per day
Indication: Depression
Start date: 2000-01-01
End date: 2005-11-21
Other drugs received by patient: Lorazepam; Phenergan; Multi-Vitamins
Possible Paxil CR side effects in male
Reported by a lawyer from United States on 2012-04-27
Patient: male, weighing 2.5 kg (5.5 pounds)
Reactions: Atrial Septal Defect, Foetal Exposure During Pregnancy, Foetal Heart Rate Abnormal, Ventricular Septal Defect, Heart Disease Congenital
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Indication: Product Used FOR Unknown Indication
Paxil CR
Dosage: 37.5mg twice per day
Indication: Bipolar Disorder
Other drugs received by patient: Digoxin; Multi-Vitamins; Iron Supplement
Possible Paxil CR side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-23
Patient: male
Reactions: Atrial Septal Defect, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Congenital Aortic Valve Incompetence, Coarctation of THE Aorta
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paroxetine HCL
Indication: Depression
Paxil CR
Indication: Depression
Other drugs received by patient: Iron Sulfatethiamin Compound TAB; Fioricet; Tylenol; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Zantac; Reglan
Possible Paxil CR side effects in male
Reported by a lawyer from United States on 2012-03-19
Patient: male
Reactions: Foetal Exposure During Pregnancy, Multiple Congenital Abnormalities, Renal Dysplasia, Hypospadias, Scrotal Disorder, Pulmonary Artery Stenosis Congenital, Adjustment Disorder, Congenital Anomaly, Patent Ductus Arteriosus, Cloacal Exstrophy, Atrial Septal Defect, Cardiac Murmur, Supraventricular Tachycardia, Ventricular Septal Defect, Intestinal Malrotation, Anxiety, Congenital Bladder Anomaly, Penis Disorder, Anal Atresia, Attention Deficit / Hyperactivity Disorder, Depressed Mood, Vesicoureteric Reflux
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Dosage: 35mg per day
Indication: Depression
Start date: 2000-01-01
End date: 2005-11-21
Paxil CR
Indication: Depression
Start date: 2002-08-20
Other drugs received by patient: Phenergan; Multi-Vitamins
Possible Paxil CR side effects in female
Reported by a physician from United States on 2012-03-13
Patient: female
Reactions: Pulmonary Artery Stenosis Congenital, Atrial Septal Defect, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Cardiac Failure Congestive
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Indication: Depression
Paxil
Dosage: 20mg per day
Indication: Depression
Start date: 1996-02-01
End date: 1999-01-01
Other drugs received by patient: Multi-Vitamins
Possible Paxil CR side effects in male
Reported by a physician from United States on 2012-02-29
Patient: male
Reactions: Double Outlet Right Ventricle, Atrial Septal Defect, Aorticopulmonary Septal Defect, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Ankyloglossia Congenital
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Dosage: 10mg per day
Indication: Depression
Start date: 2006-04-01
End date: 2006-08-31
Paxil CR
Dosage: 12.5mg unknown
Indication: Product Used FOR Unknown Indication
Start date: 2005-11-28
End date: 2006-06-01
Other drugs received by patient: Vitamin TAB
Possible Paxil CR side effects in male
Reported by a physician from United States on 2012-02-28
Patient: male
Reactions: Double Outlet Right Ventricle, Atrial Septal Defect, Aorticopulmonary Septal Defect, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Ankyloglossia Congenital
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Dosage: 12.5mg unknown
Indication: Product Used FOR Unknown Indication
Start date: 2005-11-28
End date: 2006-06-01
Paxil
Dosage: 10mg per day
Indication: Depression
Start date: 2006-04-01
End date: 2006-08-31
Other drugs received by patient: Vitamin TAB
Possible Paxil CR side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-21
Patient: male
Reactions: Foetal Exposure During Pregnancy, Ventricular Septal Defect
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-17
Patient: male
Reactions: Atrial Septal Defect, Double Outlet Right Ventricle, Foetal Exposure During Pregnancy, Aorticopulmonary Septal Defect, Ventricular Septal Defect, Ankyloglossia Congenital
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Dosage: 10mg unknown
Indication: Product Used FOR Unknown Indication
Start date: 2006-06-23
End date: 2006-08-31
Paxil CR
Dosage: 12.5mg unknown
Indication: Product Used FOR Unknown Indication
Start date: 2005-11-28
End date: 2006-06-01
Other drugs received by patient: Vitamin TAB
Possible Paxil CR side effects in male
Reported by a lawyer from United States on 2012-01-09
Patient: male
Reactions: Pneumonia Aspiration, Foetal Exposure During Pregnancy, Tricuspid Valve Incompetence, Right Ventricular Hypertrophy, Pulmonary Artery Stenosis Congenital, Patent Ductus Arteriosus, Pulmonary Oedema, Apnoea, Breech Presentation, Gastrooesophageal Reflux Disease, Cardiac Failure Congestive, Atrial Septal Defect, Cardiac Murmur, Premature Baby, Ventricular Septal Defect, Congenital Pulmonary Hypertension, Bicuspid Aortic Valve, Left Atrial Dilatation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Paxil CR
Dosage: 20mg twice per day
Indication: Anxiety
Start date: 2005-12-01
End date: 2006-01-01
Paxil
Dosage: 20mg twice per day
Indication: Anxiety
Start date: 2005-11-01
End date: 2006-01-01
Other drugs received by patient: Trazodone HCL; Adalat; Feosol; Multi-Vitamins
Possible Paxil CR side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-21
Patient: male
Reactions: Atrial Septal Defect, Double Outlet Right Ventricle, Foetal Exposure During Pregnancy, Aorticopulmonary Septal Defect, Ventricular Septal Defect, Ankyloglossia Congenital
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Dosage: 12.5mg unknown
Indication: Product Used FOR Unknown Indication
Paxil
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Vitamin TAB
Possible Paxil CR side effects in male
Reported by a physician from United States on 2011-12-05
Patient: male
Reactions: Double Outlet Right Ventricle, Atrial Septal Defect, Maternal Drugs Affecting Foetus, Aorticopulmonary Septal Defect, Foetal Exposure During Pregnancy, Ventricular Septal Defect
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Indication: Product Used FOR Unknown Indication
Paxil CR
Dosage: 12.5mg unknown
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Vitamin TAB
Possible Paxil CR side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-07
Patient: female, weighing 2.6 kg (5.7 pounds)
Reactions: Dilatation Ventricular, Left Atrial Dilatation, Ventricular Septal Defect
Drug(s) suspected as cause:
Paroxetine HCL
Indication: Bipolar I Disorder
Paxil CR
Administration route: Oral
Indication: Bipolar I Disorder
Other drugs received by patient: Methadone HCL; Seroquel; Albuterol; Multi-Vitamins
Possible Paxil CR side effects in male
Reported by a consumer/non-health professional from United States on 2011-10-31
Patient: male
Reactions: Maternal Drugs Affecting Foetus, Maternal Exposure During Pregnancy, Ventricular Septal Defect, Coarctation of THE Aorta
Drug(s) suspected as cause:
Paxil CR
Indication: Depression
Paroxetine HCL
Indication: Depression
Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Reglan; Iron Sulfatethiamin Compound TAB; Zantac; Fioricet; Tylenol-500
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