This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Paxil (Paroxetine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (1353)
Death (48)
Life Threatening Events (18)
Disability (17)
Reports by Reaction Type
Foetal Exposure During Pregnancy (684),
Atrial Septal Defect (176),
Talipes (134),
Ventricular Septal Defect (119),
Patent Ductus Arteriosus (108),
Maternal Exposure During Pregnancy (79),
Anxiety (75),
Drug Ineffective (63),
Cardiac Murmur (62),
Insomnia (48),
Depression (40),
Suicidal Ideation (39)
Below are a few examples of reports where side effects / adverse reactions may be related to Paxil (Paroxetine). For a complete list or a specific selection of reports, please use the links above.
Possible Paxil side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: Foetal Exposure During Pregnancy, Ventricular Septal Defect
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: male
Reactions: Bicuspid Aortic Valve, Foetal Exposure During Pregnancy, Congenital Heart Valve Disorder, Coarctation of THE Aorta
Drug(s) suspected as cause:
Paxil
Other drugs received by patient: Multi-Vitamins; Depakote
Possible Paxil side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: female
Reactions: Spina Bifida, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in male
Reported by a lawyer from United States on 2012-08-27
Patient: male
Reactions: Pulmonary Hypertension, Nasal Obstruction, Foetal Exposure During Pregnancy, Oesophageal Atresia, Tracheo-Oesophageal Fistula, Ventricular Septal Defect
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Bicuspid Aortic Valve, Congenital Aortic Valve Stenosis, Foetal Exposure During Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Other drugs received by patient: Ceftin; Multi-Vitamins
Possible Paxil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: male
Reactions: Tachyarrhythmia, Foetal Exposure During Pregnancy, Rhabdomyoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Other drugs received by patient: Multi-Vitamins
Possible Paxil side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Foetal Exposure During Pregnancy, Talipes, Limb Malformation
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male
Reactions: Craniosynostosis, Foetal Exposure During Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Atrial Septal Defect, Cleft LIP, Cleft Palate, Foetal Exposure During Pregnancy, Ventricular Septal Defect
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Other drugs received by patient: Multi-Vitamins; Ambien; Prevacid
Possible Paxil side effects in female
Reported by a lawyer from United States on 2012-08-27
Patient: female
Reactions: Scoliosis, Partial Seizures, Foetal Exposure During Pregnancy, Congenital Coronary Artery Malformation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Other drugs received by patient: Phenergan HCL
Possible Paxil side effects in male
Reported by a lawyer from United States on 2012-08-27
Patient: male, weighing 2.9 kg (6.4 pounds)
Reactions: Mitral Valve Disease, Bicuspid Aortic Valve, Foetal Exposure During Pregnancy, Patent Ductus Arteriosus, Coarctation of THE Aorta
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Other drugs received by patient: Multi-Vitamins
Possible Paxil side effects in male
Reported by a lawyer from United States on 2012-08-27
Patient: male
Reactions: Spina Bifida, Foetal Exposure During Pregnancy, Meningomyelocele, Cerebral Ventricle Dilatation
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: Atrial Septal Defect, Foetal Exposure During Pregnancy, Limb Hypoplasia Congenital, Congenital Multiplex Arthrogryposis, Talipes
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in female
Reported by a lawyer from United States on 2012-08-27
Patient: female
Reactions: Atrial Septal Defect, Multiple Congenital Abnormalities, Muscle Contracture, Foetal Exposure During Pregnancy, Pierre Robin Syndrome, Microcephaly, Cleft Palate, Microgenia, Patent Ductus Arteriosus, Microphthalmos
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: female
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Patent Ductus Arteriosus, Ventricular Septal Defect, Respiratory Distress
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female, weighing 2.6 kg (5.7 pounds)
Reactions: Craniosynostosis, Developmental Delay, Foetal Exposure During Pregnancy, Skull Malformation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Other drugs received by patient: Multi-Vitamins
Possible Paxil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Cleft Palate, Microcephaly, Choanal Atresia, Foetal Exposure During Pregnancy, Coloboma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: female, weighing 3.8 kg (8.4 pounds)
Reactions: Atrial Septal Defect, Foetal Exposure During Pregnancy, Patent Ductus Arteriosus, Ventricular Septal Defect
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Pulmonary Valve Stenosis, Foetal Exposure During Pregnancy, Ventricular Septal Defect
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: male
Reactions: Fallot's Tetralogy, Foetal Exposure During Pregnancy, Oesophageal Atresia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Other drugs received by patient: Ativan; Zoloft
Possible Paxil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: male
Reactions: Foetal Exposure During Pregnancy, Hypospadias
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in female
Reported by a lawyer from United States on 2012-08-24
Patient: female, weighing 2.7 kg (5.9 pounds)
Reactions: Hypoplastic Left Heart Syndrome, Heart Transplant Rejection, Multiple Congenital Abnormalities, Foetal Exposure During Pregnancy
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: male, weighing 4.0 kg (8.8 pounds)
Reactions: Cleft Palate, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: Congenital Pulmonary Valve Disorder, Cardiac Murmur, Foetal Exposure During Pregnancy, Sinus Tachycardia
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in female
Reported by a lawyer from United States on 2012-08-24
Patient: female
Reactions: Foetal Exposure During Pregnancy, Talipes
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: male
Reactions: Kyphoscoliosis, Scoliosis, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil
Possible Paxil 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 side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: male
Reactions: Pulmonary Hypertension, Bicuspid Aortic Valve, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: male, weighing 3.6 kg (7.9 pounds)
Reactions: Atrial Septal Defect, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in female
Reported by a lawyer from United States on 2012-08-24
Patient: female, weighing 3.1 kg (6.8 pounds)
Reactions: Spina Bifida, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil
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