DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Paxil (Paroxetine) - Side Effect Reports to FDA

 
 



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 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 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 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



Possible Paxil side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Developmental Delay, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy, Macroglossia, Coarctation of THE Aorta, Cardiac Failure Congestive, Beckwith-Wiedemann Syndrome

Drug(s) suspected as cause:
Paxil



Possible Paxil side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female

Reactions: Velopharyngeal Incompetence, Cleft Palate, Foetal Exposure During Pregnancy

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: Cleft LIP, Foetal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Paxil

Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Iron Supplement

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012