This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Paxil CR (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 (148)
Death (8)
Life Threatening Events (3)
Disability (3)
Reports by Reaction Type
Foetal Exposure During Pregnancy (98),
Atrial Septal Defect (43),
Ventricular Septal Defect (24),
Patent Ductus Arteriosus (18),
Talipes (17),
Cardiac Murmur (17),
Maternal Exposure During Pregnancy (12),
Suicidal Ideation (10),
Drug Ineffective (9),
Coarctation of THE Aorta (9),
Premature Baby (9),
Renal Dysplasia (8)
Below are a few examples of reports where side effects / adverse reactions may be related to Paxil CR (Paroxetine). For a complete list or a specific selection of reports, please use the links above.
Possible Paxil CR side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Atrial Septal Defect, Cardiac Murmur, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Neonatal Respiratory Distress Syndrome, Premature Baby, Foetal Exposure During Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Other drugs received by patient: Insulin
Possible Paxil CR side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: male
Reactions: Foetal Exposure During Pregnancy, Coarctation of THE Aorta
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
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:
Paroxetine HCL
Dosage: 20mg unknown
Indication: Product Used FOR Unknown Indication
Paxil
Indication: Product Used FOR Unknown Indication
Paxil CR
Dosage: 25mg unknown
Indication: Product Used FOR Unknown Indication
Possible Paxil CR side effects in female
Reported by a pharmacist from United States on 2012-08-24
Patient: female
Reactions: Atrial Septal Defect, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paroxetine HCL
Dosage: 20mg per day
Indication: Product Used FOR Unknown Indication
Start date: 2004-11-01
Paxil CR
Dosage: 25mg per day
Indication: Product Used FOR Unknown Indication
Start date: 2005-08-01
End date: 2005-09-01
Possible Paxil CR side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: male
Reactions: Cryptorchism, Foetal Exposure During Pregnancy, Hydrocele
Drug(s) suspected as cause:
Paxil CR
Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP
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 health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: male
Reactions: Cleft LIP, Nose Deformity, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: Atrial Septal Defect, Anaemia Neonatal, Neonatal Respiratory Distress Syndrome, Premature Baby, Foetal Exposure During Pregnancy, Hypertension Neonatal, Tricuspid Valve Incompetence, Respiratory Failure, Sepsis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in female
Reported by a lawyer from United States on 2012-08-21
Patient: female
Reactions: Cleft LIP, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: female
Reactions: Polydactyly, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil CR
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
Dosage: 30mg per day
Indication: Depression
Paxil CR
Indication: Anxiety
Other drugs received by patient: Vitamin TAB; Norvasc; Lotrel; Insulin
Possible Paxil CR side effects in male
Reported by a lawyer from United States on 2012-08-20
Patient: male
Reactions: Breech Delivery, Foetal Exposure During Pregnancy, Talipes
Drug(s) suspected as cause:
Paxil
Dosage: 20mg per day
Indication: Social Phobia
Start date: 2003-01-01
End date: 2003-01-01
Paxil CR
Administration route: Oral
Indication: Social Phobia
Other drugs received by patient: NO Concurrent Medication
Possible Paxil CR side effects in female
Reported by a physician from United States on 2012-08-20
Patient: female
Reactions: Cleft Palate, Dysmorphism, Foetal Exposure During Pregnancy, Talipes, Ankyloglossia Congenital
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Other drugs received by patient: Multi-Vitamins
Possible Paxil CR side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: female, weighing 3.4 kg (7.5 pounds)
Reactions: Foetal Exposure During Pregnancy, Talipes
Drug(s) suspected as cause:
Paxil
Dosage: 20mg per day
Indication: Anxiety
Start date: 2002-08-20
Paxil CR
Dosage: 25mg per day
Indication: Anxiety
Start date: 2003-02-04
Possible Paxil CR side effects in female
Reported by a physician from United States on 2012-08-17
Patient: female
Reactions: Atrial Septal Defect, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paroxetine
Dosage: 20mg unknown
Indication: Depression
Paxil
Dosage: 20mg per day
Indication: Depression
Paxil CR
Dosage: 25mg per day
Indication: Depression
Possible Paxil CR side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: female
Reactions: Craniosynostosis, Tethered Cord Syndrome, Premature Baby, Hydroureter, Foetal Exposure During Pregnancy, Pilonidal Cyst Congenital
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in female
Reported by a physician from United States on 2012-08-15
Patient: female
Reactions: Atrial Septal Defect, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in female
Reported by a physician from United States on 2012-08-15
Patient: female
Reactions: Cleft Palate, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in 43 year old female
Reported by a consumer/non-health professional from United States on 2012-08-08
Patient: 43 year old female
Reactions: Movement Disorder, Drug Ineffective, Aphasia, Speech Disorder, Malaise, Sensation of Foreign Body, Tongue Disorder, Balance Disorder, Product Quality Issue, Nightmare, Nausea, Paraesthesia Oral, Swollen Tongue, Muscle Twitching, Convulsion, Panic Attack, Insomnia
Drug(s) suspected as cause:
Paroxetine
Dosage: 25mg per day
Administration route: Oral
Indication: Depression
Start date: 2012-03-01
End date: 2012-03-31
Paxil CR
Dosage: 25mg per day
Administration route: Oral
Indication: Depression
Start date: 2003-06-01
Other drugs received by patient: Ambien; Synthroid; Birth Control; Dexilant
Possible Paxil CR side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-08
Patient: female
Reactions: Pneumonia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: male
Reactions: Atrial Septal Defect, Pulmonary Valve Stenosis, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in female
Reported by a lawyer from United States on 2012-08-03
Patient: female
Reactions: Spina Bifida, Foetal Exposure During Pregnancy, Plagiocephaly, Strabismus Congenital
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in female
Reported by a lawyer from United States on 2012-08-03
Patient: female
Reactions: Cleft Palate, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in male
Reported by a physician from United States on 2012-08-03
Patient: male
Reactions: Foetal Exposure During Pregnancy, Hernia Congenital
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-02
Patient: female
Reactions: Congenital Anomaly, Foetal Exposure During Pregnancy
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 2012-07-16
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 male
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: male
Reactions: Foetal Exposure During Pregnancy, Pulmonary Aplasia, Renal Dysplasia, Congenital Musculoskeletal Anomaly, Congenital Pulmonary Hypertension, Dextrocardia, Congenital Pulmonary Artery Anomaly, Vacterl Syndrome, Pulmonary Hypoplasia
Drug(s) suspected as cause:
Paxil CR
Other drugs received by patient: Vistaril; Sertraline Hydrochloride; Zoloft; Vistaril; Multi-Vitamins
Possible Paxil CR side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-13
Patient: female
Reactions: Anxiety, Panic Attack
Drug(s) suspected as cause:
Dilantin
Dosage: 200 mg, 2x/day
Indication: Petit MAL Epilepsy
Start date: 1994-01-01
Paxil CR
Dosage: unk, 2x/day
Indication: Anxiety
Other drugs received by patient: Bumex; Multi-Vitamins; Ascorbic Acid; Mobic; Vitamin B-12; Caltrate 600+d; Vitamin B6; Zinc; Mobic
Possible Paxil CR side effects in male
Reported by a lawyer from United States on 2012-07-13
Patient: male, weighing 4.0 kg (8.8 pounds)
Reactions: Fallot's Tetralogy, Foetal Exposure During Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Dosage: 10mg per day
Indication: Depression
Start date: 2003-01-01
End date: 2004-01-01
Paxil CR
Dosage: 25mg at night
Indication: Depression
Start date: 2003-05-06
Other drugs received by patient: Iron Supplements; Multi-Vitamins
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