Index of reports
> Cases with Maternal Exposure During Pregnancy (12)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Paxil CR (Paroxetine) where reactions include maternal exposure during pregnancy. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Paxil CR side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-31
Patient: female
Reactions: Neural Tube Defect, Cerebral Palsy, Maternal Exposure During Pregnancy, Porencephaly, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Other drugs received by patient: Vitamin B6; 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
Possible Paxil CR side effects in male
Reported by a consumer/non-health professional from United States on 2011-10-31
Patient: male
Reactions: Fallot's Tetralogy, Maternal 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 2011-10-28
Patient: male
Reactions: Hand Deformity, Cardiac Septal Defect, Atrial Septal Defect, Congenital Hand Malformation, Maternal Exposure During Pregnancy, Patent Ductus Arteriosus, Holt-Oram Syndrome
Drug(s) suspected as cause:
Paxil CR
Dosage: 37.5mg unknown
Indication: Product Used FOR Unknown Indication
Paxil
Indication: Product Used FOR Unknown Indication
Start date: 2001-01-01
End date: 2005-01-01
Other drugs received by patient: Tylenol-500; Guaifenesin; Claritin-D 24 Hour
Possible Paxil CR side effects in male
Reported by a consumer/non-health professional from United States on 2011-10-28
Patient: male
Reactions: Atrial Septal Defect, Cardiac Murmur, Maternal 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 2011-10-26
Patient: female
Reactions: Cleft Palate, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in male
Reported by a lawyer from United States on 2011-10-26
Patient: male
Reactions: Scoliosis, Asthma, Maternal Exposure During Pregnancy, Left Ventricular Hypertrophy, Renal Dysplasia, Bicuspid Aortic Valve, Limb Asymmetry, Talipes, Congenital Cystic Kidney Disease, Hypertension, Coarctation of THE Aorta
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 2011-10-26
Patient: male
Reactions: Maternal Exposure During Pregnancy, Ivth Nerve Paralysis, Arnold-Chiari Malformation, Attention Deficit / Hyperactivity Disorder
Drug(s) suspected as cause:
Paxil CR
Possible Paxil CR side effects in female
Reported by a physician from United States on 2011-10-21
Patient: female
Reactions: Atrial Septal Defect, Hydronephrosis, Neonatal Respiratory Distress Syndrome, Dandy-Walker Syndrome, Maternal Drugs Affecting Foetus, Premature Baby, Anaemia, Maternal Exposure During Pregnancy, Respiratory Distress, Pulmonary Haemorrhage, Lung Disorder, Congenital Renal Cyst, Sepsis, Patent Ductus Arteriosus, Haemangioma, Gastrooesophageal Reflux Disease, Infantile Apnoeic Attack
Drug(s) suspected as cause:
Paxil CR
Indication: Product Used FOR Unknown Indication
Paxil
Indication: Product Used FOR Unknown Indication
Possible Paxil CR side effects in male
Reported by a physician from United States on 2011-10-21
Patient: male, weighing 3.3 kg (7.3 pounds)
Reactions: Dysmorphism, Camptodactyly Congenital, Maternal Exposure During Pregnancy, Micrognathia, Strabismus, Cleft Palate, Craniosynostosis, Binocular Eye Movement Disorder, Developmental Delay, Cryptorchism, Talipes, Inguinal Hernia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil
Dosage: 30mg per day
Indication: Depression
Paxil CR
Indication: Depression
Paroxetine HCL
Dosage: 20mg per day
Indication: Anxiety
Start date: 2008-12-09
Other drugs received by patient: Zoloft; Atarax
Possible Paxil CR side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-21
Patient: female, weighing 0.9 kg (2.0 pounds)
Reactions: Atrial Septal Defect, Premature Baby, Sepsis, Patent Ductus Arteriosus, Maternal Exposure During Pregnancy, Respiratory Distress
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paxil CR
Indication: Product Used FOR Unknown Indication
Paxil
Indication: Product Used FOR Unknown Indication
Possible Paxil CR side effects in 29 year old female
Reported by a consumer/non-health professional from United States on 2011-10-07
Patient: 29 year old female
Reactions: Postpartum Disorder, Paraesthesia Oral, Maternal Exposure During Pregnancy, Quality of Life Decreased, Drug Withdrawal Syndrome, Abortion Spontaneous, Paraesthesia, Weight Increased, Anxiety, Hallucination, Visual, Withdrawal Syndrome, Heart Rate Irregular
Drug(s) suspected as cause:
Paxil
Dosage: 15mg per day
Administration route: Oral
Indication: Panic Disorder
Start date: 2000-01-01
Paxil CR
Dosage: 20mg per day
Indication: Panic Disorder
Prozac
Indication: Postpartum Disorder
Other drugs received by patient: NO Concurrent Medication
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