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Paxil CR (Paroxetine) - Maternal Exposure During Pregnancy - Suspected Cause - Side Effect Reports

 
 



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 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 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 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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