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Paxil CR (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 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 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 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 2012-08-24

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 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 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 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 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 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 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 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 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 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 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 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 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 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



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

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