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Weight Gain (14)
Joint Pain (7)
Sweating (6)
Bloating (4)
Sweating Tremendousily Mean (4)
Bladder Irritation (3)
Auditory Hallucinations (2)
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Paxil Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 9787 

Depersonalisation, Diarrhoea, Nausea, Paraesthesia, Derealisation, Anxiety, Dizziness (8422964-1)
on Jun 01, 2012 Female from RUSSIAN FEDERATION , 26 years of age, weighting 176.4 lb, was diagnosed with
  • depression
and was treated with Paxil. Directly after, patient experienced the unwanted or unexpected Paxil side effects: depersonalisation, diarrhoea, nausea, paraesthesia, derealisation, anxiety, dizziness. Paxil dosage: 20mg Per Day. Patient was hospitalized.

Irritable Bowel Syndrome (8421957-8)
Patient was taking Paxil. Patient felt the following Paxil side effects: irritable bowel syndrome on Jun 05, 2012 from UNITED STATES Additional patient health information: Female , weighting 94.00 lb, was diagnosed with
  • anxiety
  • obsessive-compulsive disorder
  • depression
and. Paxil dosage: 5 Mg 1 X A Day.

Congenital Choroid Plexus Cyst, Foetal Exposure During Pregnancy, Pyloric Stenosis (8413548-X)
Adverse event was reported on May 30, 2012 by a Male taking Paxil (Dosage: N/A) was diagnosed with
  • depression
and. Location: UNITED STATES , weighting 7.94 lb, After Paxil was administered, patient encountered several Paxil side effects: congenital choroid plexus cyst, foetal exposure during pregnancy, pyloric stenosis.
Multiple concurrent drugs taken:
  • Klonopin
  • Tranxene
Patient was hospitalized.

Cleft Lip And Palate, Foetal Exposure During Pregnancy (8413546-6)
on May 29, 2012 Male from UNITED STATES , weighting 7.94 lb, was diagnosed with
  • anxiety
and was treated with Paxil. Directly after, patient experienced the unwanted or unexpected Paxil side effects: cleft lip and palate, foetal exposure during pregnancy. Paxil dosage: 20mg Per Day.


Talipes, Foetal Exposure During Pregnancy (8413543-0)
on May 29, 2012 Male from UNITED STATES , weighting 7.50 lb, was diagnosed with
  • anxiety
and was treated with Paxil. Patient felt the following Paxil side effects: talipes, foetal exposure during pregnancy. Paxil dosage: 40mg Per Day.

Talipes, Cardiac Murmur, Heart Disease Congenital, Foetal Exposure During Pregnancy (8413537-5)
Patient was taking Paxil. After Paxil was administered, patient encountered several Paxil side effects: talipes, cardiac murmur, heart disease congenital, foetal exposure during pregnancy on May 30, 2012 from UNITED STATES Additional patient health information: Male , weighting 8.38 lb, . Paxil dosage: N/A.

Macrocephaly, Foetal Exposure During Pregnancy, Autism, Developmental Delay (8413536-3)
Adverse event was reported on May 30, 2012 by a Male taking Paxil (Dosage: N/A) was diagnosed with
  • anxiety
and. Location: UNITED STATES , weighting 7.05 lb, Directly after, patient experienced the unwanted or unexpected Paxil side effects: macrocephaly, foetal exposure during pregnancy, autism, developmental delay.

Talipes, Foetal Exposure During Pregnancy (8413533-8)
on May 30, 2012 Female from UNITED STATES , weighting 3.75 lb, was diagnosed with
  • depression
and was treated with Paxil. Patient felt the following Paxil side effects: talipes, foetal exposure during pregnancy. Paxil dosage: 20mg Per Day. Patient was hospitalized.

Ventricular Septal Defect, Congenital Aortic Anomaly, Atrial Septal Defect, Right Ventricle Outflow Tract Obstruction, Cardiac Failure Congestive, Foetal Exposure During Pregnancy (8413529-6)
on May 30, 2012 Male from UNITED STATES , weighting 5.07 lb, was treated with Paxil. After Paxil was administered, patient encountered several Paxil side effects: ventricular septal defect, congenital aortic anomaly, atrial septal defect, right ventricle outflow tract obstruction, cardiac failure congestive, foetal exposure during pregnancy. Paxil dosage: N/A.
Multiple concurrent drugs taken:
  • Multi-vitamins
Patient was hospitalized.

Injection Site Erythema, Injection Site Haematoma (8411625-0)
Patient was taking Paxil. Directly after, patient experienced the unwanted or unexpected Paxil side effects: injection site erythema, injection site haematoma on May 09, 2012 from UNITED STATES Additional patient health information: Female , 39 years of age, . Paxil dosage: Unk.
Associated medications used:
  • Folic Acid (Unk)
  • Enbrel (50 Mg, Qwk)
  • Sulfasalazine
  • Vitamin D (Unk)
  • Ibuprofen (Unk)


Cardiac Failure Congestive, Pleural Effusion, Escherichia Urinary Tract Infection, Hyperkalaemia, Condition Aggravated, Blood Chloride Decreased, Cholelithiasis, Blood Sodium Decreased, Renal Failure Acute (8410828-9)
Adverse event was reported on Mar 09, 2006 by a Female taking Paxil (Dosage: N/A) . Location: UNITED STATES , 80 years of age, Patient felt the following Paxil side effects: cardiac failure congestive, pleural effusion, escherichia urinary tract infection, hyperkalaemia, condition aggravated, blood chloride decreased, cholelithiasis, blood sodium decreased, renal failure acute.
Multiple prescriptions taken:
  • Aspirin
  • Amiodarone Hcl
  • Hydralazine Hcl
  • Tolvaptan (tolvaptan(v4.1)) 30mg (30mg, Qd, Oral)
  • Coumadin
  • Spironolactone
  • Iron (iron)
  • Prazocor (prazosin Hydrochloride)
Patient was hospitalized.

Bicuspid Aortic Valve, Mitral Valve Disease, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Coarctation Of The Aorta (8407788-3)
on May 29, 2012 Female from UNITED STATES , weighting 15.43 lb, was diagnosed with
  • depression
and was treated with Paxil. After Paxil was administered, patient encountered several Paxil side effects: bicuspid aortic valve, mitral valve disease, foetal exposure during pregnancy, ventricular septal defect, coarctation of the aorta. Paxil dosage: 30mg Per Day. Patient was hospitalized.

Ureterocele, Atrial Septal Defect, Patent Ductus Arteriosus, Hydronephrosis, Foetal Exposure During Pregnancy (8407781-0)
on May 30, 2012 Female from UNITED STATES , weighting 4.19 lb, was treated with Paxil. Directly after, patient experienced the unwanted or unexpected Paxil side effects: ureterocele, atrial septal defect, patent ductus arteriosus, hydronephrosis, foetal exposure during pregnancy. Paxil dosage: N/A. Patient was hospitalized.

Foetal Exposure During Pregnancy, Cleft Lip And Palate (8407779-2)
Patient was taking Paxil Cr. Patient felt the following Paxil side effects: foetal exposure during pregnancy, cleft lip and palate on May 30, 2012 from UNITED STATES Additional patient health information: Male , weighting 7.72 lb, . Paxil Cr dosage: 12.5mg Per Day. Patient was hospitalized.

Tracheomalacia, Foetal Exposure During Pregnancy, Atrial Septal Defect, Congenital Emphysema, Plagiocephaly, Pulmonary Hypoplasia (8407778-0)
Adverse event was reported on May 30, 2012 by a Male taking Paxil (Dosage: 20mg Per Day) was diagnosed with
  • anxiety
and. Location: UNITED STATES , weighting 6.61 lb, After Paxil was administered, patient encountered several Paxil side effects: tracheomalacia, foetal exposure during pregnancy, atrial septal defect, congenital emphysema, plagiocephaly, pulmonary hypoplasia.
Multiple concurrent drugs taken:
  • Buspar


Macrocephaly, Arachnoid Cyst, Foetal Exposure During Pregnancy (8407774-3)
on May 29, 2012 Male from UNITED STATES , weighting 7.50 lb, was treated with Paxil. Directly after, patient experienced the unwanted or unexpected Paxil side effects: macrocephaly, arachnoid cyst, foetal exposure during pregnancy. Paxil dosage: N/A.
Associated medications used:
  • Promethazine


Pulmonary Artery Stenosis Congenital, Foetal Exposure During Pregnancy, Dysmorphism, Ventricular Septal Defect, Patent Ductus Arteriosus, Atrial Septal Defect (8407758-5)
on May 25, 2012 Female from UNITED STATES , weighting 7.72 lb, was treated with Paxil. Patient felt the following Paxil side effects: pulmonary artery stenosis congenital, foetal exposure during pregnancy, dysmorphism, ventricular septal defect, patent ductus arteriosus, atrial septal defect. Paxil dosage: N/A. Patient was hospitalized.

Patent Ductus Arteriosus, Foetal Exposure During Pregnancy (8407756-1)
Patient was taking Paxil. After Paxil was administered, patient encountered several Paxil side effects: patent ductus arteriosus, foetal exposure during pregnancy on May 25, 2012 from UNITED STATES Additional patient health information: Female , weighting 5.29 lb, was diagnosed with
  • nervousness
and. Paxil dosage: N/A. Patient was hospitalized.

Feeling Abnormal, Tinnitus, Pain, Activities Of Daily Living Impaired, Visual Impairment, Withdrawal Syndrome, Cataract, Myocardial Infarction, Cardiac Arrest (8404729-X)
Adverse event was reported on May 25, 2012 by a Male taking Paxil (Dosage: 20 Mg, Daily) was diagnosed with
  • depression
  • pain
  • psoriatic arthropathy
and. Location: UNITED STATES , weighting 229.3 lb, Directly after, patient experienced the unwanted or unexpected Paxil side effects: feeling abnormal, tinnitus, pain, activities of daily living impaired, visual impairment, withdrawal syndrome, cataract, myocardial infarction, cardiac arrest.
Associated medications used:
  • Lyrica
  • Methotrexate (Unk)
  • Folic Acid (Unk)
  • Acetylsalicylic Acid (Unk, Daily)
  • Lyrica (300 Mg, 2x/day)
  • Hydrocodone (Unk)
  • Lyrica


Serotonin Syndrome, Apnoeic Attack, Unresponsive To Stimuli (8401056-1)
on May 15, 2012 Female from UNITED STATES , 68 years of age, was treated with Paxil. Patient felt the following Paxil side effects: serotonin syndrome, apnoeic attack, unresponsive to stimuli. Paxil dosage: Unk.
Multiple prescriptions taken:
  • Gabapentin
  • Suxamethonium
  • Levothyroxine Sodium
  • Multi-vitamin
  • Tiagabine Hydrochloride
  • Senna-mint Waf
  • Calcium
  • Midazolam


Ear Malformation, Foetal Exposure During Pregnancy (8399247-1)
on May 23, 2012 Male from UNITED STATES , weighting 5.95 lb, was diagnosed with
  • depression
and was treated with Paxil. After Paxil was administered, patient encountered several Paxil side effects: ear malformation, foetal exposure during pregnancy. Paxil dosage: N/A.

Pierre Robin Syndrome, Foetal Exposure During Pregnancy, Cleft Palate, Micrognathia (8399246-X)
Patient was taking Paxil. Directly after, patient experienced the unwanted or unexpected Paxil side effects: pierre robin syndrome, foetal exposure during pregnancy, cleft palate, micrognathia on May 23, 2012 from UNITED STATES Additional patient health information: Female , weighting 5.95 lb, was diagnosed with
  • depression
and. Paxil dosage: N/A.

Foetal Exposure During Pregnancy, Lymphangioma, Haemangioma (8399245-8)
Adverse event was reported on May 23, 2012 by a Female taking Paxil (Dosage: 40mg Per Day) was diagnosed with
  • depression
and. Location: UNITED STATES , weighting 4.19 lb, Patient felt the following Paxil side effects: foetal exposure during pregnancy, lymphangioma, haemangioma.

Foetal Exposure During Pregnancy, Ventricular Septal Defect (8399239-2)
on May 23, 2012 Male from UNITED STATES , weighting 6.83 lb, was treated with Paxil Cr. After Paxil was administered, patient encountered several Paxil side effects: foetal exposure during pregnancy, ventricular septal defect. Paxil Cr dosage: N/A.

Foetal Exposure During Pregnancy, Cardiac Murmur, Patent Ductus Arteriosus, Atrial Septal Defect (8399232-X)
on May 23, 2012 Female from UNITED STATES , weighting 3.53 lb, was diagnosed with
  • anxiety
and was treated with Paxil Cr. Directly after, patient experienced the unwanted or unexpected Paxil side effects: foetal exposure during pregnancy, cardiac murmur, patent ductus arteriosus, atrial septal defect. Paxil Cr dosage: N/A.

Showing 1-25 of 9787 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Paxil Information

Alternative PAXIL Names:PAROXETIN

Active Ingredient: PAROXETIN

Paxil Dosage, Warnings, Usage.

Side Effects reported to FDA: 9787. View Paxil Adverse Reports

Paxil safety alerts: 2006 2005 2004

Reported deaths: 655

Reported hospitalizations: 3021

Paxil (paroxetine hydrochloride) Tablets and Oral Suspension

Paxil (paroxetine hydrochloride) Tablets and Oral Suspension
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets

Audience: Neuropsychiatric and other healthcare professionals
[Posted 05/12/2006] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Clinical Worsening and Suicide Risk subsection of the WARNINGS section in the prescribing Information for Paxil and Paxil CR. These labeling changes relate to adult patients, particularly those who are younger adults.

A recent meta-analysis conducted of suicidal behavior and ideation in placebo-controlled clinical trials of paroxetine in adult patients with psychiatric disorders including Major Depressive Disorder (MDD), other depression and non-depression disorders. Results of this analysis showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo. Further, in the analysis of adults with MDD (all ages), the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo. This difference was statistically significant; however, as the absolute number and incidence of events are small, these data should be interpreted with caution. All of the reported events of suicidal behavior in the adult patients with MDD were non-fatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30. These MDD data suggest that the higher frequency observed in the younger adult population across psychiatric disorders may extend beyond the age of 24.

It is important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated.

[May 2006 - Dear Healthcare Professional letter - GlaxoSmithKline]

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