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Pegasys (Peginterferon Alfa-2A) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Pegasys (Peginterferon Alfa-2A) 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 (2397)
Death (302)
Life Threatening Events (116)
Disability (71)

Reports by Reaction Type

Anaemia (352)Nausea (186)Fatigue (180)White Blood Cell Count Decreased (162)Vomiting (133)Asthenia (129)Pyrexia (125)Death (125)Rash (124)Dyspnoea (116)Platelet Count Decreased (114)Diarrhoea (98)

Below are a few examples of reports where side effects / adverse reactions may be related to Pegasys (Peginterferon Alfa-2A). For a complete list or a specific selection of reports, please use the links above.

Possible Pegasys side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Night Sweats, Body Temperature Increased, Anaemia, Ascites, Dysgeusia, Insomnia, Blood Uric Acid Increased, Oedema Peripheral, Sinusitis

Drug(s) suspected as cause:
Ribavirin
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-11-20

VX-950
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-11-20
    End date: 2012-02-12

Pegasys
    Dosage: 180 a?g, unk
    Indication: Hepatitis C
    Start date: 2011-11-20



Possible Pegasys side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male, weighing 81.6 kg (179.6 pounds)

Reactions: Fatigue, Dizziness, Vision Blurred, Feeling Abnormal, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Start date: 2012-08-12

Ribavirin
    Dosage: unk
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-14
    End date: 2012-08-12

Ribavirin
    Dosage: unk
    Administration route: Oral
    Start date: 2012-08-12

Pegasys
    Dosage: 180 unk, unk
    Start date: 2012-08-12

Pegasys
    Dosage: 180 unk, unk
    Indication: Hepatitis C
    Start date: 2012-07-14
    End date: 2012-08-03

Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-14
    End date: 2012-08-10



Possible Pegasys side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 66.7 kg (146.8 pounds)

Reactions: Anaemia, Neutropenia, Thrombocytopenia

Drug(s) suspected as cause:
Pegasys
    Indication: Hepatitis C
    Start date: 2012-05-30
    End date: 2012-07-29

Incivek
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-05-31
    End date: 2012-07-29

Copegus
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-05-31
    End date: 2012-07-29



Possible Pegasys side effects in female

Reported by a consumer/non-health professional from Russian Federation on 2012-08-27

Patient: female

Reactions: Tooth Extraction, Oedema, Dental Care

Drug(s) suspected as cause:
Pegasys
    Indication: Hepatitis C
    Start date: 2011-08-16
    End date: 2012-06-29

Ribavirin
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-08-16
    End date: 2012-06-29

Other drugs received by patient: Tmc435



Possible Pegasys side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient:

Reactions: Anaemia

Drug(s) suspected as cause:
Pegasys

Ribavirin

Victrelis
    Dosage: 800 mg, tid
    Start date: 2012-03-01
    End date: 2012-05-10

Other drugs received by patient: Simvastatin; Plavix; Lisinopril and Hydrochlorothiazide



Possible Pegasys side effects in female

Reported by a physician from France on 2012-08-27

Patient: female, weighing 65.0 kg (143.0 pounds)

Reactions: Mucosal Ulceration, Purpura, Rash Maculo-Papular, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pegasys
    Dosage: dosage form: injection
    Indication: Hepatitis C
    Start date: 2012-06-01
    End date: 2012-07-17

Copegus
    Dosage: dosage form: tablets
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-06-01
    End date: 2012-07-17

Incivek
    Dosage: dosage form: tablet
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-06-01
    End date: 2012-07-15

Incivek
    Dosage: dosage form: tablet
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-07-15



Possible Pegasys side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female, weighing 83.0 kg (182.6 pounds)

Reactions: Tongue Ulceration, Thermoanaesthesia, Rash Pruritic, Oral Discomfort, Fatigue, Cough, Vomiting, Nausea, Haemorrhoids, Hypoaesthesia, Cognitive Disorder, Aptyalism, Anal Fissure, Anxiety, Throat Irritation, Diarrhoea, Dehydration, Insomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-27
    End date: 2012-08-04

Pegasys
    Dosage: 180 unk, unk
    Indication: Hepatitis C
    Start date: 2012-07-27
    End date: 2012-08-04

Ribavirin
    Dosage: 600 mg, bid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-27
    End date: 2012-08-04



Possible Pegasys side effects in male

Reported by a pharmacist from United States on 2012-08-27

Patient: male, weighing 79.0 kg (173.8 pounds)

Reactions: Swelling Face, Neutropenia, Rash Pruritic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-04-01

Pegasys
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-04-01

Ribavirin
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-04-01



Possible Pegasys side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient:

Reactions: Pruritus, Nasopharyngitis, Feeling Hot

Drug(s) suspected as cause:
Pegasys
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-07-15

Rebetol
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-07-15



Possible Pegasys side effects in 50 year old female

Reported by a consumer/non-health professional from Australia on 2012-08-27

Patient: 50 year old female

Reactions: Recurrent Cancer, Malignant Melanoma

Drug(s) suspected as cause:
Pegasys



Possible Pegasys side effects in male

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-27

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Osteonecrosis

Drug(s) suspected as cause:
Pegasys

Other drugs received by patient: Leucogen (Asparaginase)



Possible Pegasys side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient:

Reactions: Liver Injury, Viral Load Increased, Drug Ineffective

Drug(s) suspected as cause:
Pegasys
    Dosage: unk
    Start date: 2012-06-28
    End date: 2012-08-02

Rebetol
    Dosage: unk
    Start date: 2012-06-28
    End date: 2012-08-02

PEG-Intron
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2009-01-01
    End date: 2010-01-01

Rebetol
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2010-01-01
    End date: 2011-01-01

Pegasys
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2010-01-01
    End date: 2011-01-01

Telaprevir
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-06-28
    End date: 2012-08-02



Possible Pegasys side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Drug Ineffective, Diabetes Mellitus, Urinary Tract Infection, Musculoskeletal Stiffness, Diabetic Complication, Influenza Like Illness

Drug(s) suspected as cause:
Pegasys
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-02-08
    End date: 2006-06-16

Ribavirin
    Indication: Product Used FOR Unknown Indication



Possible Pegasys side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: , weighing 117.9 kg (259.4 pounds)

Reactions: Abscess Rupture, Peritonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-07-18
    End date: 2012-08-01

Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Start date: 2012-01-20
    End date: 2012-05-18

Ribavirin
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2011-07-18
    End date: 2012-05-18

Pegasys
    Dosage: 180 a?g, unk
    Indication: Hepatitis C
    Start date: 2011-07-18
    End date: 2012-05-18



Possible Pegasys side effects in

Reported by a pharmacist from Spain on 2012-08-27

Patient:

Reactions: Anaemia, Neutropenia

Drug(s) suspected as cause:
Pegasys
    Dosage: semanal
    Start date: 2011-09-29

Rebetol
    Dosage: 1200/dia y pegasys semanal.
    Administration route: Oral
    Start date: 2011-09-29



Possible Pegasys side effects in

Reported by a health professional (non-physician/pharmacist) from Colombia on 2012-08-27

Patient:

Reactions: Pallor, Asthenia

Drug(s) suspected as cause:
Pegasys

Victrelis
    Dosage: 800 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-10
    End date: 2012-08-01

Rebetol

Other drugs received by patient: Epoetin



Possible Pegasys side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female

Reactions: Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ribavirin
    Indication: Hepatitis C
    Start date: 2007-11-15
    End date: 2008-10-01

Pegasys
    Indication: Hepatitis C
    Start date: 2007-11-15
    End date: 2008-10-01



Possible Pegasys side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male, weighing 90.7 kg (199.5 pounds)

Reactions: Fatigue, Wrist Fracture, Diarrhoea, Liver Function Test Abnormal, Anaemia, Haemorrhoids, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ribavirin
    Dosage: 1000 mg, bid
    Administration route: Oral
    Indication: Hepatitis C
    End date: 2012-07-01

VX-950
    Dosage: unk
    Administration route: Oral

VX-950
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-07-01
    End date: 2011-10-01

Pegasys
    Dosage: 180 unk, unk
    Indication: Hepatitis C
    End date: 2012-07-01



Possible Pegasys side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient:

Reactions: Weight Increased, Dysgeusia, Arthritis, Full Blood Count Decreased

Drug(s) suspected as cause:
Victrelis
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-07-16

Rebetol
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-06-18

Pegasys
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-06-18



Possible Pegasys side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ribavirin
    Dosage: 600 mg, unk
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-23

VX-950
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-23

Pegasys
    Dosage: 180 unk, unk
    Indication: Hepatitis C
    Start date: 2012-07-23



Possible Pegasys side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Dyspnoea, Fatigue, DRY Mouth

Drug(s) suspected as cause:
Rebetol
    Dosage: 3 df, bid
    Administration route: Oral

Victrelis
    Dosage: 200 mg, unk

Pegasys
    Dosage: 180 micrograms/0.5 ml pfs



Possible Pegasys side effects in male

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-27

Patient: male, weighing 61.5 kg (135.3 pounds)

Reactions: Occult Blood, Anaemia, Faeces Discoloured

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pegasys
    Indication: Hepatitis C
    Start date: 2009-02-01
    End date: 2009-04-07

Ribavirin
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2008-08-01
    End date: 2009-04-07

Other drugs received by patient: Sirolimus



Possible Pegasys side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-25

Patient: female

Reactions: Cholelithiasis, Weight Decreased, Peroneal Nerve Palsy, Fear, Transfusion, Asthenia, Myocardial Infarction, Blood Test Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ribavirin
    Indication: Hepatitis C
    Start date: 2011-09-16

Pegasys
    Indication: Hepatitis C
    Start date: 2011-09-16
    End date: 2012-06-27

Victrelis
    Indication: Hepatitis C
    End date: 2012-06-27

Ribavirin
    End date: 2012-06-27



Possible Pegasys side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-25

Patient:

Reactions: Stomatitis, Fatigue, DRY Mouth, Decreased Appetite

Drug(s) suspected as cause:
Pegasys
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-06-19

Victrelis
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-07-22

Rebetol
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-06-19

Other drugs received by patient: Gabapentin; Metformin HCL; Levothyroxine Sodium; Acyclovir; Lisinopril; Levetiracetam



Possible Pegasys side effects in

Reported by a physician from United States on 2012-08-25

Patient:

Reactions: Insomnia, Pyrexia, Somnolence, Lethargy

Drug(s) suspected as cause:
Victrelis
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-07-21

Rebetol
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-06-22

Pegasys
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-06-22



Possible Pegasys side effects in

Reported by a physician from United States on 2012-08-25

Patient:

Reactions: White Blood Cell Count Decreased, Neutropenia

Drug(s) suspected as cause:
Ribasphere

Pegasys

Victrelis
    Dosage: 800 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-05-11



Possible Pegasys side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Vascular Graft

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pegasys



Possible Pegasys side effects in female

Reported by a physician from Turkey on 2012-08-24

Patient: female, weighing 58.0 kg (127.6 pounds)

Reactions: Anaemia, Platelet Count Decreased, Leukopenia

Drug(s) suspected as cause:
VX-950
    Dosage: dosage form: tablet, 3 times as two tablet
    Administration route: Oral
    Indication: Hepatitis C

Pegasys
    Dosage: dosage form: unspecified
    Indication: Hepatitis C

Copegus
    Dosage: dosage form: unknown
    Indication: Hepatitis C



Possible Pegasys side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Death, Product Quality Issue, Bacterial Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Pegasys
    Indication: Product Used FOR Unknown Indication

Alcohol Swab
    Indication: Product Used FOR Unknown Indication



Possible Pegasys side effects in 45 year old female

Reported by a pharmacist from United States on 2012-08-24

Patient: 45 year old female

Reactions: Abdominal Pain Upper

Drug(s) suspected as cause:
Ribavirin
    Dosage: 1200mg daily po
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-04

Pegasys
    Dosage: 180mcg weekly sq
    Indication: Hepatitis C
    Start date: 2012-07-04

Other drugs received by patient: Incivek

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