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Victrelis (Boceprevir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Victrelis (Boceprevir) 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 (1383)
Death (124)
Life Threatening Events (76)
Disability (71)

Reports by Reaction Type

Anaemia (280)Fatigue (202)Nausea (186)Dysgeusia (143)Dyspnoea (121)Asthenia (116)White Blood Cell Count Decreased (113)Vomiting (105)Weight Decreased (103)Diarrhoea (92)Headache (77)Haemoglobin Decreased (75)

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

Possible Victrelis side effects in

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

Patient:

Reactions: Fatigue, Vomiting, Pruritus, Diarrhoea, Dehydration, Ephelides

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Peginterferon Alfa-2A
    Dosage: 180 microgram, qw
    Start date: 2012-03-24

Rebetol
    Dosage: 1200 mg, qd
    Administration route: Oral
    Start date: 2012-03-24

Victrelis
    Dosage: unk
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-04-21

Other drugs received by patient: Metformin HCL



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

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

Victrelis
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-07-16



Possible Victrelis side effects in

Reported by a individual with unspecified qualification from Germany on 2012-08-27

Patient:

Reactions: Maternal Exposure Before Pregnancy, Abortion Induced

Drug(s) suspected as cause:
PEG-Intron
    Dosage: unk
    Indication: Hepatitis
    End date: 2012-01-01

Rebetol
    Dosage: unk
    End date: 2012-01-01

Victrelis
    Dosage: 200 mg, qd
    Indication: Hepatitis
    Start date: 2012-01-09
    End date: 2012-05-01

Other drugs received by patient: Lexotanil



Possible Victrelis side effects in

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

Patient:

Reactions: Headache

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

Rebetol
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-07-17

Victrelis
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-08-12



Possible Victrelis side effects in

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

Patient:

Reactions: White Blood Cell Count Decreased, Contusion, Anaemia, Fall, Loss of Consciousness, Haemoglobin Decreased, Anxiety, Dysgeusia, Urine Uric Acid Increased, Disturbance in Attention, Injury, Feeling Abnormal, Asthenia

Drug(s) suspected as cause:
PEG-Intron
    Dosage: unk unk, unknown
    Indication: Hepatitis C
    Start date: 2012-03-03

Rebetol
    Dosage: unk unk, qam
    Indication: Hepatitis C
    Start date: 2012-03-03

Rebetol
    Dosage: unk unk, qpm

Rebetol
    Dosage: unk unk, qam

Rebetol
    Dosage: unk unk, qpm
    Start date: 2012-03-03

Rebetol
    Dosage: unk unk, qpm

Rebetol
    Dosage: unk unk, qam

Victrelis
    Dosage: unk unk, unknown
    Indication: Hepatitis C
    Start date: 2012-03-31



Possible Victrelis side effects in

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

Patient:

Reactions: Injection Site Erythema, Nasal Dryness, Epistaxis

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

Rebetol
    Dosage: unk
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-16

Victrelis
    Dosage: unk
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-08-20



Possible Victrelis 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:
Pegasys
    Dosage: 180 micrograms/0.5 ml pfs

Rebetol
    Dosage: 3 df, bid
    Administration route: Oral

Victrelis
    Dosage: 200 mg, unk



Possible Victrelis 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 Victrelis 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

Rebetol

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

Other drugs received by patient: Epoetin



Possible Victrelis side effects in

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

Patient:

Reactions: Hypersensitivity, Drug Ineffective, Anaphylactic Reaction, Alopecia, Neutropenia, Kidney Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Victrelis

Other drugs received by patient: Pegasys; Ribavirin



Possible Victrelis side effects in

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

Patient:

Reactions: Back Pain, Drug Ineffective, Swelling

Drug(s) suspected as cause:
PEG-Intron
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-07-24

Rebetol
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-07-24

Victrelis
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-08-21



Possible Victrelis side effects in

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

Patient:

Reactions: Anaemia, Therapeutic Product Ineffective

Drug(s) suspected as cause:
Victrelis

Other drugs received by patient: Cyclobenzaprine HCL



Possible Victrelis side effects in

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

Patient:

Reactions: Haemoglobin Decreased, Dysgeusia, Nausea, Chills, Asthenia

Drug(s) suspected as cause:
PEG-Intron
    Dosage: 80 microgram, qw

Rebetol
    Dosage: unk
    Administration route: Oral

Victrelis
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Protonix



Possible Victrelis side effects in

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

Patient:

Reactions: Back Pain

Drug(s) suspected as cause:
PEG-Intron
    Indication: Hepatitis C

Rebetol
    Administration route: Oral
    Indication: Hepatitis C

Victrelis
    Administration route: Oral
    Indication: Hepatitis C



Possible Victrelis side effects in

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

Patient:

Reactions: Bronchitis

Drug(s) suspected as cause:
Peginterferon Alfa-2A
    Dosage: 180 micrograms/meter
    Indication: Hepatitis C

Rebetol
    Dosage: 200 mg, unk
    Indication: Hepatitis C

Victrelis
    Dosage: 800 mg, tid
    Administration route: Oral
    Indication: Hepatitis

Other drugs received by patient: Lamotrigine; Fish OIL; Melatonin; Hydrocodone Bitartrate; Nexium; Clonazepam; Zofran



Possible Victrelis side effects in

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

Patient:

Reactions: Breast Pain, Viral Load Increased, Varicose Vein Ruptured, Drug Ineffective, Pyrexia, Hypoaesthesia, Gynaecomastia, Malaise, Overdose, Swelling, Alopecia, Oedema Peripheral, Sensitivity of Teeth, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ribavirin
    Dosage: unk, bid
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-06-18

Ribavirin
    Dosage: unk
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2005-01-01
    End date: 2005-01-01

Ribavirin
    Dosage: unk
    Administration route: Oral
    Start date: 2011-12-01
    End date: 2012-04-01

Victrelis
    Dosage: unk, tid
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-06-18

Victrelis
    Dosage: 800 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-18
    End date: 2012-04-01

Other drugs received by patient: Coumadin; Coumadin; Pegasys; Lansoprazole; Pegasys; Pegasys



Possible Victrelis side effects in

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

Patient:

Reactions: Nausea, Flatulence

Drug(s) suspected as cause:
PEG-Intron
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-06-29

Rebetol
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-06-29

Victrelis
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-07-27



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

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

Victrelis
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-07-21



Possible Victrelis side effects in

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

Patient:

Reactions: Weight Increased, Dysgeusia, Malaise, Hepatitis C, DRY Mouth

Drug(s) suspected as cause:
PEG-Intron
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2011-09-10
    End date: 2012-03-24

Rebetol
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2011-09-10
    End date: 2012-03-30

Victrelis
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2011-10-19
    End date: 2012-03-30



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

Ribavirin
    Indication: Hepatitis C
    Start date: 2011-09-16

Ribavirin
    End date: 2012-06-27

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



Possible Victrelis side effects in

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

Patient:

Reactions: Hypotension, Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Victrelis

Other drugs received by patient: Diovan



Possible Victrelis 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:
Pegasys

Ribasphere

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



Possible Victrelis 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

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

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

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



Possible Victrelis side effects in

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

Patient:

Reactions: Weight Decreased, Fatigue, Diarrhoea, Dizziness, Thyroid Disorder, Headache

Drug(s) suspected as cause:
Pegasys
    Dosage: 180 microgram, qw
    Indication: Hepatitis C

Ribasphere
    Dosage: 1200 mg, qd
    Indication: Hepatitis C

Victrelis
    Dosage: 4 tablets 3 in one dose
    Indication: Hepatitis C



Possible Victrelis side effects in

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

Patient:

Reactions: Pruritus

Drug(s) suspected as cause:
PEG-Intron
    Dosage: unk

Ribasphere

Victrelis
    Dosage: 800 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-05-15



Possible Victrelis side effects in

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

Patient:

Reactions: Flatulence, Constipation, Discomfort

Drug(s) suspected as cause:
PEG-Intron
    Dosage: 80 microgram, qw
    Indication: Hepatitis C
    Start date: 2012-06-08

Victrelis
    Dosage: 800 mg, q8h
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-12



Possible Victrelis side effects in

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

Patient:

Reactions: Aphthous Stomatitis, DRY Skin

Drug(s) suspected as cause:
Pegasys

Victrelis
    Dosage: 200 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-12-01

Other drugs received by patient: Ribavirin



Possible Victrelis side effects in

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

Patient:

Reactions: Product Quality Issue, Overdose, Affect Lability, Hypoaesthesia

Drug(s) suspected as cause:
PEG-Intron
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-05-01

Rebetol
    Administration route: Oral

Victrelis
    Administration route: Oral



Possible Victrelis side effects in

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

Patient:

Reactions: White Blood Cell Count Decreased, Dyspnoea, Vomiting, RED Blood Cell Count Decreased, Nausea, Dizziness, Pallor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Peginterferon Alfa-2A
    Dosage: 180 microgram, qw
    Indication: Hepatitis C
    Start date: 2011-10-21

Rebetol
    Dosage: 1200 mg, qd
    Indication: Hepatitis C
    Start date: 2011-10-21

Victrelis
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2011-10-21



Possible Victrelis side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient:

Reactions: Fatigue, Sleep Disorder, Nausea, Headache

Drug(s) suspected as cause:
PEG-Intron
    Dosage: 120 microgram, qw
    Indication: Hepatitis C
    Start date: 2012-07-19

Ribasphere
    Dosage: unk
    Start date: 2012-07-19

Victrelis
    Dosage: 800 mg/tid
    Administration route: Oral
    Indication: Hepatitis C

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