Victrelis Side Effects
Generic name: boceprevir
Note: This document contains side effect information about boceprevir. Some of the dosage forms listed on this page may not apply to the brand name Victrelis.
Applies to boceprevir: oral capsule
This drug must be administered in combination with peginterferon alfa and ribavirin. The manufacturer product information for peginterferon alfa and ribavirin should be consulted for associated side effects.
Serious side effects (including anemia and neutropenia) have been reported in 11% of patients receiving boceprevir (the active ingredient contained in Victrelis) combination therapy compared to 8% of patients receiving peginterferon alfa plus ribavirin alone. The side effects reported most frequently were fatigue, anemia, nausea, headache, and dysgeusia. Therapy was discontinued due to side effects in 13% of patients using boceprevir combination therapy and 12% of patients using peginterferon alfa plus ribavirin alone. The side effects leading to discontinuation most often were anemia and fatigue.[Ref]
Decreased hemoglobin (less than 10 g/dL: 49%; less than 8.5 g/dL: up to 10%), decreased neutrophils (less than 0.75 x 10/L: up to 31%; less than 0.5 x 10/L: up to 8%), and decreased platelets (less than 50 x 10/L: up to 4%; less than 25 x 10/L: less than 1%) have been reported.
Very common (10% or more): Anemia (up to 50%), decreased hemoglobin (up to 49%), decreased neutrophils (up to 31%), neutropenia (up to 25%)
Common (1% to 10%): Decreased platelets, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis
Uncommon (0.1% to 1%): Hemorrhagic diathesis, lymphadenopathy, lymphopenia
Rare (0.01% to 0.1%): Hemolysis[Ref]
Very common (10% or more): Fatigue (up to 58%), chills (up to 34%), pyrexia (up to 32%), influenza-like illness (up to 23%), asthenia (up to 21%), decreased weight (11%)
Common (1% to 10%): Pain, peripheral edema, chest discomfort, chest pain, malaise, feeling of body temperature change, mucosal dryness
Uncommon (0.1% to 1%): Feeling abnormal, impaired healing, noncardiac chest pain, staphylococcal infection, candidiasis, ear infection, ear discomfort, flushing, pallor, peripheral coldness
Sepsis has also been reported during postmarketing experience.
Common (1% to 10%): Abdominal pain, upper abdominal pain, constipation, gastroesophageal reflux disease, hemorrhoids, abdominal discomfort, abdominal distention, anorectal discomfort, aphthous stomatitis, cheilitis, dyspepsia, flatulence, glossodynia, mouth ulceration, oral pain, stomatitis, tooth disorder, oral fungal infection
Uncommon (0.1% to 1%): Lower abdominal pain, gastritis, pancreatitis, anal pruritus, colitis, dysphagia, discolored feces, frequent bowl movements, gingival bleeding, gingival pain, gingivitis, glossitis, dry lip, odynophagia, proctalgia, rectal hemorrhage, salivary hypersecretion, sensitivity of teeth, tongue discoloration, tongue ulceration, gastroenteritis
Rare (0.01% to 0.1%): Pancreatic insufficiency[Ref]
Mouth ulceration and stomatitis have also been reported during postmarketing experience.[Ref]
Very common (10% or more): Headache (up to 45%), dizziness (up to 19%)
Common (1% to 10%): Affect lability, agitation, libido disorder, altered mood, sleep disorder
Uncommon (0.1% to 1%): Aggression, homicidal ideation, panic attack, paranoia, substance abuse, suicidal ideation, abnormal behavior, anger, apathy, confusional state, mental status changes, restlessness
Common (1% to 10%): Dermatitis, eczema, erythema, hyperhidrosis, night sweats, psoriasis, erythematous rash, macular rash, maculopapular rash, papular rash, pruritic rash, skin lesion, cellulitis, herpes simplex
Postmarketing reports: Angioedema, drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, exfoliative rash, exfoliative dermatitis, Stevens-Johnson syndrome, toxic skin eruption, toxicoderma[Ref]
Urticaria has also been reported during postmarketing experience.[Ref]
Very common (10% or more): Decreased appetite/anorexia (up to 26%)
Common (1% to 10%): Dehydration, hyperglycemia, hypertriglyceridemia, hyperuricemia
Rare (0.01% to 0.1%): Non-acute porphyria
Frequency not reported: Increased uric acid, increased triglycerides, increased cholesterol[Ref]
Very common (10% or more): Myalgia (up to 24%), arthralgia (up to 23%)
Uncommon (0.1% to 1%): Musculoskeletal chest pain, arthritis, bone pain, joint swelling, musculoskeletal pain[Ref]
Very common (10% or more): Exertional dyspnea (up to 11%), cough, dyspnea
Common (1% to 10%): Bronchitis, influenza, sinusitis, epistaxis, nasal congestion, oropharyngeal pain, respiratory tract congestion, sinus congestion, wheezing
Uncommon (0.1% to 1%): Pneumonia, nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, pleuritic pain, pulmonary embolism, dry throat, dysphonia, increased upper airway secretion, oropharyngeal blistering
Common (1% to 10%): Goiter, hypothyroidism
Uncommon (0.1% to 1%): Hyperthyroidism
Common (1% to 10%): Pollakiuria, erectile dysfunction
Rare (0.01% to 0.1%): Aspermia
Common (1% to 10%): Dry eye, retinal exudates, blurred vision, visual impairment
Uncommon (0.1% to 1%): Retinal ischemia, retinopathy, abnormal sensation in eye, conjunctival hemorrhage, conjunctivitis, eye pain, eye pruritus, eye swelling, eyelid edema, increased lacrimation, ocular hyperemia, photophobia
Rare (0.01% to 0.1%): Papilledema
Uncommon (0.1% to 1%): Hyperbilirubinemia
Rare (0.01% to 0.1%): Cholecystitis
Rare (0.01% to 0.1%): Sarcoidosis
Rare (0.01% to 0.1%): Thyroid neoplasm (nodules)
Frequency not reported: Renal impairment, GFR decreased
Medically reviewed by Drugs.com. Last updated on Mar 29, 2021.
Frequently asked questions
More about Victrelis (boceprevir)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
- Drug Interactions
- 3 Reviews
- Drug class: protease inhibitors
- FDA Approval History
Related treatment guides
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
3. Cerner Multum, Inc. "Australian Product Information." O 0
4. "Product Information. Victrelis (boceprevir)." Schering-Plough Corporation, Kenilworth, NJ.
5. Rowe IA, Mutimer DJ "Protease inhibitors for treatment of genotype 1 hepatitis C virus infection." BMJ 343 (2011): d6972
Some side effects may not be reported. You may report them to the FDA.