Victrelis Side Effects

Generic name: boceprevir

Medically reviewed by Drugs.com. Last updated on Oct 16, 2024.

Note: This document provides detailed information about Victrelis Side Effects associated with boceprevir. Some dosage forms listed on this page may not apply specifically to the brand name Victrelis.

Applies to boceprevir: oral capsule.

Important warnings This medicine can cause some serious health issues

Boceprevir must be used in combination with peginterferon alfa and ribavirin.

Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant.

Certain other drugs may interact with boceprevir or should not be used at the same time. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Get emergency medical help if you have any of these signs of an allergic reaction while taking boceprevir (the active ingredient contained in Victrelis) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using boceprevir and call your doctor at once if you have:

• tired feeling, weakness, confusion;

• easy bruising or bleeding (nosebleed, bleeding gums);

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• fever, chills, body aches, flu symptoms, sores in your mouth and throat.

Common side effects may include:

• headache;

• altered sense of taste; or

• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to boceprevir: oral capsule.

General adverse events

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]

Hematologic

• 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]

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[9]/L: up to 31%; less than 0.5 x 10[9]/L: up to 8%), and decreased platelets (less than 50 x 10[9]/L: up to 4%; less than 25 x 10[9]/L: less than 1%) have been reported.

Agranulocytosis, pancytopenia, and thrombocytopenia have also been reported during postmarketing experience.^[Ref]

Hypersensitivity

• Frequency not reported: Serious acute hypersensitivity reactions (e.g., urticaria, angioedema)^[Ref]

Other

• 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
• Rare (0.01% to 0.1%): Otitis media, sepsis

Sepsis has also been reported during postmarketing experience.

Gastrointestinal

• Very common (10% or more): Nausea (up to 46%), dysgeusia (up to 44%), diarrhea (up to 25%), vomiting (up to 20%), dry mouth (up to 15%)
• 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]

Nervous system

• Very common (10% or more): Headache (up to 45%), dizziness (up to 19%)
• Common (1% to 10%): Hypoesthesia, paresthesia, syncope, amnesia, attention disturbance, memory impairment, migraine, parosmia, tremor, vertigo, tinnitus
• Uncommon (0.1% to 1%): Peripheral neuropathy, cognitive disorder, hyperesthesia, lethargy, loss of consciousness, mental impairment, neuralgia, presyncope, deafness, impaired hearing
• Rare (0.01% to 0.1%): Cerebral ischemia, encephalopathy^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (up to 34%), irritability (up to 22%), depression (up to 21%), anxiety (12%)
• 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
• Rare (0.01% to 0.1%): Bipolar disorder, completed suicide, suicide attempt, auditory hallucination, visual hallucination, psychiatric decompensation^[Ref]

Dermatologic

• Very common (10% or more): Alopecia (up to 27%), dry skin (up to 22%), rash (up to 17%)
• 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
• Uncommon (0.1% to 1%): Photosensitivity reaction, skin ulcer, urticaria, fungal skin infection, onychomycosis, skin infection
• 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]

Metabolic

• Very common (10% or more): Decreased appetite/anorexia (up to 26%)
• Common (1% to 10%): Dehydration, hyperglycemia, hypertriglyceridemia, hyperuricemia
• Uncommon (0.1% to 1%): Hypokalemia, appetite disorder, diabetes mellitus, gout, hypercalcemia
• Rare (0.01% to 0.1%): Non-acute porphyria
• Frequency not reported: Increased uric acid, increased triglycerides, increased cholesterol^[Ref]

Musculoskeletal

• Very common (10% or more): Myalgia (up to 24%), arthralgia (up to 23%)
• Common (1% to 10%): Back pain, pain in extremity, muscle spasms, muscular weakness, neck pain
• Uncommon (0.1% to 1%): Musculoskeletal chest pain, arthritis, bone pain, joint swelling, musculoskeletal pain^[Ref]

Respiratory

• 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
• Rare (0.01% to 0.1%): Epiglottitis, pleural fibrosis, orthopnea, respiratory failure^[Ref]

Pneumonia has also been reported during postmarketing experience.^[Ref]

Cardiovascular

• Common (1% to 10%): Palpitations, hypotension, hypertension
• Uncommon (0.1% to 1%): Cardiac murmur, increased heart rate, tachycardia, arrhythmia, cardiovascular disorder, deep vein thrombosis
• Rare (0.01% to 0.1%): Acute myocardial infarction, atrial fibrillation, coronary artery disease, pericarditis, pericardial effusion, venous thrombosis

Endocrine

• Common (1% to 10%): Goiter, hypothyroidism
• Uncommon (0.1% to 1%): Hyperthyroidism

Genitourinary

• Common (1% to 10%): Pollakiuria, erectile dysfunction
• Uncommon (0.1% to 1%): Urinary tract infection, dysuria, nocturia, amenorrhea, menorrhagia, metrorrhagia
• Rare (0.01% to 0.1%): Aspermia

Ocular

• 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

Hepatic

• Uncommon (0.1% to 1%): Hyperbilirubinemia
• Rare (0.01% to 0.1%): Cholecystitis

Immunologic

• Rare (0.01% to 0.1%): Sarcoidosis

Oncologic

• Rare (0.01% to 0.1%): Thyroid neoplasm (nodules)

Renal

• Frequency not reported: Renal impairment, GFR decreased

Frequently asked questions

• What are the new drugs for the treatment of hepatitis C?

Further information

Victrelis side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer