Note: This document contains side effect information about vemurafenib. Some dosage forms listed on this page may not apply to the brand name Zelboraf.

Summary

Common side effects of Zelboraf include: squamous cell carcinoma, keratoacanthoma, skin photosensitivity, and erythema of skin. Continue reading for a comprehensive list of adverse effects.

Applies to vemurafenib: oral tablet.

Serious side effects of Zelboraf

Along with its needed effects, vemurafenib (the active ingredient contained in Zelboraf) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking vemurafenib:

More common

• Blistering, peeling, or loosening of the skin
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody urine
• blurred vision or other change in vision
• chills
• cough
• decreased frequency or amount of urine
• diarrhea
• dizziness
• eye pain
• fainting
• fast or irregular heartbeat
• fever
• increased sensitivity of the skin to sunlight
• increased thirst
• itching or skin rash
• joint or muscle pain
• loss of appetite
• lower back or side pain
• lump or growth on the skin
• nausea
• pain in the ankles or knees
• painful, red lumps under the skin, mostly on the legs
• paralysis of the nerves
• rapid weight gain
• rash with flat lesions or small raised lesions on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• redness or other discoloration of the skin
• redness, soreness, swelling, or itching of the skin
• scaling of the skin on the hands and feet
• sensitivity of the eye to light
• severe sunburn
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sores, welts, or blisters
• tearing
• tingling of the hands and feet
• tiredness
• trouble breathing
• ulceration of the skin
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• weight gain

Other side effects of Zelboraf

Some side effects of vemurafenib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back or bone pain
• burning, itching, and pain in the hairy areas, or pus at the root of the hair
• change in taste
• cough
• decreased appetite
• decreased weight
• difficulty having a bowel movement
• difficulty with moving
• dry skin
• hair loss or thinning of the hair
• headache
• lack or loss of strength
• loss of taste
• muscle stiffness
• pain in the arms or legs
• sunburn

For Healthcare Professionals

Applies to vemurafenib: oral tablet.

Oncologic

Very common (10% or more): Skin papilloma, (29%), squamous cell carcinoma of skin (20%), seborrheic keratosis (14%), keratoacanthoma (11%)

Common (1% to 10%): Basal cell carcinoma, new primary melanoma

Uncommon (0.1% to 1%): Non-cuSCC

Rare (0.01% to 0.1%): Chronic myelomonocytic leukemia, pancreatic adenocarcinoma

Frequency not reported: Chronic myelomonocytic leukemia (CMML), pancreatic adenocarcinoma^[Ref]

Cardiovascular

Common (1% to 10%): Vasculitis, prolonged OT interval

Uncommon (0.1% to 1%): Atrial fibrillation^[Ref]

Hepatic

Common (1% to 10%): ALT increased, alkaline phosphatase increased, AST increased, bilirubin increased, gamma-glutamyl transferase (GGT) increased

Uncommon (0.1% to 1%): Liver injury^[Ref]

Respiratory

Very common (10% or more): Cough (15%)^[Ref]

General

The most common adverse drug reactions of any Grade (greater than 30%) include arthralgia, fatigue, rash, photosensitivity reaction, alopecia, nausea diarrhea, headache, pruritus, vomiting, skin papilloma, and hyperkeratosis.^[Ref]

Dermatologic

Very common (10% or more): Alopecia (48%), rash (all Grades) (43%), photosensitivity reaction (40%), hyperkeratosis (29%), pruritus (26%), dry skin (24%), erythema (18%), sunburn (17%), actinic keratosis (13%), maculopapular rash (10%), palmar-plantar erythrodysesthesia syndrome (10%), dry skin, keratosis pilaris (10%), sunburn

Common (1% to 10%): Folliculitis, papular rash, panniculitis (including erythema nodosum), keratosis pilaris

Uncommon (0.1% to 1%): Toxic epidermal necrolysis, Stevens-Johnson syndrome

Rare (less than 0.1%): Drug reaction with eosinophilia and systemic symptoms (DRESS)^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (39%), diarrhea (37%), vomiting (22%), constipation (16%)

Uncommon (0.1% to 1%): Pancreatitis^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (23%), weight loss (10%)^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (56%), pain in extremity (23%), myalgia (15%), back pain (16%), musculoskeletal pain (13%)

Common (1% to 10%): Arthritis

Uncommon (0.1% to 1%): Plantar fascial fibromatosis, Dupuytren's contracture^[Ref]

Nervous system

Very common (10% or more): Headache (34%), dysgeusia (16%), dizziness (12%)

Common (1% to 10%): Peripheral neuropathy

Uncommon (0.1% to 1%): Bell's palsy (7th cranial nerve paralysis)^[Ref]

Other

Very common (10% or more): Fatigue (47%), pyrexia (22%), edema peripheral (15%), asthenia (15%)

Common (1% to 10%): Potentiation of radiation toxicity^[Ref]

Ocular

Common (1% to 10%): Uveitis

Uncommon (0.1% to 1%): Retinal vein occlusion, iridocyclitis^[Ref]

Hematologic

Common (1% to 10%): Neutropenia

Immunologic

Rare (0.01% to 0.1%): Sarcoidosis

Renal

Common (1% to 10%): Blood creatinine increased

Rare (0.01% to 0.1%): Acute interstitial nephritis, acute tubular necrosis