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Zelboraf Side Effects

Generic Name: vemurafenib

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

In Summary

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

For the Consumer

Applies to vemurafenib: oral tablet

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

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 (up to 30%), cutaneous SCC (24%), seborrheic keratosis (up to 14%)
Common (1% to 10%): Basal cell carcinoma, oropharyngeal squamous cell carcinoma
Postmarketing reports: Progression of a preexisting-existing chronic myelomonocytic leukemia with NRAS mutation[Ref]

Cardiovascular

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

Hepatic

Very common (10% or more): Hepatic laboratory abnormalities (GGT, AST, ALT, alkaline phosphatase, bilirubin) (up to 11.5%)[Ref]

Respiratory

Common (1% to 10%): Cough[Ref]

General

The most common side effects reported were arthralgia, rash, alopecia, fatigue, photosensitivity reaction, nausea, pruritus, and skin papilloma.[Ref]

Dermatologic

Very common (10% or more): Rash (up to 52%), photosensitivity (up to 49 %), alopecia (up to 45%), pruritus (up to 30%), hyperkeratosis (up to 28%), dry skin (up to 19%), erythema (up to 14%), sunburn (up to 14%)
Common (1% to 10%): Maculo-papular rash, actinic keratosis, papular rash, palmar-plantar erythrodysesthesia syndrome, keratosis pilaris, erythema nodosum, folliculitis
Uncommon (0.1% to 1%): Stevens-Johnson syndrome, toxic epidermal necrolysis
Postmarketing reports: DRESS syndrome[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 37%), diarrhea (up to 29%), vomiting (up to 26%), constipation (up to 16%)[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 21%)[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (Up to 67%), myalgia (up to 24%), pain in extremity (up to 18%)
Common (1% to 10%): Musculoskeletal pain, back pain, arthritis
Uncommon (0.1% to 1%): VIIth nerve paralysis[Ref]

Nervous system

Very common (10% or more): Headache (up to 27%), dysgeusia (up to 14%)
Common (1% to 10%): Dizziness, peripheral neuropathy[Ref]

Other

Very common (10% or more): Fatigue (up to 54%), peripheral edema (up to 23%), pyrexia (up to 19%), asthenia (up to 11%)[Ref]

Ocular

Common (1% to 10%): Uveitis
Uncommon (0.1% to 1%): Retinal vein occlusion[Ref]

References

1. "Product Information. Zelboraf (vemurafenib)." Genentech, South San Francisco, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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