Vemurafenib Side Effects

Some side effects of vemurafenib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to vemurafenib: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking vemurafenib: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using vemurafenib and call your doctor at once if you have a serious side effect such as:

• severe dizziness, fainting, fast or pounding heartbeats;

• white patches on your eyes;

• new or worsening skin lesions; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of vemurafenib may include:

• joint pain;

• tired feeling;

• nausea;

• hair loss;

• mild rash or itching;

• skin growths; or

• blurred vision, increased sensitivity of your eyes to light.

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 vemurafenib: oral tablet

Cardiovascular

Cardiovascular side effects have included atrial fibrillation (less than 10%) and vasculitis (less than 10%).

Dermatologic

Dermatologic side effects have included rash (less than 52%), photosensitivity reactions (less than 49%), alopecia (less than 45%), pruritus (less than 30%), hyperkeratosis (less than 28%), maculopapular rash (less than 21%), dry skin (less than 19%), actinic keratosis (less than 17%), sunburn (less than 14%), erythema (less than 14%) and papular rash (less than 13%), palmar-plantar erythrodysesthesia syndrome (less than 10%), keratosis pilaris (less than 10%), erythema nodosum (less than 10%), folliculitis (less than 10%), and Stevens-Johnson syndrome (less than 10%).

Gastrointestinal

Gastrointestinal side effects have included nausea (less than 37%), diarrhea (less than 29%), vomiting (less than 26%), and constipation (less than 16%).

General

General side effects have included fatigue (less than 54%), peripheral edema (less than 23%), pyrexia (less than 19%), and asthenia (less than 11%).

Metabolic

Metabolic side effects have included decreased appetite (less than 21%) and decreased weight (less than 10%).

Laboratory abnormalities have included increased gamma-glutamyltransferase (GGT) (less than 15%), elevated liver transaminases (AST and ALT) (less than 10%), and elevated bilirubin (less than 10%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (less than 67%), myalgia (less than 24%), pain in extremity (less than 18%), musculoskeletal pain (less than 11%), back pain (less than 11%), and arthritis (less than 10%).

Nervous system

Nervous system side effects have included headache (less than 27%), dysgeusia (less than 14%), dizziness (less than 10%), peripheral neuropathy (less than 10%), and 7th nerve paralysis (less than 10%).

Ocular

Ocular side effects have included retinal vein occlusion (less than 10%), and uveitis (less than 10%).

Oncologic

Oncologic side effects have included cutaneous squamous cell carcinoma (less than 24%), and basal cell carcinoma (less than 10%).

Respiratory

Respiratory side effects have included cough (less than 12%).

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