VEMURAFENIB

N/A

Manufactured by Genentech, Inc.

23,551 FDA adverse event reports analyzed

Last updated: 2026-04-14

About VEMURAFENIB

VEMURAFENIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. The most commonly reported adverse reactions for VEMURAFENIB include RASH, DEATH, ARTHRALGIA, FATIGUE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VEMURAFENIB.

Top Adverse Reactions

RASH1,534 reports
DEATH1,053 reports
ARTHRALGIA1,034 reports
FATIGUE1,029 reports
OFF LABEL USE841 reports
DIARRHOEA822 reports
NAUSEA808 reports
DISEASE PROGRESSION764 reports
PYREXIA735 reports
ALOPECIA557 reports
DECREASED APPETITE530 reports
VOMITING471 reports
PHOTOSENSITIVITY REACTION411 reports
PRURITUS385 reports
SUNBURN372 reports
MYALGIA353 reports
NO ADVERSE EVENT345 reports
ASTHENIA344 reports
HEADACHE336 reports
ERYTHEMA311 reports
INTENTIONAL PRODUCT USE ISSUE257 reports
DRUG INEFFECTIVE248 reports
METASTASES TO CENTRAL NERVOUS SYSTEM243 reports
SQUAMOUS CELL CARCINOMA239 reports
MASS237 reports
SKIN PAPILLOMA234 reports
ANAEMIA229 reports
DYSPNOEA219 reports
PAIN216 reports
WEIGHT DECREASED215 reports
RASH MACULO PAPULAR211 reports
DYSPHAGIA204 reports
PAIN IN EXTREMITY204 reports
HYPERKERATOSIS191 reports
PNEUMONIA189 reports
CONSTIPATION180 reports
ACUTE KIDNEY INJURY178 reports
DEHYDRATION178 reports
SKIN TOXICITY173 reports
RENAL FAILURE168 reports
DYSGEUSIA164 reports
ELECTROCARDIOGRAM QT PROLONGED162 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS161 reports
BLISTER160 reports
MALIGNANT NEOPLASM PROGRESSION157 reports
DRY SKIN155 reports
VISION BLURRED153 reports
PERIPHERAL SWELLING151 reports
GENERAL PHYSICAL HEALTH DETERIORATION143 reports
BLOOD CREATININE INCREASED138 reports
MELANOCYTIC NAEVUS137 reports
SKIN EXFOLIATION137 reports
MALIGNANT MELANOMA131 reports
VISUAL IMPAIRMENT129 reports
RASH GENERALISED127 reports
CHILLS122 reports
SWELLING120 reports
UVEITIS120 reports
SQUAMOUS CELL CARCINOMA OF SKIN119 reports
MALAISE118 reports
BLOOD LACTATE DEHYDROGENASE INCREASED109 reports
NEUTROPENIA109 reports
KERATOACANTHOMA104 reports
ALANINE AMINOTRANSFERASE INCREASED103 reports
ABDOMINAL PAIN101 reports
HEPATIC ENZYME INCREASED100 reports
METASTATIC MALIGNANT MELANOMA100 reports
COUGH99 reports
DIZZINESS99 reports
ACNE98 reports
ASPARTATE AMINOTRANSFERASE INCREASED98 reports
JOINT SWELLING96 reports
SEPSIS96 reports
OEDEMA PERIPHERAL95 reports
THROMBOCYTOPENIA93 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED92 reports
HEPATOTOXICITY91 reports
HYPERTENSION91 reports
RASH ERYTHEMATOUS89 reports
ATRIAL FIBRILLATION87 reports
URTICARIA87 reports
NEOPLASM86 reports
CONFUSIONAL STATE82 reports
DERMATITIS ACNEIFORM82 reports
SWELLING FACE82 reports
STEVENS JOHNSON SYNDROME81 reports
BLOOD BILIRUBIN INCREASED80 reports
CARDIAC FAILURE79 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME79 reports
HYPOKALAEMIA78 reports
HYPOTENSION76 reports
INSOMNIA76 reports
TOXIC SKIN ERUPTION75 reports
SKIN MASS74 reports
HYPERSENSITIVITY73 reports
NEOPLASM PROGRESSION73 reports
DRUG INTERACTION72 reports
RENAL FAILURE ACUTE72 reports
INFECTION71 reports
STOMATITIS71 reports

Report Outcomes

Out of 11,869 classified reports for VEMURAFENIB:

Serious 74.7%Non-Serious 25.3%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male6,016 (55.2%)
Female4,666 (42.8%)
Unknown210 (1.9%)

Reports by Age

Age 60189 reports
Age 70186 reports
Age 63182 reports
Age 68182 reports
Age 65179 reports
Age 69178 reports
Age 67175 reports
Age 66174 reports
Age 62168 reports
Age 64162 reports
Age 53161 reports
Age 58155 reports
Age 51153 reports
Age 72151 reports
Age 59149 reports
Age 73148 reports
Age 55147 reports
Age 57143 reports
Age 54140 reports
Age 61138 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with VEMURAFENIB?

This profile reflects 23,551 FDA FAERS reports that mention VEMURAFENIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for VEMURAFENIB?

Frequently reported terms in FAERS include RASH, DEATH, ARTHRALGIA, FATIGUE, OFF LABEL USE, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures VEMURAFENIB?

Labeling and FAERS entries often list Genentech, Inc. in connection with VEMURAFENIB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.