What the label lists and what reports show
Vemurafenib side effects
Vemurafenib's FDA label: “Most common adverse reactions (≥ 30%) are arthralgia, rash, alopecia, fatigue, photosensitivity reaction, nausea, pruritus, and skin papilloma.” FAERS holds 11,949 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is rash (1,547 reports).
- No generic listed
Check it at the source: the vemurafenib FDA label on DailyMed (effective August 28, 2026, Genentech, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ZELBORAF?ZELBORAF may cause serious side effects, including: See " What is the most important information I should know about ZELBORAF? " Allergic reactions can happen while taking ZELBORAF and can be severe. Stop taking ZELBORAF and get medical help right away if you get any of these symptoms of an allergic reaction: rash or redness all over your body trouble breathing or swallowing swelling of the face, lips, or tongue throat tightness or hoarseness feel faint a fast heartbeat Severe skin reactions. Stop taking ZELBORAF and call your healthcare provider right away if you get a skin rash with any of the following symptoms because you may have a severe skin reaction: blisters on your skin blisters or sores in your mouth peeling of your skin fever redness or swelling of your face, hands, or soles of your feet Changes in the electrical activity of your heart called QT prolongation. […]
Source: FDA drug label, NDA202429 (Hoffmann La Roche), as published by Genentech, Inc., effective August 28, 2026 (SPL set 38eea320-7e0c-485a-bc30-98c3c45e2763), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 30%) are arthralgia, rash, alopecia, fatigue, photosensitivity reaction, nausea, pruritus, and skin papilloma.
Table 1 Adverse Reactions Reported in ≥ 10% of Unresectable or Metastatic Melanoma Patients Treated with ZELBORAF Adverse drug reactions, reported using MedDRA and graded using NCI-CTC-AE v 4.0 (NCI common toxicity…
| Reaction | All Grades (%) | Grade 3 Grade 4 adverse reactions limited to gamma-glutamyltransferase increased (< 1% in… | All Grades (%) | Grade 3 (%) | All Grades (%) | Grade 3 (%) |
|---|---|---|---|---|---|---|
| Rash | 37 | 8 | 2 | 0 | 52 | 7 |
| Photosensitivity reaction | 33 | 3 | 4 | 0 | 49 | 3 |
| Alopecia | 45 | < 1 | 2 | 0 | 36 | 0 |
| Pruritus | 23 | 1 | 1 | 0 | 30 | 2 |
| Hyperkeratosis | 24 | 1 | < 1 | 0 | 28 | 0 |
| Rash maculo-papular | 9 | 2 | < 1 | 0 | 21 | 6 |
| Actinic keratosis | 8 | 0 | 3 | 0 | 17 | 0 |
| Dry skin | 19 | 0 | 1 | 0 | 16 | 0 |
| Rash papular | 5 | < 1 | 0 | 0 | 13 | 0 |
| Erythema | 14 | 0 | 2 | 0 | 8 | 0 |
| Arthralgia | 53 | 4 | 3 | < 1 | 67 | 8 |
| Myalgia | 13 | < 1 | 1 | 0 | 24 | < 1 |
| Pain in extremity | 18 | < 1 | 6 | 2 | 9 | 0 |
| Musculoskeletal pain | 8 | 0 | 4 | < 1 | 11 | 0 |
| Back pain | 8 | < 1 | 5 | < 1 | 11 | < 1 |
| Fatigue | 38 | 2 | 33 | 2 | 54 | 4 |
| Edema peripheral | 17 | < 1 | 5 | 0 | 23 | 0 |
| Pyrexia | 19 | < 1 | 9 | < 1 | 17 | 2 |
| Asthenia | 11 | < 1 | 9 | < 1 | 2 | 0 |
| Nausea | 35 | 2 | 43 | 2 | 37 | 2 |
| Diarrhea | 28 | < 1 | 13 | < 1 | 29 | < 1 |
| Vomiting | 18 | 1 | 26 | 1 | 26 | 2 |
| Constipation | 12 | < 1 | 24 | 0 | 16 | 0 |
| Headache | 23 | < 1 | 10 | 0 | 27 | 0 |
| Dysgeusia | 14 | 0 | 3 | 0 | 11 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the label: New Primary Malignancies [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Dermatologic Reactions [see Warnings and Precautions (5.4) ] QT Prolongation [see Warnings and Precautions (5.5) ] Hepatotoxicity [see Warnings and Precautions (5.6) ] Photosensitivity [see Warnings and Precautions (5.7) ] Ophthalmologic Reactions [see Warnings and Precautions (5.8) ] Radiation Sensitization and Radiation Recall [see Warnings and Precautions (5.10) ] Renal Failure [see Warnings and Precautions (5.11) ] Dupuytren's Contracture and Plantar Fascial Fibromatosis [see Warnings and Precautions (5.12) ] Melanoma: Most common adverse reactions (≥ 30%) are arthralgia, rash, alopecia, fatigue, photosensitivity reaction, nausea, pruritus, and skin papilloma. ( 6.1 ) Erdheim-Chester Disease: Most common adverse reactions (>50%) are arthralgia, rash maculo-papular, alopecia, fatigue, electrocardiogram QT interval prolonged, and skin papilloma. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, NDA202429 (Hoffmann La Roche), as published by Genentech, Inc., effective August 28, 2026 (SPL set 38eea320-7e0c-485a-bc30-98c3c45e2763), via openFDA; the full label on DailyMed
What do FAERS reports show?
11,949 reports list vemurafenib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,073 are coded as a death and 3,397 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (2,670, against a median of 467 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 19 reactions below, 17 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Vemurafenib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions