Prescription medicine
Vemurafenib Brand names: Zelboraf
Vemurafenib (Zelboraf) is a prescription medicine with an FDA approval on record since 2011. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the vemurafenib FDA label on DailyMed (effective August 28, 2026, Genentech, Inc.); the NDA 202429 record on Drugs@FDA; every vemurafenib label on DailyMed.
Highlights of the record
FDA label of August 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
Forms and strengths
- 240 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 17, 2011 Zelboraf, Hoffmann La Roche; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 6, 2032 Zelboraf tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 11,949 through July 30, 2026
What is vemurafenib used for?
From the label: indications and usageZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1 , 2.1 ) ZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. ( 1.2 , 2.1 ) Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma ( 2.1 , 5.2 ) 1.1 Unresectable or Metastatic Melanoma ZELBORAF ® is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. […]
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (ZELBORAF), 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 patient leaflet for vemurafenib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ZELBORAF?ZELBORAF can cause serious side effects, including: Risk of new cancers. ZELBORAF may cause certain types of skin cancer called cutaneous squamous cell carcinoma (cuSCC) and keratoacanthoma. New melanoma lesions have occurred in people who take ZELBORAF. ZELBORAF may also cause another type of cancer called non-cutaneous squamous cell carcinoma (non-cuSCC). Talk with your healthcare provider about your risk for these cancers. Check your skin and tell your healthcare provider right away about any skin changes including a: new wart skin sore or reddish bump that bleeds or does not heal change in size or color of a mole Your healthcare provider should check your skin before you start taking ZELBORAF, and every 2 months during treatment with ZELBORAF, to look for any new skin cancers. Your healthcare provider may continue to check your skin for 6 months after you stop taking ZELBORAF. Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that you get while taking ZELBORAF. Other blood cell cancers have happened in some people with Erdheim-Chester Disease (ECD) including those who take ZELBORAF. If you have other blood cell cancers and take ZELBORAF for ECD, your healthcare provider will monitor your blood cancer through routine blood tests. See " What are the possible side effects of ZELBORAF? " for more information about side effects.
From the patient leaflet: What should I avoid while taking ZELBORAF?Avoid sunlight during treatment with ZELBORAF. ZELBORAF can make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. To help protect against sunburn: When you go outside, wear clothes that protect your skin, including your head, face, hands, arms, and legs. Use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.
From the patient leaflet: How should I store ZELBORAF?Store ZELBORAF at room temperature between 68°F to 77°F (20°C to 25°C). Store ZELBORAF in the original container with the lid tightly closed. Ask your healthcare provider or pharmacist how to safely throw away (dispose of) any unused or expired ZELBORAF. Keep ZELBORAF and all medicine out of the reach of children.
Source: FDA drug label (ZELBORAF), 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
Is there a generic for vemurafenib (Zelboraf)?
No generic vemurafenib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Zelboraf tablets: the compound patent runs to July 27, 2030, and the last listed entry to June 6, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2011 earliest approval on file
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the vemurafenib label say about other medicines?
The vemurafenib label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name vemurafenib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Avoid coadministration of ZELBORAF with strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin), and replace these drugs with alternative drugs when possible. |
| Dacarbazine | warnings and precautions | In Trial 1, in patients with unresectable or metastatic melanoma, new primary malignant melanoma occurred in 2.1% (7/336) of patients receiving ZELBORAF compared to none of the patients receiving dacarbazine. |
| Digoxin | drug interactions | Vemurafenib on P-gp Substrates Coadministration of ZELBORAF with digoxin, a sensitive P-glycoprotein (P-gp) substrate, increased digoxin systemic exposure by 1.8-fold. |
| Ipilimumab | drug interactions | Increases in transaminases and bilirubin occurred in a majority of patients who received concurrent ipilimumab and ZELBORAF [see Warnings and Precautions Section 5.6 ]. |
| Phenytoin | drug interactions | Avoid coadministration of ZELBORAF with strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin), and replace these drugs with alternative drugs when possible. |
| Rifampin | drug interactions | Strong CYP3A4 Inducers Coadministration of ZELBORAF with rifampin, a strong CYP3A4 inducer, decreased vemurafenib plasma concentrations and may result in decreased efficacy. |
| Tizanidine | drug interactions | Vemurafenib on CYP1A2 Substrates Coadministration of ZELBORAF with tizanidine, a sensitive CYP1A2 substrate, increased tizanidine systemic exposure by 4.7-fold. |
Other labels that name vemurafenib
Source: FDA drug label (ZELBORAF), 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 for vemurafenib?
The FDA Adverse Event Reporting System holds 11,949 reports that list vemurafenib among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Vemurafenib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other