Prescription medicine
Vismodegib Brand names: Erivedge
Vismodegib (Erivedge) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the vismodegib FDA label on DailyMed (effective December 2, 2024, Genentech, Inc.); the NDA 203388 record on Drugs@FDA; every vismodegib label on DailyMed.
Highlights of the record
FDA label of December 2, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
EMBRYO-FETAL TOXICITY.
ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ERIVEDGE is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations [see Warnings and Precautions (5.1), Use in Specific Populations (8.1) ]. Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after ERIVEDGE [ see Dosage and Administration (2.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1 , 8.3) ]. Advise males of the potential risk of ERIVEDGE exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential [see Warnings and Precautions (5.1), Use in Specific Populations (8.3) ]. WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ERIVEDGE is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations. […]
Used for
From the label: indications and usageERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation.
Forms and strengths
- 150 mg
Capsule.
On the market
- Earliest approval on file
- January 30, 2012 Erivedge, Genentech; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- December 15, 2028 Erivedge capsules; 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
- 8,850 through July 30, 2026
What is vismodegib used for?
From the label: indications and usageERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation. ERIVEDGE ® (vismodegib) is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation.
FDA pharmacologic class: Hedgehog Pathway Inhibitor.
Source: FDA drug label (ERIVEDGE), Genentech, Inc., effective December 2, 2024 (SPL set eb368bb6-80e3-4df9-8a85-91df0a2ada6a), via openFDA; the full label on DailyMed
What does the patient leaflet for vismodegib 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 ERIVEDGE?ERIVEDGE can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects. For females who can become pregnant: You should talk with your healthcare provider about the risks of ERIVEDGE to your unborn child. Your healthcare provider will do a pregnancy test within 7 days before you start taking ERIVEDGE. In order to avoid pregnancy, you should use birth control during treatment and for 24 months after your final dose of ERIVEDGE. Talk with your healthcare provider about what birth control method is right for you during this time. Talk to your healthcare provider right away if you have unprotected sex or if you think that your birth control has failed. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant. For males: ERIVEDGE is present in semen. Do not donate semen while you are taking ERIVEDGE and for 3 months after your final dose. You should always use a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment with ERIVEDGE and for 3 months after your final dose to protect your female partner from being exposed to ERIVEDGE. Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking ERIVEDGE. Pregnancy Exposure Registry: There is a Pregnancy Exposure Registry for females taking ERIVEDGE who become pregnant. The purpose of this registry is to monitor the health of you and your unborn baby. If you think that you or your female partner may have been exposed to ERIVEDGE during pregnancy, talk to your healthcare provider right away. […]
From the patient leaflet: What should I avoid while taking ERIVEDGE?Do not donate blood or blood products while you are taking ERIVEDGE and for 24 months after your final dose. For Males: Do not donate semen while you are taking ERIVEDGE and for 3 months after your final dose.
From the patient leaflet: How should I store ERIVEDGE?Store ERIVEDGE at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed to protect ERIVEDGE from moisture. Keep ERIVEDGE and all medicines out of the reach of children.
Source: FDA drug label (ERIVEDGE), Genentech, Inc., effective December 2, 2024 (SPL set eb368bb6-80e3-4df9-8a85-91df0a2ada6a), via openFDA; the full label on DailyMed
Is there a generic for vismodegib (Erivedge)?
No generic vismodegib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Erivedge capsules: the compound patent runs to November 11, 2028, and the last listed entry to December 15, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for vismodegib?
The FDA Adverse Event Reporting System holds 8,850 reports that list vismodegib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 987 are coded as a death and 1,147 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 received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other hedgehog pathway inhibitors
- the pharmacologic class, with prices and generics
- Vismodegib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other