What the label lists and what reports show
Vismodegib side effects
Vismodegib's FDA label: “The most common adverse reactions (incidence of ≥ 10%) are muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia.” FAERS holds 8,850 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 muscle spasms (2,065 reports).
- No generic listed
- Boxed warning
Check it at the source: the vismodegib FDA label on DailyMed (effective December 2, 2024, 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 ERIVEDGE?ERIVEDGE can cause serious side effects, including: See " What is the most important information I should know about ERIVEDGE? " Severe skin reactions. Severe skin reactions have happened in some people taking ERIVEDGE. You may need to be treated in a hospital because these severe skin reactions can be life-threatening or lead to death. Tell your healthcare provider right away if you develop any of the following signs or symptoms of a severe skin reaction, including: blisters or peeling of your skin blisters on your lip, or around your mouth or eyes mouth sores or genital sores high fever or flu-like symptoms enlarged lymph nodes skin pain and burning Your healthcare provider may permanently stop ERIVEDGE if you develop a severe skin reaction. Muscle Problems. Muscle problems are common with ERIVEDGE, but can also sometimes be serious. […]
Source: FDA drug label, Genentech, Inc., effective December 2, 2024 (SPL set eb368bb6-80e3-4df9-8a85-91df0a2ada6a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence of ≥ 10%) are muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia.
Table 1: Adverse Reactions Occurring in ≥ 10% of Patients with Advanced Basal Cell Carcinoma
| Reaction | All Grades Grading according to National Cancer Institute-Common Terminology Criteria for… | Grade 3 (%) | Grade 4 (%) |
|---|---|---|---|
| Nausea | 30% | 0.7% | - |
| Diarrhea | 29% | 0.7% | - |
| Constipation | 21% | - | - |
| Vomiting | 14% | - | - |
| Fatigue | 40% | 5% | 0.7% |
| Weight loss | 45% | 7% | - |
| Decreased appetite | 25% | 2.2% | - |
| Muscle spasms | 72% | 3.6% | - |
| Dysgeusia | 55% | - | - |
| Ageusia | 11% | - | - |
| Alopecia | 64% | - | - |
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 clinically significant adverse reactions are described elsewhere in the labeling: Embryo-Fetal Toxicity [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Musculoskeletal Adverse Reactions [see Warnings and Precautions (5.3) ] Premature Fusion of the Epiphyses [see Warnings and Precautions (5.4) ] The most common adverse reactions (incidence of ≥ 10%) are muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia. To report SUSPECTED ADVERSE REACTIONS, contact Genentech, Inc. at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data described below reflect exposure to ERIVEDGE in 138 patients with advanced basal cell carcinoma (BCC) who received ERIVEDGE at doses ≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging or fixed single dose clinical trials [Study SHH3925g, SHH4437g, SHH4476g and SHH4610g]. …
Source: FDA drug label, Genentech, Inc., effective December 2, 2024 (SPL set eb368bb6-80e3-4df9-8a85-91df0a2ada6a), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,850 reports list vismodegib among the medicines taken, 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. Of the 20 reactions below, 11 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?
- Vismodegib: 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