Vismodegib side effects: what 8,833 FDA adverse event reports show
Drug class
Hedgehog Pathway Inhibitor
Brand names
Erivedge
Who reports
8,833 reports · 43% serious · 987 with death outcome · 40% female
Used for
ERIVEDGE 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. ER.
What it is
Vismodegib is a hedgehog (Hh) pathway inhibitor, which is described chemically as 2-Chloro- N -(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide.
Boxed warning
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 .
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 652 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Ageusia (loss of taste) | 1,011 | 99.8 94.1–105.9ROR 112.6 · χ² 94,882 / p <1e-300 | 95.6 EB05 90.8 · IC025 +6.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 58.8 · 70% consumer | no trial data cached |
| Malignant neoplasm of eye | 11 | 94.9 51.9–173.3ROR 95.0 · χ² 894 / p 1e-196 | 79.1 EB05 47.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Hypogeusia | 48 | 59.5 44.7–79.1ROR 59.8 · χ² 2,634 / p <1e-300 | 56.8 EB05 44.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=11 · 73% consumer | no trial data cached |
| Taste disorder | 240 | 28.7 25.3–32.6ROR 29.5 · χ² 6,320 / p <1e-300 | 28.3 EB05 25.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · 78% consumer | no trial data cached |
| Squamous cell carcinoma | 111 | 28.2 23.4–34.0ROR 28.6 · χ² 2,855 / p <1e-300 | 27.8 EB05 23.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 38.2 | no trial data cached |
| Muscle spasms | 2,065 | 27.0 25.9–28.0ROR 34.8 · χ² 51,438 / p <1e-300 | 26.6 EB05 25.7 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.8 | no trial data cached |
| Dysgeusia (altered taste) | 747 | 23.9 22.3–25.6ROR 26.0 · χ² 16,282 / p <1e-300 | 23.7 EB05 22.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.8 | no trial data cached |
| Basal cell carcinoma | 140 | 21.4 18.2–25.3ROR 21.8 · χ² 2,683 / p <1e-300 | 21.2 EB05 18.4 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 23.8 | no trial data cached |
| Alopecia (hair loss) | 1,401 | 17.0 16.2–17.8ROR 20.0 · χ² 21,107 / p <1e-300 | 16.9 EB05 16.1 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 | no trial data cached |
| Madarosis | 60 | 12.2 9.5–15.7ROR 12.3 · χ² 603 / p 2e-133 | 11.9 EB05 9.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Recurrent cancer | 20 | 11.7 7.6–18.2ROR 11.8 · χ² 185 / p 2e-42 | 10.8 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=18 · 90% consumer | no trial data cached |
| Tumour haemorrhage | 14 | 11.7 6.9–19.7ROR 11.7 · χ² 126 / p 2e-29 | 10.2 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Hair growth abnormal | 29 | 10.0 6.9–14.3ROR 10.0 · χ² 224 / p 6e-51 | 9.2 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Actinic keratosis | 10 | 9.1 4.9–16.9ROR 9.1 · χ² 64 / p 6e-16 | 7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Anosmia (loss of smell) | 48 | 7.9 5.9–10.4ROR 7.9 · χ² 280 / p 4e-63 | 7.4 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=14 · 77% consumer | no trial data cached |
| Embolism | 27 | 7.7 5.3–11.2ROR 7.7 · χ² 150 / p 1e-34 | 6.9 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · 100% clinician | no trial data cached |
| Decreased appetite (loss of appetite) | 706 | 7.2 6.7–7.8ROR 7.8 · χ² 3,822 / p <1e-300 | 7.2 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Neoplasm | 33 | 6.8 4.8–9.6ROR 6.8 · χ² 157 / p 2e-36 | 6.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Squamous cell carcinoma of skin | 17 | 6.7 4.2–10.8ROR 6.7 · χ² 77 / p 1e-18 | 5.8 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Hypophosphataemia | 20 | 6.5 4.2–10.0ROR 6.5 · χ² 87 / p 6e-21 | 5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 100% clinician | no trial data cached |
| Weight decreased (weight loss) | 738 | 6.3 5.9–6.7ROR 6.8 · χ² 3,307 / p <1e-300 | 6.2 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Metastatic neoplasm | 10 | 5.5 3.0–10.2ROR 5.5 · χ² 32 / p 6e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Appetite disorder | 14 | 5.1 3.0–8.6ROR 5.1 · χ² 42 / p 4e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Ulcer haemorrhage | 13 | 4.6 2.6–7.9ROR 4.6 · χ² 33 / p 6e-9 | 4.0 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Duodenal ulcer | 13 | 4.4 2.5–7.5ROR 4.4 · χ² 30 / p 2e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Lymphocyte count decreased | 31 | 4.2 2.9–5.9ROR 4.2 · χ² 71 / p 2e-17 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 6.9 · 100% clinician | no trial data cached |
| Constipation | 379 | 4.2 3.8–4.6ROR 4.3 · χ² 913 / p 9e-201 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 · 73% consumer | no trial data cached |
| Hepatotoxicity (liver damage) | 34 | 3.6 2.6–5.1ROR 3.6 · χ² 62 / p 1e-15 | 3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 · 91% clinician | no trial data cached |
| No adverse event | 258 | 3.5 3.1–3.9ROR 3.5 · χ² 450 / p 4e-100 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Deafness | 38 | 3.4 2.5–4.7ROR 3.5 · χ² 63 / p 9e-16 | 3.3 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 76% consumer | no trial data cached |
| Hypoalbuminaemia | 11 | 3.4 1.9–6.2ROR 3.4 · χ² 16 / p 3e-5 | 3.1 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Tongue disorder | 10 | 3.3 1.8–6.0ROR 3.3 · χ² 13 / p 1e-4 | 2.9 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | – | no trial data cached |
| Sensory loss | 11 | 3.2 1.8–5.8ROR 3.2 · χ² 15 / p 6e-5 | 2.9 EB05 1.8 · IC025 +0.5 | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Neutrophil count decreased | 55 | 3.2 2.5–4.2ROR 3.2 · χ² 82 / p 7e-20 | 3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 · 93% clinician | no trial data cached |
| Skin cancer | 29 | 3.2 2.2–4.6ROR 3.2 · χ² 41 / p 6e-11 | 3.1 EB05 2.2 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 · 82% consumer | no trial data cached |
| Malignant melanoma | 18 | 3.2 2.0–5.0ROR 3.2 · χ² 25 / p 3e-7 | 3.0 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Myalgia (muscle pain) | 218 | 3.0 2.7–3.5ROR 3.1 · χ² 299 / p 3e-67 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Fatigue (tiredness) | 970 | 3.0 2.8–3.1ROR 3.2 · χ² 1,305 / p 6e-286 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Feeding disorder | 24 | 2.9 1.9–4.3ROR 2.9 · χ² 27 / p 1e-7 | 2.7 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Intentional product use issue | 104 | 2.8 2.3–3.4ROR 2.8 · χ² 119 / p 5e-28 | 2.8 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Muscle spasms | 2,065 | 27.0 25.9–28.0ROR 34.8 · χ² 51,438 / p <1e-300 | 26.6 EB05 25.7 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.8 | no trial data cached |
| Alopecia (hair loss) | 1,401 | 17.0 16.2–17.8ROR 20.0 · χ² 21,107 / p <1e-300 | 16.9 EB05 16.1 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 | no trial data cached |
| Ageusia (loss of taste) | 1,011 | 99.8 94.1–105.9ROR 112.6 · χ² 94,882 / p <1e-300 | 95.6 EB05 90.8 · IC025 +6.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 58.8 · 70% consumer | no trial data cached |
| Fatigue (tiredness) | 970 | 3.0 2.8–3.1ROR 3.2 · χ² 1,305 / p 6e-286 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Death | 750 | 2.1 1.9–2.2ROR 2.2 · χ² 428 / p 3e-95 | 2.1 EB05 1.9 · IC025 +0.9 | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 2.7 | no trial data cached |
| Dysgeusia (altered taste) | 747 | 23.9 22.3–25.6ROR 26.0 · χ² 16,282 / p <1e-300 | 23.7 EB05 22.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.8 | no trial data cached |
| Weight decreased (weight loss) | 738 | 6.3 5.9–6.7ROR 6.8 · χ² 3,307 / p <1e-300 | 6.2 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Nausea | 714 | 2.1 2.0–2.3ROR 2.2 · χ² 452 / p 1e-100 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Decreased appetite (loss of appetite) | 706 | 7.2 6.7–7.8ROR 7.8 · χ² 3,822 / p <1e-300 | 7.2 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Diarrhoea (diarrhea) | 472 | 1.7 1.6–1.9ROR 1.8 · χ² 152 / p 3e-35 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Constipation | 379 | 4.2 3.8–4.6ROR 4.3 · χ² 913 / p 9e-201 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 · 73% consumer | no trial data cached |
| Off label use (used outside approved label) | 375 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.330 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | no trial data cached |
| Asthenia (weakness) | 294 | 1.9 1.7–2.1ROR 1.9 · χ² 117 / p 2e-27 | 1.9 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Arthralgia (joint pain) | 283 | 1.6 1.4–1.8ROR 1.6 · χ² 68 / p 1e-16 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Vomiting | 259 | 1.3 1.2–1.5ROR 1.3 · χ² 19 / p 7e-6 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Hypogeusia — n=48, PRR 59.5
- Taste disorder — n=240, PRR 28.7
- Squamous cell carcinoma — n=111, PRR 28.2
- Madarosis — n=60, PRR 12.2
- Recurrent cancer — n=20, PRR 11.7
- Hair growth abnormal — n=29, PRR 10.0
- Anosmia — n=48, PRR 7.9
- Embolism — n=27, PRR 7.7
- Neoplasm — n=33, PRR 6.8
- Hypophosphataemia — n=20, PRR 6.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Vismodegib?
In FDA FAERS, the most frequently co-reported reaction terms for Vismodegib are muscle spasms, alopecia, ageusia, fatigue, dysgeusia, weight decreased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Vismodegib have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: 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 .
Do FAERS signals prove that Vismodegib causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID eb368bb6-80e3-4df9-8a85-91df0a2ada6a, effective 20241202; matched on
openfda.generic_name.exact:"VISMODEGIB") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 692 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.