Drug · FAERS side-effect profile with label screen
Vemurafenib side effects: what 11,948 FDA adverse event reports show
Brand names
Zelboraf
openFDA label
Who reports
11,948 reports · 75% serious · 2,073 with death outcome · 44% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ZELBORAF ® 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.
FDA label, Indications and Usage
What it is
ZELBORAF (vemurafenib) is a kinase inhibitor available as 240 mg tablets for oral use. Vemurafenib has the chemical name propane-1-sulfonic acid {3-[5-(4-chlorophenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl]- 2,4-difluoro-phenyl}-amide.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 12Labeled (related wording) 7Likely indication confounding 2Not in label — unassessed 19
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.
- 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. 960 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Neutrophilic panniculitis | 17 | 535.0 310.6–921.3ROR 535.7 · χ² 6,519 / p <1e-300 | 280.1 EB05 185.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Keratoacanthoma | 105 | 321.1 260.9–395.1ROR 323.9 · χ² 27,992 / p <1e-300 | 258.3 EB05 219.4 · IC025 +6.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=99 · 94% clinician | no trial data cached |
| Keratosis pilaris | 34 | 273.7 190.7–392.8ROR 274.5 · χ² 7,743 / p <1e-300 | 208.8 EB05 156.3 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=25 · 97% clinician | no trial data cached |
| Solar dermatitis | 20 | 139.6 88.5–220.1ROR 139.8 · χ² 2,420 / p <1e-300 | 115.3 EB05 78.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Rash follicular | 10 | 120.2 63.3–228.1ROR 120.3 · χ² 997 / p 5e-219 | 93.0 EB05 54.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Papilloma | 19 | 111.5 70.1–177.2ROR 111.6 · χ² 1,852 / p <1e-300 | 95.0 EB05 64.3 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=16 | no trial data cached |
| Skin papilloma | 234 | 108.6 95.3–123.8ROR 110.7 · χ² 23,372 / p <1e-300 | 101.4 EB05 91.0 · IC025 +6.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=129 | no trial data cached |
| Sunburn | 373 | 92.4 83.4–102.4ROR 95.4 · χ² 31,951 / p <1e-300 | 87.4 EB05 80.2 · IC025 +6.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=172 | no trial data cached |
| Metastatic malignant melanoma | 102 | 81.6 67.0–99.5ROR 82.3 · χ² 7,680 / p <1e-300 | 76.9 EB05 65.2 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious n=102 | no trial data cached |
| Hairy cell leukaemia | 10 | 79.4 42.1–149.6ROR 79.5 · χ² 667 / p 2e-147 | 66.7 EB05 38.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Serous retinal detachment | 32 | 73.6 51.7–104.7ROR 73.7 · χ² 2,128 / p <1e-300 | 67.9 EB05 50.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=31 · 100% clinician | no trial data cached |
| Intracranial tumour haemorrhage | 14 | 66.4 38.9–113.2ROR 66.5 · χ² 806 / p 1e-177 | 59.1 EB05 37.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Acrochordon | 48 | 66.2 49.6–88.3ROR 66.5 · χ² 2,906 / p <1e-300 | 62.3 EB05 48.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Hyperkeratosis | 192 | 63.1 54.7–72.7ROR 64.1 · χ² 11,257 / p <1e-300 | 60.5 EB05 53.7 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=138 | no trial data cached |
| Skin toxicity | 176 | 57.2 49.2–66.3ROR 58.0 · χ² 9,347 / p <1e-300 | 55.0 EB05 48.5 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=157 · 95% clinician | no trial data cached |
| Melanocytic naevus | 137 | 56.6 47.8–67.0ROR 57.2 · χ² 7,190 / p <1e-300 | 54.4 EB05 47.2 · IC025 +5.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=76 | no trial data cached |
| Chorioretinopathy | 43 | 54.0 39.9–73.1ROR 54.2 · χ² 2,117 / p <1e-300 | 51.2 EB05 39.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=41 · 100% clinician | no trial data cached |
| Palmoplantar keratoderma | 19 | 47.5 30.1–74.9ROR 47.6 · χ² 798 / p 9e-176 | 44.4 EB05 30.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Melanoma recurrent | 11 | 47.2 26.0–86.0ROR 47.3 · χ² 441 / p 4e-98 | 42.9 EB05 25.5 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=11 | no trial data cached |
| Radiation skin injury | 30 | 46.5 32.4–66.8ROR 46.6 · χ² 1,258 / p 1e-275 | 44.2 EB05 32.4 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · 93% clinician | no trial data cached |
| Squamous cell carcinoma | 239 | 45.6 40.2–51.8ROR 46.6 · χ² 10,130 / p <1e-300 | 44.4 EB05 39.8 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 34.0 | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 414 | 45.3 41.1–49.8ROR 46.9 · χ² 17,439 / p <1e-300 | 44.1 EB05 40.6 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 40.3 | no trial data cached |
| Panniculitis | 58 | 43.2 33.3–56.1ROR 43.4 · χ² 2,294 / p <1e-300 | 41.7 EB05 33.4 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=52 · ♀ 71% (drug 44%) · 97% clinician | no trial data cached |
| Autoimmune colitis | 15 | 41.9 25.1–69.9ROR 41.9 · χ² 545 / p 7e-121 | 39.0 EB05 25.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Radiation necrosis | 12 | 37.8 21.3–66.9ROR 37.8 · χ² 385 / p 5e-86 | 35.1 EB05 21.4 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Squamous cell carcinoma of skin | 120 | 35.7 29.8–42.7ROR 36.0 · χ² 3,931 / p <1e-300 | 34.8 EB05 29.9 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=115 | no trial data cached |
| Metastases to central nervous system | 244 | 34.1 30.0–38.6ROR 34.8 · χ² 7,651 / p <1e-300 | 33.3 EB05 30.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 25.2 | no trial data cached |
| Enanthema | 10 | 30.9 16.5–57.7ROR 30.9 · χ² 256 / p 8e-58 | 28.8 EB05 16.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Mass | 237 | 30.2 26.6–34.3ROR 30.8 · χ² 6,547 / p <1e-300 | 29.6 EB05 26.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 · 70% consumer | no trial data cached |
| Seborrhoeic keratosis | 22 | 26.7 17.5–40.7ROR 26.8 · χ² 511 / p 2e-113 | 25.8 EB05 17.9 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=16 · 100% clinician | no trial data cached |
| Malignant melanoma in situ | 18 | 25.4 16.0–40.5ROR 25.4 · χ² 392 / p 1e-87 | 24.5 EB05 16.3 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | no trial data cached |
| Dermatitis acneiform | 82 | 24.1 19.4–29.9ROR 24.3 · χ² 1,768 / p <1e-300 | 23.7 EB05 19.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=65 · 91% clinician | no trial data cached |
| Neoplasm skin | 21 | 24.0 15.6–36.9ROR 24.0 · χ² 434 / p 9e-97 | 23.2 EB05 16.0 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | no trial data cached |
| Recall phenomenon | 10 | 21.2 11.4–39.6ROR 21.3 · χ² 171 / p 2e-39 | 19.8 EB05 10.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Skin mass | 76 | 20.3 16.2–25.4ROR 20.4 · χ² 1,360 / p 6e-298 | 20.0 EB05 16.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=40 | no trial data cached |
| Xerosis | 14 | 20.3 12.0–34.4ROR 20.3 · χ² 235 / p 2e-53 | 19.4 EB05 11.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Ocular toxicity | 11 | 18.4 10.2–33.4ROR 18.4 · χ² 163 / p 2e-37 | 17.1 EB05 9.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Iridocyclitis | 32 | 18.1 12.8–25.7ROR 18.2 · χ² 496 / p 4e-110 | 17.7 EB05 13.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=32 · 97% clinician | no trial data cached |
| Malignant melanoma | 131 | 17.3 14.6–20.5ROR 17.5 · χ² 1,977 / p <1e-300 | 17.1 EB05 14.8 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.0 | no trial data cached |
| Actinic keratosis | 25 | 17.0 11.4–25.1ROR 17.0 · χ² 356 / p 1e-79 | 16.5 EB05 11.5 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=24 · 95% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Rash | 1,547 | 6.3 6.0–6.6ROR 7.1 · χ² 6,982 / p <1e-300 | 6.3 EB05 6.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Death | 1,062 | 2.2 2.0–2.3ROR 2.3 · χ² 693 / p 6e-153 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Outcome field, not a reaction | serious PRR 1.7 | no trial data cached |
| Arthralgia (joint pain) | 1,039 | 4.4 4.2–4.7ROR 4.7 · χ² 2,783 / p <1e-300 | 4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Fatigue (tiredness) | 1,033 | 2.3 2.2–2.5ROR 2.5 · χ² 817 / p 7e-180 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Off label use (used outside approved label) | 866 | 1.8 1.6–1.9ROR 1.8 · χ² 290 / p 2e-65 | 1.8 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.3 | no trial data cached |
| Diarrhoea (diarrhea) | 825 | 2.3 2.1–2.4ROR 2.3 · χ² 591 / p 9e-131 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Nausea | 811 | 1.8 1.7–1.9ROR 1.9 · χ² 301 / p 9e-68 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Disease progression | 768 | 11.5 10.7–12.3ROR 12.2 · χ² 7,343 / p <1e-300 | 11.4 EB05 10.7 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 9.3 | no trial data cached |
| Pyrexia (fever) | 742 | 3.8 3.5–4.0ROR 4.0 · χ² 1,527 / p <1e-300 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Alopecia (hair loss) | 561 | 5.0 4.6–5.4ROR 5.2 · χ² 1,811 / p <1e-300 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Decreased appetite (loss of appetite) | 532 | 4.0 3.7–4.4ROR 4.2 · χ² 1,224 / p 2e-268 | 4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Vomiting | 474 | 1.8 1.6–1.9ROR 1.8 · χ² 163 / p 1e-37 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 414 | 45.3 41.1–49.8ROR 46.9 · χ² 17,439 / p <1e-300 | 44.1 EB05 40.6 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 40.3 | no trial data cached |
| Pruritus (itching) | 389 | 1.8 1.6–2.0ROR 1.8 · χ² 142 / p 5e-33 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Sunburn | 373 | 92.4 83.4–102.4ROR 95.4 · χ² 31,951 / p <1e-300 | 87.4 EB05 80.2 · IC025 +6.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=172 | 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.
- Solar dermatitis — n=20, PRR 139.6
- Serous retinal detachment — n=32, PRR 73.6
- Acrochordon — n=48, PRR 66.2
- Chorioretinopathy — n=43, PRR 54.0
- Metastases to central nervous system — n=244, PRR 34.1
- Mass — n=237, PRR 30.2
- Dermatitis acneiform — n=82, PRR 24.1
- Skin mass — n=76, PRR 20.3
- Iridocyclitis — n=32, PRR 18.1
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 Vemurafenib?
In FDA FAERS, the most frequently co-reported reaction terms for Vemurafenib are rash, arthralgia, fatigue, diarrhoea, nausea, pyrexia. 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 Vemurafenib have an FDA boxed warning?
No. The FDA label retrieved for Vemurafenib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Vemurafenib 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 38eea320-7e0c-485a-bc30-98c3c45e2763, effective 20260828; matched on
openfda.generic_name.exact:"VEMURAFENIB") - 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, 1,000 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.