Drug · FAERS side-effect profile with label screen
Binimetinib side effects: what 7,756 FDA adverse event reports show
Drug class
Kinase inhibitor
FDA label, Indications wording
Brand names
Mektovi
openFDA label
Who reports
7,756 reports · 69% serious · 1,209 with death outcome · 47% female
openFDA FAERS counts, all years, deduplication not applied
Used for
MEKTOVI is a kinase inhibitor indicated: • in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. ( 1.1 , 2.1 ) • in combination .
FDA label, Indications and Usage
What it is
Binimetinib is a kinase inhibitor.
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 11Labeled (related wording) 8Likely indication confounding 1Reporting / coding artifact 4Lab value / disease marker 3Not in label — unassessed 13
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. 195 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 |
|---|---|---|---|---|---|---|
| Neoplasm progression | 394 | 30.7 27.8–33.8ROR 32.3 · χ² 11,173 / p <1e-300 | 30.3 EB05 27.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 | no trial data cached |
| Retinal detachment | 92 | 27.3 22.3–33.5ROR 27.6 · χ² 2,283 / p <1e-300 | 26.9 EB05 22.6 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.5 | no trial data cached |
| Uveitis | 70 | 14.1 11.1–17.8ROR 14.2 · χ² 834 / p 1e-183 | 13.9 EB05 11.3 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.2 | no trial data cached |
| Hospice care | 39 | 10.7 7.9–14.7ROR 10.8 · χ² 334 / p 7e-75 | 10.2 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Blood creatine phosphokinase increased | 114 | 10.6 8.8–12.7ROR 10.7 · χ² 976 / p 1e-214 | 10.4 EB05 8.8 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 7.7 | no trial data cached |
| Hepatic cytolysis | 47 | 10.4 7.8–13.9ROR 10.5 · χ² 390 / p 4e-87 | 10.0 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · 96% clinician | no trial data cached |
| Metastases to central nervous system | 48 | 10.2 7.7–13.5ROR 10.2 · χ² 386 / p 3e-86 | 9.7 EB05 7.5 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.1 | no trial data cached |
| Colitis | 139 | 10.0 8.5–11.8ROR 10.2 · χ² 1,116 / p 5e-245 | 9.8 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 | no trial data cached |
| Malignant melanoma | 44 | 8.9 6.6–11.9ROR 8.9 · χ² 300 / p 2e-67 | 8.4 EB05 6.4 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.3 | no trial data cached |
| Ejection fraction decreased | 45 | 7.8 5.9–10.5ROR 7.9 · χ² 261 / p 6e-59 | 7.4 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Brain neoplasm | 23 | 6.8 4.5–10.2ROR 6.8 · χ² 107 / p 2e-25 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Rash maculo-papular | 55 | 6.7 5.2–8.8ROR 6.8 · χ² 262 / p 3e-59 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Vitreous floaters | 22 | 6.1 4.0–9.3ROR 6.1 · χ² 89 / p 2e-21 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=11 | no trial data cached |
| Hepatic function abnormal | 82 | 6.0 4.8–7.4ROR 6.0 · χ² 336 / p 2e-75 | 5.8 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Hepatitis (liver inflammation) | 56 | 5.9 4.6–7.7ROR 6.0 · χ² 224 / p 6e-51 | 5.7 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Product use in unapproved indication | 523 | 5.8 5.3–6.3ROR 6.1 · χ² 2,092 / p <1e-300 | 5.8 EB05 5.4 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · 86% consumer | no trial data cached |
| Pneumonitis | 57 | 5.7 4.4–7.4ROR 5.7 · χ² 217 / p 3e-49 | 5.5 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Liver function test increased | 44 | 5.6 4.2–7.5ROR 5.6 · χ² 161 / p 3e-37 | 5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 | no trial data cached |
| Liver disorder | 87 | 5.3 4.3–6.6ROR 5.4 · χ² 301 / p 1e-67 | 5.2 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 | no trial data cached |
| Blood lactate dehydrogenase increased | 31 | 5.3 3.7–7.5ROR 5.3 · χ² 103 / p 2e-24 | 4.9 EB05 3.6 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 4.4 · ♀ 68% (drug 47%) | no trial data cached |
| Malignant neoplasm progression | 189 | 5.0 4.4–5.8ROR 5.1 · χ² 607 / p 3e-134 | 5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Gamma-glutamyltransferase increased | 40 | 4.9 3.6–6.7ROR 4.9 · χ² 120 / p 4e-28 | 4.6 EB05 3.5 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 3.5 | no trial data cached |
| Adrenal insufficiency | 21 | 4.7 3.1–7.3ROR 4.8 · χ² 58 / p 1e-14 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 41 | 4.7 3.5–6.4ROR 4.8 · χ² 117 / p 1e-27 | 4.5 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Disease progression | 201 | 4.6 4.0–5.3ROR 4.7 · χ² 568 / p 9e-126 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 27 | 4.4 3.0–6.5ROR 4.5 · χ² 69 / p 6e-17 | 4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Pyrexia (fever) | 542 | 4.2 3.9–4.6ROR 4.5 · χ² 1,358 / p 2e-297 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Aspartate aminotransferase increased | 83 | 4.2 3.4–5.2ROR 4.3 · χ² 202 / p 4e-46 | 4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 · 91% clinician | no trial data cached |
| Therapy change | 15 | 4.2 2.5–7.0ROR 4.2 · χ² 34 / p 3e-9 | 3.8 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Vision blurred (blurred vision) | 212 | 4.2 3.7–4.8ROR 4.3 · χ² 516 / p 1e-114 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Cholestasis (bile flow blockage) | 29 | 4.1 2.9–5.9ROR 4.1 · χ² 65 / p 4e-16 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Intestinal perforation | 17 | 4.1 2.5–6.6ROR 4.1 · χ² 37 / p 7e-10 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Alanine aminotransferase increased | 92 | 4.1 3.3–5.0ROR 4.1 · χ² 209 / p 1e-47 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 · 91% clinician | no trial data cached |
| Eye disorder | 48 | 4.0 3.0–5.3ROR 4.0 · χ² 103 / p 1e-24 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Visual impairment | 180 | 4.0 3.4–4.6ROR 4.0 · χ² 397 / p 1e-88 | 3.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Erythema multiforme | 13 | 3.8 2.2–6.5ROR 3.8 · χ² 24 / p 5e-7 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Brain oedema | 17 | 3.6 2.3–5.9ROR 3.6 · χ² 30 / p 2e-8 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | no trial data cached |
| Polyneuropathy | 16 | 3.6 2.2–5.9ROR 3.6 · χ² 28 / p 6e-8 | 3.3 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Blood creatinine increased | 86 | 3.6 2.9–4.4ROR 3.6 · χ² 156 / p 5e-36 | 3.5 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.4 | no trial data cached |
| Iron deficiency anaemia | 12 | 3.5 2.0–6.2ROR 3.5 · χ² 19 / p 6e-6 | 3.2 EB05 2.0 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.6 | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 976 | 3.0 2.9–3.2ROR 3.3 · χ² 1,393 / p <1e-300 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Death | 812 | 2.6 2.4–2.7ROR 2.7 · χ² 796 / p 2e-175 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.1 | no trial data cached |
| Nausea | 715 | 2.5 2.3–2.6ROR 2.6 · χ² 636 / p 1e-140 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Fatigue (tiredness) | 604 | 2.1 1.9–2.3ROR 2.2 · χ² 361 / p 7e-81 | 2.1 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Diarrhoea (diarrhea) | 570 | 2.4 2.2–2.6ROR 2.5 · χ² 477 / p 5e-106 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Pyrexia (fever) | 542 | 4.2 3.9–4.6ROR 4.5 · χ² 1,358 / p 2e-297 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Product use in unapproved indication | 523 | 5.8 5.3–6.3ROR 6.1 · χ² 2,092 / p <1e-300 | 5.8 EB05 5.4 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · 86% consumer | no trial data cached |
| Vomiting | 415 | 2.4 2.2–2.6ROR 2.5 · χ² 343 / p 7e-77 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Rash | 397 | 2.5 2.3–2.7ROR 2.6 · χ² 355 / p 2e-79 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Neoplasm progression | 394 | 30.7 27.8–33.8ROR 32.3 · χ² 11,173 / p <1e-300 | 30.3 EB05 27.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 | no trial data cached |
| Arthralgia (joint pain) | 229 | 1.5 1.3–1.7ROR 1.5 · χ² 38 / p 4e-10 | 1.5 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Malaise (feeling unwell) | 225 | 1.4 1.2–1.6ROR 1.4 · χ² 24 / p 5e-7 | 1.4 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Decreased appetite (loss of appetite) | 225 | 2.6 2.3–3.0ROR 2.7 · χ² 228 / p 1e-51 | 2.6 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Vision blurred (blurred vision) | 212 | 4.2 3.7–4.8ROR 4.3 · χ² 516 / p 1e-114 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Disease progression | 201 | 4.6 4.0–5.3ROR 4.7 · χ² 568 / p 9e-126 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 | 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.
- Neoplasm progression — n=394, PRR 30.7
- Hospice care — n=39, PRR 10.7
- Hepatic cytolysis — n=47, PRR 10.4
- Brain neoplasm — n=23, PRR 6.8
- Hepatic function abnormal — n=82, PRR 6.0
- Hepatitis — n=56, PRR 5.9
- Adrenal insufficiency — n=21, PRR 4.7
- Palmar-plantar erythrodysaesthesia syndrome — n=41, PRR 4.7
- Cholestasis — n=29, PRR 4.1
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 Binimetinib?
In FDA FAERS, the most frequently co-reported reaction terms for Binimetinib are nausea, fatigue, diarrhoea, pyrexia, vomiting, rash. 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 Binimetinib have an FDA boxed warning?
No. The FDA label retrieved for Binimetinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Binimetinib 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 6c3408ac-d401-4925-8a03-26591afbc240, effective 20250320; matched on
openfda.generic_name.exact:"BINIMETINIB") - 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, 235 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.