Drug · FAERS side-effect profile with label screen
Cobimetinib side effects: what 4,385 FDA adverse event reports show
Drug class
Kinase inhibitor
FDA label, Indications wording
Brand names
Cotellic
openFDA label
Who reports
4,385 reports · 83% serious · 579 with death outcome · 49% female
openFDA FAERS counts, all years, deduplication not applied
Used for
COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms.
FDA label, Indications and Usage
What it is
Cobimetinib fumarate 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 10Labeled (related wording) 3Reporting / coding artifact 1Lab value / disease marker 5Not in label — unassessed 21
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.
- 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. 102 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 |
|---|---|---|---|---|---|---|
| Photosensitivity reaction (sun sensitivity) | 132 | 38.6 32.6–45.7ROR 39.8 · χ² 4,765 / p <1e-300 | 38.1 EB05 33.0 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 36.7 | no trial data cached |
| Rash maculo-papular | 124 | 26.9 22.6–32.0ROR 27.6 · χ² 3,050 / p <1e-300 | 26.6 EB05 22.9 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.4 · 98% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 120 | 22.5 18.9–26.9ROR 23.1 · χ² 2,440 / p <1e-300 | 22.4 EB05 19.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.6 · 99% clinician | no trial data cached |
| Retinal detachment | 42 | 21.9 16.2–29.6ROR 22.1 · χ² 814 / p 2e-179 | 21.6 EB05 16.7 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.3 · 98% clinician | no trial data cached |
| Ejection fraction decreased | 70 | 21.6 17.1–27.2ROR 21.9 · χ² 1,348 / p 3e-295 | 21.4 EB05 17.5 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.0 · 93% clinician | no trial data cached |
| Uveitis | 59 | 21.0 16.3–27.0ROR 21.2 · χ² 1,097 / p 7e-241 | 20.7 EB05 16.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · 95% clinician | no trial data cached |
| Metastases to central nervous system | 54 | 20.2 15.5–26.4ROR 20.5 · χ² 964 / p 6e-212 | 20.0 EB05 15.9 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.1 | no trial data cached |
| Blood creatine phosphokinase increased | 119 | 19.5 16.3–23.3ROR 20.0 · χ² 2,066 / p <1e-300 | 19.4 EB05 16.6 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 13.3 · 95% clinician | no trial data cached |
| Toxic skin eruption | 41 | 19.5 14.3–26.4ROR 19.6 · χ² 697 / p 7e-154 | 19.2 EB05 14.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · 98% clinician | no trial data cached |
| Erythema multiforme | 35 | 18.0 12.9–25.1ROR 18.1 · χ² 543 / p 2e-120 | 17.7 EB05 13.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · ♀ 81% (drug 49%) · 100% clinician | no trial data cached |
| Hyperthyroidism | 37 | 12.2 8.9–16.9ROR 12.3 · χ² 370 / p 8e-83 | 11.8 EB05 8.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 97% clinician | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 52 | 11.2 8.5–14.6ROR 11.3 · χ² 471 / p 1e-104 | 10.8 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 96% clinician | no trial data cached |
| Pneumonitis | 63 | 11.2 8.7–14.3ROR 11.3 · χ² 572 / p 1e-126 | 10.9 EB05 8.7 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 · 100% clinician | no trial data cached |
| Myocarditis | 25 | 10.6 7.1–15.6ROR 10.6 · χ² 207 / p 4e-47 | 9.8 EB05 6.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 100% clinician | no trial data cached |
| Hepatocellular injury | 27 | 9.1 6.2–13.2ROR 9.1 · χ² 186 / p 1e-42 | 8.3 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 96% clinician | no trial data cached |
| Hepatitis (liver inflammation) | 43 | 8.0 6.0–10.8ROR 8.1 · χ² 258 / p 3e-58 | 7.5 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 98% clinician | no trial data cached |
| Cholestasis (bile flow blockage) | 31 | 7.8 5.5–11.0ROR 7.8 · χ² 176 / p 2e-40 | 7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 23% (drug 49%) · 100% clinician | no trial data cached |
| Colitis | 58 | 7.4 5.7–9.5ROR 7.5 · χ² 313 / p 3e-70 | 7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · 98% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 34 | 7.3 5.2–10.3ROR 7.4 · χ² 180 / p 3e-41 | 6.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 94% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 24 | 7.2 4.8–10.7ROR 7.2 · χ² 122 / p 1e-28 | 6.4 EB05 4.5 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 · ♀ 76% (drug 49%) · 92% clinician | no trial data cached |
| Mucosal inflammation | 39 | 7.2 5.2–9.8ROR 7.2 · χ² 200 / p 8e-46 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · 97% clinician | no trial data cached |
| Folliculitis | 15 | 6.9 4.2–11.5ROR 7.0 · χ² 70 / p 2e-17 | 5.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Gamma-glutamyltransferase increased | 32 | 6.9 4.9–9.7ROR 6.9 · χ² 156 / p 5e-36 | 6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 4.8 · 90% clinician | no trial data cached |
| Transaminases increased | 32 | 6.9 4.9–9.7ROR 6.9 · χ² 155 / p 6e-36 | 6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 97% clinician | no trial data cached |
| Face oedema | 24 | 6.8 4.5–10.1ROR 6.8 · χ² 112 / p 1e-26 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 92% clinician | no trial data cached |
| Blood alkaline phosphatase increased | 34 | 6.5 4.7–9.1ROR 6.6 · χ² 154 / p 1e-35 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 · 94% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 49 | 6.5 4.9–8.6ROR 6.6 · χ² 223 / p 9e-51 | 6.2 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 94% clinician | no trial data cached |
| Oral candidiasis (oral thrush) | 17 | 6.2 3.9–10.0ROR 6.3 · χ² 70 / p 3e-17 | 5.4 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Urosepsis | 12 | 6.2 3.5–11.0ROR 6.2 · χ² 47 / p 3e-12 | 5.1 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Squamous cell carcinoma | 12 | 6.1 3.5–10.7ROR 6.1 · χ² 46 / p 6e-12 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Malignant melanoma | 17 | 6.1 3.8–9.7ROR 6.1 · χ² 67 / p 1e-16 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 | no trial data cached |
| Hypokalaemia (low potassium) | 58 | 6.0 4.7–7.8ROR 6.1 · χ² 239 / p 3e-54 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · ♀ 74% (drug 49%) · 93% clinician | no trial data cached |
| Hyperbilirubinaemia | 13 | 6.0 3.5–10.4ROR 6.0 · χ² 50 / p 9e-13 | 5.1 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Rash generalised | 33 | 6.0 4.3–8.4ROR 6.0 · χ² 133 / p 5e-31 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 73% (drug 49%) | no trial data cached |
| Skin infection | 14 | 6.0 3.6–10.1ROR 6.0 · χ² 53 / p 1e-13 | 5.1 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 51 | 5.9 4.5–7.7ROR 5.9 · χ² 201 / p 7e-46 | 5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 98% clinician | no trial data cached |
| Cytokine release syndrome | 23 | 5.8 3.8–8.7ROR 5.8 · χ² 86 / p 9e-21 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 96% clinician | no trial data cached |
| Bacteraemia | 14 | 5.7 3.4–9.6ROR 5.7 · χ² 49 / p 1e-12 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Intentional product use issue | 104 | 5.7 4.7–6.8ROR 5.8 · χ² 395 / p 3e-88 | 5.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Blood bilirubin increased | 32 | 5.6 4.0–8.0ROR 5.7 · χ² 118 / p 9e-28 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 4.1 · ♀ 24% (drug 49%) · 97% 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 470 | 2.6 2.4–2.8ROR 2.8 · χ² 476 / p 8e-106 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Diarrhoea (diarrhea) | 441 | 3.3 3.0–3.6ROR 3.5 · χ² 717 / p 3e-158 | 3.3 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Rash | 398 | 4.4 4.0–4.8ROR 4.7 · χ² 1,059 / p 1e-232 | 4.4 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Pyrexia (fever) | 366 | 5.1 4.6–5.6ROR 5.4 · χ² 1,205 / p 2e-264 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Death | 251 | 1.4 1.2–1.6ROR 1.4 · χ² 29 / p 5e-8 | 1.4 EB05 1.3 · IC025 +0.3 | Outcome field, not a reaction | serious PRR 1.0 | no trial data cached |
| No adverse event | 182 | 4.9 4.3–5.7ROR 5.1 · χ² 566 / p 2e-125 | 4.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 139 | 4.4 3.7–5.1ROR 4.5 · χ² 359 / p 2e-80 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 · 99% clinician | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 132 | 38.6 32.6–45.7ROR 39.8 · χ² 4,765 / p <1e-300 | 38.1 EB05 33.0 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 36.7 | no trial data cached |
| Rash maculo-papular | 124 | 26.9 22.6–32.0ROR 27.6 · χ² 3,050 / p <1e-300 | 26.6 EB05 22.9 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.4 · 98% clinician | no trial data cached |
| Anaemia (low red blood cells) | 121 | 3.0 2.5–3.6ROR 3.1 · χ² 164 / p 8e-38 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 · 94% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 120 | 22.5 18.9–26.9ROR 23.1 · χ² 2,440 / p <1e-300 | 22.4 EB05 19.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.6 · 99% clinician | no trial data cached |
| Blood creatine phosphokinase increased | 119 | 19.5 16.3–23.3ROR 20.0 · χ² 2,066 / p <1e-300 | 19.4 EB05 16.6 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 13.3 · 95% clinician | no trial data cached |
| Disease progression | 109 | 4.4 3.7–5.3ROR 4.5 · χ² 286 / p 2e-64 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 · 96% clinician | no trial data cached |
| Intentional product use issue | 104 | 5.7 4.7–6.8ROR 5.8 · χ² 395 / p 3e-88 | 5.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Sepsis (blood infection) | 79 | 3.4 2.7–4.2ROR 3.4 · χ² 131 / p 1e-30 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 · 96% clinician | 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.
- Drug reaction with eosinophilia and systemic symptoms — n=120, PRR 22.5
- Uveitis — n=59, PRR 21.0
- Toxic skin eruption — n=41, PRR 19.5
- Erythema multiforme — n=35, PRR 18.0
- Hyperthyroidism — n=37, PRR 12.2
- Stevens-johnson syndrome — n=52, PRR 11.2
- Myocarditis — n=25, PRR 10.6
- Hepatocellular injury — n=27, PRR 9.1
- Hepatitis — n=43, PRR 8.0
- Cholestasis — n=31, PRR 7.8
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 Cobimetinib?
In FDA FAERS, the most frequently co-reported reaction terms for Cobimetinib are diarrhoea, rash, pyrexia, acute kidney injury, photosensitivity reaction, rash maculo-papular. 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 Cobimetinib have an FDA boxed warning?
No. The FDA label retrieved for Cobimetinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cobimetinib 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 c387579e-cee0-4334-bd1e-73f93ac1bde6, effective 20260729; matched on
openfda.generic_name.exact:"COBIMETINIB") - 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, 142 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.