Encorafenib side effects: what 9,843 FDA adverse event reports show

Encorafenib · Braftovi · 996 reaction terms · 27,088 drug–reaction co-reports · data 2026-09-14

Drug class

Kinase inhibitor

FDA label, Indications wording

Brand names

Braftovi

openFDA label

Who reports

9,843 reports · 70% serious · 1,627 with death outcome · 49% female

openFDA FAERS counts, all years, deduplication not applied

Used for

BRAFTOVI is a kinase inhibitor indicated: Melanoma • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test. ( 1.1 , 2.1 ) Color.

FDA label, Indications and Usage

What it is

Encorafenib 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 4Labeled (related wording) 5Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 27

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. 956 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Serous retinopathy	56	2,503.4 1,699.6–3,687.2ROR 2,517.7 · χ² 62,782 / p <1e-300	820.1 EB05 655.1 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=56	no trial data cached
Serous retinal detachment	345	1,647.4 1,432.8–1,894.1ROR 1,707.2 · χ² 317,275 / p <1e-300	878.4 EB05 803.4 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious n=344 · 92% clinician	no trial data cached
Macular detachment	13	121.9 69.7–213.2ROR 122.1 · χ² 1,362 / p 2e-298	99.0 EB05 61.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Dysplastic naevus	10	61.1 32.6–114.5ROR 61.1 · χ² 517 / p 8e-115	53.7 EB05 31.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Ocular toxicity	29	60.0 41.5–86.8ROR 60.2 · χ² 1,580 / p <1e-300	56.3 EB05 41.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=20	no trial data cached
Central serous chorioretinopathy	16	56.6 34.5–93.0ROR 56.7 · χ² 798 / p 9e-176	51.9 EB05 33.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=16	no trial data cached
Detachment of retinal pigment epithelium	22	55.2 36.1–84.2ROR 55.3 · χ² 1,088 / p 7e-239	51.5 EB05 35.9 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious n=22	no trial data cached
Lentigo	10	43.6 23.3–81.5ROR 43.6 · χ² 367 / p 4e-82	39.7 EB05 23.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Subretinal fluid	21	43.2 28.1–66.5ROR 43.3 · χ² 808 / p 6e-178	40.9 EB05 28.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=18	no trial data cached
Melanocytic naevus	71	35.0 27.7–44.3ROR 35.3 · χ² 2,277 / p <1e-300	34.2 EB05 28.0 · IC025 +4.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=57	no trial data cached
Metastatic malignant melanoma	37	34.9 25.2–48.3ROR 35.0 · χ² 1,165 / p 1e-255	33.8 EB05 25.6 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious n=37 · ♀ 27% (drug 49%)	no trial data cached
Neoplasm progression	552	34.0 31.3–36.9ROR 36.0 · χ² 17,406 / p <1e-300	33.5 EB05 31.2 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 22.2	no trial data cached
Second primary malignancy	128	33.3 28.0–39.6ROR 33.7 · χ² 3,917 / p <1e-300	32.6 EB05 28.2 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 27.1	no trial data cached
Retinal oedema	26	29.8 20.2–43.8ROR 29.9 · χ² 685 / p 3e-151	28.8 EB05 20.7 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious n=25	no trial data cached
Large intestinal ulcer	37	29.6 21.4–40.9ROR 29.7 · χ² 979 / p 3e-215	28.8 EB05 21.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=35	no trial data cached
Acrochordon	17	27.8 17.2–44.8ROR 27.8 · χ² 407 / p 8e-91	26.7 EB05 17.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Retinopathy	46	26.5 19.9–35.5ROR 26.7 · χ² 1,092 / p 1e-239	26.0 EB05 20.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=41	no trial data cached
Colorectal cancer metastatic	27	25.4 17.4–37.1ROR 25.5 · χ² 602 / p 3e-133	24.7 EB05 17.8 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=27	no trial data cached
Halo vision	13	24.7 14.3–42.7ROR 24.8 · χ² 270 / p 7e-61	23.6 EB05 14.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Dermatitis acneiform	65	23.1 18.1–29.5ROR 23.3 · χ² 1,339 / p 2e-293	22.7 EB05 18.5 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious n=55	no trial data cached
Demyelinating polyneuropathy	11	23.0 12.7–41.6ROR 23.0 · χ² 208 / p 2e-47	21.7 EB05 12.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Retinal detachment	98	22.9 18.8–28.0ROR 23.2 · χ² 2,013 / p <1e-300	22.6 EB05 19.1 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.8	no trial data cached
Immune-mediated hepatitis	18	19.7 12.4–31.3ROR 19.7 · χ² 298 / p 4e-67	19.1 EB05 12.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=18	no trial data cached
Chorioretinopathy	13	19.4 11.2–33.5ROR 19.4 · χ² 207 / p 3e-47	18.4 EB05 10.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Macular oedema	49	18.8 14.2–24.9ROR 18.9 · χ² 801 / p 1e-176	18.5 EB05 14.5 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious n=48	no trial data cached
Suspected off label use	15	18.6 11.2–30.8ROR 18.6 · χ² 230 / p 3e-52	17.8 EB05 11.0 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious n=12	no trial data cached
Cystoid macular oedema	16	18.5 11.3–30.2ROR 18.5 · χ² 245 / p 2e-55	17.7 EB05 11.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=16	no trial data cached
Retinitis	13	16.7 9.7–28.8ROR 16.7 · χ² 175 / p 3e-40	15.6 EB05 8.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Carcinoembryonic antigen increased	15	16.7 10.0–27.7ROR 16.7 · χ² 204 / p 1e-46	15.8 EB05 9.6 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious n=13	no trial data cached
Hospice care	70	15.2 12.1–19.3ROR 15.3 · χ² 911 / p 2e-200	15.0 EB05 12.3 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.8	no trial data cached
Seborrhoeic keratosis	10	14.6 7.9–27.2ROR 14.6 · χ² 113 / p 1e-26	12.8 EB05 6.3 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Metamorphopsia	12	14.0 7.9–24.7ROR 14.0 · χ² 131 / p 1e-30	12.5 EB05 6.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Uveitis	84	13.3 10.8–16.5ROR 13.4 · χ² 940 / p 1e-206	13.1 EB05 10.9 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.5	no trial data cached
Neoplasm recurrence	21	13.2 8.6–20.3ROR 13.3 · χ² 224 / p 5e-51	12.5 EB05 8.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Amylase increased	22	12.9 8.5–19.5ROR 12.9 · χ² 228 / p 1e-51	12.1 EB05 8.0 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious n=20 · 91% clinician	no trial data cached
Brain operation	13	12.3 7.2–21.3ROR 12.4 · χ² 124 / p 5e-29	10.8 EB05 6.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious n=13	no trial data cached
Ileal stenosis	10	12.0 6.5–22.4ROR 12.1 · χ² 90 / p 1e-21	9.9 EB05 5.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Iridocyclitis	17	11.6 7.2–18.7ROR 11.7 · χ² 154 / p 1e-35	10.5 EB05 6.4 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=17	no trial data cached
Tumour lysis syndrome	46	11.3 8.4–15.0ROR 11.3 · χ² 418 / p 3e-93	10.9 EB05 8.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	no trial data cached
Immune-mediated enterocolitis	18	10.9 6.9–17.4ROR 10.9 · χ² 152 / p 4e-35	9.8 EB05 6.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=18	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
Death	1,158	2.9 2.7–3.0ROR 3.1 · χ² 1,464 / p <1e-300	2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree	Outcome field, not a reaction	serious PRR 2.3	no trial data cached
Off label use (used outside approved label)	1,137	2.8 2.6–3.0ROR 3.0 · χ² 1,362 / p 2e-298	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 2.6	no trial data cached
Nausea	842	2.3 2.1–2.4ROR 2.4 · χ² 623 / p 8e-138	2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.2	no trial data cached
Fatigue (tiredness)	770	2.1 2.0–2.3ROR 2.2 · χ² 467 / p 8e-104	2.1 EB05 2.0 · IC025 +1.0	Labeled adverse reaction exact term	serious PRR 1.8	no trial data cached
Diarrhoea (diarrhea)	634	2.1 1.9–2.3ROR 2.2 · χ² 376 / p 5e-84	2.1 EB05 2.0 · IC025 +0.9	Labeled adverse reaction exact term	serious PRR 2.1	no trial data cached
Pyrexia (fever)	599	3.7 3.4–4.0ROR 3.9 · χ² 1,190 / p 5e-261	3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.8	no trial data cached
Neoplasm progression	552	34.0 31.3–36.9ROR 36.0 · χ² 17,406 / p <1e-300	33.5 EB05 31.2 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 22.2	no trial data cached
Product use in unapproved indication	523	4.6 4.2–5.0ROR 4.8 · χ² 1,468 / p <1e-300	4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2 · 85% consumer	no trial data cached
Vomiting	478	2.2 2.0–2.4ROR 2.2 · χ² 308 / p 3e-69	2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.8	no trial data cached
Rash	470	2.3 2.1–2.5ROR 2.4 · χ² 355 / p 2e-79	2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.0	no trial data cached
Serous retinal detachment	345	1,647.4 1,432.8–1,894.1ROR 1,707.2 · χ² 317,275 / p <1e-300	878.4 EB05 803.4 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious n=344 · 92% clinician	no trial data cached
Arthralgia (joint pain)	323	1.7 1.5–1.8ROR 1.7 · χ² 86 / p 9e-21	1.7 EB05 1.5 · IC025 +0.5	Labeled adverse reaction exact term	serious PRR 1.4	no trial data cached
Decreased appetite (loss of appetite)	306	2.8 2.5–3.1ROR 2.9 · χ² 360 / p 1e-80	2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.9	no trial data cached
Malaise (feeling unwell)	295	1.4 1.3–1.6ROR 1.4 · χ² 38 / p 3e-10	1.4 EB05 1.3 · IC025 +0.3	Not in label — unassessed	serious PRR 1.3	no trial data cached
Malignant neoplasm progression	250	5.2 4.6–5.9ROR 5.3 · χ² 855 / p 3e-188	5.2 EB05 4.7 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.2	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.

Serous retinopathy — n=56, PRR 2,503.4
Serous retinal detachment — n=345, PRR 1,647.4
Ocular toxicity — n=29, PRR 60.0
Subretinal fluid — n=21, PRR 43.2
Neoplasm progression — n=552, PRR 34.0
Second primary malignancy — n=128, PRR 33.3
Large intestinal ulcer — n=37, PRR 29.6
Retinopathy — n=46, PRR 26.5
Retinal detachment — n=98, PRR 22.9
Hospice care — n=70, PRR 15.2

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 Encorafenib?

In FDA FAERS, the most frequently co-reported reaction terms for Encorafenib are nausea, fatigue, diarrhoea, pyrexia, neoplasm progression, vomiting. 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 Encorafenib have an FDA boxed warning?

No. The FDA label retrieved for Encorafenib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Encorafenib 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 235dfc38-0f0b-4037-b501-7a9f4294740c, effective 20260226; matched on openfda.generic_name.exact:"ENCORAFENIB")
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, field patient.drug.openfda.generic_name.exact, 996 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.