Capmatinib side effects: what 2,345 FDA adverse event reports show

Capmatinib · Tabrecta · 53 reaction terms · 2,389 drug–reaction co-reports · data 2026-09-14

Drug class

Kinase inhibitor

FDA label, Indications wording

Brand names

Tabrecta

openFDA label

Who reports

2,345 reports · 60% serious · 566 with death outcome · 55% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. TABREC.

FDA label, Indications and Usage

What it is

Capmatinib 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 38 strongest signals

Labeled adverse reaction 8Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 6Lab value / disease marker 4Outcome field, not a reaction 1Not in label — unassessed 16

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.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
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. 15 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
Generalised oedema	32	23.3 16.5–32.9ROR 23.6 · χ² 659 / p 1e-145	23.0 EB05 17.0 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 19.2	no trial data cached
Oedema	134	22.2 18.8–26.2ROR 23.5 · χ² 2,690 / p <1e-300	22.1 EB05 19.1 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.7	no trial data cached
Product use complaint	32	18.5 13.1–26.1ROR 18.7 · χ² 512 / p 1e-113	18.2 EB05 13.5 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious n=13	no trial data cached
Oedema peripheral (swelling of legs/feet)	245	17.9 15.9–20.2ROR 19.9 · χ² 3,918 / p <1e-300	17.9 EB05 16.1 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.4	no trial data cached
Peripheral swelling	288	16.8 15.1–18.7ROR 19.0 · χ² 4,291 / p <1e-300	16.8 EB05 15.2 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.0 · 88% consumer	no trial data cached
Metastases to central nervous system	24	16.8 11.3–25.0ROR 16.9 · χ² 340 / p 3e-76	16.4 EB05 11.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.1	no trial data cached
Malignant neoplasm progression	180	15.8 13.8–18.2ROR 17.1 · χ² 2,493 / p <1e-300	15.8 EB05 13.9 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 15.4	no trial data cached
Hepatic cytolysis	21	15.4 10.1–23.6ROR 15.5 · χ² 268 / p 2e-60	14.9 EB05 9.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.7 · 100% clinician	no trial data cached
Blood calcium decreased	16	12.7 7.8–20.7ROR 12.8 · χ² 161 / p 4e-37	11.6 EB05 7.0 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 14.2	no trial data cached
Deafness	36	12.3 8.9–17.0ROR 12.5 · χ² 363 / p 4e-81	11.9 EB05 8.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 12.2 · ♀ 22% (drug 55%)	no trial data cached
Blood potassium increased	17	9.4 5.8–15.1ROR 9.4 · χ² 119 / p 5e-28	8.1 EB05 5.1 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	serious PRR 11.6	no trial data cached
Hypoacusis	44	9.2 6.8–12.3ROR 9.3 · χ² 312 / p 3e-70	8.7 EB05 6.6 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.8 · 75% consumer	no trial data cached
Fluid retention	52	9.2 7.0–12.0ROR 9.3 · χ² 370 / p 9e-83	8.7 EB05 6.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.5 · ♀ 35% (drug 55%) · 73% consumer	no trial data cached
Lung neoplasm malignant	42	9.1 6.7–12.3ROR 9.2 · χ² 295 / p 2e-66	8.6 EB05 6.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	no trial data cached
Blood creatinine increased	66	9.0 7.1–11.5ROR 9.3 · χ² 464 / p 3e-103	8.7 EB05 7.0 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.7	no trial data cached
Hepatotoxicity (liver damage)	22	8.9 5.9–13.5ROR 9.0 · χ² 146 / p 6e-34	7.9 EB05 5.4 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.3	no trial data cached
Pleural effusion	58	8.5 6.6–11.0ROR 8.7 · χ² 378 / p 1e-84	8.2 EB05 6.5 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.0	no trial data cached
Pneumonitis	25	8.3 5.6–12.2ROR 8.4 · χ² 153 / p 2e-35	7.5 EB05 5.2 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.9	no trial data cached
Metastases to bone	15	8.2 5.0–13.6ROR 8.3 · χ² 88 / p 4e-21	6.9 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Blood urea increased	15	8.0 4.8–13.2ROR 8.0 · χ² 85 / p 2e-20	6.7 EB05 4.2 · IC025 +1.8 3/3 methods agree	Lab value / disease marker	serious PRR 8.4	no trial data cached
Dysphagia (difficulty swallowing)	83	7.8 6.4–9.7ROR 8.1 · χ² 491 / p 5e-109	7.6 EB05 6.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 2.8	no trial data cached
Joint swelling	92	6.8 5.6–8.3ROR 7.1 · χ² 455 / p 4e-101	6.6 EB05 5.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.0 · 93% consumer	no trial data cached
Conjunctivitis	14	6.8 4.0–11.5ROR 6.9 · χ² 64 / p 7e-16	5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 12.1	no trial data cached
Product availability issue	15	6.0 3.6–9.9ROR 6.0 · χ² 57 / p 2e-14	5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 7.1	no trial data cached
Taste disorder	13	5.8 3.4–10.0ROR 5.8 · χ² 47 / p 4e-12	4.9 EB05 3.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Blood sodium decreased	12	5.7 3.2–10.0ROR 5.7 · χ² 42 / p 5e-11	4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree	Lab value / disease marker	serious PRR 5.2	no trial data cached
Swelling	59	5.7 4.4–7.3ROR 5.8 · χ² 222 / p 2e-50	5.4 EB05 4.4 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.9 · 81% consumer	no trial data cached
Liver function test increased	13	5.5 3.2–9.4ROR 5.5 · χ² 43 / p 3e-11	4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.1	no trial data cached
Gynaecomastia (male breast enlargement)	19	5.4 3.5–8.5ROR 5.5 · χ² 64 / p 5e-16	4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 16.7	no trial data cached
Red blood cell count decreased	17	5.3 3.3–8.5ROR 5.3 · χ² 55 / p 5e-14	4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 5.9	no trial data cached
Neoplasm malignant	36	4.8 3.5–6.7ROR 4.9 · χ² 106 / p 4e-25	4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.6 · 89% consumer	no trial data cached
Death	414	4.3 3.9–4.7ROR 5.0 · χ² 1,089 / p 3e-239	4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree	Outcome field, not a reaction	serious PRR 4.1	no trial data cached
Thrombosis	38	4.2 3.1–5.8ROR 4.3 · χ² 90 / p 1e-21	4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Drug resistance	12	4.2 2.4–7.3ROR 4.2 · χ² 26 / p 2e-7	3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 4.1	no trial data cached
Hepatic function abnormal	16	3.9 2.4–6.3ROR 3.9 · χ² 31 / p 1e-8	3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.5	no trial data cached
Disease progression	47	3.6 2.7–4.7ROR 3.6 · χ² 85 / p 2e-20	3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 2.5	no trial data cached
Neoplasm progression	11	2.8 1.6–5.1ROR 2.8 · χ² 11 / p 4e-4	2.6 EB05 1.6 · IC025 +0.4	Not in label — unassessed	serious PRR 2.7	no trial data cached
Therapy interrupted	19	2.5 1.6–3.9ROR 2.5 · χ² 15 / p 5e-5	2.4 EB05 1.6 · IC025 +0.5	Reporting / coding artifact	serious PRR 4.0	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	414	4.3 3.9–4.7ROR 5.0 · χ² 1,089 / p 3e-239	4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree	Outcome field, not a reaction	serious PRR 4.1	no trial data cached
Peripheral swelling	288	16.8 15.1–18.7ROR 19.0 · χ² 4,291 / p <1e-300	16.8 EB05 15.2 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.0 · 88% consumer	no trial data cached
Oedema peripheral (swelling of legs/feet)	245	17.9 15.9–20.2ROR 19.9 · χ² 3,918 / p <1e-300	17.9 EB05 16.1 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.4	no trial data cached
Malignant neoplasm progression	180	15.8 13.8–18.2ROR 17.1 · χ² 2,493 / p <1e-300	15.8 EB05 13.9 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 15.4	no trial data cached
Oedema	134	22.2 18.8–26.2ROR 23.5 · χ² 2,690 / p <1e-300	22.1 EB05 19.1 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.7	no trial data cached
Joint swelling	92	6.8 5.6–8.3ROR 7.1 · χ² 455 / p 4e-101	6.6 EB05 5.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.0 · 93% consumer	no trial data cached
Dysphagia (difficulty swallowing)	83	7.8 6.4–9.7ROR 8.1 · χ² 491 / p 5e-109	7.6 EB05 6.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 2.8	no trial data cached
Blood creatinine increased	66	9.0 7.1–11.5ROR 9.3 · χ² 464 / p 3e-103	8.7 EB05 7.0 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.7	no trial data cached
Swelling	59	5.7 4.4–7.3ROR 5.8 · χ² 222 / p 2e-50	5.4 EB05 4.4 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.9 · 81% consumer	no trial data cached
Pleural effusion	58	8.5 6.6–11.0ROR 8.7 · χ² 378 / p 1e-84	8.2 EB05 6.5 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.0	no trial data cached
Fluid retention	52	9.2 7.0–12.0ROR 9.3 · χ² 370 / p 9e-83	8.7 EB05 6.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.5 · ♀ 35% (drug 55%) · 73% consumer	no trial data cached
Disease progression	47	3.6 2.7–4.7ROR 3.6 · χ² 85 / p 2e-20	3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 2.5	no trial data cached
Hypoacusis	44	9.2 6.8–12.3ROR 9.3 · χ² 312 / p 3e-70	8.7 EB05 6.6 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.8 · 75% consumer	no trial data cached
Lung neoplasm malignant	42	9.1 6.7–12.3ROR 9.2 · χ² 295 / p 2e-66	8.6 EB05 6.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	no trial data cached
Thrombosis	38	4.2 3.1–5.8ROR 4.3 · χ² 90 / p 1e-21	4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	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.

Metastases to central nervous system — n=24, PRR 16.8
Hepatic cytolysis — n=21, PRR 15.4
Deafness — n=36, PRR 12.3
Hypoacusis — n=44, PRR 9.2
Fluid retention — n=52, PRR 9.2
Lung neoplasm malignant — n=42, PRR 9.1
Dysphagia — n=83, PRR 7.8
Joint swelling — n=92, PRR 6.8
Neoplasm malignant — n=36, PRR 4.8
Thrombosis — n=38, PRR 4.2

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 Capmatinib?

In FDA FAERS, the most frequently co-reported reaction terms for Capmatinib are peripheral swelling, oedema peripheral, oedema, joint swelling, dysphagia, blood creatinine increased. 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 Capmatinib have an FDA boxed warning?

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

Do FAERS signals prove that Capmatinib 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 455892c3-d144-4ba8-9ab4-79cabff9876d, effective 20251215; matched on openfda.generic_name.exact:"CAPMATINIB")
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, 53 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.