Drug · FAERS side-effect profile with label screen

Avutometinib and Defactinib side effects: what 794 FDA adverse event reports show

Avutometinib Potassium And Defactinib Hydrochloride · 12 reaction terms · 194 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Avutometinib Potassium And Defactinib Hydrochloride (Avmapki Fakzynja Co-Pack)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

794 reports · 16% serious · 26 with death outcome

openFDA FAERS counts, all years, deduplication not applied

Used for

AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response .

FDA label, Indications and Usage

What it is

AVMAPKI FAKZYNJA CO-PACK contains AVMAPKI (avutometinib) capsules co-packaged with FAKZYNJA (defactinib) tablets. AVMAPKI capsules contain avutometinib, 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 12 strongest signals

Labeled adverse reaction 5Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 3

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.
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. 0 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
Vitreous floaters	8	21.7 10.9–43.3ROR 21.9 · χ² 138 / p 4e-32	19.9 EB05 9.6 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=2	no trial data cached
Product dose omission in error	17	16.7 10.4–26.8ROR 17.1 · χ² 236 / p 1e-53	16.1 EB05 10.2 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 13.9	no trial data cached
Skin fissures	11	15.4 8.6–27.7ROR 15.6 · χ² 134 / p 3e-31	14.0 EB05 7.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Blood creatine phosphokinase increased	17	15.4 9.6–24.6ROR 15.7 · χ² 214 / p 8e-49	14.7 EB05 9.1 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 10.8	no trial data cached
Acne	43	14.9 11.2–19.9ROR 15.7 · χ² 546 / p 5e-121	14.7 EB05 11.3 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 36.5 · 91% consumer	no trial data cached
Blood bilirubin increased	15	14.6 8.9–24.2ROR 14.9 · χ² 177 / p 1e-40	13.7 EB05 8.1 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 16.0	no trial data cached
Retinal detachment	5	14.4 6.0–34.4ROR 14.4 · χ² 50 / p 1e-12	9.9 EB05 3.5 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Dry eye	21	11.5 7.5–17.5ROR 11.7 · χ² 190 / p 1e-43	10.6 EB05 6.9 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.6 · 90% consumer	no trial data cached
Accidental underdose	6	10.9 4.9–24.2ROR 11.0 · χ² 44 / p 1e-11	7.5 EB05 3.3 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Laboratory test abnormal	10	9.0 4.8–16.6ROR 9.1 · χ² 63 / p 1e-15	7.0 EB05 3.9 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 7.6	no trial data cached
Insurance issue	5	8.9 3.7–21.3ROR 8.9 · χ² 28 / p 8e-8	5.7 EB05 2.5 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
Dry skin	36	7.2 5.3–9.9ROR 7.5 · χ² 188 / p 4e-43	6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.2 · 94% consumer	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
Acne	43	14.9 11.2–19.9ROR 15.7 · χ² 546 / p 5e-121	14.7 EB05 11.3 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 36.5 · 91% consumer	no trial data cached
Dry skin	36	7.2 5.3–9.9ROR 7.5 · χ² 188 / p 4e-43	6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.2 · 94% consumer	no trial data cached
Dry eye	21	11.5 7.5–17.5ROR 11.7 · χ² 190 / p 1e-43	10.6 EB05 6.9 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.6 · 90% consumer	no trial data cached
Blood creatine phosphokinase increased	17	15.4 9.6–24.6ROR 15.7 · χ² 214 / p 8e-49	14.7 EB05 9.1 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 10.8	no trial data cached
Product dose omission in error	17	16.7 10.4–26.8ROR 17.1 · χ² 236 / p 1e-53	16.1 EB05 10.2 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 13.9	no trial data cached
Blood bilirubin increased	15	14.6 8.9–24.2ROR 14.9 · χ² 177 / p 1e-40	13.7 EB05 8.1 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 16.0	no trial data cached
Skin fissures	11	15.4 8.6–27.7ROR 15.6 · χ² 134 / p 3e-31	14.0 EB05 7.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Laboratory test abnormal	10	9.0 4.8–16.6ROR 9.1 · χ² 63 / p 1e-15	7.0 EB05 3.9 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 7.6	no trial data cached
Vitreous floaters	8	21.7 10.9–43.3ROR 21.9 · χ² 138 / p 4e-32	19.9 EB05 9.6 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=2	no trial data cached
Accidental underdose	6	10.9 4.9–24.2ROR 11.0 · χ² 44 / p 1e-11	7.5 EB05 3.3 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Insurance issue	5	8.9 3.7–21.3ROR 8.9 · χ² 28 / p 8e-8	5.7 EB05 2.5 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
Retinal detachment	5	14.4 6.0–34.4ROR 14.4 · χ² 50 / p 1e-12	9.9 EB05 3.5 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Avutometinib and Defactinib?

In FDA FAERS, the most frequently co-reported reaction terms for Avutometinib and Defactinib are acne, dry skin, dry eye, blood creatine phosphokinase increased, blood bilirubin increased, skin fissures. 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 Avutometinib and Defactinib have an FDA boxed warning?

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

Do FAERS signals prove that Avutometinib and Defactinib 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 65889527-1406-45df-8a85-e2690dcf427d, effective 20250501; matched on openfda.generic_name.exact:"AVUTOMETINIB POTASSIUM AND DEFACTINIB HYDROCHLORIDE")
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, 12 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.