Revumenib side effects: what 863 FDA adverse event reports show

Revumenib · Revuforj · 18 reaction terms · 588 drug–reaction co-reports · data 2026-09-14

Drug class

Menin inhibitor

FDA label, Indications wording

Brand names

Revuforj

openFDA label

Who reports

863 reports · 61% serious · 123 with death outcome · 51% female

openFDA FAERS counts, all years, deduplication not applied

Used for

REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older.

FDA label, Indications and Usage

What it is

REVUFORJ contains revumenib, a menin inhibitor. Revumenib is present as revumenib citrate hydrate with a chemical name of benzamide, N -ethyl-2-[[4-[7-[[trans-4- [(ethylsulfonyl)amino]cyclohex.

FDA label, Description section

Boxed warning

DIFFERENTIATION SYNDROME, QTc PROLONGATION and TORSADES DE POINTES Differentiation syndrome, which can be fatal, has occurred with REVUFORJ. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction.

FDA 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 17 strongest signals

Labeled — boxed warning 2Labeled adverse reaction 2Labeled (related wording) 2Reporting / coding artifact 2Lab value / disease marker 4Not in label — unassessed 5

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
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. 1 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
Full blood count decreased	42	49.8 37.1–67.0ROR 52.3 · χ² 1,960 / p <1e-300	48.7 EB05 37.6 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious PRR 42.6 · 90% consumer	no trial data cached
Full blood count abnormal	20	45.4 29.4–70.0ROR 46.4 · χ² 823 / p 3e-181	43.6 EB05 29.8 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious PRR 31.7 · 85% consumer	no trial data cached
Transfusion	18	40.9 25.9–64.7ROR 41.8 · χ² 661 / p 4e-146	39.3 EB05 26.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 41.1	no trial data cached
Platelet count decreased	139	31.2 26.8–36.4ROR 36.9 · χ² 4,049 / p <1e-300	31.0 EB05 27.0 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious PRR 26.1 · 94% consumer	no trial data cached
Hospice care	12	29.1 16.6–51.1ROR 29.5 · χ² 298 / p 4e-67	27.9 EB05 16.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 20.2	no trial data cached
Taste disorder	24	28.6 19.3–42.5ROR 29.4 · χ² 613 / p 2e-135	28.0 EB05 19.8 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 36.7 · 100% consumer	no trial data cached
Electrocardiogram qt prolonged	42	27.9 20.8–37.5ROR 29.3 · χ² 1,063 / p 2e-233	27.6 EB05 21.2 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 27.1	no trial data cached
Laboratory test abnormal	30	24.3 17.1–34.6ROR 25.2 · χ² 648 / p 3e-143	24.0 EB05 17.6 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 36.8 · 93% consumer	no trial data cached
Cytopenia	12	24.0 13.7–42.1ROR 24.3 · χ² 242 / p 7e-55	23.1 EB05 13.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 23.7	no trial data cached
Neutrophil count decreased	37	21.8 15.9–29.9ROR 22.7 · χ² 715 / p 6e-158	21.6 EB05 16.3 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 15.8 · 89% consumer	no trial data cached
Leukaemia	7	17.7 8.5–37.1ROR 17.9 · χ² 94 / p 1e-22	15.2 EB05 6.2 · IC025 +1.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 17.1	no trial data cached
Red blood cell count decreased	17	14.2 8.9–22.7ROR 14.4 · χ² 196 / p 1e-44	13.4 EB05 8.3 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 12.6	no trial data cached
White blood cell count decreased	64	14.1 11.1–17.8ROR 15.1 · χ² 769 / p 1e-169	14.0 EB05 11.2 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.0 · 98% consumer	no trial data cached
Sluggishness	5	11.8 4.9–28.2ROR 11.8 · χ² 39 / p 2e-10	7.6 EB05 3.0 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Acute myeloid leukaemia	7	10.7 5.1–22.5ROR 10.8 · χ² 52 / p 2e-13	7.8 EB05 3.6 · IC025 +1.4 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 10.3	no trial data cached
Product dose omission issue	103	8.6 7.2–10.4ROR 9.7 · χ² 698 / p 5e-154	8.4 EB05 7.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 17.9 · 96% consumer	no trial data cached
Myelosuppression	6	4.2 1.9–9.4ROR 4.2 · χ² 12 / p 3e-4	3.3 EB05 1.7 · IC025 +0.3	Not in label — unassessed	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
Platelet count decreased	139	31.2 26.8–36.4ROR 36.9 · χ² 4,049 / p <1e-300	31.0 EB05 27.0 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious PRR 26.1 · 94% consumer	no trial data cached
Product dose omission issue	103	8.6 7.2–10.4ROR 9.7 · χ² 698 / p 5e-154	8.4 EB05 7.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 17.9 · 96% consumer	no trial data cached
White blood cell count decreased	64	14.1 11.1–17.8ROR 15.1 · χ² 769 / p 1e-169	14.0 EB05 11.2 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.0 · 98% consumer	no trial data cached
Electrocardiogram qt prolonged	42	27.9 20.8–37.5ROR 29.3 · χ² 1,063 / p 2e-233	27.6 EB05 21.2 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 27.1	no trial data cached
Full blood count decreased	42	49.8 37.1–67.0ROR 52.3 · χ² 1,960 / p <1e-300	48.7 EB05 37.6 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious PRR 42.6 · 90% consumer	no trial data cached
Neutrophil count decreased	37	21.8 15.9–29.9ROR 22.7 · χ² 715 / p 6e-158	21.6 EB05 16.3 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 15.8 · 89% consumer	no trial data cached
Laboratory test abnormal	30	24.3 17.1–34.6ROR 25.2 · χ² 648 / p 3e-143	24.0 EB05 17.6 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 36.8 · 93% consumer	no trial data cached
Taste disorder	24	28.6 19.3–42.5ROR 29.4 · χ² 613 / p 2e-135	28.0 EB05 19.8 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 36.7 · 100% consumer	no trial data cached
Full blood count abnormal	20	45.4 29.4–70.0ROR 46.4 · χ² 823 / p 3e-181	43.6 EB05 29.8 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious PRR 31.7 · 85% consumer	no trial data cached
Transfusion	18	40.9 25.9–64.7ROR 41.8 · χ² 661 / p 4e-146	39.3 EB05 26.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 41.1	no trial data cached
Red blood cell count decreased	17	14.2 8.9–22.7ROR 14.4 · χ² 196 / p 1e-44	13.4 EB05 8.3 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 12.6	no trial data cached
Cytopenia	12	24.0 13.7–42.1ROR 24.3 · χ² 242 / p 7e-55	23.1 EB05 13.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 23.7	no trial data cached
Hospice care	12	29.1 16.6–51.1ROR 29.5 · χ² 298 / p 4e-67	27.9 EB05 16.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 20.2	no trial data cached
Acute myeloid leukaemia	7	10.7 5.1–22.5ROR 10.8 · χ² 52 / p 2e-13	7.8 EB05 3.6 · IC025 +1.4 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 10.3	no trial data cached
Leukaemia	7	17.7 8.5–37.1ROR 17.9 · χ² 94 / p 1e-22	15.2 EB05 6.2 · IC025 +1.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 17.1	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 Revumenib?

In FDA FAERS, the most frequently co-reported reaction terms for Revumenib are platelet count decreased, white blood cell count decreased, electrocardiogram qt prolonged, full blood count decreased, neutrophil count decreased, taste disorder. 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 Revumenib have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: DIFFERENTIATION SYNDROME, QTc PROLONGATION and TORSADES DE POINTES Differentiation syndrome, which can be fatal, has occurred with REVUFORJ. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction.

Do FAERS signals prove that Revumenib 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 6eb3cdbc-0e74-477d-82d6-3bb172d3f63f, effective 20260204; matched on openfda.generic_name.exact:"REVUMENIB")
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, 18 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.