Vorasidenib side effects: what 337 FDA adverse event reports show

Vorasidenib · 9 reaction terms · 302 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

337 reports · 94% serious · 7 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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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 9 strongest signals

Reporting / coding artifact 1Lab value / disease marker 3No label text to screen 5

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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
Hepatic cytolysis	34	110.4 79.7–152.9ROR 117.9 · χ² 3,569 / p <1e-300	103.8 EB05 77.7 · IC025 +4.8 3/3 methods agree	No label text to screen	–	no trial data cached
Gamma-glutamyltransferase increased	28	50.0 34.9–71.7ROR 52.7 · χ² 1,296 / p 5e-284	48.4 EB05 35.1 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Alanine aminotransferase increased	76	49.0 39.8–60.4ROR 57.0 · χ² 3,532 / p <1e-300	48.4 EB05 39.9 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Aspartate aminotransferase increased	61	45.5 35.9–57.6ROR 51.3 · χ² 2,614 / p <1e-300	44.9 EB05 36.2 · IC025 +4.6 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Liver function test increased	18	33.4 21.2–52.6ROR 34.6 · χ² 534 / p 2e-118	32.4 EB05 21.7 · IC025 +3.4 3/3 methods agree	No label text to screen	–	no trial data cached
Hepatotoxicity (liver damage)	18	32.2 20.4–50.6ROR 33.2 · χ² 513 / p 8e-114	31.2 EB05 20.9 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Brain oedema	9	28.2 14.8–53.9ROR 28.7 · χ² 210 / p 8e-48	26.6 EB05 14.6 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Drug-induced liver injury	17	21.8 13.7–34.8ROR 22.5 · χ² 317 / p 3e-71	21.3 EB05 13.9 · IC025 +3.0 3/3 methods agree	No label text to screen	–	no trial data cached
Malignant neoplasm progression	41	15.9 11.9–21.4ROR 17.2 · χ² 561 / p 2e-124	15.7 EB05 12.0 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	–	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
Alanine aminotransferase increased	76	49.0 39.8–60.4ROR 57.0 · χ² 3,532 / p <1e-300	48.4 EB05 39.9 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Aspartate aminotransferase increased	61	45.5 35.9–57.6ROR 51.3 · χ² 2,614 / p <1e-300	44.9 EB05 36.2 · IC025 +4.6 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Malignant neoplasm progression	41	15.9 11.9–21.4ROR 17.2 · χ² 561 / p 2e-124	15.7 EB05 12.0 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Hepatic cytolysis	34	110.4 79.7–152.9ROR 117.9 · χ² 3,569 / p <1e-300	103.8 EB05 77.7 · IC025 +4.8 3/3 methods agree	No label text to screen	–	no trial data cached
Gamma-glutamyltransferase increased	28	50.0 34.9–71.7ROR 52.7 · χ² 1,296 / p 5e-284	48.4 EB05 35.1 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Hepatotoxicity (liver damage)	18	32.2 20.4–50.6ROR 33.2 · χ² 513 / p 8e-114	31.2 EB05 20.9 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Liver function test increased	18	33.4 21.2–52.6ROR 34.6 · χ² 534 / p 2e-118	32.4 EB05 21.7 · IC025 +3.4 3/3 methods agree	No label text to screen	–	no trial data cached
Drug-induced liver injury	17	21.8 13.7–34.8ROR 22.5 · χ² 317 / p 3e-71	21.3 EB05 13.9 · IC025 +3.0 3/3 methods agree	No label text to screen	–	no trial data cached
Brain oedema	9	28.2 14.8–53.9ROR 28.7 · χ² 210 / p 8e-48	26.6 EB05 14.6 · IC025 +2.4 3/3 methods agree	No label text to screen	–	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 Vorasidenib?

In FDA FAERS, the most frequently co-reported reaction terms for Vorasidenib are alanine aminotransferase increased, aspartate aminotransferase increased, hepatic cytolysis, gamma-glutamyltransferase increased, hepatotoxicity, liver function test 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 Vorasidenib have an FDA boxed warning?

No validated FDA label could be retrieved for this product name, so this page cannot say.

Do FAERS signals prove that Vorasidenib 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

No FDA label passed the name-validation check for this product string, so label-based screening was skipped
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, 9 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.