Belinostat side effects: what 347 FDA adverse event reports show

Belinostat · Beleodaq · 7 reaction terms · 155 drug–reaction co-reports · data 2026-09-14

Drug class

Histone Deacetylase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Beleodaq

openFDA label

Who reports

347 reports · 89% serious · 116 with death outcome · 40% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has not been established.

FDA label, Indications and Usage

What it is

Beleodaq is a histone deacetylase inhibitor with a sulfonamide-hydroxamide structure.

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 7 strongest signals

Labeled (related wording) 1Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 3

What the badges mean

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. 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
Hypomagnesaemia	13	56.7 33.2–96.6ROR 58.8 · χ² 656 / p 5e-145	52.5 EB05 32.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 37.8	no trial data cached
Sinus tachycardia	11	46.9 26.2–84.0ROR 48.4 · χ² 450 / p 4e-100	43.6 EB05 26.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 31.1	no trial data cached
Lymphocyte count decreased	13	44.4 26.1–75.8ROR 46.1 · χ² 510 / p 4e-113	41.9 EB05 26.1 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 35.3	no trial data cached
Hypocalcaemia (low calcium)	13	41.6 24.4–71.0ROR 43.2 · χ² 476 / p 8e-106	39.4 EB05 24.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 28.7	no trial data cached
Disease progression	73	37.4 30.5–45.9ROR 47.1 · χ² 2,565 / p <1e-300	37.1 EB05 30.5 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 26.2 · 93% clinician	no trial data cached
Neutrophil count decreased	23	34.3 23.1–51.0ROR 36.7 · χ² 712 / p 3e-157	33.5 EB05 23.5 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.9 · 96% clinician	no trial data cached
Blood lactate dehydrogenase increased	9	34.1 17.9–65.0ROR 35.0 · χ² 257 / p 3e-58	31.9 EB05 17.9 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 23.6	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
Disease progression	73	37.4 30.5–45.9ROR 47.1 · χ² 2,565 / p <1e-300	37.1 EB05 30.5 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 26.2 · 93% clinician	no trial data cached
Neutrophil count decreased	23	34.3 23.1–51.0ROR 36.7 · χ² 712 / p 3e-157	33.5 EB05 23.5 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.9 · 96% clinician	no trial data cached
Hypocalcaemia (low calcium)	13	41.6 24.4–71.0ROR 43.2 · χ² 476 / p 8e-106	39.4 EB05 24.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 28.7	no trial data cached
Lymphocyte count decreased	13	44.4 26.1–75.8ROR 46.1 · χ² 510 / p 4e-113	41.9 EB05 26.1 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 35.3	no trial data cached
Hypomagnesaemia	13	56.7 33.2–96.6ROR 58.8 · χ² 656 / p 5e-145	52.5 EB05 32.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 37.8	no trial data cached
Sinus tachycardia	11	46.9 26.2–84.0ROR 48.4 · χ² 450 / p 4e-100	43.6 EB05 26.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 31.1	no trial data cached
Blood lactate dehydrogenase increased	9	34.1 17.9–65.0ROR 35.0 · χ² 257 / p 3e-58	31.9 EB05 17.9 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 23.6	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 Belinostat?

In FDA FAERS, the most frequently co-reported reaction terms for Belinostat are neutrophil count decreased, hypocalcaemia, lymphocyte count decreased, hypomagnesaemia, sinus tachycardia, blood lactate dehydrogenase 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 Belinostat have an FDA boxed warning?

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

Do FAERS signals prove that Belinostat 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 2e8ef36b-71fa-4492-a16f-577d5f7d111d, effective 20250407; matched on openfda.generic_name.exact:"BELINOSTAT")
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, 7 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.