Drug · FAERS side-effect profile with label screen

Idarubicin side effects: what 1,119 FDA adverse event reports show

Idarubicin Hydrochloride · 43 reaction terms · 1,006 drug–reaction co-reports · data 2026-09-14

Drug class

Anthracycline topoisomerase inhibitor

FDA label, Indications wording of the closest related product

Label matched

Idarubicin Hydrochloride (Idamycin Pfs)

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

Who reports

1,119 reports · 99% serious · 249 with death outcome · 45% female

openFDA FAERS counts, all years, deduplication not applied

Used for

IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. IDAMYCIN PFS is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. (1)

FDA label, Indications and Usage

What it is

IDAMYCIN PFS contains idarubicin hydrochloride, which is an anthracycline topoisomerase inhibitor.

FDA label, Description section

Boxed warning

CARDIOMYOPATHY, SECONDARY MALIGNANCIES, and EXTRAVASATION AND TISSUE NECROSIS • Cardiomyopathy: IDAMYCIN PFS can cause myocardial damage, including acute left ventricular failure, during or after termination of therapy. The risk of cardiomyopathy is increased in patients who have received prior anthracyclines or who have pre-existing cardiac disease.

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 26 strongest signals

Labeled — boxed warning 4Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 14

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 (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.
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. 17 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
Myelosuppression	180	99.7 87.1–114.0ROR 118.6 · χ² 17,419 / p <1e-300	98.1 EB05 86.7 · IC025 +6.0 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 57.9	no trial data cached
Acute myeloid leukaemia	38	45.8 33.5–62.7ROR 47.4 · χ² 1,619 / p <1e-300	44.8 EB05 34.1 · IC025 +4.3 3/3 methods agree	Likely indication confounding term in indications	serious PRR 26.8	no trial data cached
Febrile neutropenia	147	41.7 35.8–48.5ROR 47.8 · χ² 5,802 / p <1e-300	41.4 EB05 36.1 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 24.2 · 92% clinician	no trial data cached
Myelodysplastic syndrome	26	33.7 23.1–49.3ROR 34.5 · χ² 792 / p 1e-174	32.9 EB05 23.6 · IC025 +3.7 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 19.8 · 100% clinician	no trial data cached
Hyperbilirubinaemia	15	27.3 16.5–45.2ROR 27.7 · χ² 354 / p 3e-79	26.4 EB05 17.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.2	no trial data cached
Agranulocytosis (severe loss of white cells)	25	25.4 17.2–37.4ROR 25.9 · χ² 561 / p 3e-124	24.9 EB05 17.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 14.8	no trial data cached
Neutrophil count decreased	45	20.8 15.6–27.7ROR 21.7 · χ² 831 / p 6e-183	20.7 EB05 16.1 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious PRR 13.8	no trial data cached
Bone marrow failure	20	18.3 11.9–28.3ROR 18.6 · χ² 311 / p 8e-70	17.9 EB05 12.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Cardiomyopathy	13	16.5 9.6–28.3ROR 16.7 · χ² 174 / p 6e-40	15.5 EB05 8.9 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 9.7	no trial data cached
Multiple organ dysfunction syndrome	24	16.1 10.9–24.0ROR 16.5 · χ² 326 / p 4e-73	15.7 EB05 10.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.4 · 100% clinician	no trial data cached
Fungal infection	24	13.5 9.1–20.1ROR 13.8 · χ² 266 / p 4e-60	13.0 EB05 8.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.4 · ♀ 23% (drug 45%) · 91% clinician	no trial data cached
Neurotoxicity	12	12.9 7.4–22.7ROR 13.1 · χ² 121 / p 2e-28	11.4 EB05 6.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Haemorrhage intracranial	10	12.5 6.7–23.2ROR 12.6 · χ² 95 / p 1e-22	10.5 EB05 5.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.3	no trial data cached
Neoplasm progression	22	11.7 7.8–17.8ROR 12.0 · χ² 206 / p 5e-47	10.9 EB05 7.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Mucosal inflammation	16	11.5 7.1–18.7ROR 11.7 · χ² 143 / p 3e-33	10.3 EB05 6.2 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.1	no trial data cached
Pancytopenia (all blood cells low)	34	11.4 8.2–15.9ROR 11.8 · χ² 314 / p 1e-70	10.9 EB05 8.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Septic shock	26	11.3 7.7–16.5ROR 11.5 · χ² 234 / p 5e-53	10.6 EB05 7.3 · IC025 +2.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 6.6 · 100% clinician	no trial data cached
Drug eruption	10	10.6 5.7–19.7ROR 10.7 · χ² 78 / p 5e-19	8.5 EB05 4.5 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.1	no trial data cached
Hepatic function abnormal	20	10.1 6.6–15.6ROR 10.3 · χ² 155 / p 5e-36	9.1 EB05 5.9 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.0	no trial data cached
White blood cell count decreased	58	10.0 7.8–12.9ROR 10.5 · χ² 464 / p 3e-103	9.7 EB05 7.7 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 8.3	no trial data cached
Hepatotoxicity (liver damage)	11	9.3 5.2–16.8ROR 9.4 · χ² 73 / p 5e-18	7.5 EB05 4.2 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Full blood count decreased	10	9.3 5.0–17.2ROR 9.4 · χ² 66 / p 2e-16	7.3 EB05 4.0 · IC025 +1.7 3/3 methods agree	Lab value / disease marker	serious PRR 7.8	no trial data cached
Platelet count decreased	50	8.8 6.7–11.5ROR 9.2 · χ² 339 / p 4e-76	8.4 EB05 6.5 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 6.2	no trial data cached
Rash maculo-papular	10	8.5 4.6–15.7ROR 8.5 · χ² 59 / p 1e-14	6.6 EB05 3.7 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Drug resistance	11	8.0 4.5–14.5ROR 8.1 · χ² 61 / p 3e-15	6.4 EB05 3.7 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 5.3	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	51	7.1 5.4–9.2ROR 7.3 · χ² 261 / p 6e-59	6.7 EB05 5.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 4.3 · 100% clinician	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
Myelosuppression	180	99.7 87.1–114.0ROR 118.6 · χ² 17,419 / p <1e-300	98.1 EB05 86.7 · IC025 +6.0 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 57.9	no trial data cached
Febrile neutropenia	147	41.7 35.8–48.5ROR 47.8 · χ² 5,802 / p <1e-300	41.4 EB05 36.1 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 24.2 · 92% clinician	no trial data cached
White blood cell count decreased	58	10.0 7.8–12.9ROR 10.5 · χ² 464 / p 3e-103	9.7 EB05 7.7 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 8.3	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	51	7.1 5.4–9.2ROR 7.3 · χ² 261 / p 6e-59	6.7 EB05 5.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 4.3 · 100% clinician	no trial data cached
Platelet count decreased	50	8.8 6.7–11.5ROR 9.2 · χ² 339 / p 4e-76	8.4 EB05 6.5 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 6.2	no trial data cached
Neutrophil count decreased	45	20.8 15.6–27.7ROR 21.7 · χ² 831 / p 6e-183	20.7 EB05 16.1 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious PRR 13.8	no trial data cached
Acute myeloid leukaemia	38	45.8 33.5–62.7ROR 47.4 · χ² 1,619 / p <1e-300	44.8 EB05 34.1 · IC025 +4.3 3/3 methods agree	Likely indication confounding term in indications	serious PRR 26.8	no trial data cached
Pancytopenia (all blood cells low)	34	11.4 8.2–15.9ROR 11.8 · χ² 314 / p 1e-70	10.9 EB05 8.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Septic shock	26	11.3 7.7–16.5ROR 11.5 · χ² 234 / p 5e-53	10.6 EB05 7.3 · IC025 +2.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 6.6 · 100% clinician	no trial data cached
Myelodysplastic syndrome	26	33.7 23.1–49.3ROR 34.5 · χ² 792 / p 1e-174	32.9 EB05 23.6 · IC025 +3.7 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 19.8 · 100% clinician	no trial data cached
Agranulocytosis (severe loss of white cells)	25	25.4 17.2–37.4ROR 25.9 · χ² 561 / p 3e-124	24.9 EB05 17.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 14.8	no trial data cached
Fungal infection	24	13.5 9.1–20.1ROR 13.8 · χ² 266 / p 4e-60	13.0 EB05 8.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.4 · ♀ 23% (drug 45%) · 91% clinician	no trial data cached
Multiple organ dysfunction syndrome	24	16.1 10.9–24.0ROR 16.5 · χ² 326 / p 4e-73	15.7 EB05 10.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.4 · 100% clinician	no trial data cached
Neoplasm progression	22	11.7 7.8–17.8ROR 12.0 · χ² 206 / p 5e-47	10.9 EB05 7.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Hepatic function abnormal	20	10.1 6.6–15.6ROR 10.3 · χ² 155 / p 5e-36	9.1 EB05 5.9 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.0	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.

Febrile neutropenia — n=147, PRR 41.7
Agranulocytosis — n=25, PRR 25.4
Bone marrow failure — n=20, PRR 18.3
Multiple organ dysfunction syndrome — n=24, PRR 16.1
Fungal infection — n=24, PRR 13.5
Neoplasm progression — n=22, PRR 11.7
Pancytopenia — n=34, PRR 11.4
Neutropenia — n=51, PRR 7.1

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 Idarubicin?

In FDA FAERS, the most frequently co-reported reaction terms for Idarubicin are myelosuppression, febrile neutropenia, white blood cell count decreased, neutropenia, platelet count decreased, neutrophil count decreased. 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 Idarubicin have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, and EXTRAVASATION AND TISSUE NECROSIS • Cardiomyopathy: IDAMYCIN PFS can cause myocardial damage, including acute left ventricular failure, during or after termination of therapy. The risk of cardiomyopathy is increased in patients who have received prior anthracyclines or who have pre-existing cardiac disease.

Do FAERS signals prove that Idarubicin 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 0a5a6d93-cc1e-4d7f-8da1-446c134503b3, effective 20260415; matched on openfda.generic_name.exact:"IDARUBICIN 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, 43 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.