Dexrazoxane side effects: what 926 FDA adverse event reports show

Dexrazoxane · 32 reaction terms · 621 drug–reaction co-reports · data 2026-09-14

Drug class

Cytoprotective agent

FDA label, Indications wording

Who reports

926 reports · 97% serious · 115 with death outcome · 57% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy .

FDA label, Indications and Usage

What it is

Dexrazoxane for Injection, a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration.

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 19 strongest signals

Labeled adverse reaction 2Labeled (related wording) 1Likely indication confounding 1Lab value / disease marker 3Not in label — unassessed 12

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.
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.
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. 13 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
Febrile neutropenia	141	48.3 41.5–56.3ROR 56.8 · χ² 6,493 / p <1e-300	47.9 EB05 41.6 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 28.8 · 96% clinician	no trial data cached
Clostridium difficile colitis	16	34.2 21.0–55.6ROR 34.8 · χ² 482 / p 4e-107	32.9 EB05 21.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Bacteraemia	17	32.8 20.4–52.5ROR 33.3 · χ² 492 / p 3e-109	31.7 EB05 20.9 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 19.7	no trial data cached
Myelosuppression	43	28.7 21.4–38.4ROR 30.0 · χ² 1,121 / p 6e-246	28.3 EB05 21.9 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.1	no trial data cached
Lymphocyte count decreased	20	25.6 16.6–39.6ROR 26.2 · χ² 449 / p 6e-100	25.1 EB05 17.1 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 17.7 · 95% clinician	no trial data cached
Acute myeloid leukaemia	16	23.3 14.3–37.9ROR 23.7 · χ² 319 / p 1e-71	22.7 EB05 14.7 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.1	no trial data cached
Nephropathy toxic	11	22.4 12.4–40.3ROR 22.6 · χ² 204 / p 2e-46	21.4 EB05 12.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.6	no trial data cached
Malnutrition	10	20.4 11.0–37.8ROR 20.6 · χ² 166 / p 4e-38	19.2 EB05 10.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 12.6	no trial data cached
Ejection fraction decreased	14	20.4 12.1–34.3ROR 20.7 · χ² 239 / p 3e-54	19.7 EB05 12.1 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious PRR 12.4	no trial data cached
Neutrophil count decreased	35	19.6 14.1–27.1ROR 20.3 · χ² 599 / p 1e-132	19.4 EB05 14.5 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious PRR 13.2 · 100% clinician	no trial data cached
Lymphopenia	12	19.3 11.0–33.9ROR 19.6 · χ² 191 / p 1e-43	18.4 EB05 10.6 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 12.4	no trial data cached
Hypocalcaemia (low calcium)	16	19.2 11.8–31.2ROR 19.5 · χ² 258 / p 2e-58	18.6 EB05 11.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.1	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	104	17.4 14.5–20.8ROR 19.5 · χ² 1,600 / p <1e-300	17.3 EB05 14.7 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.8 · 97% clinician	no trial data cached
Mucosal inflammation	18	15.6 9.9–24.7ROR 15.9 · χ² 233 / p 8e-53	15.0 EB05 9.6 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.9	no trial data cached
Multiple organ dysfunction syndrome	19	15.4 9.9–24.1ROR 15.7 · χ² 242 / p 6e-55	14.8 EB05 9.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Cardiomyopathy	10	15.3 8.3–28.4ROR 15.5 · χ² 120 / p 3e-28	13.7 EB05 6.8 · IC025 +2.1 3/3 methods agree	Likely indication confounding term in indications	serious PRR 9.2	no trial data cached
Bacterial infection	12	14.6 8.3–25.7ROR 14.8 · χ² 139 / p 2e-32	13.3 EB05 7.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.1	no trial data cached
Bone marrow failure	13	14.4 8.4–24.7ROR 14.6 · χ² 149 / p 1e-34	13.2 EB05 7.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.6	no trial data cached
Hepatic function abnormal	23	14.1 9.4–21.1ROR 14.4 · χ² 266 / p 3e-60	13.5 EB05 9.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.0 · 96% 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
Febrile neutropenia	141	48.3 41.5–56.3ROR 56.8 · χ² 6,493 / p <1e-300	47.9 EB05 41.6 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 28.8 · 96% clinician	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	104	17.4 14.5–20.8ROR 19.5 · χ² 1,600 / p <1e-300	17.3 EB05 14.7 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.8 · 97% clinician	no trial data cached
Myelosuppression	43	28.7 21.4–38.4ROR 30.0 · χ² 1,121 / p 6e-246	28.3 EB05 21.9 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.1	no trial data cached
Neutrophil count decreased	35	19.6 14.1–27.1ROR 20.3 · χ² 599 / p 1e-132	19.4 EB05 14.5 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious PRR 13.2 · 100% clinician	no trial data cached
Hepatic function abnormal	23	14.1 9.4–21.1ROR 14.4 · χ² 266 / p 3e-60	13.5 EB05 9.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.0 · 96% clinician	no trial data cached
Lymphocyte count decreased	20	25.6 16.6–39.6ROR 26.2 · χ² 449 / p 6e-100	25.1 EB05 17.1 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 17.7 · 95% clinician	no trial data cached
Multiple organ dysfunction syndrome	19	15.4 9.9–24.1ROR 15.7 · χ² 242 / p 6e-55	14.8 EB05 9.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Mucosal inflammation	18	15.6 9.9–24.7ROR 15.9 · χ² 233 / p 8e-53	15.0 EB05 9.6 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.9	no trial data cached
Bacteraemia	17	32.8 20.4–52.5ROR 33.3 · χ² 492 / p 3e-109	31.7 EB05 20.9 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 19.7	no trial data cached
Hypocalcaemia (low calcium)	16	19.2 11.8–31.2ROR 19.5 · χ² 258 / p 2e-58	18.6 EB05 11.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.1	no trial data cached
Acute myeloid leukaemia	16	23.3 14.3–37.9ROR 23.7 · χ² 319 / p 1e-71	22.7 EB05 14.7 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.1	no trial data cached
Clostridium difficile colitis	16	34.2 21.0–55.6ROR 34.8 · χ² 482 / p 4e-107	32.9 EB05 21.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Ejection fraction decreased	14	20.4 12.1–34.3ROR 20.7 · χ² 239 / p 3e-54	19.7 EB05 12.1 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious PRR 12.4	no trial data cached
Bone marrow failure	13	14.4 8.4–24.7ROR 14.6 · χ² 149 / p 1e-34	13.2 EB05 7.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.6	no trial data cached
Bacterial infection	12	14.6 8.3–25.7ROR 14.8 · χ² 139 / p 2e-32	13.3 EB05 7.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.1	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=141, PRR 48.3
Neutropenia — n=104, PRR 17.4
Hepatic function abnormal — n=23, PRR 14.1

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 Dexrazoxane?

In FDA FAERS, the most frequently co-reported reaction terms for Dexrazoxane are febrile neutropenia, neutropenia, myelosuppression, neutrophil count decreased, hepatic function abnormal, lymphocyte 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 Dexrazoxane have an FDA boxed warning?

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

Do FAERS signals prove that Dexrazoxane 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 68089182-d4a2-4053-8d0d-fc97a901515d, effective 20250122; matched on openfda.generic_name.exact:"DEXRAZOXANE")
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, 32 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.