Epirubicin side effects: what 6,333 FDA adverse event reports show
Drug class
Anthracycline topoisomerase inhibitor
Label matched
Epirubicin Hydrochloride (Ellence)
Who reports
6,333 reports · 97% serious · 474 with death outcome · 86% female
Used for
ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer . ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer ( 1 ).
What it is
ELLENCE (epirubicin hydrochloride injection) is an anthracycline topoisomerase inhibitor for intravenous administration. ELLENCE is supplied as a sterile, clear, red solution and is available in polypropylene vials containing 50 and 200 mg of epirubicin hydrochloride as a preservative-free, ready-to-use solution.
Boxed warning
CARDIAC TOXICITY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION • Cardiac Toxicity: Myocardial damage, including acute left ventricular failure, can occur with ELLENCE. The ri.
Causality screen of the 40 strongest signals
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.
- 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. 152 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Myelosuppression | 695 | 69.0 64.3–74.1ROR 77.4 · χ² 45,650 / p <1e-300 | 67.5 EB05 63.4 · IC025 +5.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 40.2 · 95% clinician | no trial data cached |
| Madarosis | 102 | 29.1 24.0–35.3ROR 29.6 · χ² 2,716 / p <1e-300 | 28.7 EB05 24.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Hair colour changes | 108 | 28.7 23.8–34.6ROR 29.1 · χ² 2,833 / p <1e-300 | 28.3 EB05 24.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Hair texture abnormal | 109 | 27.0 22.4–32.5ROR 27.4 · χ² 2,678 / p <1e-300 | 26.6 EB05 22.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Hepatic function abnormal | 263 | 23.7 21.0–26.6ROR 24.6 · χ² 5,653 / p <1e-300 | 23.5 EB05 21.2 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.0 · 93% clinician | no trial data cached |
| Neutrophil count decreased | 263 | 21.6 19.2–24.4ROR 22.5 · χ² 5,130 / p <1e-300 | 21.5 EB05 19.4 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.3 · 94% clinician | no trial data cached |
| Febrile neutropenia | 367 | 18.4 16.7–20.4ROR 19.5 · χ² 6,024 / p <1e-300 | 18.3 EB05 16.8 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.0 · 95% clinician | no trial data cached |
| Bone marrow failure | 102 | 16.6 13.7–20.1ROR 16.8 · χ² 1,472 / p <1e-300 | 16.4 EB05 13.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · ♀ 58% (drug 86%) · 98% clinician | no trial data cached |
| Impaired quality of life | 68 | 15.7 12.4–19.9ROR 15.9 · χ² 919 / p 4e-202 | 15.5 EB05 12.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · 100% consumer | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 84 | 15.1 12.2–18.7ROR 15.3 · χ² 1,089 / p 5e-239 | 15.0 EB05 12.4 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 · 94% clinician | no trial data cached |
| White blood cell count decreased | 482 | 14.8 13.6–16.1ROR 15.9 · χ² 6,178 / p <1e-300 | 14.7 EB05 13.6 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.3 · 95% clinician | no trial data cached |
| Breast cancer metastatic | 44 | 13.6 10.1–18.3ROR 13.7 · χ² 501 / p 4e-111 | 13.3 EB05 10.2 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.2 · 95% clinician | no trial data cached |
| Neoplasm progression | 140 | 13.3 11.2–15.6ROR 13.5 · χ² 1,570 / p <1e-300 | 13.1 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Ejection fraction decreased | 56 | 11.9 9.2–15.5ROR 12.0 · χ² 549 / p 9e-122 | 11.7 EB05 9.2 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 7.8 · 100% clinician | no trial data cached |
| Liver injury | 84 | 11.5 9.3–14.3ROR 11.7 · χ² 796 / p 2e-175 | 11.3 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 | no trial data cached |
| Metastases to bone | 51 | 10.4 7.9–13.6ROR 10.4 · χ² 421 / p 9e-94 | 10.0 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 92% clinician | no trial data cached |
| Pneumocystis jirovecii pneumonia | 30 | 10.0 7.0–14.2ROR 10.0 · χ² 232 / p 9e-53 | 9.3 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 100% clinician | no trial data cached |
| Drug-induced liver injury | 91 | 9.8 8.0–12.0ROR 9.9 · χ² 709 / p 2e-156 | 9.6 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 | no trial data cached |
| Metastases to liver | 51 | 9.7 7.3–12.7ROR 9.7 · χ² 386 / p 3e-86 | 9.2 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 94% clinician | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 66 | 9.4 7.4–11.9ROR 9.5 · χ² 484 / p 1e-107 | 9.0 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · 100% clinician | no trial data cached |
| Cardiomyopathy | 41 | 9.2 6.8–12.5ROR 9.3 · χ² 291 / p 2e-65 | 8.7 EB05 6.6 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.4 · 97% clinician | no trial data cached |
| Metastases to lung | 31 | 8.9 6.3–12.7ROR 9.0 · χ² 209 / p 9e-48 | 8.2 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Acute myeloid leukaemia | 41 | 8.7 6.4–11.9ROR 8.8 · χ² 273 / p 1e-61 | 8.2 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 98% clinician | no trial data cached |
| Lymphocyte count decreased | 42 | 7.9 5.8–10.7ROR 7.9 · χ² 245 / p 2e-55 | 7.4 EB05 5.6 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 5.7 · 100% clinician | no trial data cached |
| Alopecia (hair loss) | 458 | 7.7 7.1–8.4ROR 8.2 · χ² 2,692 / p <1e-300 | 7.7 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.4 · 74% consumer | no trial data cached |
| Leukopenia (low white blood cells) | 115 | 7.6 6.4–9.2ROR 7.8 · χ² 658 / p 2e-145 | 7.5 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 99% clinician | no trial data cached |
| Transaminases increased | 47 | 7.0 5.3–9.3ROR 7.1 · χ² 236 / p 1e-53 | 6.6 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 91% clinician | no trial data cached |
| Interstitial lung disease | 102 | 7.0 5.8–8.5ROR 7.1 · χ² 519 / p 4e-115 | 6.8 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 99% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 274 | 6.7 6.0–7.5ROR 7.0 · χ² 1,331 / p 1e-291 | 6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 96% clinician | no trial data cached |
| Polyneuropathy | 23 | 6.4 4.3–9.6ROR 6.4 · χ² 100 / p 9e-24 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Mucosal inflammation | 45 | 5.7 4.3–7.7ROR 5.8 · χ² 171 / p 3e-39 | 5.4 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 · 98% clinician | no trial data cached |
| Hepatic failure | 52 | 5.7 4.4–7.5ROR 5.7 · χ² 197 / p 5e-45 | 5.4 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Temperature intolerance | 17 | 5.5 3.4–8.9ROR 5.5 · χ² 58 / p 1e-14 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Neutrophil count increased | 17 | 5.5 3.4–8.8ROR 5.5 · χ² 58 / p 1e-14 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 3.6 | no trial data cached |
| Adrenal insufficiency | 18 | 5.0 3.1–7.9ROR 5.0 · χ² 53 / p 1e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Platelet count decreased | 158 | 4.9 4.2–5.7ROR 5.0 · χ² 491 / p 5e-109 | 4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 · 96% clinician | no trial data cached |
| Cytopenia | 17 | 4.7 2.9–7.6ROR 4.7 · χ² 46 / p 6e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Pancytopenia (all blood cells low) | 79 | 4.7 3.8–5.9ROR 4.7 · χ² 227 / p 2e-51 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 · 99% clinician | no trial data cached |
| Myocarditis | 16 | 4.7 2.9–7.6ROR 4.7 · χ² 43 / p 3e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Hepatocellular injury | 20 | 4.7 3.0–7.2ROR 4.7 · χ² 54 / p 1e-13 | 4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · 100% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 695 | 69.0 64.3–74.1ROR 77.4 · χ² 45,650 / p <1e-300 | 67.5 EB05 63.4 · IC025 +5.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 40.2 · 95% clinician | no trial data cached |
| Nausea | 538 | 2.3 2.1–2.4ROR 2.4 · χ² 391 / p 3e-87 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 92% clinician | no trial data cached |
| White blood cell count decreased | 482 | 14.8 13.6–16.1ROR 15.9 · χ² 6,178 / p <1e-300 | 14.7 EB05 13.6 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.3 · 95% clinician | no trial data cached |
| Alopecia (hair loss) | 458 | 7.7 7.1–8.4ROR 8.2 · χ² 2,692 / p <1e-300 | 7.7 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.4 · 74% consumer | no trial data cached |
| Vomiting | 411 | 2.9 2.6–3.2ROR 3.0 · χ² 523 / p 6e-116 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 90% clinician | no trial data cached |
| Febrile neutropenia | 367 | 18.4 16.7–20.4ROR 19.5 · χ² 6,024 / p <1e-300 | 18.3 EB05 16.8 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.0 · 95% clinician | no trial data cached |
| Pyrexia (fever) | 329 | 3.1 2.8–3.5ROR 3.3 · χ² 488 / p 2e-108 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.3 · 94% clinician | no trial data cached |
| Asthenia (weakness) | 319 | 2.8 2.5–3.1ROR 2.9 · χ² 377 / p 3e-84 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 274 | 6.7 6.0–7.5ROR 7.0 · χ² 1,331 / p 1e-291 | 6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 96% clinician | no trial data cached |
| Neutrophil count decreased | 263 | 21.6 19.2–24.4ROR 22.5 · χ² 5,130 / p <1e-300 | 21.5 EB05 19.4 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.3 · 94% clinician | no trial data cached |
| Hepatic function abnormal | 263 | 23.7 21.0–26.6ROR 24.6 · χ² 5,653 / p <1e-300 | 23.5 EB05 21.2 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.0 · 93% clinician | no trial data cached |
| Decreased appetite (loss of appetite) | 183 | 2.6 2.3–3.0ROR 2.7 · χ² 183 / p 5e-42 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 · 93% clinician | no trial data cached |
| Anaemia (low red blood cells) | 161 | 2.8 2.4–3.3ROR 2.8 · χ² 185 / p 2e-42 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 · 97% clinician | no trial data cached |
| Platelet count decreased | 158 | 4.9 4.2–5.7ROR 5.0 · χ² 491 / p 5e-109 | 4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 · 96% clinician | no trial data cached |
| Neoplasm progression | 140 | 13.3 11.2–15.6ROR 13.5 · χ² 1,570 / p <1e-300 | 13.1 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | 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.
- Madarosis — n=102, PRR 29.1
- Hair colour changes — n=108, PRR 28.7
- Hair texture abnormal — n=109, PRR 27.0
- Bone marrow failure — n=102, PRR 16.6
- Impaired quality of life — n=68, PRR 15.7
- Neoplasm progression — n=140, PRR 13.3
- Metastases to bone — n=51, PRR 10.4
- Pneumocystis jirovecii pneumonia — n=30, PRR 10.0
- Metastases to liver — n=51, PRR 9.7
- Palmar-plantar erythrodysaesthesia syndrome — n=66, PRR 9.4
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 Epirubicin?
In FDA FAERS, the most frequently co-reported reaction terms for Epirubicin are myelosuppression, nausea, white blood cell count decreased, alopecia, vomiting, febrile neutropenia. 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 Epirubicin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: CARDIAC TOXICITY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION • Cardiac Toxicity: Myocardial damage, including acute left ventricular failure, can occur with ELLENCE. The ri.
Do FAERS signals prove that Epirubicin 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 0a03c798-a652-4895-b29c-3b521a89ba42, effective 20260724; matched on
openfda.generic_name.exact:"EPIRUBICIN 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, fieldpatient.drug.openfda.generic_name.exact, 192 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.