Prescription medicine
Epirubicin Brand names: Ellence
Epirubicin (Ellence) is a prescription medicine with an FDA approval on record since 1999. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the epirubicin FDA label on DailyMed (effective July 24, 2026, Pharmacia & Upjohn Company LLC); the NDA 50778 record on Drugs@FDA; every epirubicin label on DailyMed.
Highlights of the record
FDA label of July 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 0.9% at a cumulative dose of 550 mg/m 2 , 1.6% at 700 mg/m 2 , and 3.3% at 900 mg/m 2 . The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with ELLENCE [see Warnings and Precautions (5.1) ].
Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including ELLENCE [see Warnings and Precautions (5.2) ].
Extravasation and Tissue Necrosis: Extravasation of ELLENCE can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area [see Warnings and Precautions (5.3) ].
Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4) ]. […]
Used for
From the label: indications and usageELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ].
Forms and strengths
- 2 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- September 15, 1999 Ellence, Pfizer Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first April 19, 2007; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,333 through July 30, 2026
What is epirubicin used for?
From the label: indications and usageELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ]. 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 ).
FDA pharmacologic class: Anthracycline Topoisomerase Inhibitor.
Source: FDA drug label (Ellence), NDA050778 (Pfizer Inc), as published by Pharmacia & Upjohn Company LLC, effective July 24, 2026 (SPL set 0a03c798-a652-4895-b29c-3b521a89ba42), via openFDA; the full label on DailyMed
Is there a generic for epirubicin (Ellence)?
The FDA approved the first generic epirubicin on April 19, 2007. 13 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
- 1999 earliest approval on file
- 2007 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the epirubicin label say about other medicines?
The epirubicin label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name epirubicin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Allopurinol | warnings and precautions | Consider hydration, urine alkalinization, and prophylaxis with allopurinol to minimize potential complications of hyperuricemia and tumor lysis syndrome ( 5.7 ). |
| Cimetidine | drug interactions | Cimetidine increases the exposure to epirubicin [see Clinical Pharmacology (12.3) ]. |
| Dexrazoxane | warnings and precautions | If appropriate, administer dexrazoxane at the site of extravasation as soon as possible and within the first 6 hours after extravasation. |
| Docetaxel | drug interactions | The administration of epirubicin immediately prior to or after docetaxel did not have an effect on the systemic exposure of epirubicin, but increased the systemic exposure of epirubicinol and 7-deoxydoxorubicin aglycone [see Clinical Pharmacology (12.3) ]. |
| Paclitaxel | drug interactions | The administration of epirubicin immediately prior to or after paclitaxel increased the systemic exposure of epirubicin, epirubicinol and 7-deoxydoxorubicin aglycone [see Clinical Pharmacology (12.3) ]. |
| Trastuzumab | drug interactions | Patients receiving ELLENCE after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, may be at an increased risk of developing cardiotoxicity [see Dosage and Administration (2) and Warnings and Precautions (5.1) ]. |
Source: FDA drug label (Ellence), NDA050778 (Pfizer Inc), as published by Pharmacia & Upjohn Company LLC, effective July 24, 2026 (SPL set 0a03c798-a652-4895-b29c-3b521a89ba42), via openFDA; the full label on DailyMed
What do FAERS reports show for epirubicin?
The FDA Adverse Event Reporting System holds 6,333 reports that list epirubicin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 474 are coded as a death and 2,461 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other anthracycline topoisomerase inhibitors
- the pharmacologic class, with prices and generics
- Epirubicin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other