Epirubicin hydrochloride: adverse event reports filed with FDA

6,411

reports as suspect product

0% of all reports · about 286 a year

594

reports, 12 months to June 2026

650 in the 12 months before

99.3%

marked serious by the reporter

97% across the class

9.3%

record death among outcomes, as reported

594 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Epirubicin hydrochloride reports recording the termmedian drug in anthracycline topoisomerase inhibitor

1. Myelosuppression10.7%686
2. Nauseafeeling sick8.8%562
3. Vomitingbeing sick7%447
4. White blood cell count decreasedlow white cell count6.9%444
5. Astheniaweakness or lack of energy5.6%361
6. Febrile neutropeniafever with low white blood cells5.3%338
7. Pyrexiafever5.3%337
8. Neutropenialow neutrophils, a type of white blood cell4.7%303
9. Hepatic function abnormal4%257
10. Diarrhoealoose or frequent stools3.9%248
11. Neutrophil count decreased3.5%223
12. Fatiguetiredness3.4%219
13. Off label useused for a purpose or in a way not on the label3.3%211
14. Decreased appetitereduced appetite2.8%180
15. Neoplasm progression2.8%180
16. Anaemialow red blood cells2.7%171
17. Dyspnoeashortness of breath2.3%145
18. Cardiac failureheart failure2.1%137
19. Platelet count decreasedlow platelet count2.1%132
20. Leukopenialow white blood cells2%128
21. Neuropathy peripheralnerve damage in hands or feet1.8%114
22. Alopeciahair loss1.8%113
23. Malignant neoplasm progression1.8%113
24. Second primary malignancy1.7%110
25. Bone marrow failure1.5%99
26. Dizzinesslight-headedness or unsteadiness1.5%98
27. Gastrointestinal disorder1.5%98
28. Interstitial lung diseasescarring or inflammation of lung tissue1.5%96
29. Painpain, site not specified1.5%96
30. Thrombocytopenialow platelets1.5%96

Top 30 of 832 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 7 drugs in the anthracycline topoisomerase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 109,832 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 2.2% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 6,411 reports.

Drugs most often listed in the same reports

Other products listed in reports where Epirubicin hydrochloride is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the anthracycline topoisomerase inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Epirubicin hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (655) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.