Daunorubicin hydrochloride: adverse event reports filed with FDA

3,431

reports as suspect product

0% of all reports · about 153 a year

118

reports, 12 months to June 2026

155 in the 12 months before

96.2%

marked serious by the reporter

97% across the class

27.7%

record death among outcomes, as reported

951 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 Daunorubicin hydrochloride reports recording the termmedian drug in anthracycline topoisomerase inhibitor

1. Febrile neutropeniafever with low white blood cells10.2%349
2. Pyrexiafever8.2%280
3. Sepsisa severe body-wide response to infection6.3%216
4. Neutropenialow neutrophils, a type of white blood cell6.1%209
5. Hypotensionlow blood pressure5.8%198
6. Pneumonialung infection5.3%181
7. Bacterial infectiona bacterial infection5.2%178
8. Myelosuppression4.6%159
9. Pancytopenialow counts of all blood cells4.2%143
10. Infectionan infection, type not specified4.1%139
11. Secondary immunodeficiency3.8%130
12. Fungal infectiona fungal infection3.5%120
13. Platelet count decreasedlow platelet count3.5%119
14. Septic shockshock arising from infection3.3%114
15. Clostridium difficile colitisa bowel infection with C. difficile3.2%110
16. Respiratory failurethe lungs could not supply enough oxygen3.2%109
17. Thrombocytopenialow platelets3%103
18. Dyspnoeashortness of breath2.9%99
19. Diarrhoealoose or frequent stools2.9%98
20. Blood bilirubin increased2.8%97
21. White blood cell count decreasedlow white cell count2.7%94
22. Bone marrow failure2.7%93
23. Bronchopulmonary aspergillosis2.7%92
24. Haemoglobin decreasedlow haemoglobin2.7%91
25. Viral infectiona viral infection2.6%88
26. Hypoxialow oxygen2.5%87
27. Nauseafeeling sick2.5%86
28. Off label useused for a purpose or in a way not on the label2.5%86
29. Renal failure acute2.5%85
30. Vomitingbeing sick2.4%84

Top 30 of 847 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. 33.2% 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 3,431 reports.

Drugs most often listed in the same reports

Other products listed in reports where Daunorubicin 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 Daunorubicin hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (583) 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.