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Daunorubicin Side Effects

The most commonly reported side effects of daunorubicin include febrile neutropenia, pyrexia, and neutropenia, based on 18,156 FDA adverse event reports from 2004 to 2025. 3.8% of reports found the drug to be ineffective.

Daunorubicin side effects

Percentages show how often each reaction appears relative to total reports for daunorubicin.

1
Febrile Neutropenia10.9%1,984
2
Pyrexia5.3%961
3
Neutropenia4.7%854
4
Off Label Use4.6%836
5
Sepsis4.5%825
6
Drug Ineffective3.8%694
7
Pneumonia3.5%634
8
Thrombocytopenia3.1%555
9
Death2.9%525
10
Septic Shock2.8%513
11
Pancytopenia2.6%477
12
Bacterial Infection2.4%428
13
Acute Myeloid Leukaemia2.3%419
14
Myelosuppression2.2%401
15
Hypotension2.1%384

These are voluntary reports and do not establish that daunorubicin caused these reactions.

Report severity

95.4%Serious17,312 reports
41.4%Hospitalizations7,509 reports
24.1%Fatal4,376 reports

Seriousness is determined by the reporter, not by OpenClaim.

Daunorubicin drug interactions

Other drugs that appear in adverse event reports alongside daunorubicin. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Cytarabine64.6%11,727
2
Vincristine-sulfate40.3%7,310
3
Methotrexate34.1%6,183
4
Cyclophosphamide22.6%4,104
5
Dexamethasone20.5%3,724
6
Prednisone19.0%3,454
7
Asparaginase18.7%3,393
8
Pegaspargase16.1%2,923
9
Etoposide14.1%2,566
10
Mercaptopurine13.7%2,490
11
Prednisolone9.0%1,629
12
Hydrocortisone8.4%1,525
13
Doxorubicin-hydrochloride7.7%1,389
14
Methylprednisolone5.1%922
15
Gemtuzumab-ozogamicin4.7%854

Taken alongside

1
Cytarabine8.8%1,598
2
Vincristine-sulfate8.7%1,581
3
Cyclophosphamide5.5%992
4
Methotrexate5.3%964
5
Dexamethasone4.3%780
6
Prednisone4.1%751
7
Ondansetron4.0%727
8
Acyclovir3.9%701
9
Acetaminophen3.8%688
10
Sulfamethoxazole3.4%615
11
Allopurinol3.4%610
12
Vancomycin3.1%564
13
Trimethoprim3.0%540
14
Asparaginase2.8%502
15
Prednisolone2.5%453

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports daunorubicin side effects

37.3% of daunorubicin adverse event reports involve female patients and 44.6% involve male patients. The largest age group is adult at 46%. These figures reflect who reports side effects, not underlying risk.

Sex

Female37.3%
Male44.6%
Unknown18.1%

Age group

< 25.3%
2–1120.2%
12–1712.8%
18–6446.2%
65+15.5%

What is daunorubicin used for

Conditions and purposes for which patients were taking daunorubicin when the adverse event was reported.

Acute Lymphoblastic LeukemiaAcute Biphenotypic LeukaemiaAcute LeukaemiaAcute Leukaemia In RemissionAcute Lymphatic LeukemiaAcute Lymphoblastic LeukemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia (in Remission)Acute Lymphocytic Leukaemia RecurrentAcute Lymphocytic Leukaemia RefractoryAcute Lymphocytic LeukemiaAcute Megakaryocytic LeukaemiaAcute Monocytic LeukaemiaAcute Myeloblastic LeukemiaAcute Myeloid Leukaemia

Showing 15 of 366 indications

Daunorubicin brand names and reporting trend

Daunorubicin is sold under brand names including Vyxeos, Daunorubicin Hydrochloride, Daunoxome.

Brand names

Vyxeos17,534
Daunorubicin Hydrochloride5
Daunoxome4

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking daunorubicin with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.