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Doxorubicin Side Effects

The most commonly reported side effects of doxorubicin include febrile neutropenia, off label use, and neutropenia, based on 124,676 FDA adverse event reports from 2004 to 2025. 4.4% of reports found the drug to be ineffective.

#1 Reported: Febrile NeutropeniaAll side effects ↓Top Co-Medication: CyclophosphamideDrug interactions ↓60% of Reports Are AdultDemographics ↓

Doxorubicin side effects

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

1
Febrile Neutropenia8.2%10,274
2
Off Label Use7.6%9,504
3
Neutropenia5.7%7,133
4
Disease Progression5.6%6,926
5
Drug Ineffective4.4%5,451
6
Alopecia4.3%5,355
7
Pyrexia3.6%4,549
8
Anaemia3.5%4,341
9
Thrombocytopenia3.4%4,281
10
Nausea3.0%3,791
11
Death3.0%3,766
12
Product Use In Unapproved Indication2.8%3,457
13
Sepsis2.6%3,240
14
Pneumonia2.6%3,209
15
Diarrhoea2.4%3,043

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

Report severity

94.7%Serious118,108 reports
34.9%Hospitalizations43,572 reports
18.9%Fatal23,512 reports

Seriousness is determined by the reporter, not by OpenClaim.

Doxorubicin drug interactions

Other drugs that appear in adverse event reports alongside doxorubicin. 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
Cyclophosphamide51.5%64,151
2
Vincristine-sulfate45.6%56,801
3
Rituximab30.8%38,408
4
Prednisone26.5%33,062
5
Etoposide17.4%21,668
6
Dexamethasone15.1%18,798
7
Methotrexate12.4%15,446
8
Prednisolone10.8%13,438
9
Cytarabine10.6%13,273
10
Cisplatin9.8%12,218
11
Ifosfamide7.6%9,513
12
Docetaxel6.7%8,386
13
Carboplatin6.3%7,907
14
Paclitaxel5.6%6,956
15
Gemcitabine4.6%5,762

Taken alongside

1
Cyclophosphamide14.1%17,577
2
Vincristine-sulfate7.8%9,748
3
Dexamethasone6.7%8,407
4
Prednisone5.4%6,759
5
Acetaminophen4.9%6,171
6
Ondansetron4.6%5,727
7
Acyclovir3.5%4,423
8
Sulfamethoxazole3.3%4,125
9
Allopurinol3.1%3,832
10
Trimethoprim3.0%3,707
11
Pantoprazole-sodium2.8%3,496
12
Rituximab2.7%3,330
13
Etoposide2.6%3,244
14
Prednisolone2.5%3,150
15
Filgrastim2.5%3,104

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 doxorubicin side effects

45.5% of doxorubicin adverse event reports involve female patients and 33.5% involve male patients. The largest age group is adult at 60%. These figures reflect who reports side effects, not underlying risk.

Sex

Female45.5%
Male33.5%
Unknown21.0%

Age group

< 21.7%
2–115.9%
12–174.5%
18–6459.5%
65+28.4%

What is doxorubicin used for

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

5q Minus SyndromeAbdominal LymphadenopathyAbdominal NeoplasmAbdominal PainAbdominal Wall NeoplasmAbdominal Wall Neoplasm MalignantAccidental ExposureAcquired Immunodeficiency SyndromeAcute Biphenotypic LeukaemiaAcute Coronary SyndromeAcute Kidney InjuryAcute LeukaemiaAcute Leukaemia In RemissionAcute Lymphoblastic LeukemiaAcute Lymphocytic Leukaemia

Showing 15 of 2,049 indications

Doxorubicin brand names and reporting trend

Doxorubicin is sold under the brand name Adriamycin Pfs.

Brand names

Adriamycin Pfs8

Quarterly reports (2004–2025)

20052010201520202025

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

Taking doxorubicin with another medication?

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