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Bleomycin Side Effects

The most commonly reported side effects of bleomycin include off label use, febrile neutropenia, and neutropenia, based on 10,260 FDA adverse event reports from 2004 to 2025. 4.6% of reports found the drug to be ineffective.

Bleomycin side effects

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

1
Off Label Use7.5%769
2
Febrile Neutropenia6.5%671
3
Neutropenia4.7%487
4
Drug Ineffective4.6%467
5
Pyrexia3.2%324
6
Anaemia2.9%301
7
Nausea2.9%300
8
Product Use In Unapproved Indication2.9%294
9
Thrombocytopenia2.8%292
10
Vomiting2.8%291
11
Pulmonary Toxicity2.8%284
12
Disease Progression2.5%261
13
Respiratory Failure2.5%259
14
Acute Myeloid Leukaemia2.5%252
15
Second Primary Malignancy2.4%242

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

Report severity

97.2%Serious9,974 reports
31.9%Hospitalizations3,269 reports
22.9%Fatal2,348 reports

Seriousness is determined by the reporter, not by OpenClaim.

Bleomycin drug interactions

Other drugs that appear in adverse event reports alongside bleomycin. 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
Doxorubicin-hydrochloride50.1%5,144
2
Etoposide48.4%4,970
3
Vincristine-sulfate30.4%3,122
4
Vinblastine-sulfate29.3%3,002
5
Cisplatin28.8%2,958
6
Cyclophosphamide26.6%2,725
7
Dacarbazine25.8%2,647
8
Prednisone21.6%2,217
9
Procarbazine-hydrochloride17.1%1,751
10
Rituximab8.5%873
11
Ifosfamide8.2%844
12
Methotrexate8.2%839
13
Prednisolone7.8%799
14
Carboplatin7.1%725
15
Cytarabine6.5%667

Taken alongside

1
Doxorubicin-hydrochloride7.4%758
2
Etoposide6.8%696
3
Vinblastine-sulfate5.3%545
4
Dacarbazine5.3%540
5
Dexamethasone4.6%477
6
Cisplatin4.2%433
7
Prednisone4.2%428
8
Ondansetron3.6%368
9
Cyclophosphamide3.6%367
10
Vincristine-sulfate3.4%352
11
Acetaminophen2.7%272
12
Sulfamethoxazole2.2%224
13
Filgrastim2.2%222
14
Trimethoprim1.9%195
15
Acyclovir1.7%173

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 bleomycin side effects

30.6% of bleomycin adverse event reports involve female patients and 46.3% involve male patients. The largest age group is adult at 75%. These figures reflect who reports side effects, not underlying risk.

Sex

Female30.6%
Male46.3%
Unknown23.1%

Age group

< 22.5%
2–113.8%
12–177.3%
18–6475.1%
65+11.4%

What is bleomycin used for

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

Abdominal LymphadenopathyAcquired Immunodeficiency SyndromeAcute Lymphocytic LeukaemiaAcute Monocytic LeukaemiaAcute Myeloid LeukaemiaAdenocarcinomaAdenocarcinoma GastricAdult T-cell Lymphoma/leukaemiaAnaemiaAnaemia Haemolytic AutoimmuneAnal CancerAnal Cancer RecurrentAnal Cancer Stage 0Anal Squamous Cell CarcinomaAnaplastic Large Cell Lymphoma T- And Null-cell Types

Showing 15 of 601 indications

Bleomycin brand names and reporting trend

Bleomycin is sold under the brand name Blenoxane.

Brand names

Blenoxane11,744

Quarterly reports (20042025)

20052010201520202025

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

Taking bleomycin with another medication?

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