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Bendamustine Side Effects

The most commonly reported side effects of bendamustine include off label use, disease progression, and pyrexia, based on 27,105 FDA adverse event reports from 2004 to 2025. 4.9% of reports found the drug to be ineffective.

#1 Reported: Off Label UseAll side effects ↓Top Co-Medication: RituximabDrug interactions ↓59% of Reports Are ElderlyDemographics ↓

Bendamustine side effects

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

1
Off Label Use11.2%3,038
2
Disease Progression9.9%2,695
3
Pyrexia6.1%1,661
4
Neutropenia5.5%1,500
5
Drug Ineffective4.9%1,337
6
Pneumonia4.3%1,179
7
Febrile Neutropenia4.3%1,175
8
Thrombocytopenia4.3%1,163
9
Covid-194.1%1,122
10
Death3.8%1,030
11
Anaemia3.8%1,023
12
Rash2.9%791
13
Product Use In Unapproved Indication2.8%746
14
Diarrhoea2.7%742
15
Malignant Neoplasm Progression2.7%723

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

Report severity

90.7%Serious24,596 reports
38.3%Hospitalizations10,377 reports
19.6%Fatal5,300 reports

Seriousness is determined by the reporter, not by OpenClaim.

Bendamustine drug interactions

Other drugs that appear in adverse event reports alongside bendamustine. 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
Rituximab53.4%14,483
2
Cyclophosphamide20.3%5,502
3
Vincristine-sulfate18.1%4,910
4
Doxorubicin-hydrochloride17.5%4,753
5
Polatuzumab-vedotin-piiq15.4%4,173
6
Prednisone15.3%4,134
7
Dexamethasone14.3%3,886
8
Obinutuzumab11.8%3,187
9
Cytarabine9.9%2,679
10
Etoposide8.8%2,380
11
Lenalidomide7.9%2,131
12
Cisplatin7.1%1,934
13
Gemcitabine6.4%1,731
14
Bortezomib5.8%1,578
15
Ibrutinib5.5%1,497

Taken alongside

1
Rituximab8.6%2,343
2
Acyclovir7.0%1,906
3
Acetaminophen6.7%1,809
4
Allopurinol6.4%1,722
5
Dexamethasone5.8%1,562
6
Sulfamethoxazole4.7%1,264
7
Trimethoprim4.1%1,108
8
Prednisone3.9%1,048
9
Ondansetron3.8%1,041
10
Cyclophosphamide3.7%998
11
Aspirin3.1%828
12
Omeprazole2.8%759
13
Vincristine-sulfate2.6%709
14
Doxorubicin-hydrochloride2.5%683
15
Amoxicillin2.4%661

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 bendamustine side effects

33.0% of bendamustine adverse event reports involve female patients and 48.9% involve male patients. The largest age group is elderly at 59%. These figures reflect who reports side effects, not underlying risk.

Sex

Female33.0%
Male48.9%
Unknown18.1%

Age group

< 2<0.1%
2–110.2%
12–170.6%
18–6440.6%
65+58.5%

What is bendamustine used for

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

Abdominal MassAbdominal NeoplasmAcquired HaemophiliaAcquired Immunodeficiency SyndromeAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Myeloid LeukaemiaAcute Promyelocytic LeukaemiaAdult T-cell Lymphoma/leukaemiaAgranulocytosisAllogenic Stem Cell TransplantationAmyloidosisAnaplastic AstrocytomaAnaplastic Large Cell Lymphoma T- And Null-cell Types

Showing 15 of 564 indications

Bendamustine brand names and reporting trend

Bendamustine is sold under the brand name Bendeka.

Brand names

Bendeka105

Quarterly reports (2004–2025)

20042010201520202025

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

Taking bendamustine with another medication?

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