Bendamustine hydrochloride: adverse event reports filed with FDA

6,941

reports as suspect product

0% of all reports · about 419 a year

253

reports, 12 months to June 2026

341 in the 12 months before

96%

marked serious by the reporter

93.5% across the class

19.5%

record death among outcomes, as reported

1,353 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 Bendamustine hydrochloride reports recording the termmedian drug in alkylating drug

1. Off label useused for a purpose or in a way not on the label13.9%963
2. Pyrexiafever7.4%511
3. Disease progressionthe disease advanced6.5%452
4. Product use in unapproved indicationused for a purpose not on the label5.7%393
5. Drug ineffectivethe medicine did not work as expected5.2%360
6. Malignant neoplasm progression5%349
7. Febrile neutropeniafever with low white blood cells4.9%340
8. Neutropenialow neutrophils, a type of white blood cell4.7%326
9. Pneumonialung infection4.4%306
10. Anaemialow red blood cells4.1%285
11. Covid-19COVID-19 infection4%277
12. Neutrophil count decreased3.9%273
13. Prescribed underdose3.9%269
14. Platelet count decreasedlow platelet count3.9%268
15. Thrombocytopenialow platelets3.7%255
16. Deaththe patient died; cause not stated by this term3.2%220
17. Diarrhoealoose or frequent stools3.2%219
18. Pancytopenialow counts of all blood cells3.1%216
19. Cytomegalovirus infection3%208
20. White blood cell count decreasedlow white cell count2.9%200
21. Myelosuppression2.8%197
22. Rashskin rash2.7%188
23. Nauseafeeling sick2.6%180
24. Sepsisa severe body-wide response to infection2.6%178
25. Product use issuea problem in how the product was used2.5%172
26. Lymphocyte count decreased2.5%171
27. Acute kidney injurysudden loss of kidney function2.4%166
28. Infectionan infection, type not specified2.4%164
29. Infusion related reactiona reaction during or soon after an infusion2.3%163
30. Cytopenia2.2%153

Top 30 of 1,032 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 23 drugs in the alkylating drug 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 253,205 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. 13.9% 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 6,941 reports.

Drugs most often listed in the same reports

Other products listed in reports where Bendamustine 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 alkylating drug 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 Bendamustine hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (973) 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.