Bleomycin: adverse event reports filed with FDA

6,341

reports as suspect product

0% of all reports · about 282 a year

352

reports, 12 months to June 2026

350 in the 12 months before

98%

marked serious by the reporter

98.2% across the class

22.6%

record death among outcomes, as reported

1,434 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 Bleomycin reports recording the termmedian drug in cytoprotective agent

1. Off label useused for a purpose or in a way not on the label8.4%530
2. Febrile neutropeniafever with low white blood cells7.6%481
3. Neutropenialow neutrophils, a type of white blood cell6.1%385
4. Drug ineffectivethe medicine did not work as expected5.7%363
5. Pyrexiafever4.6%293
6. Thrombocytopenialow platelets3.9%247
7. Disease progressionthe disease advanced3.9%246
8. Pulmonary toxicity3.7%237
9. Nauseafeeling sick3.7%232
10. Respiratory failurethe lungs could not supply enough oxygen3.6%226
11. Vomitingbeing sick3.5%224
12. Anaemialow red blood cells3.4%215
13. Product use in unapproved indicationused for a purpose not on the label3.4%214
14. Sepsisa severe body-wide response to infection3.1%199
15. Toxicity to various agentspoisoning or toxic effect of one or more substances2.9%183
16. Dyspnoeashortness of breath2.8%177
17. Pneumonialung infection2.8%177
18. Acute myeloid leukaemia2.6%168
19. Fatiguetiredness2.3%145
20. Pneumonitis2.2%141
21. Interstitial lung diseasescarring or inflammation of lung tissue2.2%140
22. Second primary malignancy2.1%133
23. Pulmonary fibrosis2%129
24. Pancytopenialow counts of all blood cells2%128
25. Deaththe patient died; cause not stated by this term1.9%121
26. Infectionan infection, type not specified1.9%119
27. Mucosal inflammation1.8%116
28. Hodgkin's disease1.8%114
29. Foetal exposure during pregnancythe unborn baby was exposed to the medicine1.8%113
30. Pulmonary embolisma blood clot in the lung1.8%113

Top 30 of 1,118 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 3 drugs in the cytoprotective agent 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 13,325 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. 23% 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 6,341 reports.

Drugs most often listed in the same reports

Other products listed in reports where Bleomycin 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 cytoprotective agent 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 Bleomycin as a suspect or interacting product; reports listing it only as a concomitant medication (1,103) 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.