What the label lists and what reports show
Bleomycin side effects
Bleomycin's FDA label: “The most common changes in pulmonary function tests are a decrease in total lung volume and a decrease in vital capacity.” FAERS holds 10,269 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is febrile neutropenia (826 reports).
- Generic listed
- Boxed warning
Check it at the source: the bleomycin FDA label on DailyMed (effective October 10, 2024, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common changes in pulmonary function tests are a decrease in total lung volume and a decrease in vital capacity.
From the label: adverse reactions, continuedPulmonary The most serious side effects are pulmonary adverse reactions, occurring in approximately 10% of treated patients. The most frequent presentation is pneumonitis occasionally progressing to pulmonary fibrosis. Approximately 1% of patients treated have died of pulmonary fibrosis. Pulmonary toxicity is both dose and age related, being more common in patients over 70 years of age and in those receiving over 400 units total dose. This toxicity, however, is unpredictable and has been seen in young patients receiving low doses. Some published reports have suggested that the risk of pulmonary toxicity may be increased when bleomycin is used in combination with G-CSF (filgrastim) or other cytokines. However, randomized clinical studies completed to date have not demonstrated an increased risk of pulmonary complications in patients treated with bleomycin and G-CSF. Because of lack of specificity of the clinical syndrome, the identification of patients with pulmonary toxicity due to bleomycin has been extremely difficult. The earliest symptom associated with bleomycin pulmonary toxicity is dyspnea. The earliest sign is fine rales. Radiographically, bleomycin-induced pneumonitis produces nonspecific patchy opacities, usually of the lower lung fields. The most common changes in pulmonary function tests are a decrease in total lung volume and a decrease in vital capacity. …
Source: FDA drug label, Fresenius Kabi USA, LLC, effective October 10, 2024 (SPL set b5806c40-12ce-48e3-8abd-9f8997ef4428), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,269 reports list bleomycin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,370 are coded as a death and 3,290 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Bleomycin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions