Bleomycin side effects: what 7,427 FDA adverse event reports show
Drug class
Not stated in label
Who reports
7,427 reports · 97% serious · 1,614 with death outcome · 41% female
Used for
Bleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: Squamo.
What it is
DESCRIPTION Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus . It is freely soluble in water. Bleomycin for In.
Boxed warning
It is recommended that Bleomycin for Injection, USP be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 231 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Acute myeloid leukaemia | 195 | 35.8 31.1–41.2ROR 36.7 · χ² 6,483 / p <1e-300 | 35.2 EB05 31.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 21.1 · 97% clinician | no trial data cached |
| Haematotoxicity | 100 | 30.8 25.3–37.4ROR 31.2 · χ² 2,821 / p <1e-300 | 30.3 EB05 25.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.6 · 98% clinician | no trial data cached |
| Myelodysplastic syndrome | 128 | 25.2 21.2–29.9ROR 25.6 · χ² 2,924 / p <1e-300 | 24.9 EB05 21.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 · 97% clinician | no trial data cached |
| Febrile neutropenia | 544 | 23.4 21.6–25.4ROR 25.1 · χ² 11,571 / p <1e-300 | 23.2 EB05 21.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 · 98% clinician | no trial data cached |
| Pulmonary fibrosis | 139 | 20.7 17.5–24.4ROR 21.1 · χ² 2,566 / p <1e-300 | 20.5 EB05 17.8 · IC025 +4.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 12.2 · 93% clinician | no trial data cached |
| Pneumocystis jirovecii pneumonia | 64 | 18.2 14.2–23.2ROR 18.3 · χ² 1,016 / p 3e-223 | 18.0 EB05 14.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · 98% clinician | no trial data cached |
| Mucosal inflammation | 152 | 16.6 14.1–19.4ROR 16.9 · χ² 2,196 / p <1e-300 | 16.4 EB05 14.3 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.4 · 96% clinician | no trial data cached |
| Pneumonitis | 151 | 15.9 13.5–18.6ROR 16.2 · χ² 2,077 / p <1e-300 | 15.7 EB05 13.7 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.6 · 100% clinician | no trial data cached |
| Acute respiratory distress syndrome | 98 | 15.7 12.9–19.1ROR 15.9 · χ² 1,330 / p 2e-291 | 15.6 EB05 13.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · 98% clinician | no trial data cached |
| Therapy partial responder | 68 | 12.8 10.1–16.2ROR 12.9 · χ² 725 / p 5e-160 | 12.6 EB05 10.2 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 9.0 · 100% clinician | no trial data cached |
| Candida infection (yeast infection) | 73 | 12.4 9.9–15.6ROR 12.5 · χ² 751 / p 1e-165 | 12.2 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · ♀ 88% (drug 41%) | no trial data cached |
| Bone marrow failure | 89 | 12.3 10.0–15.2ROR 12.5 · χ² 912 / p 1e-200 | 12.1 EB05 10.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 100% clinician | no trial data cached |
| Pneumothorax | 60 | 10.7 8.3–13.8ROR 10.8 · χ² 518 / p 7e-115 | 10.4 EB05 8.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · 100% clinician | no trial data cached |
| Brain oedema | 46 | 10.3 7.7–13.8ROR 10.4 · χ² 377 / p 3e-84 | 9.9 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 91% clinician | no trial data cached |
| Splenomegaly | 40 | 9.7 7.1–13.2ROR 9.7 · χ² 302 / p 7e-68 | 9.1 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · ♀ 81% (drug 41%) | no trial data cached |
| Leukaemia | 32 | 9.6 6.8–13.6ROR 9.6 · χ² 238 / p 7e-54 | 8.9 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 97% clinician | no trial data cached |
| Respiratory failure | 243 | 9.4 8.3–10.7ROR 9.7 · χ² 1,823 / p <1e-300 | 9.3 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 444 | 9.3 8.5–10.2ROR 9.8 · χ² 3,282 / p <1e-300 | 9.2 EB05 8.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 93% clinician | no trial data cached |
| Acute hepatic failure | 42 | 8.7 6.5–11.8ROR 8.8 · χ² 280 / p 5e-63 | 8.2 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 90% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 34 | 8.7 6.2–12.1ROR 8.7 · χ² 223 / p 1e-50 | 8.0 EB05 5.9 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.8 · ♀ 93% (drug 41%) | no trial data cached |
| Interstitial lung disease | 146 | 8.6 7.3–10.0ROR 8.7 · χ² 966 / p 2e-212 | 8.4 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.0 · 96% clinician | no trial data cached |
| Spinal pain | 34 | 8.2 5.9–11.5ROR 8.3 · χ² 208 / p 2e-47 | 7.6 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · ♀ 100% (drug 41%) | no trial data cached |
| Pulmonary congestion | 38 | 8.1 5.9–11.2ROR 8.2 · χ² 230 / p 3e-52 | 7.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 94% (drug 41%) | no trial data cached |
| Cytopenia | 34 | 8.1 5.8–11.3ROR 8.1 · χ² 203 / p 3e-46 | 7.4 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 97% clinician | no trial data cached |
| Deafness | 74 | 8.0 6.4–10.0ROR 8.1 · χ² 445 / p 4e-99 | 7.7 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 100% clinician | no trial data cached |
| Muscle spasticity | 34 | 7.8 5.5–10.9ROR 7.8 · χ² 193 / p 3e-44 | 7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 84% (drug 41%) | no trial data cached |
| Bacterial infection | 49 | 7.5 5.6–9.9ROR 7.5 · χ² 267 / p 2e-60 | 7.0 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 100% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 147 | 7.5 6.4–8.8ROR 7.6 · χ² 816 / p 7e-180 | 7.3 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 93% clinician | no trial data cached |
| Cardiomyopathy | 39 | 7.5 5.5–10.2ROR 7.5 · χ² 211 / p 4e-48 | 6.9 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 97% clinician | no trial data cached |
| Thrombotic microangiopathy | 25 | 7.3 4.9–10.8ROR 7.3 · χ² 129 / p 3e-30 | 6.6 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 92% clinician | no trial data cached |
| Septic shock | 111 | 7.3 6.0–8.7ROR 7.4 · χ² 593 / p 2e-131 | 7.1 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 96% clinician | no trial data cached |
| Lymphopenia | 36 | 7.2 5.2–10.0ROR 7.3 · χ² 187 / p 7e-43 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.6 · ♀ 75% (drug 41%) · 100% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 283 | 7.2 6.4–8.1ROR 7.4 · χ² 1,504 / p <1e-300 | 7.1 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 97% clinician | no trial data cached |
| Nephropathy toxic | 28 | 7.1 4.9–10.3ROR 7.1 · χ² 141 / p 9e-33 | 6.5 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 96% clinician | no trial data cached |
| Tenderness | 26 | 7.0 4.8–10.3ROR 7.1 · χ² 129 / p 4e-30 | 6.4 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=26 · ♀ 100% (drug 41%) | no trial data cached |
| Hypokinesia | 36 | 7.0 5.1–9.7ROR 7.0 · χ² 179 / p 4e-41 | 6.5 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 88% (drug 41%) | no trial data cached |
| Cytomegalovirus infection | 41 | 7.0 5.1–9.5ROR 7.0 · χ² 204 / p 2e-46 | 6.5 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Premature baby | 74 | 6.9 5.5–8.7ROR 7.0 · χ² 369 / p 1e-82 | 6.7 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 100% clinician | no trial data cached |
| Acute myocardial infarction | 72 | 6.9 5.5–8.7ROR 6.9 · χ² 356 / p 1e-79 | 6.6 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 · ♀ 3% (drug 41%) · 97% clinician | no trial data cached |
| Neurotoxicity | 42 | 6.8 5.1–9.2ROR 6.9 · χ² 203 / p 2e-46 | 6.4 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 97% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 623 | 2.0 1.9–2.2ROR 2.1 · χ² 337 / p 1e-75 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 2.2 · 96% clinician | no trial data cached |
| Febrile neutropenia | 544 | 23.4 21.6–25.4ROR 25.1 · χ² 11,571 / p <1e-300 | 23.2 EB05 21.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 · 98% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 444 | 9.3 8.5–10.2ROR 9.8 · χ² 3,282 / p <1e-300 | 9.2 EB05 8.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 93% clinician | no trial data cached |
| Pyrexia (fever) | 338 | 2.8 2.5–3.1ROR 2.8 · χ² 383 / p 1e-85 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 2.0 | no trial data cached |
| Thrombocytopenia (low platelets) | 283 | 7.2 6.4–8.1ROR 7.4 · χ² 1,504 / p <1e-300 | 7.1 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 97% clinician | no trial data cached |
| Disease progression | 273 | 6.5 5.8–7.4ROR 6.8 · χ² 1,282 / p 4e-281 | 6.5 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 98% clinician | no trial data cached |
| Vomiting | 271 | 1.6 1.5–1.8ROR 1.7 · χ² 67 / p 1e-16 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Anaemia (low red blood cells) | 262 | 3.9 3.4–4.4ROR 4.0 · χ² 562 / p 2e-124 | 3.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · 97% clinician | no trial data cached |
| Product use in unapproved indication | 243 | 2.8 2.5–3.2ROR 2.9 · χ² 285 / p 4e-64 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 95% clinician | no trial data cached |
| Respiratory failure | 243 | 9.4 8.3–10.7ROR 9.7 · χ² 1,823 / p <1e-300 | 9.3 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Sepsis (blood infection) | 224 | 5.7 5.0–6.5ROR 5.8 · χ² 861 / p 1e-189 | 5.6 EB05 5.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Pneumonia (lung infection) | 220 | 1.9 1.7–2.2ROR 2.0 · χ² 98 / p 2e-23 | 1.9 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.2 | no trial data cached |
| Acute myeloid leukaemia | 195 | 35.8 31.1–41.2ROR 36.7 · χ² 6,483 / p <1e-300 | 35.2 EB05 31.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 21.1 · 97% clinician | no trial data cached |
| Toxicity to various agents | 194 | 3.3 2.8–3.8ROR 3.3 · χ² 305 / p 1e-68 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.0 · 99% clinician | no trial data cached |
| Mucosal inflammation | 152 | 16.6 14.1–19.4ROR 16.9 · χ² 2,196 / p <1e-300 | 16.4 EB05 14.3 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.4 · 96% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Acute myeloid leukaemia — n=195, PRR 35.8
- Haematotoxicity — n=100, PRR 30.8
- Myelodysplastic syndrome — n=128, PRR 25.2
- Febrile neutropenia — n=544, PRR 23.4
- Pneumocystis jirovecii pneumonia — n=64, PRR 18.2
- Acute respiratory distress syndrome — n=98, PRR 15.7
- Candida infection — n=73, PRR 12.4
- Bone marrow failure — n=89, PRR 12.3
- Pneumothorax — n=60, PRR 10.7
- Brain oedema — n=46, PRR 10.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Bleomycin ↔ Pulmonary fibrosis.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Bleomycin?
In FDA FAERS, the most frequently co-reported reaction terms for Bleomycin are febrile neutropenia, neutropenia, pyrexia, thrombocytopenia, vomiting, anaemia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Bleomycin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: It is recommended that Bleomycin for Injection, USP be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Do FAERS signals prove that Bleomycin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 6824b1e1-e5fa-4371-ade9-1346e12ab0c7, effective 20260417; matched on
openfda.generic_name.exact:"BLEOMYCIN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 271 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.