Bleomycin Sulfate side effects: what 10,269 FDA adverse event reports show
Drug class
Not stated in label
Who reports
10,269 reports · 97% serious · 2,370 with death outcome · 40% 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.
- 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.
- 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. 965 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 |
|---|---|---|---|---|---|---|
| Growing teratoma syndrome | 25 | 12,586.7 4,381.2–36,160.0ROR 12,617.4 · χ² 41,676 / p <1e-300 | 742.5 EB05 528.9 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 · 100% clinician | no trial data cached |
| Flagellate dermatitis | 29 | 1,668.6 1,020.4–2,728.6ROR 1,673.4 · χ² 25,527 / p <1e-300 | 568.5 EB05 415.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=27 · 100% clinician | no trial data cached |
| Ovarian germ cell teratoma | 32 | 1,342.6 858.7–2,099.0ROR 1,346.8 · χ² 24,940 / p <1e-300 | 542.9 EB05 402.6 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=32 · ♀ 100% (drug 40%) · 100% clinician | no trial data cached |
| Necrotising gastritis | 12 | 1,208.3 590.8–2,471.1ROR 1,209.7 · χ² 8,308 / p <1e-300 | 342.5 EB05 208.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Teratoma benign | 19 | 1,093.2 625.6–1,910.4ROR 1,095.3 · χ² 12,740 / p <1e-300 | 413.1 EB05 279.5 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=19 | no trial data cached |
| Basal ganglion degeneration | 33 | 1,071.9 703.0–1,634.5ROR 1,075.3 · χ² 22,348 / p <1e-300 | 497.1 EB05 370.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 100% (drug 40%) | no trial data cached |
| Teratoma | 46 | 554.7 400.5–768.4ROR 557.2 · χ² 19,502 / p <1e-300 | 368.3 EB05 287.3 · IC025 +5.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=46 · ♀ 74% (drug 40%) · 100% clinician | no trial data cached |
| Pleuroparenchymal fibroelastosis | 16 | 370.4 217.4–631.0ROR 370.9 · χ² 4,671 / p <1e-300 | 228.0 EB05 148.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Choriocarcinoma | 10 | 319.7 164.1–622.8ROR 320.0 · χ² 2,473 / p <1e-300 | 181.2 EB05 105.2 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious n=10 | no trial data cached |
| Tissue infiltration | 34 | 268.5 187.8–383.8ROR 269.4 · χ² 7,761 / p <1e-300 | 209.3 EB05 156.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 100% (drug 40%) | no trial data cached |
| Azoospermia | 44 | 261.4 191.0–357.6ROR 262.5 · χ² 9,873 / p <1e-300 | 210.4 EB05 163.2 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Nail bed inflammation | 35 | 252.6 177.9–358.8ROR 253.5 · χ² 7,573 / p <1e-300 | 200.2 EB05 150.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 100% (drug 40%) | no trial data cached |
| Synovial sarcoma | 10 | 236.9 123.1–456.1ROR 237.2 · χ² 1,896 / p <1e-300 | 151.5 EB05 87.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Endocarditis noninfective | 15 | 230.6 135.2–393.3ROR 230.9 · χ² 2,874 / p <1e-300 | 164.2 EB05 105.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Treatment related secondary malignancy | 16 | 172.3 103.5–287.0ROR 172.6 · χ² 2,355 / p <1e-300 | 133.8 EB05 87.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Anaesthesia | 26 | 158.7 106.5–236.4ROR 159.1 · χ² 3,631 / p <1e-300 | 133.0 EB05 95.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 100% (drug 40%) | no trial data cached |
| Neutropenic infection | 67 | 152.1 118.8–194.9ROR 153.1 · χ² 9,212 / p <1e-300 | 136.1 EB05 110.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=67 · 100% clinician | no trial data cached |
| Acute myelomonocytic leukaemia | 16 | 137.7 83.0–228.4ROR 137.9 · χ² 1,906 / p <1e-300 | 112.1 EB05 73.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Chloroma | 26 | 133.9 90.1–199.1ROR 134.3 · χ² 3,093 / p <1e-300 | 115.2 EB05 82.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=26 · 96% clinician | no trial data cached |
| Cutaneous calcification | 11 | 130.3 70.8–239.7ROR 130.4 · χ² 1,207 / p 9e-265 | 101.4 EB05 60.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Nasal mucosal disorder | 35 | 130.0 92.4–182.9ROR 130.5 · χ² 4,090 / p <1e-300 | 114.7 EB05 86.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 100% (drug 40%) | no trial data cached |
| Pulmonary toxicity | 415 | 128.3 116.4–141.4ROR 133.7 · χ² 49,183 / p <1e-300 | 120.0 EB05 110.7 · IC025 +6.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 71.2 · 96% clinician | no trial data cached |
| Uterine enlargement | 34 | 91.2 64.7–128.5ROR 91.5 · χ² 2,815 / p <1e-300 | 83.3 EB05 62.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 100% (drug 40%) | no trial data cached |
| Streptococcal sepsis | 48 | 85.5 64.1–114.1ROR 85.9 · χ² 3,767 / p <1e-300 | 79.6 EB05 62.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 100% (drug 40%) | no trial data cached |
| Hodgkin's disease | 29 | 83.8 57.8–121.4ROR 84.0 · χ² 2,199 / p <1e-300 | 76.6 EB05 55.9 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications | serious n=29 | no trial data cached |
| Abdominal compartment syndrome | 24 | 81.8 54.4–122.9ROR 82.0 · χ² 1,764 / p <1e-300 | 74.2 EB05 52.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 100% (drug 40%) · 100% clinician | no trial data cached |
| Autoimmune neutropenia | 11 | 80.0 43.8–146.1ROR 80.1 · χ² 751 / p 1e-165 | 68.2 EB05 40.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Hepatitis b reactivation | 107 | 71.1 58.7–86.2ROR 71.9 · χ² 7,078 / p <1e-300 | 67.9 EB05 57.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=107 · ♀ 84% (drug 40%) · 92% clinician | no trial data cached |
| Psychogenic seizure | 31 | 70.9 49.6–101.4ROR 71.2 · χ² 1,998 / p <1e-300 | 65.9 EB05 48.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 100% (drug 40%) | no trial data cached |
| Hypochromic anaemia | 32 | 66.5 46.8–94.5ROR 66.7 · χ² 1,936 / p <1e-300 | 62.1 EB05 46.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 100% (drug 40%) | no trial data cached |
| Second primary malignancy | 241 | 60.9 53.7–69.2ROR 62.4 · χ² 13,739 / p <1e-300 | 58.9 EB05 52.9 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 35.0 · 98% clinician | no trial data cached |
| Pneumomediastinum | 51 | 60.1 45.5–79.3ROR 60.4 · χ² 2,819 / p <1e-300 | 57.2 EB05 45.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 14% (drug 40%) · 98% clinician | no trial data cached |
| Acute promyelocytic leukaemia | 29 | 59.7 41.3–86.3ROR 59.8 · χ² 1,568 / p <1e-300 | 55.9 EB05 40.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Pseudomonal sepsis | 48 | 57.2 42.9–76.1ROR 57.4 · χ² 2,521 / p <1e-300 | 54.5 EB05 42.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 100% (drug 40%) | no trial data cached |
| Vulvovaginal inflammation | 11 | 52.4 28.8–95.3ROR 52.4 · χ² 491 / p 4e-109 | 47.2 EB05 28.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Subcutaneous emphysema | 23 | 48.9 32.4–73.9ROR 49.0 · χ² 1,008 / p 2e-221 | 46.1 EB05 32.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 13% (drug 40%) | no trial data cached |
| Malignant transformation | 10 | 46.5 24.9–87.0ROR 46.6 · χ² 392 / p 2e-87 | 42.1 EB05 24.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Traumatic lung injury | 42 | 45.1 33.2–61.1ROR 45.2 · χ² 1,727 / p <1e-300 | 43.3 EB05 33.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=42 · 100% clinician | no trial data cached |
| Peripheral t-cell lymphoma unspecified | 12 | 42.6 24.1–75.5ROR 42.7 · χ² 438 / p 2e-97 | 39.4 EB05 24.0 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
| Cerebral artery stenosis | 10 | 42.5 22.7–79.5ROR 42.5 · χ² 357 / p 6e-80 | 38.8 EB05 22.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 826 | 25.8 24.1–27.5ROR 27.9 · χ² 19,462 / p <1e-300 | 25.5 EB05 24.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · 97% clinician | no trial data cached |
| Off label use (used outside approved label) | 790 | 1.9 1.7–2.0ROR 1.9 · χ² 326 / p 3e-73 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.0 · 96% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 599 | 9.1 8.4–9.8ROR 9.6 · χ² 4,297 / p <1e-300 | 9.0 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · 91% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 506 | 0.8 0.7–0.9ROR 0.8 · χ² 32 / p 9e-9 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.3 · 97% clinician | no trial data cached |
| Pyrexia (fever) | 463 | 2.7 2.5–3.0ROR 2.8 · χ² 515 / p 3e-114 | 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 |
| Pulmonary toxicity | 415 | 128.3 116.4–141.4ROR 133.7 · χ² 49,183 / p <1e-300 | 120.0 EB05 110.7 · IC025 +6.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 71.2 · 96% clinician | no trial data cached |
| Vomiting | 370 | 1.6 1.5–1.8ROR 1.6 · χ² 87 / p 5e-21 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.4 · ♀ 61% (drug 40%) | no trial data cached |
| Nausea | 367 | 0.9 0.9–1.1ROR 0.9 · χ² 1 / p 0.164 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Anaemia (low red blood cells) | 356 | 3.8 3.4–4.2ROR 3.9 · χ² 742 / p 1e-163 | 3.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · 94% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 354 | 6.5 5.9–7.2ROR 6.7 · χ² 1,645 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 95% clinician | no trial data cached |
| Respiratory failure | 322 | 9.0 8.1–10.1ROR 9.3 · χ² 2,293 / p <1e-300 | 8.9 EB05 8.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 91% clinician | no trial data cached |
| Sepsis (blood infection) | 321 | 5.9 5.3–6.6ROR 6.0 · χ² 1,301 / p 4e-285 | 5.8 EB05 5.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Acute myeloid leukaemia | 305 | 40.8 36.5–45.6ROR 42.0 · χ² 11,570 / p <1e-300 | 39.9 EB05 36.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 · 94% clinician | no trial data cached |
| Disease progression | 295 | 5.1 4.6–5.7ROR 5.2 · χ² 976 / p 1e-214 | 5.1 EB05 4.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 98% clinician | no trial data cached |
| Product use in unapproved indication | 294 | 2.5 2.2–2.8ROR 2.5 · χ² 256 / p 7e-58 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · 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.
- Flagellate dermatitis — n=29, PRR 1,668.6
- Basal ganglion degeneration — n=33, PRR 1,071.9
- Tissue infiltration — n=34, PRR 268.5
- Azoospermia — n=44, PRR 261.4
- Nail bed inflammation — n=35, PRR 252.6
- Anaesthesia — n=26, PRR 158.7
- Neutropenic infection — n=67, PRR 152.1
- Chloroma — n=26, PRR 133.9
- Nasal mucosal disorder — n=35, PRR 130.0
- Uterine enlargement — n=34, PRR 91.2
✓ 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, pulmonary toxicity, vomiting, nausea. 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, 1,005 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.