Carmustine side effects: what 4,612 FDA adverse event reports show
Drug class
Nitrosourea
Who reports
4,612 reports · 98% serious · 1,192 with death outcome · 37% female
Used for
Carmustine for injection, USP is indicated as palliative therapy as a single agent or in established combination therapy in the following: - Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - Multiple myeloma in combination with prednisone. - Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs.
What it is
The active ingredient in carmustine for injection, USP is a nitrosourea with the chemical name 1,3-bis(2-chloroethyl)-1-nitrosourea and a molecular weight of 214.06. The drug product is suppli.
Boxed warning
MYELOSUPPRESSION and PULMONARY TOXICITY Myelosuppression Carmustine for injection, USP causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections. [see Warnings and Precautions (5.1 ) and Adverse Reactions (6) ] .
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. 145 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 |
|---|---|---|---|---|---|---|
| Myelodysplastic syndrome | 296 | 94.9 84.9–106.1ROR 101.4 · χ² 26,865 / p <1e-300 | 92.4 EB05 83.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 55.1 · 97% clinician | no trial data cached |
| Acute myeloid leukaemia | 172 | 50.8 43.8–58.8ROR 52.7 · χ² 8,256 / p <1e-300 | 50.0 EB05 44.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 29.7 · 95% clinician | no trial data cached |
| Brain oedema | 137 | 49.9 42.2–58.9ROR 51.4 · χ² 6,443 / p <1e-300 | 49.0 EB05 42.5 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 29.3 · 94% clinician | no trial data cached |
| Mucosal inflammation | 219 | 38.5 33.8–43.9ROR 40.4 · χ² 7,909 / p <1e-300 | 38.1 EB05 34.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 23.9 · 95% clinician | no trial data cached |
| Haematotoxicity | 65 | 32.1 25.2–40.9ROR 32.5 · χ² 1,914 / p <1e-300 | 31.6 EB05 25.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.2 · 97% clinician | no trial data cached |
| Febrile neutropenia | 391 | 27.0 24.5–29.7ROR 29.4 · χ² 9,736 / p <1e-300 | 26.8 EB05 24.7 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.8 · 95% clinician | no trial data cached |
| Pneumocystis jirovecii pneumonia | 50 | 22.9 17.3–30.1ROR 23.1 · χ² 1,018 / p 9e-224 | 22.6 EB05 17.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 · 98% clinician | no trial data cached |
| Therapy partial responder | 69 | 20.9 16.5–26.5ROR 21.2 · χ² 1,284 / p 2e-281 | 20.7 EB05 16.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 14.6 · 99% clinician | no trial data cached |
| Cytomegalovirus infection | 74 | 20.3 16.2–25.5ROR 20.6 · χ² 1,335 / p 2e-292 | 20.1 EB05 16.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · 96% clinician | no trial data cached |
| Cytopenia | 50 | 19.1 14.5–25.2ROR 19.3 · χ² 836 / p 3e-184 | 18.9 EB05 14.9 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.5 | no trial data cached |
| Acute respiratory distress syndrome | 63 | 16.2 12.7–20.8ROR 16.5 · χ² 884 / p 2e-194 | 16.1 EB05 13.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 · 93% clinician | no trial data cached |
| Bacteraemia | 40 | 15.5 11.4–21.1ROR 15.6 · χ² 527 / p 8e-117 | 15.3 EB05 11.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · ♀ 70% (drug 37%) · 98% clinician | no trial data cached |
| Basal cell carcinoma | 50 | 14.6 11.1–19.2ROR 14.7 · χ² 618 / p 9e-137 | 14.4 EB05 11.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 0% (drug 37%) · 98% clinician | no trial data cached |
| Cytokine release syndrome | 60 | 14.4 11.2–18.5ROR 14.5 · χ² 731 / p 3e-161 | 14.2 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · 95% clinician | no trial data cached |
| Lymphoma | 47 | 13.8 10.4–18.4ROR 14.0 · χ² 545 / p 7e-121 | 13.6 EB05 10.5 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.4 · 96% clinician | no trial data cached |
| Clostridium difficile colitis | 28 | 12.0 8.3–17.4ROR 12.1 · χ² 271 / p 3e-61 | 11.4 EB05 8.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · ♀ 67% (drug 37%) · 100% clinician | no trial data cached |
| Lymphopenia | 37 | 12.0 8.7–16.5ROR 12.1 · χ² 361 / p 9e-81 | 11.6 EB05 8.5 · IC025 +2.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.6 · 100% clinician | no trial data cached |
| Disease progression | 292 | 11.3 10.1–12.6ROR 12.0 · χ² 2,735 / p <1e-300 | 11.2 EB05 10.2 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · 93% clinician | no trial data cached |
| Nephropathy toxic | 27 | 11.0 7.6–16.1ROR 11.1 · χ² 236 / p 1e-53 | 10.3 EB05 7.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · 100% clinician | no trial data cached |
| Septic shock | 101 | 10.6 8.8–12.9ROR 10.9 · χ² 873 / p 4e-192 | 10.5 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 98% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 250 | 10.2 9.1–11.5ROR 10.7 · χ² 2,075 / p <1e-300 | 10.1 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.2 · 90% clinician | no trial data cached |
| Status epilepticus | 23 | 9.3 6.2–13.9ROR 9.3 · χ² 161 / p 3e-37 | 8.3 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 76% (drug 37%) · 100% clinician | no trial data cached |
| Post procedural complication | 39 | 9.2 6.8–12.6ROR 9.3 · χ² 278 / p 1e-62 | 8.7 EB05 6.5 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Blood lactate dehydrogenase increased | 32 | 9.1 6.5–12.9ROR 9.2 · χ² 224 / p 7e-51 | 8.5 EB05 6.1 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 · ♀ 11% (drug 37%) · 100% clinician | no trial data cached |
| Bone marrow failure | 41 | 9.1 6.7–12.4ROR 9.2 · χ² 288 / p 6e-65 | 8.6 EB05 6.5 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 | no trial data cached |
| Staphylococcal infection | 66 | 9.1 7.1–11.5ROR 9.2 · χ² 466 / p 1e-103 | 8.7 EB05 7.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Intestinal perforation | 22 | 8.9 5.9–13.5ROR 9.0 · χ² 147 / p 5e-34 | 8.0 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 100% clinician | no trial data cached |
| Candida infection (yeast infection) | 32 | 8.7 6.2–12.3ROR 8.8 · χ² 211 / p 4e-48 | 8.1 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · 97% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 105 | 8.6 7.1–10.4ROR 8.8 · χ² 696 / p 1e-153 | 8.4 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.1 · 93% clinician | no trial data cached |
| Ataxia | 22 | 8.4 5.5–12.8ROR 8.4 · χ² 136 / p 1e-31 | 7.5 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 95% clinician | no trial data cached |
| Wound infection | 20 | 8.4 5.4–13.0ROR 8.4 · χ² 123 / p 9e-29 | 7.4 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Colitis | 69 | 8.3 6.6–10.5ROR 8.5 · χ² 439 / p 1e-97 | 8.0 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 97% clinician | no trial data cached |
| Multi-organ failure | 32 | 8.3 5.9–11.7ROR 8.4 · χ² 198 / p 3e-45 | 7.6 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Glomerular filtration rate decreased | 22 | 8.3 5.4–12.6ROR 8.3 · χ² 133 / p 4e-31 | 7.3 EB05 5.0 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 · ♀ 0% (drug 37%) · 91% clinician | no trial data cached |
| Device related infection | 28 | 8.3 5.7–12.0ROR 8.3 · χ² 171 / p 2e-39 | 7.5 EB05 5.4 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · ♀ 14% (drug 37%) · 93% clinician | no trial data cached |
| Drug toxicity | 25 | 8.2 5.6–12.2ROR 8.3 · χ² 152 / p 4e-35 | 7.4 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 | no trial data cached |
| Pneumonitis | 48 | 8.1 6.1–10.7ROR 8.2 · χ² 291 / p 2e-65 | 7.6 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 95% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 39 | 8.0 5.9–11.0ROR 8.1 · χ² 232 / p 1e-52 | 7.5 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 100% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 84 | 7.7 6.2–9.5ROR 7.8 · χ² 481 / p 8e-107 | 7.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.7 · ♀ 63% (drug 37%) · 96% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 16 | 7.7 4.7–12.5ROR 7.7 · χ² 86 / p 9e-21 | 6.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | 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) | 515 | 2.7 2.5–2.9ROR 2.9 · χ² 573 / p 8e-127 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 · 96% clinician | no trial data cached |
| Febrile neutropenia | 391 | 27.0 24.5–29.7ROR 29.4 · χ² 9,736 / p <1e-300 | 26.8 EB05 24.7 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.8 · 95% clinician | no trial data cached |
| Myelodysplastic syndrome | 296 | 94.9 84.9–106.1ROR 101.4 · χ² 26,865 / p <1e-300 | 92.4 EB05 83.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 55.1 · 97% clinician | no trial data cached |
| Disease progression | 292 | 11.3 10.1–12.6ROR 12.0 · χ² 2,735 / p <1e-300 | 11.2 EB05 10.2 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · 93% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 250 | 10.2 9.1–11.5ROR 10.7 · χ² 2,075 / p <1e-300 | 10.1 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.2 · 90% clinician | no trial data cached |
| Pyrexia (fever) | 239 | 3.1 2.8–3.6ROR 3.3 · χ² 352 / p 8e-79 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 91% clinician | no trial data cached |
| Mucosal inflammation | 219 | 38.5 33.8–43.9ROR 40.4 · χ² 7,909 / p <1e-300 | 38.1 EB05 34.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 23.9 · 95% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 206 | 6.9 6.1–7.9ROR 7.2 · χ² 1,043 / p 4e-229 | 6.8 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · 92% clinician | no trial data cached |
| Pneumonia (lung infection) | 202 | 2.8 2.5–3.3ROR 2.9 · χ² 243 / p 4e-55 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 1.7 · 95% clinician | no trial data cached |
| Infection | 177 | 5.6 4.8–6.5ROR 5.8 · χ² 666 / p 4e-147 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.1 · 97% clinician | no trial data cached |
| Acute myeloid leukaemia | 172 | 50.8 43.8–58.8ROR 52.7 · χ² 8,256 / p <1e-300 | 50.0 EB05 44.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 29.7 · 95% clinician | no trial data cached |
| Sepsis (blood infection) | 159 | 6.5 5.6–7.6ROR 6.7 · χ² 735 / p 3e-162 | 6.4 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 94% clinician | no trial data cached |
| Product use in unapproved indication | 155 | 2.9 2.5–3.4ROR 3.0 · χ² 191 / p 8e-44 | 2.9 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 98% clinician | no trial data cached |
| Brain oedema | 137 | 49.9 42.2–58.9ROR 51.4 · χ² 6,443 / p <1e-300 | 49.0 EB05 42.5 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 29.3 · 94% clinician | no trial data cached |
| Malignant neoplasm progression | 129 | 5.8 4.9–6.8ROR 5.9 · χ² 505 / p 4e-112 | 5.6 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 92% 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.
- Myelodysplastic syndrome — n=296, PRR 94.9
- Acute myeloid leukaemia — n=172, PRR 50.8
- Brain oedema — n=137, PRR 49.9
- Mucosal inflammation — n=219, PRR 38.5
- Haematotoxicity — n=65, PRR 32.1
- Pneumocystis jirovecii pneumonia — n=50, PRR 22.9
- Cytomegalovirus infection — n=74, PRR 20.3
- Acute respiratory distress syndrome — n=63, PRR 16.2
- Bacteraemia — n=40, PRR 15.5
- Basal cell carcinoma — n=50, PRR 14.6
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 Carmustine?
In FDA FAERS, the most frequently co-reported reaction terms for Carmustine are febrile neutropenia, myelodysplastic syndrome, thrombocytopenia, pyrexia, mucosal inflammation, neutropenia. 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 Carmustine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: MYELOSUPPRESSION and PULMONARY TOXICITY Myelosuppression Carmustine for injection, USP causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections. [see Warnings and Precautions (5.1 ) and Adverse Reactions (6) ] .
Do FAERS signals prove that Carmustine 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 0bdd91e1-fd94-4ce8-9c99-1b0fa6fe8ae4, effective 20251121; matched on
openfda.generic_name.exact:"CARMUSTINE") - 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, 185 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.