Dacarbazine side effects: what 7,411 FDA adverse event reports show
Who reports
7,411 reports · 95% serious · 1,301 with death outcome · 46% female
Used for
Dacarbazine for Injection is indicated in the treatment of metastatic malignant melanoma. In addition, Dacarbazine for Injection is also indicated for Hodgkin's disease as a secondary-line therapy when used in combination with other effective agents.
What it is
DESCRIPTION Dacarbazine for Injection, USP is a white to an ivory colored solid which is light sensitive. Each 20 mL vial contains 200 mg of dacarbazine, USP (active ingredient).
Boxed warning
It is recommended that dacarbazine for injection be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Hemopoietic depression is the most common toxicity with dacarbazine for injection. (See WARNINGS .) Hepatic necrosis has been reported.
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.
- 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 | 188 | 34.6 30.0–39.8ROR 35.4 · χ² 6,025 / p <1e-300 | 34.1 EB05 30.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 · 93% clinician | no trial data cached |
| Febrile neutropenia | 643 | 27.7 25.8–29.9ROR 30.3 · χ² 16,433 / p <1e-300 | 27.5 EB05 25.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 · 98% clinician | no trial data cached |
| Pneumocystis jirovecii pneumonia | 86 | 24.5 19.9–30.3ROR 24.8 · χ² 1,903 / p <1e-300 | 24.2 EB05 20.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 · 94% clinician | no trial data cached |
| Haematotoxicity | 55 | 16.9 13.0–22.0ROR 17.0 · χ² 801 / p 1e-176 | 16.7 EB05 13.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · 100% clinician | no trial data cached |
| Myelodysplastic syndrome | 85 | 16.7 13.5–20.7ROR 16.9 · χ² 1,233 / p 2e-270 | 16.5 EB05 13.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · 95% clinician | no trial data cached |
| Cytopenia | 61 | 14.5 11.3–18.6ROR 14.6 · χ² 750 / p 2e-165 | 14.3 EB05 11.5 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.0 | no trial data cached |
| Therapy partial responder | 71 | 13.4 10.6–16.9ROR 13.5 · χ² 799 / p 5e-176 | 13.2 EB05 10.8 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · 99% clinician | no trial data cached |
| Mucosal inflammation | 105 | 11.4 9.5–13.8ROR 11.6 · χ² 987 / p 5e-217 | 11.3 EB05 9.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 98% clinician | no trial data cached |
| Candida infection (yeast infection) | 65 | 11.1 8.7–14.1ROR 11.2 · χ² 583 / p 4e-129 | 10.8 EB05 8.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · ♀ 69% (drug 46%) | no trial data cached |
| Posterior reversible encephalopathy syndrome | 36 | 10.7 7.7–14.9ROR 10.8 · χ² 307 / p 4e-69 | 10.2 EB05 7.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · ♀ 71% (drug 46%) · 100% clinician | no trial data cached |
| Pneumonitis | 102 | 10.7 8.8–13.0ROR 10.8 · χ² 886 / p 5e-195 | 10.5 EB05 8.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 99% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 504 | 10.6 9.7–11.5ROR 11.3 · χ² 4,365 / p <1e-300 | 10.5 EB05 9.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 91% clinician | no trial data cached |
| Polyneuropathy | 43 | 10.3 7.6–13.8ROR 10.3 · χ² 349 / p 3e-78 | 9.8 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 98% clinician | no trial data cached |
| Ileus | 44 | 10.1 7.6–13.6ROR 10.2 · χ² 353 / p 5e-79 | 9.7 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 91% clinician | no trial data cached |
| Neutrophil count decreased | 132 | 9.2 7.8–11.0ROR 9.4 · χ² 961 / p 2e-211 | 9.1 EB05 7.8 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 6.1 · 97% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 300 | 9.0 8.1–10.1ROR 9.3 · χ² 2,129 / p <1e-300 | 8.9 EB05 8.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Red blood cell sedimentation rate increased | 35 | 9.0 6.4–12.5ROR 9.0 · χ² 239 / p 4e-54 | 8.3 EB05 6.1 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.9 · ♀ 94% (drug 46%) | no trial data cached |
| Splenomegaly | 36 | 8.7 6.3–12.1ROR 8.8 · χ² 238 / p 6e-54 | 8.1 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 88% (drug 46%) | no trial data cached |
| Spinal pain | 36 | 8.7 6.3–12.1ROR 8.8 · χ² 238 / p 6e-54 | 8.1 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 100% (drug 46%) | no trial data cached |
| Ejection fraction decreased | 47 | 8.6 6.4–11.4ROR 8.6 · χ² 306 / p 9e-69 | 8.1 EB05 6.3 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 · ♀ 68% (drug 46%) · 98% clinician | no trial data cached |
| Myelosuppression | 99 | 8.3 6.8–10.0ROR 8.4 · χ² 623 / p 8e-138 | 8.0 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 97% clinician | no trial data cached |
| Pulmonary congestion | 38 | 8.1 5.9–11.2ROR 8.2 · χ² 230 / p 2e-52 | 7.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 91% (drug 46%) | no trial data cached |
| Clostridium difficile colitis | 30 | 8.0 5.6–11.5ROR 8.0 · χ² 177 / p 1e-40 | 7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 97% clinician | no trial data cached |
| Tenderness | 29 | 7.9 5.5–11.3ROR 7.9 · χ² 167 / p 2e-38 | 7.2 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 100% (drug 46%) | no trial data cached |
| Pulmonary fibrosis | 53 | 7.9 6.0–10.3ROR 7.9 · χ² 310 / p 1e-69 | 7.5 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 96% clinician | no trial data cached |
| Lymphopenia | 39 | 7.9 5.7–10.8ROR 7.9 · χ² 226 / p 2e-51 | 7.3 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 94% clinician | no trial data cached |
| Muscle spasticity | 34 | 7.8 5.6–10.9ROR 7.8 · χ² 194 / p 3e-44 | 7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 87% (drug 46%) | no trial data cached |
| Interstitial lung disease | 130 | 7.6 6.4–9.1ROR 7.7 · χ² 742 / p 1e-163 | 7.5 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 96% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 134 | 7.6 6.4–9.0ROR 7.7 · χ² 763 / p 2e-168 | 7.4 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.8 · 97% clinician | no trial data cached |
| Disease progression | 313 | 7.5 6.8–8.4ROR 7.8 · χ² 1,770 / p <1e-300 | 7.4 EB05 6.8 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 · 97% clinician | no trial data cached |
| Hypothyroidism | 82 | 7.3 5.9–9.1ROR 7.4 · χ² 439 / p 8e-98 | 7.0 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Hypokinesia | 35 | 6.8 4.9–9.5ROR 6.9 · χ² 168 / p 1e-38 | 6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 94% (drug 46%) | no trial data cached |
| Bacteraemia | 28 | 6.7 4.7–9.8ROR 6.8 · χ² 131 / p 1e-30 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · ♀ 74% (drug 46%) · 100% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 132 | 6.7 5.7–8.0ROR 6.8 · χ² 637 / p 9e-141 | 6.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.0 · 98% clinician | no trial data cached |
| Cardiomyopathy | 35 | 6.7 4.8–9.3ROR 6.7 · χ² 164 / p 8e-38 | 6.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 100% clinician | no trial data cached |
| Neoplasm progression | 83 | 6.7 5.4–8.3ROR 6.8 · χ² 397 / p 1e-88 | 6.5 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 90% clinician | no trial data cached |
| Metastases to lung | 27 | 6.6 4.5–9.7ROR 6.7 · χ² 123 / p 6e-29 | 6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · ♀ 25% (drug 46%) · 96% clinician | no trial data cached |
| Premature baby | 68 | 6.4 5.0–8.1ROR 6.4 · χ² 303 / p 3e-68 | 6.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 100% clinician | no trial data cached |
| Intestinal perforation | 25 | 6.3 4.3–9.3ROR 6.3 · χ² 106 / p 3e-25 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 96% clinician | no trial data cached |
| Colitis | 83 | 6.2 5.0–7.7ROR 6.3 · χ² 360 / p 1e-80 | 6.0 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 95% 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 643 | 27.7 25.8–29.9ROR 30.3 · χ² 16,433 / p <1e-300 | 27.5 EB05 25.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 · 98% clinician | no trial data cached |
| Off label use (used outside approved label) | 613 | 2.0 1.9–2.2ROR 2.1 · χ² 318 / p 2e-71 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 2.1 · 94% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 504 | 10.6 9.7–11.5ROR 11.3 · χ² 4,365 / p <1e-300 | 10.5 EB05 9.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 91% clinician | no trial data cached |
| Pyrexia (fever) | 387 | 3.2 2.9–3.5ROR 3.3 · χ² 580 / p 2e-128 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 2.4 | no trial data cached |
| Disease progression | 313 | 7.5 6.8–8.4ROR 7.8 · χ² 1,770 / p <1e-300 | 7.4 EB05 6.8 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 · 97% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 300 | 9.0 8.1–10.1ROR 9.3 · χ² 2,129 / p <1e-300 | 8.9 EB05 8.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Anaemia (low red blood cells) | 254 | 3.8 3.3–4.3ROR 3.9 · χ² 518 / p 6e-115 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.5 · 91% clinician | no trial data cached |
| Product use in unapproved indication | 239 | 2.8 2.4–3.1ROR 2.8 · χ² 271 / p 3e-61 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 · 97% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 223 | 5.7 5.0–6.5ROR 5.8 · χ² 855 / p 2e-188 | 5.6 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.5 · 94% clinician | no trial data cached |
| Sepsis (blood infection) | 212 | 5.4 4.7–6.1ROR 5.5 · χ² 755 / p 2e-166 | 5.3 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Malignant neoplasm progression | 211 | 5.9 5.1–6.7ROR 6.0 · χ² 850 / p 3e-187 | 5.8 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 · 92% clinician | no trial data cached |
| Pneumonia (lung infection) | 207 | 1.8 1.6–2.1ROR 1.8 · χ² 76 / p 2e-18 | 1.8 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Acute myeloid leukaemia | 188 | 34.6 30.0–39.8ROR 35.4 · χ² 6,025 / p <1e-300 | 34.1 EB05 30.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 · 93% clinician | no trial data cached |
| Abdominal pain | 181 | 2.2 1.9–2.5ROR 2.2 · χ² 119 / p 5e-28 | 2.2 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 1.7 · 92% clinician | no trial data cached |
| Respiratory failure | 146 | 5.7 4.8–6.7ROR 5.8 · χ² 558 / p 1e-123 | 5.6 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | 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=188, PRR 34.6
- Febrile neutropenia — n=643, PRR 27.7
- Pneumocystis jirovecii pneumonia — n=86, PRR 24.5
- Haematotoxicity — n=55, PRR 16.9
- Myelodysplastic syndrome — n=85, PRR 16.7
- Mucosal inflammation — n=105, PRR 11.4
- Candida infection — n=65, PRR 11.1
- Posterior reversible encephalopathy syndrome — n=36, PRR 10.7
- Pneumonitis — n=102, PRR 10.7
- Neutropenia — n=504, PRR 10.6
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 Dacarbazine?
In FDA FAERS, the most frequently co-reported reaction terms for Dacarbazine are febrile neutropenia, neutropenia, pyrexia, neuropathy peripheral, anaemia, thrombocytopenia. 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 Dacarbazine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: It is recommended that dacarbazine for injection be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Hemopoietic depression is the most common toxicity with dacarbazine for injection. (See WARNINGS .) Hepatic necrosis has been reported.
Do FAERS signals prove that Dacarbazine 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 64037f45-6245-49f0-9ae8-18d75753ae1f, effective 20240322; matched on
openfda.generic_name.exact:"DACARBAZINE") - 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.