Daunorubicin side effects: what 1,580 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Daunorubicin Hydrochloride (Daunorubicin Hydrochloride)
Who reports
1,580 reports · 99% serious · 394 with death outcome · 48% female
Used for
Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
What it is
DESCRIPTION Daunorubicin Hydrochloride Injection consists of the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus . It is provided as a deep red sterile liquid in vials for intravenous administration only.
Boxed warning
Daunorubicin hydrochloride injection must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration.
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. 37 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 |
|---|---|---|---|---|---|---|
| Clostridium difficile colitis | 110 | 138.9 115.9–166.5ROR 149.2 · χ² 14,774 / p <1e-300 | 134.3 EB05 114.5 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 81.4 | no trial data cached |
| Bacterial infection | 154 | 111.0 95.4–129.0ROR 122.8 · χ² 16,546 / p <1e-300 | 108.6 EB05 94.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 73.8 | no trial data cached |
| Myelosuppression | 161 | 63.1 54.5–73.1ROR 70.1 · χ² 9,747 / p <1e-300 | 62.4 EB05 54.7 · IC025 +5.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 36.5 | no trial data cached |
| Lymphopenia | 59 | 55.9 43.5–71.8ROR 58.0 · χ² 3,114 / p <1e-300 | 54.7 EB05 44.0 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 34.9 · ♀ 18% (drug 48%) | no trial data cached |
| Bone marrow failure | 61 | 39.7 31.0–50.8ROR 41.2 · χ² 2,257 / p <1e-300 | 39.1 EB05 31.6 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.1 · ♀ 5% (drug 48%) | no trial data cached |
| Febrile neutropenia | 194 | 39.0 34.2–44.5ROR 44.3 · χ² 7,145 / p <1e-300 | 38.7 EB05 34.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 22.7 · 93% clinician | no trial data cached |
| Fungal infection | 87 | 34.8 28.3–42.7ROR 36.7 · χ² 2,816 / p <1e-300 | 34.4 EB05 28.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 36.8 · ♀ 4% (drug 48%) | no trial data cached |
| Viral infection | 86 | 34.4 28.0–42.3ROR 36.3 · χ² 2,754 / p <1e-300 | 34.1 EB05 28.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 28.0 · ♀ 100% (drug 48%) | no trial data cached |
| Hyperbilirubinaemia | 21 | 27.1 17.7–41.5ROR 27.5 · χ² 501 / p 2e-111 | 26.5 EB05 18.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 · 95% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 19 | 26.5 17.0–41.5ROR 26.9 · χ² 441 / p 3e-98 | 25.9 EB05 17.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 | no trial data cached |
| Acute myeloid leukaemia | 31 | 26.5 18.7–37.5ROR 27.0 · χ² 734 / p 7e-162 | 26.0 EB05 19.2 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 15.4 · 100% clinician | no trial data cached |
| Bacteraemia | 20 | 22.6 14.6–34.9ROR 22.9 · χ² 391 / p 3e-87 | 22.1 EB05 15.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 | no trial data cached |
| Pancytopenia (all blood cells low) | 92 | 21.9 18.0–26.8ROR 23.2 · χ² 1,820 / p <1e-300 | 21.8 EB05 18.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Lymphadenopathy | 48 | 18.0 13.6–23.8ROR 18.5 · χ² 754 / p 3e-166 | 17.8 EB05 14.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 · ♀ 7% (drug 48%) | no trial data cached |
| Disseminated intravascular coagulation | 19 | 17.9 11.4–28.0ROR 18.1 · χ² 286 / p 2e-64 | 17.4 EB05 11.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Oral herpes | 26 | 17.8 12.1–26.0ROR 18.0 · χ² 395 / p 4e-88 | 17.5 EB05 12.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 24.2 | no trial data cached |
| Electrolyte imbalance | 15 | 17.3 10.5–28.7ROR 17.5 · χ² 215 / p 7e-49 | 16.6 EB05 10.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Device related infection | 20 | 17.2 11.1–26.6ROR 17.4 · χ² 289 / p 3e-65 | 16.8 EB05 11.2 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.2 · 90% clinician | no trial data cached |
| Coagulopathy | 21 | 16.8 11.0–25.7ROR 17.0 · χ² 296 / p 1e-66 | 16.3 EB05 11.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · 100% clinician | no trial data cached |
| Polyneuropathy | 15 | 16.8 10.1–27.7ROR 16.9 · χ² 207 / p 4e-47 | 16.0 EB05 9.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Mucosal inflammation | 32 | 16.3 11.6–23.0ROR 16.6 · χ² 445 / p 5e-99 | 16.1 EB05 11.8 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.1 · 97% clinician | no trial data cached |
| Premature delivery | 19 | 15.8 10.1–24.7ROR 16.0 · χ² 248 / p 3e-56 | 15.2 EB05 9.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Hepatotoxicity (liver damage) | 25 | 15.0 10.2–22.1ROR 15.2 · χ² 312 / p 3e-70 | 14.6 EB05 10.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · ♀ 73% (drug 48%) · 100% clinician | no trial data cached |
| Septic shock | 48 | 14.8 11.2–19.5ROR 15.2 · χ² 602 / p 3e-133 | 14.6 EB05 11.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Cytomegalovirus infection | 18 | 14.4 9.1–22.8ROR 14.5 · χ² 211 / p 5e-48 | 13.6 EB05 8.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Incorrect route of product administration | 18 | 14.2 9.0–22.5ROR 14.4 · χ² 208 / p 2e-47 | 13.5 EB05 8.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 16.5 | no trial data cached |
| Cellulitis (skin infection) | 54 | 14.2 10.9–18.5ROR 14.7 · χ² 651 / p 6e-144 | 14.0 EB05 11.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 · ♀ 0% (drug 48%) | no trial data cached |
| Tooth infection | 14 | 14.1 8.4–23.8ROR 14.2 · χ² 157 / p 2e-36 | 13.0 EB05 7.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Ileus | 13 | 14.0 8.2–24.1ROR 14.1 · χ² 145 / p 1e-33 | 12.8 EB05 7.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Myelodysplastic syndrome | 15 | 13.8 8.3–22.8ROR 13.9 · χ² 165 / p 5e-38 | 12.7 EB05 7.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Drug resistance | 23 | 11.9 7.9–17.8ROR 12.1 · χ² 219 / p 8e-50 | 11.1 EB05 7.4 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 7.8 · 100% clinician | no trial data cached |
| Neutrophil count decreased | 36 | 11.8 8.5–16.3ROR 12.1 · χ² 346 / p 2e-77 | 11.4 EB05 8.4 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 8.0 | no trial data cached |
| Acute respiratory distress syndrome | 15 | 11.3 6.8–18.6ROR 11.4 · χ² 130 / p 2e-30 | 9.9 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Multiple organ dysfunction syndrome | 23 | 10.9 7.3–16.4ROR 11.1 · χ² 198 / p 3e-45 | 10.1 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Circulatory collapse | 14 | 10.9 6.5–18.3ROR 11.0 · χ² 116 / p 3e-27 | 9.4 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Blood bilirubin increased | 22 | 10.8 7.1–16.3ROR 10.9 · χ² 186 / p 1e-42 | 9.9 EB05 6.6 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 6.9 | no trial data cached |
| Cystitis | 25 | 10.4 7.0–15.3ROR 10.5 · χ² 203 / p 2e-46 | 9.6 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 14 | 10.1 6.0–16.9ROR 10.1 · χ² 105 / p 5e-25 | 8.6 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Cardiomyopathy | 11 | 9.9 5.5–17.8ROR 9.9 · χ² 79 / p 3e-19 | 8.0 EB05 4.4 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Colitis | 27 | 9.5 6.5–13.8ROR 9.7 · χ² 198 / p 3e-45 | 8.7 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | 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 | 194 | 39.0 34.2–44.5ROR 44.3 · χ² 7,145 / p <1e-300 | 38.7 EB05 34.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 22.7 · 93% clinician | no trial data cached |
| Myelosuppression | 161 | 63.1 54.5–73.1ROR 70.1 · χ² 9,747 / p <1e-300 | 62.4 EB05 54.7 · IC025 +5.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 36.5 | no trial data cached |
| Bacterial infection | 154 | 111.0 95.4–129.0ROR 122.8 · χ² 16,546 / p <1e-300 | 108.6 EB05 94.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 73.8 | no trial data cached |
| Clostridium difficile colitis | 110 | 138.9 115.9–166.5ROR 149.2 · χ² 14,774 / p <1e-300 | 134.3 EB05 114.5 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 81.4 | no trial data cached |
| Pancytopenia (all blood cells low) | 92 | 21.9 18.0–26.8ROR 23.2 · χ² 1,820 / p <1e-300 | 21.8 EB05 18.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Fungal infection | 87 | 34.8 28.3–42.7ROR 36.7 · χ² 2,816 / p <1e-300 | 34.4 EB05 28.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 36.8 · ♀ 4% (drug 48%) | no trial data cached |
| Viral infection | 86 | 34.4 28.0–42.3ROR 36.3 · χ² 2,754 / p <1e-300 | 34.1 EB05 28.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 28.0 · ♀ 100% (drug 48%) | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 69 | 6.8 5.4–8.5ROR 7.0 · χ² 335 / p 4e-75 | 6.5 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Bone marrow failure | 61 | 39.7 31.0–50.8ROR 41.2 · χ² 2,257 / p <1e-300 | 39.1 EB05 31.6 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.1 · ♀ 5% (drug 48%) | no trial data cached |
| Lymphopenia | 59 | 55.9 43.5–71.8ROR 58.0 · χ² 3,114 / p <1e-300 | 54.7 EB05 44.0 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 34.9 · ♀ 18% (drug 48%) | no trial data cached |
| Platelet count decreased | 55 | 6.9 5.3–8.9ROR 7.1 · χ² 270 / p 4e-61 | 6.5 EB05 5.2 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 4.9 | no trial data cached |
| Cellulitis (skin infection) | 54 | 14.2 10.9–18.5ROR 14.7 · χ² 651 / p 6e-144 | 14.0 EB05 11.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 · ♀ 0% (drug 48%) | no trial data cached |
| White blood cell count decreased | 53 | 6.5 5.0–8.5ROR 6.7 · χ² 242 / p 9e-55 | 6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.3 · 90% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 52 | 6.2 4.7–8.1ROR 6.4 · χ² 222 / p 1e-50 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 92% clinician | no trial data cached |
| Septic shock | 48 | 14.8 11.2–19.5ROR 15.2 · χ² 602 / p 3e-133 | 14.6 EB05 11.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | 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.
- Clostridium difficile colitis — n=110, PRR 138.9
- Bacterial infection — n=154, PRR 111.0
- Febrile neutropenia — n=194, PRR 39.0
- Fungal infection — n=87, PRR 34.8
- Viral infection — n=86, PRR 34.4
- Hyperbilirubinaemia — n=21, PRR 27.1
- Bacteraemia — n=20, PRR 22.6
- Pancytopenia — n=92, PRR 21.9
- Lymphadenopathy — n=48, PRR 18.0
- Oral herpes — n=26, PRR 17.8
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 Daunorubicin?
In FDA FAERS, the most frequently co-reported reaction terms for Daunorubicin are febrile neutropenia, myelosuppression, bacterial infection, clostridium difficile colitis, pancytopenia, fungal infection. 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 Daunorubicin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Daunorubicin hydrochloride injection must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration.
Do FAERS signals prove that Daunorubicin 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 ff6b9bd4-8a9f-400f-a0b9-70e25fa8a28f, effective 20250521; matched on
openfda.generic_name.exact:"DAUNORUBICIN HYDROCHLORIDE") - 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, 77 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.