Drug · FAERS side-effect profile with label screen

Daunorubicin and Cytarabine) Liposome side effects: what 2,336 FDA adverse event reports show

(Daunorubicin And Cytarabine) Liposome · 63 reaction terms · 2,804 drug–reaction co-reports · data 2026-09-14

Drug class

Nucleoside Metabolic Inhibitor, Anthracycline Topoisomerase Inhibitor

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

(Daunorubicin And Cytarabine) Liposome (Vyxeos)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

2,336 reports · 88% serious · 771 with death outcome · 41% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VYXEOS is indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older. VYXEOS is a liposomal combination of daunoru.

FDA label, Indications and Usage

What it is

VYXEOS (daunorubicin and cytarabine) liposome for injection is a combination of daunorubicin and cytarabine in a 1:5 molar ratio encapsulated in liposomes for intravenous administration. The l.

FDA label, Description section

Boxed warning

DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS • VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled — boxed warning 3Labeled adverse reaction 18Labeled (related wording) 4Likely indication confounding 2Reporting / coding artifact 3Not in label — unassessed 10

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.
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. 23 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Acute myeloid leukaemia	287	168.6 151.1–188.1ROR 192.0 · χ² 46,784 / p <1e-300	163.7 EB05 148.4 · IC025 +6.8 3/3 methods agree	Likely indication confounding term in indications	serious PRR 109.4 · 97% clinician	no trial data cached
Febrile neutropenia	502	68.6 63.4–74.1ROR 87.1 · χ² 33,203 / p <1e-300	67.9 EB05 63.0 · IC025 +5.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 44.7 · 91% clinician	no trial data cached
Cytopenia	80	60.5 48.7–75.1ROR 62.6 · χ² 4,592 / p <1e-300	59.3 EB05 49.2 · IC025 +5.1 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 40.9	no trial data cached
Bacteraemia	57	43.7 33.8–56.5ROR 44.7 · χ² 2,324 / p <1e-300	42.9 EB05 34.3 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 28.9 · 95% clinician	no trial data cached
Therapeutic product effect incomplete	195	24.8 21.7–28.4ROR 27.0 · χ² 4,437 / p <1e-300	24.7 EB05 21.9 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 29.7 · 100% clinician	no trial data cached
Bone marrow failure	52	22.9 17.5–29.9ROR 23.4 · χ² 1,064 / p 1e-233	22.6 EB05 17.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.1	no trial data cached
Toxic skin eruption	23	20.5 13.6–30.8ROR 20.7 · χ² 406 / p 1e-90	20.1 EB05 14.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.5	no trial data cached
Device related infection	31	18.1 12.7–25.6ROR 18.3 · χ² 482 / p 4e-107	17.8 EB05 13.0 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 12.2 · 90% clinician	no trial data cached
Myelosuppression	66	17.4 13.7–22.1ROR 17.9 · χ² 1,006 / p 4e-221	17.3 EB05 14.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.3 · 98% clinician	no trial data cached
Drug eruption	34	17.3 12.4–24.2ROR 17.6 · χ² 507 / p 1e-112	17.1 EB05 12.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.3	no trial data cached
Pneumocystis jirovecii pneumonia	19	17.1 10.9–26.8ROR 17.2 · χ² 272 / p 3e-61	16.6 EB05 10.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Mucosal inflammation	47	16.2 12.2–21.5ROR 16.5 · χ² 655 / p 7e-145	16.0 EB05 12.5 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.4	no trial data cached
Septic shock	75	15.6 12.5–19.5ROR 16.1 · χ² 1,011 / p 4e-222	15.5 EB05 12.7 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.3	no trial data cached
Ejection fraction decreased	24	13.9 9.3–20.6ROR 14.0 · χ² 273 / p 1e-61	13.3 EB05 9.1 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.8	no trial data cached
Disseminated intravascular coagulation	20	12.7 8.2–19.7ROR 12.8 · χ² 204 / p 1e-46	11.9 EB05 7.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.4 · 100% clinician	no trial data cached
Acute respiratory distress syndrome	25	12.7 8.6–18.8ROR 12.8 · χ² 258 / p 3e-58	12.1 EB05 8.3 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.4 · 100% clinician	no trial data cached
Rash maculo-papular	29	11.8 8.2–16.9ROR 11.9 · χ² 275 / p 5e-62	11.2 EB05 7.9 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.3 · 93% clinician	no trial data cached
Neutrophil count decreased	51	11.3 8.6–14.8ROR 11.5 · χ² 470 / p 2e-104	11.0 EB05 8.5 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.5 · ♀ 61% (drug 41%) · 94% clinician	no trial data cached
Sepsis (blood infection)	134	10.8 9.2–12.7ROR 11.4 · χ² 1,185 / p 5e-260	10.7 EB05 9.2 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.1	no trial data cached
Cardiomyopathy	16	9.7 6.0–15.8ROR 9.8 · χ² 116 / p 2e-27	8.4 EB05 5.2 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.4	no trial data cached
Pericarditis	18	9.7 6.1–15.4ROR 9.8 · χ² 132 / p 8e-31	8.5 EB05 5.4 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.4	no trial data cached
Hepatocellular injury	14	8.8 5.2–14.9ROR 8.9 · χ² 90 / p 1e-21	7.4 EB05 4.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Haemorrhoids	19	8.7 5.6–13.7ROR 8.8 · χ² 122 / p 9e-29	7.6 EB05 5.0 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.1	no trial data cached
Cellulitis (skin infection)	45	8.0 6.0–10.7ROR 8.2 · χ² 270 / p 7e-61	7.6 EB05 5.8 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Multiple organ dysfunction syndrome	23	7.4 4.9–11.1ROR 7.5 · χ² 121 / p 2e-28	6.6 EB05 4.6 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.9	no trial data cached
Hepatic cytolysis	10	7.4 4.0–13.6ROR 7.4 · χ² 49 / p 2e-12	5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.8	no trial data cached
Cerebral haemorrhage	29	7.3 5.1–10.5ROR 7.4 · χ² 151 / p 5e-35	6.6 EB05 4.8 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.8	no trial data cached
Cardiogenic shock	11	6.9 3.8–12.5ROR 7.0 · χ² 50 / p 8e-13	5.6 EB05 3.3 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.5	no trial data cached
Bacterial infection	14	6.8 4.0–11.4ROR 6.8 · χ² 63 / p 9e-16	5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.1	no trial data cached
Haemorrhage intracranial	11	6.6 3.7–11.9ROR 6.6 · χ² 47 / p 4e-12	5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.3	no trial data cached
Fungal infection	24	6.5 4.3–9.6ROR 6.5 · χ² 106 / p 4e-25	5.8 EB05 4.1 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.5	no trial data cached
Myelodysplastic syndrome	10	6.2 3.3–11.5ROR 6.2 · χ² 39 / p 3e-10	5.0 EB05 2.9 · IC025 +1.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 4.1	no trial data cached
Acute respiratory failure	13	6.1 3.5–10.5ROR 6.1 · χ² 50 / p 6e-13	5.1 EB05 3.2 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.0	no trial data cached
Disease progression	79	6.0 4.8–7.5ROR 6.2 · χ² 327 / p 2e-73	5.8 EB05 4.8 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.6	no trial data cached
Pancytopenia (all blood cells low)	37	6.0 4.3–8.2ROR 6.0 · χ² 148 / p 2e-34	5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 3.9	no trial data cached
Arrhythmia	28	5.3 3.7–7.6ROR 5.3 · χ² 93 / p 2e-22	4.9 EB05 3.5 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.6 · 96% clinician	no trial data cached
Rectal haemorrhage	24	5.0 3.4–7.4ROR 5.0 · χ² 73 / p 7e-18	4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.4	no trial data cached
Platelet count decreased	58	4.9 3.8–6.3ROR 5.0 · χ² 176 / p 1e-40	4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 3.6 · 91% clinician	no trial data cached
Cholestasis (bile flow blockage)	10	4.7 2.5–8.7ROR 4.7 · χ² 26 / p 2e-7	3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 3.1	no trial data cached
Pulmonary oedema	23	4.6 3.1–6.9ROR 4.6 · χ² 62 / p 2e-15	4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.7	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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	502	68.6 63.4–74.1ROR 87.1 · χ² 33,203 / p <1e-300	67.9 EB05 63.0 · IC025 +5.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 44.7 · 91% clinician	no trial data cached
Acute myeloid leukaemia	287	168.6 151.1–188.1ROR 192.0 · χ² 46,784 / p <1e-300	163.7 EB05 148.4 · IC025 +6.8 3/3 methods agree	Likely indication confounding term in indications	serious PRR 109.4 · 97% clinician	no trial data cached
Death	228	2.4 2.1–2.7ROR 2.5 · χ² 188 / p 4e-43	2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 1.6	no trial data cached
Therapeutic product effect incomplete	195	24.8 21.7–28.4ROR 27.0 · χ² 4,437 / p <1e-300	24.7 EB05 21.9 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 29.7 · 100% clinician	no trial data cached
Sepsis (blood infection)	134	10.8 9.2–12.7ROR 11.4 · χ² 1,185 / p 5e-260	10.7 EB05 9.2 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.1	no trial data cached
Cytopenia	80	60.5 48.7–75.1ROR 62.6 · χ² 4,592 / p <1e-300	59.3 EB05 49.2 · IC025 +5.1 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 40.9	no trial data cached
Disease progression	79	6.0 4.8–7.5ROR 6.2 · χ² 327 / p 2e-73	5.8 EB05 4.8 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.6	no trial data cached
Septic shock	75	15.6 12.5–19.5ROR 16.1 · χ² 1,011 / p 4e-222	15.5 EB05 12.7 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.3	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	66	4.4 3.4–5.5ROR 4.5 · χ² 169 / p 5e-39	4.3 EB05 3.5 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.9	no trial data cached
Myelosuppression	66	17.4 13.7–22.1ROR 17.9 · χ² 1,006 / p 4e-221	17.3 EB05 14.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.3 · 98% clinician	no trial data cached
Platelet count decreased	58	4.9 3.8–6.3ROR 5.0 · χ² 176 / p 1e-40	4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 3.6 · 91% clinician	no trial data cached
Bacteraemia	57	43.7 33.8–56.5ROR 44.7 · χ² 2,324 / p <1e-300	42.9 EB05 34.3 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 28.9 · 95% clinician	no trial data cached
Thrombocytopenia (low platelets)	54	4.3 3.3–5.7ROR 4.4 · χ² 137 / p 7e-32	4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 2.9	no trial data cached
Bone marrow failure	52	22.9 17.5–29.9ROR 23.4 · χ² 1,064 / p 1e-233	22.6 EB05 17.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.1	no trial data cached
Neutrophil count decreased	51	11.3 8.6–14.8ROR 11.5 · χ² 470 / p 2e-104	11.0 EB05 8.5 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.5 · ♀ 61% (drug 41%) · 94% 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.

Bone marrow failure — n=52, PRR 22.9
Toxic skin eruption — n=23, PRR 20.5
Myelosuppression — n=66, PRR 17.4
Drug eruption — n=34, PRR 17.3
Disseminated intravascular coagulation — n=20, PRR 12.7
Cellulitis — n=45, PRR 8.0

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 and Cytarabine) Liposome?

In FDA FAERS, the most frequently co-reported reaction terms for Daunorubicin and Cytarabine) Liposome are febrile neutropenia, acute myeloid leukaemia, sepsis, cytopenia, septic shock, 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 Daunorubicin and Cytarabine) Liposome have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS • VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection.

Do FAERS signals prove that Daunorubicin and Cytarabine) Liposome 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 7ea701ce-e7d3-4349-a9c2-642a501d45c8, effective 20260130; matched on openfda.generic_name.exact:"(DAUNORUBICIN AND CYTARABINE) LIPOSOME")
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, field patient.drug.openfda.generic_name.exact, 63 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.