Cedazuridine and Decitabine side effects: what 875 FDA adverse event reports show

Cedazuridine And Decitabine · Inqovi · 22 reaction terms · 789 drug–reaction co-reports · data 2026-09-14

Drug class

Nucleoside Metabolic Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Inqovi

openFDA label

Who reports

875 reports · 82% serious · 176 with death outcome · 42% female

openFDA FAERS counts, all years, deduplication not applied

Used for

INQOVI is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor, indicated: For treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de n.

FDA label, Indications and Usage

What it is

Decitabine Decitabine is a nucleoside metabolic inhibitor. Decitabine is a white to off-white solid with the molecular formula of C 8 H 12 N 4 O 4 and a molecular weight of 228.21 daltons. Its.

FDA label, Description section

Boxed warning

None in the current 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 15 strongest signals

Labeled adverse reaction 8Labeled (related wording) 1Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 1

What the badges mean

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.
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. 7 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
Cytopenia	105	212.4 177.4–254.4ROR 241.3 · χ² 21,702 / p <1e-300	202.8 EB05 172.3 · IC025 +6.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 141.6 · 76% consumer	no trial data cached
Transfusion	69	158.3 126.1–198.7ROR 171.7 · χ² 10,562 / p <1e-300	150.7 EB05 123.2 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 116.3 · 83% consumer	no trial data cached
Full blood count abnormal	15	34.1 20.7–56.4ROR 34.7 · χ² 450 / p 5e-100	32.8 EB05 21.1 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 27.6	no trial data cached
Platelet count decreased	103	23.2 19.3–27.8ROR 26.2 · χ² 2,174 / p <1e-300	23.1 EB05 19.6 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.9 · 92% consumer	no trial data cached
Blood count abnormal	13	20.3 11.8–34.8ROR 20.6 · χ² 219 / p 6e-50	19.5 EB05 11.7 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 20.0	no trial data cached
Pancytopenia (all blood cells low)	44	18.9 14.2–25.3ROR 19.9 · χ² 731 / p 3e-161	18.8 EB05 14.5 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.4	no trial data cached
White blood cell count decreased	82	18.1 14.7–22.3ROR 19.9 · χ² 1,315 / p 3e-288	18.0 EB05 15.0 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.0 · 91% consumer	no trial data cached
Red blood cell count decreased	20	16.8 10.9–25.8ROR 17.1 · χ² 281 / p 2e-63	16.3 EB05 10.8 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 15.6 · 90% consumer	no trial data cached
Inappropriate schedule of product administration	119	16.1 13.7–19.1ROR 18.5 · χ² 1,688 / p <1e-300	16.1 EB05 13.8 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 22.5 · 85% consumer	no trial data cached
Full blood count decreased	12	14.3 8.1–25.0ROR 14.5 · χ² 135 / p 2e-31	12.9 EB05 7.0 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 9.7	no trial data cached
Neutrophil count decreased	23	13.6 9.1–20.4ROR 14.0 · χ² 257 / p 5e-58	13.0 EB05 8.8 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.2 · 87% consumer	no trial data cached
Febrile neutropenia	37	13.4 9.8–18.4ROR 13.9 · χ² 413 / p 4e-92	13.1 EB05 9.7 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.5	no trial data cached
Haemoglobin decreased	51	11.9 9.1–15.5ROR 12.6 · χ² 500 / p 6e-111	11.6 EB05 9.0 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.7 · 94% consumer	no trial data cached
Myelosuppression	11	7.8 4.3–13.9ROR 7.8 · χ² 58 / p 1e-14	6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.0	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	43	7.6 5.7–10.2ROR 7.9 · χ² 242 / p 8e-55	7.1 EB05 5.5 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.7	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
Inappropriate schedule of product administration	119	16.1 13.7–19.1ROR 18.5 · χ² 1,688 / p <1e-300	16.1 EB05 13.8 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 22.5 · 85% consumer	no trial data cached
Cytopenia	105	212.4 177.4–254.4ROR 241.3 · χ² 21,702 / p <1e-300	202.8 EB05 172.3 · IC025 +6.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 141.6 · 76% consumer	no trial data cached
Platelet count decreased	103	23.2 19.3–27.8ROR 26.2 · χ² 2,174 / p <1e-300	23.1 EB05 19.6 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.9 · 92% consumer	no trial data cached
White blood cell count decreased	82	18.1 14.7–22.3ROR 19.9 · χ² 1,315 / p 3e-288	18.0 EB05 15.0 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.0 · 91% consumer	no trial data cached
Transfusion	69	158.3 126.1–198.7ROR 171.7 · χ² 10,562 / p <1e-300	150.7 EB05 123.2 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 116.3 · 83% consumer	no trial data cached
Haemoglobin decreased	51	11.9 9.1–15.5ROR 12.6 · χ² 500 / p 6e-111	11.6 EB05 9.0 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.7 · 94% consumer	no trial data cached
Pancytopenia (all blood cells low)	44	18.9 14.2–25.3ROR 19.9 · χ² 731 / p 3e-161	18.8 EB05 14.5 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.4	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	43	7.6 5.7–10.2ROR 7.9 · χ² 242 / p 8e-55	7.1 EB05 5.5 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.7	no trial data cached
Febrile neutropenia	37	13.4 9.8–18.4ROR 13.9 · χ² 413 / p 4e-92	13.1 EB05 9.7 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.5	no trial data cached
Neutrophil count decreased	23	13.6 9.1–20.4ROR 14.0 · χ² 257 / p 5e-58	13.0 EB05 8.8 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.2 · 87% consumer	no trial data cached
Red blood cell count decreased	20	16.8 10.9–25.8ROR 17.1 · χ² 281 / p 2e-63	16.3 EB05 10.8 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 15.6 · 90% consumer	no trial data cached
Full blood count abnormal	15	34.1 20.7–56.4ROR 34.7 · χ² 450 / p 5e-100	32.8 EB05 21.1 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 27.6	no trial data cached
Blood count abnormal	13	20.3 11.8–34.8ROR 20.6 · χ² 219 / p 6e-50	19.5 EB05 11.7 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 20.0	no trial data cached
Full blood count decreased	12	14.3 8.1–25.0ROR 14.5 · χ² 135 / p 2e-31	12.9 EB05 7.0 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 9.7	no trial data cached
Myelosuppression	11	7.8 4.3–13.9ROR 7.8 · χ² 58 / p 1e-14	6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.0	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.

Transfusion — n=69, PRR 158.3

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 Cedazuridine and Decitabine?

In FDA FAERS, the most frequently co-reported reaction terms for Cedazuridine and Decitabine are cytopenia, platelet count decreased, white blood cell count decreased, transfusion, haemoglobin decreased, pancytopenia. 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 Cedazuridine and Decitabine have an FDA boxed warning?

No. The FDA label retrieved for Cedazuridine and Decitabine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Cedazuridine and Decitabine 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 91a0f80b-f865-4d06-a40d-4d148d99ee71, effective 20260525; matched on openfda.generic_name.exact:"CEDAZURIDINE AND DECITABINE")
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, 22 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.