Daprodustat side effects: what 1,878 FDA adverse event reports show

Daprodustat · Jesduvroq · 48 reaction terms · 1,434 drug–reaction co-reports · data 2026-09-14

Drug class

Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor

FDA label (Established Pharmacologic Class)

Brand names

Jesduvroq

openFDA label

Who reports

1,878 reports · 95% serious · 419 with death outcome · 47% female

openFDA FAERS counts, all years, deduplication not applied

Used for

JESDUVROQ is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Limitations of Use JESDUVROQ has not been shown to improve quality of life, fatigue, or patient well-being. JESDUVROQ is not indicated for use: • As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.

FDA label, Indications and Usage

What it is

JESDUVROQ contains daprodustat, an inhibitor of hypoxia inducible factor (HIF), prolyl 4-hydroxylases (PH)1, PH2 and PH3.

FDA label, Description section

Boxed warning

INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS JESDUVROQ increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE) [see Warnings and Precautions ( 5.1 )] .

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 32 strongest signals

Labeled — boxed warning 5Labeled (related wording) 1Reporting / coding artifact 4Not in label — unassessed 22

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 (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.
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. 16 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
Cerebral infarction	56	25.6 19.8–33.2ROR 26.4 · χ² 1,299 / p 9e-285	25.4 EB05 20.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 15.5 · 100% clinician	no trial data cached
Dialysis	31	24.4 17.2–34.6ROR 24.8 · χ² 671 / p 3e-148	24.0 EB05 17.7 · IC025 +3.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 15.5 · 100% clinician	no trial data cached
Fracture	36	21.3 15.4–29.4ROR 21.7 · χ² 674 / p 6e-149	21.0 EB05 15.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 14.1 · 100% clinician	no trial data cached
Hospitalisation	276	20.3 18.2–22.6ROR 23.6 · χ² 5,062 / p <1e-300	20.2 EB05 18.3 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 12.6 · ♀ 70% (drug 47%) · 100% clinician	no trial data cached
Prescribed underdose	35	19.6 14.1–27.3ROR 20.0 · χ² 600 / p 1e-132	19.4 EB05 14.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.2 · 97% clinician	no trial data cached
Myelodysplastic syndrome	22	17.0 11.2–25.8ROR 17.2 · χ² 315 / p 8e-71	16.6 EB05 11.3 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.4 · 100% clinician	no trial data cached
Colon cancer	20	15.0 9.7–23.2ROR 15.1 · χ² 247 / p 6e-56	14.4 EB05 9.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.2 · 100% clinician	no trial data cached
Renal impairment	91	12.2 9.9–14.9ROR 12.7 · χ² 923 / p 5e-203	12.0 EB05 10.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.7 · 98% clinician	no trial data cached
Cardiac failure (heart failure)	86	12.0 9.7–14.7ROR 12.5 · χ² 855 / p 2e-188	11.8 EB05 9.8 · IC025 +3.1 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 7.3 · 97% clinician	no trial data cached
Peritonitis	21	11.3 7.4–17.3ROR 11.4 · χ² 188 / p 5e-43	10.4 EB05 6.8 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.9 · 100% clinician	no trial data cached
Pneumonia aspiration	25	11.2 7.6–16.6ROR 11.3 · χ² 222 / p 1e-50	10.5 EB05 7.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.8 · 96% clinician	no trial data cached
Feeding disorder	19	10.7 6.8–16.7ROR 10.7 · χ² 157 / p 3e-36	9.6 EB05 6.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.6	no trial data cached
Haemoglobin decreased	94	10.2 8.4–12.4ROR 10.7 · χ² 775 / p 9e-171	10.0 EB05 8.4 · IC025 +2.9 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 6.6 · 98% clinician	no trial data cached
Malnutrition	10	10.1 5.4–18.7ROR 10.1 · χ² 73 / p 7e-18	8.0 EB05 4.3 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Hypothyroidism	28	9.8 6.8–14.2ROR 10.0 · χ² 213 / p 1e-48	9.1 EB05 6.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.6 · 100% clinician	no trial data cached
Dysphagia (difficulty swallowing)	76	9.0 7.2–11.2ROR 9.3 · χ² 532 / p 4e-118	8.7 EB05 7.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.9 · 100% clinician	no trial data cached
Product use issue	145	8.7 7.4–10.1ROR 9.3 · χ² 984 / p 3e-216	8.5 EB05 7.4 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 10.2 · 99% clinician	no trial data cached
Metastases to liver	13	8.3 4.8–14.2ROR 8.3 · χ² 76 / p 1e-18	6.8 EB05 4.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Device related infection	10	7.2 3.9–13.4ROR 7.3 · χ² 48 / p 2e-12	5.7 EB05 3.2 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5	no trial data cached
Hypophagia	16	7.0 4.3–11.5ROR 7.1 · χ² 77 / p 8e-19	6.0 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.2	no trial data cached
Hyperkalaemia (high potassium)	22	7.0 4.6–10.7ROR 7.1 · χ² 108 / p 1e-25	6.3 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.4 · 100% clinician	no trial data cached
Dementia	15	6.0 3.6–10.0ROR 6.1 · χ² 58 / p 1e-14	5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.9	no trial data cached
Femur fracture	16	5.8 3.5–9.4ROR 5.8 · χ² 58 / p 1e-14	5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.5	no trial data cached
Altered state of consciousness	11	5.7 3.2–10.3ROR 5.7 · χ² 38 / p 3e-10	4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.5	no trial data cached
Gastric cancer	13	5.7 3.3–9.7ROR 5.7 · χ² 45 / p 8e-12	4.8 EB05 3.0 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.4	no trial data cached
Therapeutic response decreased	28	5.2 3.6–7.5ROR 5.2 · χ² 91 / p 8e-22	4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 6.9 · 100% clinician	no trial data cached
Faeces discoloured	10	5.2 2.8–9.6ROR 5.2 · χ² 29 / p 3e-8	4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.3	no trial data cached
Deep vein thrombosis (leg blood clot)	27	4.6 3.2–6.7ROR 4.7 · χ² 73 / p 6e-18	4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 2.9 · 100% clinician	no trial data cached
Lung neoplasm malignant	17	4.6 2.9–7.4ROR 4.6 · χ² 44 / p 1e-11	4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 2.8	no trial data cached
Gastrointestinal haemorrhage	32	4.3 3.0–6.0ROR 4.3 · χ² 77 / p 1e-18	4.0 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 2.6 · 91% clinician	no trial data cached
Hepatic function abnormal	14	4.2 2.5–7.1ROR 4.2 · χ² 31 / p 1e-8	3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 2.8	no trial data cached
Neoplasm malignant	20	3.3 2.2–5.2ROR 3.4 · χ² 31 / p 1e-8	3.1 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.1 · 100% clinician	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
Hospitalisation	276	20.3 18.2–22.6ROR 23.6 · χ² 5,062 / p <1e-300	20.2 EB05 18.3 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 12.6 · ♀ 70% (drug 47%) · 100% clinician	no trial data cached
Product use issue	145	8.7 7.4–10.1ROR 9.3 · χ² 984 / p 3e-216	8.5 EB05 7.4 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 10.2 · 99% clinician	no trial data cached
Haemoglobin decreased	94	10.2 8.4–12.4ROR 10.7 · χ² 775 / p 9e-171	10.0 EB05 8.4 · IC025 +2.9 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 6.6 · 98% clinician	no trial data cached
Renal impairment	91	12.2 9.9–14.9ROR 12.7 · χ² 923 / p 5e-203	12.0 EB05 10.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.7 · 98% clinician	no trial data cached
Cardiac failure (heart failure)	86	12.0 9.7–14.7ROR 12.5 · χ² 855 / p 2e-188	11.8 EB05 9.8 · IC025 +3.1 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 7.3 · 97% clinician	no trial data cached
Dysphagia (difficulty swallowing)	76	9.0 7.2–11.2ROR 9.3 · χ² 532 / p 4e-118	8.7 EB05 7.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.9 · 100% clinician	no trial data cached
Cerebral infarction	56	25.6 19.8–33.2ROR 26.4 · χ² 1,299 / p 9e-285	25.4 EB05 20.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 15.5 · 100% clinician	no trial data cached
Fracture	36	21.3 15.4–29.4ROR 21.7 · χ² 674 / p 6e-149	21.0 EB05 15.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 14.1 · 100% clinician	no trial data cached
Prescribed underdose	35	19.6 14.1–27.3ROR 20.0 · χ² 600 / p 1e-132	19.4 EB05 14.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.2 · 97% clinician	no trial data cached
Gastrointestinal haemorrhage	32	4.3 3.0–6.0ROR 4.3 · χ² 77 / p 1e-18	4.0 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 2.6 · 91% clinician	no trial data cached
Dialysis	31	24.4 17.2–34.6ROR 24.8 · χ² 671 / p 3e-148	24.0 EB05 17.7 · IC025 +3.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 15.5 · 100% clinician	no trial data cached
Therapeutic response decreased	28	5.2 3.6–7.5ROR 5.2 · χ² 91 / p 8e-22	4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 6.9 · 100% clinician	no trial data cached
Hypothyroidism	28	9.8 6.8–14.2ROR 10.0 · χ² 213 / p 1e-48	9.1 EB05 6.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.6 · 100% clinician	no trial data cached
Deep vein thrombosis (leg blood clot)	27	4.6 3.2–6.7ROR 4.7 · χ² 73 / p 6e-18	4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 2.9 · 100% clinician	no trial data cached
Pneumonia aspiration	25	11.2 7.6–16.6ROR 11.3 · χ² 222 / p 1e-50	10.5 EB05 7.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.8 · 96% 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.

Cerebral infarction — n=56, PRR 25.6
Fracture — n=36, PRR 21.3
Prescribed underdose — n=35, PRR 19.6
Myelodysplastic syndrome — n=22, PRR 17.0
Colon cancer — n=20, PRR 15.0
Renal impairment — n=91, PRR 12.2
Peritonitis — n=21, PRR 11.3
Pneumonia aspiration — n=25, PRR 11.2
Hypothyroidism — n=28, PRR 9.8
Dysphagia — n=76, PRR 9.0

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 Daprodustat?

In FDA FAERS, the most frequently co-reported reaction terms for Daprodustat are haemoglobin decreased, renal impairment, cardiac failure, dysphagia, cerebral infarction, fracture. 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 Daprodustat have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS JESDUVROQ increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE) [see Warnings and Precautions ( 5.1 )] .

Do FAERS signals prove that Daprodustat 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 d82aa06e-5a33-4844-99b7-4701313455a4, effective 20230830; matched on openfda.generic_name.exact:"DAPRODUSTAT")
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, 48 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.