What the label lists and what reports show
Daprodustat side effects
Daprodustat's FDA label: “Most common adverse reactions (incidence ≥10%) are hypertension, thrombotic vascular events, and abdominal pain.” FAERS holds 1,878 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is haemoglobin decreased (94 reports).
- No generic listed
- Boxed warning
Check it at the source: the daprodustat FDA label on DailyMed (effective August 30, 2023, GlaxoSmithKline LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of JESDUVROQ?JESDUVROQ may cause serious side effects, including: • See “What is the most important information I should know about JESDUVROQ?” • Risk of hospitalization for heart failure. People who have a history of heart failure have an increased risk of hospitalization for heart failure with JESDUVROQ. Tell your healthcare provider right away if you get worsening signs and symptoms of heart failure, including: ○shortness of breath or trouble breathing ○sudden weight gain ○swelling of your feet, ankles or legs ○feeling tired or weak • High blood pressure. High blood pressure is common with JESDUVROQ. Your blood pressure may go up or worsen, and may be difficult to treat during treatment with JESDUVROQ. Your healthcare provider should check your blood pressure regularly during treatment with JESDUVROQ. […]
Source: FDA drug label, GlaxoSmithKline LLC, effective August 30, 2023 (SPL set d82aa06e-5a33-4844-99b7-4701313455a4), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥10%) are hypertension, thrombotic vascular events, and abdominal pain.
Table 4: Adverse Reactions Reported in ≥5% of Patients Treated with JESDUVROQ in the ASCEND-D Trial
| Adverse Reaction | JESDUVROQ (n = 1,482) % | rhEPO (n = 1,474) % |
|---|---|---|
| Hypertension | 24 | 24 |
| Abdominal pain a | 11 | 8 |
| Dizziness | 7 | 6 |
| Hypersensitivity b | 7 | 7 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: • Increased Risk of Death, Myocardial Infarction, Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access [see Boxed Warning, Warnings and Precautions ( 5.1 )]. • Risk of Hospitalization for Heart Failure [see Warnings and Precautions ( 5.2 )]. • Hypertension [see Warnings and Precautions ( 5.3 )]. • Gastrointestinal Erosion [see Warnings and Precautions ( 5.4 )]. Most common adverse reactions (incidence ≥10%) are hypertension, thrombotic vascular events, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of JESDUVROQ was evaluated in adults with dialysis-dependent chronic kidney disease with anemia in the ASCEND-D trial based on an on-study analysis (on and off treatment) [see Clinical Studies ( 14.1 )]. Patients were randomized to JESDUVROQ or rhEPO (epoetin alfa for patients on hemodialysis; darbepoetin alfa for patients on peritoneal dialysis). …
Source: FDA drug label, GlaxoSmithKline LLC, effective August 30, 2023 (SPL set d82aa06e-5a33-4844-99b7-4701313455a4), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,878 reports list daprodustat among the medicines taken, each a report of something that happened, not proof the medicine caused it; 419 are coded as a death and 993 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Daprodustat: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions