Prescription medicine
Daprodustat Brand names: Jesduvroq
Daprodustat (Jesduvroq) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the daprodustat FDA label on DailyMed (effective August 30, 2023, GlaxoSmithKline LLC); the NDA 216951 record on Drugs@FDA; every daprodustat label on DailyMed.
Highlights of the record
FDA label of August 30, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 )]. Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels [see Warnings and Precautions ( 5.1 )]. No trial has identified a hemoglobin target level, dose of JESDUVROQ, or dosing strategy that does not increase these risks [see Dosage and Administration ( 2.4 )]. Use the lowest dose of JESDUVROQ sufficient to reduce the need for red blood cell transfusions [see Dosage and Administration ( 2.4 )]. WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS See full prescribing information for complete boxed warning.
JESDUVROQ increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). ( 5.1 )
Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. […]
Used for
From the label: indications and usageJESDUVROQ 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.
Forms and strengths
- 1 mg
- 2 mg
- 4 mg
- 6 mg
- 8 mg
Film-coated tablet.
On the market
- Earliest approval on file
- February 1, 2023 Jesduvroq, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 13, 2038 Jesduvroq tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,878 through July 30, 2026
What is daprodustat used for?
From the label: indications and usageJESDUVROQ 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.
For treatment of anemia of chronic kidney disease in patients who are not on dialysis. […]
Conditions named in the indications of daprodustat's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor.
Source: FDA drug label (Jesduvroq), GlaxoSmithKline LLC, effective August 30, 2023 (SPL set d82aa06e-5a33-4844-99b7-4701313455a4), via openFDA; the full label on DailyMed
What does the patient leaflet for daprodustat say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about JESDUVROQ?JESDUVROQ may cause serious side effects, including: • Increased risk of death, heart attack, stroke, and blood clots. These risks may happen if you are treated with JESDUVROQ to increase red blood cells (RBCs) to near the same level found in healthy people. These risks may be increased if you have heart or blood vessel problems, or problems with blood flow to your brain (cerebrovascular disease). Blood clots can form in the blood vessels (veins), including in your legs (deep vein thrombosis or DVT), lungs (pulmonary embolism or PE), and in your dialysis access (vascular access thrombosis or VAT). Get medical help right away if you get any of the following symptoms: ○chest pain ○sudden trouble seeing ○trouble breathing or shortness of breath ○sudden trouble walking, dizziness, loss of balance or coordination ○pain in your leg or arm, with or without swelling ○lightheadedness or fainting ○unusual coolness or warmth in arm or leg ○dialysis access stops working ○sudden confusion, trouble speaking, or trouble understanding others’ speech ○do not feel a vibration (“thrill”) over the dialysis access area ○sudden numbness or weakness in your face, arm, or leg, especially on one side of your body See “What are the possible side effects of JESDUVROQ?” for more information about side effects. If you decide to take JESDUVROQ, your healthcare provider should prescribe the lowest dose of JESDUVROQ that is necessary to reduce your chance of needing red blood cell transfusions.
From the patient leaflet: How should I store JESDUVROQ?Store JESDUVROQ at room temperature between 68°F to 77°F (20°C to 25°C). Keep JESDUVROQ and all medicines out of the reach of children.
Source: FDA drug label (Jesduvroq), GlaxoSmithKline LLC, effective August 30, 2023 (SPL set d82aa06e-5a33-4844-99b7-4701313455a4), via openFDA; the full label on DailyMed
Is there a generic for daprodustat (Jesduvroq)?
No generic daprodustat is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Jesduvroq tablets: the compound patent runs to March 13, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the daprodustat label say about other medicines?
The daprodustat label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clopidogrel | drug interactions | Concomitant administration of moderate CYP2C8 inhibitors (e.g., clopidogrel) increases daprodustat exposure [see Clinical Pharmacology ( 12.3 )]. |
| Gemfibrozil | contraindications | CONTRAINDICATIONS JESDUVROQ is contraindicated in patients: Receiving a strong CYP2C8 inhibitor such as gemfibrozil [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )]. |
| Rifampin | drug interactions | CYP2C8 Inducers CYP2C8 inducers (e.g., rifampin) may decrease daprodustat exposure, which may result in loss of efficacy. |
Source: FDA drug label (Jesduvroq), 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 for daprodustat?
The FDA Adverse Event Reporting System holds 1,878 reports that list daprodustat among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as daprodustat?
6 other medicines are given the same way (oral) and in the same FDA class as daprodustat or labeled mainly for the same use (anemia), the same class first. Anemia lists all 25 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Vadadustat | Anemia | none listed | n/a | No current entry |
| Eltrombopag | Anemia | 13 labelers | $25.85 per tablet 50 mg tablet | No current entry |
| Prednisolone | Anemia | 23 labelers | $0.568 per mL 15 mg/5 mL solution | No current entry |
| Mitapivat | Anemia | none listed | n/a | No current entry |
| Tetraferric tricitrate decahydrate | Anemia | none listed | $6.28 per tablet 210 mg tablet | No current entry |
| Ferric citrate | Anemia | 1 labeler | n/a | No current entry |
Every medicine labeled for the same conditions as daprodustat
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to daprodustat
- 6 medicines for the same use
- Other hypoxia-inducible factor prolyl hydroxylase inhibitors
- the pharmacologic class, with prices and generics
- Daprodustat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other