FDA-filed SPL labeling · retrieved through openFDA

Daprodustat

Daprodustat (Jesduvroq) is an oral medication used to treat anemia caused by chronic kidney disease in adults on dialysis.

Brand name Jesduvroq
Drug class Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveAug 30, 2023
AvailabilityRx
Earliest approval/marketing year 2023
FDA-listed product records 21
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 24, 2026
Daprodustat at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Jesduvroq (daprodustat) is a once-daily oral tablet that treats anemia in adults with chronic kidney disease who are on dialysis, by prompting the body to make more red blood cells. It carries a serious boxed warning about increased risk of heart attack, stroke, and blood clots, so it requires close monitoring and careful dose management. Use the lowest effective dose, keep all follow-up appointments for blood tests, and report any new cardiovascular symptoms to your doctor right away.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Jesduvroq carries a serious boxed warning about life-threatening blood clots. Taking this medication increases the risk of major cardiovascular events — including heart attack, stroke, blood clots in the veins, and clotting of your dialysis access site. Targeting a hemoglobin level above 11 g/dL makes these risks even greater. No dose or dosing approach has been proven completely safe from these risks. Your doctor will prescribe the lowest dose that reduces your need for blood transfusions and will monitor your hemoglobin regularly. Seek emergency medical care immediately if you experience chest pain, sudden weakness, difficulty speaking, or signs of a clot.

Read the full warning on DailyMed →

📖 Daprodustat: Patient Information Guide

A plain-language walkthrough of Daprodustat — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Daprodustat (brand name Jesduvroq) is approved for one specific use in adults:

  • Jesduvroq is used to treat anemia caused by chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months.
  • It is intended to reduce the need for red blood cell transfusions — not to replace them in an emergency.
  • Jesduvroq is not approved for people with CKD who are not yet on dialysis.
  • Jesduvroq has not been shown to improve quality of life, fatigue, or patient well-being.
⚙️How it works

Daprodustat works by blocking enzymes called HIF prolyl hydroxylases (HIF-PH1, PH2, and PH3). Under normal circumstances, these enzymes break down proteins called hypoxia-inducible factors (HIFs). When daprodustat blocks these enzymes, HIF proteins accumulate and travel into the cell's nucleus, where they switch on genes — including the gene for erythropoietin, a hormone that tells the bone marrow to make more red blood cells. This mirrors the body's natural response to low oxygen. The result is a gradual, dose-related increase in red blood cell production over several weeks.

💊How it's taken

Jesduvroq is taken once daily by mouth, as a whole tablet. It can be taken with or without food, and the timing relative to dialysis does not matter. Your doctor will determine your starting dose based on your current hemoglobin level and whether you have been on another anemia medication called an ESA (erythropoiesis-stimulating agent). Doses are adjusted every four weeks at most, based on your blood test results.

  • Swallow Jesduvroq tablets whole — never cut, crush, or chew them.
  • If you miss a dose, take it as soon as you remember — unless your next dose falls on the same day, in which case skip the missed one.
  • Never take two doses on the same day to make up for a missed one.
  • People with moderate liver impairment or who take certain interacting medications may need a lower starting dose.
🤒Side effects — in detail

The most common side effects reported in clinical trials of Jesduvroq include:

  • High blood pressure (hypertension) — reported in about 1 in 4 patients
  • Blood clots and thrombotic vascular events — including clotting of dialysis access sites, heart attack, and stroke
  • Abdominal (belly) pain
  • Dizziness
  • Allergic reactions such as rash, hives, or skin inflammation

Serious reactions — including heart attack, stroke, severe high blood pressure, heart failure hospitalization, and stomach or esophageal bleeding — require prompt medical attention. Contact your doctor or seek emergency care if you experience any of these.

⚠️Warnings & precautions
  • Blood clots and cardiovascular events: Jesduvroq increases the risk of heart attack, stroke, venous blood clots, and blockage of dialysis access. This is the most critical risk. Pushing hemoglobin above 11 g/dL makes it worse. No safe dose has been identified. Use the lowest effective dose and have hemoglobin checked regularly.
  • Heart failure: People with a prior history of heart failure face a higher risk of being hospitalized for it while on Jesduvroq. Tell your doctor about any heart history before starting.
  • High blood pressure: Jesduvroq is contraindicated if your blood pressure is uncontrolled. Even patients with controlled hypertension should have their blood pressure monitored regularly, as worsening — including hypertensive crisis and seizures — has been reported.
  • Stomach and esophageal erosions: Gastric and esophageal erosions and GI bleeding have occurred. Risk is higher in those with a history of ulcers or GI problems, smokers, and heavy drinkers.
  • Not for use without dialysis: In a trial of non-dialysis CKD patients, Jesduvroq was associated with increased risk of serious cardiovascular events, kidney injury, and GI complications — it is not approved or recommended in that population.
  • Active cancer: Because the HIF pathway may affect cancer growth, Jesduvroq is not recommended in people with active malignancies.
🔀What it interacts with

Daprodustat is mainly processed by a liver enzyme called CYP2C8. Drugs that affect this enzyme can significantly change daprodustat levels in your blood:

  • Gemfibrozil (strong CYP2C8 inhibitor): Completely contraindicated — it causes an almost 19-fold increase in daprodustat exposure, which is dangerous.
  • Clopidogrel and other moderate CYP2C8 inhibitors: Raise daprodustat levels — your starting dose of Jesduvroq will need to be reduced by half, and your hemoglobin will be monitored closely.
  • Rifampin and other CYP2C8 inducers: Can lower daprodustat levels and reduce how well it works — dose adjustment and more frequent hemoglobin checks may be needed when starting or stopping these drugs.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Uncontrolled high blood pressure: Do not take Jesduvroq — it is contraindicated until blood pressure is adequately managed.
  • Recent heart attack, stroke, or acute coronary syndrome (within 3 months): Avoid starting Jesduvroq; discuss with your doctor.
  • History of heart failure: Use with caution — higher risk of hospitalization for heart failure.
  • History of stomach ulcers or GI bleeding, or current tobacco or alcohol use: Increased risk of gastrointestinal erosions; inform your doctor.
  • Liver problems: Moderate liver impairment requires a lower starting dose; severe liver impairment — Jesduvroq is not recommended.
  • Pregnancy: Animal studies suggest potential harm to the fetus. Tell your doctor if you are pregnant or planning to become pregnant.
  • Breastfeeding: Do not breastfeed during treatment or for one week after the last dose.
  • Children: Safety and effectiveness have not been established in pediatric patients.
  • Older adults (65+): No overall difference in safety or effectiveness was seen in clinical trials, but individual monitoring remains important.
🚑If you take too much

Taking too much Jesduvroq may cause headache and gastrointestinal symptoms such as nausea. There is no specific antidote for an overdose. Because daprodustat binds very tightly to proteins in the blood, hemodialysis will not effectively remove it from the body.

📡Pharmacodynamics — effects in the body

After a dose, daprodustat begins increasing the body's own erythropoietin (the hormone that drives red blood cell production) within 6 to 8 hours. With repeated dosing, new red blood cell precursors (reticulocytes) peak between 7 and 15 days, and hemoglobin levels stabilize after several weeks — roughly 4 weeks in patients previously on ESA therapy, and 16–20 weeks in those who were not. Daprodustat also affects iron metabolism: it raises transferrin and total iron-binding capacity while lowering ferritin, transferrin saturation, and hepcidin, meaning iron supplementation is commonly needed during treatment.

🔬Pharmacokinetics — how your body processes it

Jesduvroq tablets are well absorbed after oral dosing, reaching peak blood levels within 1 to 4 hours, with an absolute bioavailability of 65%. Food — even a high-fat meal — does not meaningfully affect how much of the drug is absorbed. Daprodustat is more than 99% bound to proteins in the blood and has a short elimination half-life of approximately 1 to 4 hours, with steady-state levels reached within 24 hours of starting treatment. It is broken down primarily by a liver enzyme called CYP2C8 (about 95%), with most of the drug and its metabolites leaving the body in stool (74%) and urine (21%) within 7 days.

📦How to store it

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F).

📄 Written from Daprodustat’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

28

Supplements & herbs that interact with Daprodustat

28 supplements and herbal products have documented interactions with Daprodustat in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 16
  • Minor · 11
Every supplement checked against Daprodustat — ranked by severity The full interaction hub: 1 major · 16 moderate · 11 minor · every one linked to its full report. Check Daprodustat against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Daprodustat — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Jesduvroq supposed to do for me?
Jesduvroq is designed to treat anemia — low red blood cell levels — that comes from chronic kidney disease in people on dialysis. It works by prompting your body to produce more of its own erythropoietin, the hormone that tells your bone marrow to make red blood cells. Over several weeks, this should raise your hemoglobin and reduce your need for blood transfusions. Keep in mind, though — it won't necessarily make you feel more energetic or improve your quality of life directly, based on what the clinical trials showed.
How long does it take to start working?
Daprodustat starts boosting your body's erythropoietin within about 6 to 8 hours of your first dose. You'll start seeing new red blood cells appear in your blood within 1 to 2 weeks. But reaching a stable hemoglobin level takes longer — roughly 4 weeks if you were previously on an ESA (another anemia medication), or anywhere from 4 to 5 months if you weren't. Your doctor will check your blood levels every 2 weeks at first to track progress.
What are the most important side effects I should know about?
The most common ones are high blood pressure, belly pain, and dizziness. But the most serious risk — one serious enough to be on a warning label — is blood clots. This includes clots that can cause a heart attack, stroke, a blocked dialysis access site, or clots in your legs or lungs. Get emergency help right away if you have chest pain, sudden weakness, trouble speaking, or leg pain and swelling. Also report any worsening blood pressure or shortness of breath to your doctor promptly.
Are there any medications I absolutely cannot take with Jesduvroq?
Yes — gemfibrozil, a medication used for high cholesterol and triglycerides, cannot be taken with Jesduvroq at all. It causes daprodustat levels in your blood to skyrocket to a dangerous level. If you take clopidogrel (a common blood thinner) or certain other drugs that affect the same liver enzyme, your doctor will start you on a lower dose and watch your blood counts closely. Always give your doctor and pharmacist a full list of everything you take, including supplements.
Can I take Jesduvroq if I'm pregnant or want to become pregnant?
This is an important conversation to have with your doctor before starting. Animal studies showed that daprodustat can harm a developing fetus at high doses. There isn't enough human data yet to know the full risk, but the potential is there. If you could become pregnant, use effective birth control while on this medication. If you're already pregnant, let your doctor know right away so you can weigh the risks together.
Do I need to take it at a specific time of day, or with food?
Jesduvroq is taken once a day, and it doesn't matter whether you take it with or without food — even a high-fat meal won't change how well it's absorbed. You also don't need to time it around your dialysis sessions. The one firm rule is to swallow the tablet whole — don't cut, crush, or chew it. If you miss a dose, take it as soon as you remember, unless your next dose is already due that same day — in that case, just skip the missed dose and carry on as normal.
Is Daprodustat available over the counter?
Daprodustat is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Daprodustat first available?
Daprodustat has been available in the United States since at least 2023, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Daprodustat?
Daprodustat is supplied by 4 manufacturers listed in the FDA NDC Directory, including GlaxoSmithKline LLC, Catalent Pharma Solutions, LLC, Glaxo Operations UK Ltd.

💬 Answers drafted from Daprodustat’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Daprodustat comes

Daprodustat is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Jesduvroq
How this form is used
What it may be used for
  • Jesduvroq tablets are used to treat anemia due to chronic kidney disease in adults who have been on dialysis for at least four months
  • Jesduvroq tablets are not for use in CKD patients who are not on dialysis
  • Jesduvroq tablets are not a substitute for emergency blood transfusions
Important instructions
  • Jesduvroq tablets are taken once daily by mouth, with or without food
  • Jesduvroq tablets must be swallowed whole — do not cut, crush, or chew them
  • Jesduvroq can be taken without regard to the timing or type of dialysis
  • If you miss a dose of Jesduvroq, take it as soon as possible — but if your next dose is due that same day, skip the missed dose and resume your normal schedule; never take two doses at once
Available strengths 5 strengths
20 FDA-listed product records

📊 Daprodustat across the U.S. market

How Daprodustat appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
4
Manufacturers
1
Brand names
21
FDA-listed product records
2023
First marketed

Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

GlaxoSmithKline LLC48%
Catalent Pharma Solutions, LLC24%
Glaxo Operations UK Ltd24%
Glaxo Wellcome Manufacturing Pte. Ltd5%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

🔍 Compare Daprodustat products

A representative set of FDA-listed product records for Daprodustat — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 21 of 21 products — FDA National Drug Code Directory. See every product, package size and price: browse all 21 Daprodustat NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Daprodustat RxCUI 2628210 1 dose form · 5 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 2628214 In current FDA listings
    Clinical drug / strength (SCD) 1 MG RxCUI 2628215 2 MG RxCUI 2628223 4 MG RxCUI 2628227 6 MG RxCUI 2628231 8 MG RxCUI 2628235

Look up RxCUI 2628210 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Jesduvroq

🏭 Manufacturers & labelers

GlaxoSmithKline LLC 10 Catalent Pharma Solutions, LLC 5 Glaxo Operations UK Ltd 5 Glaxo Wellcome Manufacturing Pte. Ltd 1

RxNorm drug class

Daprodustat belongs to the Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor class.

Pharmacologic class Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor
Drug family (ATC) Other antianemic preparations
How it works Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 30, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Daprodustat.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Daprodustat after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
21
Distinct labelers/manufacturers represented
4
Linked representative label
GlaxoSmithKline LLC
Linked label effective
Aug 30, 2023
Composite sections available
25
Linked SPL Set ID
d82aa06e-5a33-4844-99b7-4701313455a4
Linked SPL Document ID
d52a823a-35bd-4c6a-a016-4b4f21a43d7d
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. GlaxoSmithKline LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.