Prescription medicine
Vadadustat Brand names: Vafseo
Vadadustat (Vafseo) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the vadadustat FDA label on DailyMed (effective March 30, 2026, Akebia Therapeutics, Inc.); the NDA 215192 record on Drugs@FDA; every vadadustat label on DailyMed.
Highlights of the record
FDA label of March 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM,.
and THROMBOSIS OF VASCULAR ACCESS VAFSEO 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 and 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 VAFSEO, or dosing strategy that does not increase these risks [see Dosage and Administration ( 2.4 )]. Use the lowest dose of VAFSEO 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. VAFSEO 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 and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. […]
Used for
From the label: indications and usageVAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.
Forms and strengths
- 150 mg
- 300 mg
- 450 mg
Film-coated tablet.
On the market
- Earliest approval on file
- March 27, 2024 Vafseo, Akebia; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 31, 2036 Vafseo 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
- 284 through July 30, 2026
What is vadadustat used for?
From the label: indications and usageVAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being. VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemia In patients with anemia due to CKD not on dialysis [see Warnings and Precautions ( 5.6 )]. […]
Conditions named in the indications of vadadustat's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor.
Source: FDA drug label (VAFSEO), Akebia Therapeutics, Inc., effective March 30, 2026 (SPL set ac9da724-5a62-4ab6-a89c-376a25f6195b), via openFDA; the full label on DailyMed
What does the patient leaflet for vadadustat 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 VAFSEO?VAFSEO 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 VAFSEO 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 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 signs or symptoms: chest pain trouble breathing or shortness of breath cold sweat sudden numbness or weakness in your face, arm or leg, especially on one side of your body sudden confusion, trouble speaking, or trouble understanding others’ speech sudden trouble seeing sudden trouble walking, dizziness, loss of balance or coordination loss of consciousness (fainting) severe headache pain in your legs, with or without swelling a cool or pale arm or leg changes to your dialysis access site, including swelling or discoloration near the site do not feel a vibration (“thrill”) over the dialysis access area See “ What are the possible side effects of VAFSEO? ” for more information about side effects. If you decide to take VAFSEO, your healthcare provider should prescribe the lowest dose of VAFSEO that is necessary to reduce your chance of needing red blood cell transfusions.
From the patient leaflet: How should I store VAFSEO?Store VAFSEO at room temperature between 68℉ to 77℉ (20℃ to 25℃). Keep VAFSEO and all medicines out of the reach of children.
Source: FDA drug label (VAFSEO), Akebia Therapeutics, Inc., effective March 30, 2026 (SPL set ac9da724-5a62-4ab6-a89c-376a25f6195b), via openFDA; the full label on DailyMed
Is there a generic for vadadustat (Vafseo)?
No generic vadadustat is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 14 patents for Vafseo tablets: the compound patent runs to November 14, 2034, and the last listed entry to March 31, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the vadadustat label say about other medicines?
The vadadustat label names 17 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 |
|---|---|---|
| Calcium acetate | drug interactions | Examples *; Iron supplements: ferric citrate, ferrous sulfate, sodium ferrous citrate Iron-containing phosphate binders: ferric citrate, sucroferric oxyhydroxide Non-iron-containing phosphate binders: calcium acetate, sevelamer carbonate |
| Cefaclor | drug interactions | Examples *; cefaclor, ceftizoxime, famotidine, furosemide, oseltamivir carboxylate, penicillin G, sitagliptin |
| Darbepoetin alfa | warnings and precautions | In the INNO 2 VATE-1 and INNO 2 VATE-2 clinical trials, seizures occurred in 1.6% (1.0 per 100 PY) of patients who received VAFSEO and 1.6% (1.0 per 100 PY) of patients who received darbepoetin alfa. Following initiation of VAFSEO, monitor patients closely for premonitory neurologic symptoms. |
| Famotidine | drug interactions | Examples *; cefaclor, ceftizoxime, famotidine, furosemide, oseltamivir carboxylate, penicillin G, sitagliptin |
| Ferric citrate | drug interactions | Examples *; Iron supplements: ferric citrate, ferrous sulfate, sodium ferrous citrate Iron-containing phosphate binders: ferric citrate, sucroferric oxyhydroxide Non-iron-containing phosphate binders: calcium acetate, sevelamer carbonate |
| Ferrous sulfate | drug interactions | Examples *; Iron supplements: ferric citrate, ferrous sulfate, sodium ferrous citrate Iron-containing phosphate binders: ferric citrate, sucroferric oxyhydroxide Non-iron-containing phosphate binders: calcium acetate, sevelamer carbonate |
| Furosemide | drug interactions | Examples *; cefaclor, ceftizoxime, famotidine, furosemide, oseltamivir carboxylate, penicillin G, sitagliptin |
| Gemfibrozil | drug interactions | Prevention or Management Closely monitor for too large or too rapid an increase in Hb response and for adverse reactions. Examples * OAT1 inhibitors: probenecid, rifampicin OAT3 inhibitors: gemfibrozil, probenecid, teriflunomide * These examples are not a comprehensive list of all possible drugs that may fit this … |
| Oseltamivir | drug interactions | Examples *; cefaclor, ceftizoxime, famotidine, furosemide, oseltamivir carboxylate, penicillin G, sitagliptin |
| Penicillin g | drug interactions | Examples *; cefaclor, ceftizoxime, famotidine, furosemide, oseltamivir carboxylate, penicillin G, sitagliptin |
| Probenecid | drug interactions | Prevention or Management Closely monitor for too large or too rapid an increase in Hb response and for adverse reactions. Examples * OAT1 inhibitors: probenecid, rifampicin OAT3 inhibitors: gemfibrozil, probenecid, teriflunomide * These examples are not a comprehensive list of all possible drugs that may fit this … |
| Rosuvastatin | drug interactions | Rosuvastatin Maximum daily dose of rosuvastatin not to exceed 5 mg. |
| Sevelamer | drug interactions | Examples *; Iron supplements: ferric citrate, ferrous sulfate, sodium ferrous citrate Iron-containing phosphate binders: ferric citrate, sucroferric oxyhydroxide Non-iron-containing phosphate binders: calcium acetate, sevelamer carbonate |
| Simvastatin | drug interactions | Concomitant Drug Name Recommendation Simvastatin Starting dose of simvastatin should be 5 mg/day. |
Every other medicine the vadadustat label names
| Medicine named | Section | What the label says |
|---|---|---|
| Sitagliptin | drug interactions | Examples *; cefaclor, ceftizoxime, famotidine, furosemide, oseltamivir carboxylate, penicillin G, sitagliptin |
| Sulfasalazine | drug interactions | Example *; sulfasalazine |
| Teriflunomide | drug interactions | … inhibitors: probenecid, rifampicin OAT3 inhibitors: gemfibrozil, probenecid, teriflunomide * These examples are not a comprehensive list of all possible drugs that may fit this category. |
Source: FDA drug label (VAFSEO), Akebia Therapeutics, Inc., effective March 30, 2026 (SPL set ac9da724-5a62-4ab6-a89c-376a25f6195b), via openFDA; the full label on DailyMed
What do FAERS reports show for vadadustat?
The FDA Adverse Event Reporting System holds 284 reports that list vadadustat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 95 are coded as a death and 102 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.
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 vadadustat?
6 other medicines are given the same way (oral) and in the same FDA class as vadadustat 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 |
|---|---|---|---|---|
| Daprodustat | 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 vadadustat
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to vadadustat
- 6 medicines for the same use
- Other hypoxia-inducible factor prolyl hydroxylase inhibitors
- the pharmacologic class, with prices and generics
- Vadadustat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other