What the label lists and what reports show
Vadadustat side effects
Vadadustat's FDA label: “The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea.” FAERS holds 284 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 diarrhoea (25 reports).
- No generic listed
- Boxed warning
Check it at the source: the vadadustat FDA label on DailyMed (effective March 30, 2026, Akebia Therapeutics, Inc.); 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 VAFSEO?VAFSEO may cause serious side effects, including: See “ What is the most important information I should know about VAFSEO? ” Liver problems. VAFSEO may cause changes in blood liver tests, which may be a sign of liver injury. Your healthcare provider will do blood liver tests before starting treatment with VAFSEO, monthly for the first 6 months and then as needed. Your healthcare provider may stop treatment with VAFSEO if you have changes in your blood liver tests. Tell your healthcare provider if you get any of these symptoms: tiredness pain in your right upper stomach area (abdomen) yellowing of your skin or the white part of your eyes loss of appetite dark urine High blood pressure. VAFSEO may cause you to develop new or worsening high blood pressure. […]
Source: FDA drug label, Akebia Therapeutics, Inc., effective March 30, 2026 (SPL set ac9da724-5a62-4ab6-a89c-376a25f6195b), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reactions | VAFSEO N=1947 (%) | Darbepoetin Alfa N=1955 (%) |
|---|---|---|
| Hypertension | 14 | 17 |
| Diarrhea | 13 | 10 |
| Headache | 9 | 8 |
| Nausea | 8 | 8 |
| Fatigue | 8 | 5 |
| Abdominal pain | 7 | 7 |
| Vomiting | 7 | 7 |
| Gastrointestinal erosion | 6 | 5 |
| Dizziness | 6 | 5 |
| Dyspnea | 6 | 7 |
| Arteriovenous fistula thrombosis | 6 | 5 |
| Dialysis related complication | 5 | 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 discussed elsewhere in the labeling: Increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access [see Boxed Warning and Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Seizures [see Warnings and Precautions ( 5.4 )] Gastrointestinal erosion [see Warnings and Precautions ( 5.5 )] Serious adverse reactions in patients with anemia due to chronic kidney disease and not on dialysis [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Akebia Therapeutics, Inc. at 1-844-445-3799 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of VAFSEO was evaluated in adults with dialysis-dependent chronic kidney disease (DD-CKD) with anemia in the INNO 2 VATE-1 and INNO 2 VATE-2 trials [see Clinical Studies ( 14.1 )]. …
Source: FDA drug label, 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?
284 reports list vadadustat among the medicines taken, 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. Of the 18 reactions below, 4 are 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.
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?
- Vadadustat: 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