Vadadustat Side Effects
Medically reviewed by Drugs.com. Last updated on Nov 10, 2024.
Applies to vadadustat: oral tablets film-coated.
Important warnings
This medicine can cause some serious health issues
-
Increased Risk of Mortality, MI, Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access
- Increased risk of thrombotic vascular events, including major adverse cardiovascular events (MACE).1
- Targeting a hemoglobin level >11 g/dL is expected to further increase risks of mortality and arterial/venous thrombotic events.1
- Studies have not identified a target hemoglobin level, dose, or dosing strategy that does not increase these risks.1
- Use lowest dose sufficient to reduce RBC transfusion requirements.1
Side effects include:
Most common adverse effects (≥10%): hypertension, diarrhea.
For healthcare professionals
Applies to vadadustat: oral tablet.
General adverse events
The most common adverse reactions were thromboembolic events, diarrhea, hypertension, and pneumonia.[Ref]
Cardiovascular
- Very common (10% or more): Hypertension (up to 14%)
- Common (1% to 10%): Hypotension, atrial fibrillation, arteriovenous fistula thrombosis, arteriovenous fistula site complication, acute myocardial infarction, arteriovenous graft thrombosis
- Uncommon (0.1% to 1%): Deep vein thrombosis, cerebrovascular accident, transient ischemic attack[Ref]
Gastrointestinal
- Very common (10% or more): Diarrhea (13%)
- Common (1% to 10%): Nausea, vomiting, abdominal pain, gastrointestinal erosion, constipation[Ref]
Gastrointestinal erosion includes duodenal ulcers and perforation, gastrointestinal ulcers and perforation, esophageal ulcers and perforation, and unspecified site or hematemesis, gastrointestinal hemorrhage, helicobacter duodenitis and gastritis, melena, and gastric hemorrhage.[Ref]
Hepatic
- Common (1% to 10%): Elevated serum ALT, elevated serum AST
- Uncommon (0.1% to 1%): Elevated bilirubin
- Frequency not reported: Hepatocellular injury with jaundice[Ref]
Metabolic
- Common (1% to 10%): Fluid overload, hyperkalemia[Ref]
Musculoskeletal
Other
- Very common (10% or more): Death (11.9%)
- Common (1% to 10%): Sepsis, fall, dialysis-related complication[Ref]
Renal
- Common (1% to 10%): Urinary tract infection, dialysis related complication[Ref]
Respiratory
- Very common (10% or more): Pneumonia (10.7%)
- Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis, cough, dyspnea
- Uncommon (0.1% to 1%): Pulmonary embolism[Ref]
Nervous system
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References
1. (2023) "Product Information. Vafseo (vadadustat)." Adjutor Healthcare Pty Ltd
2. (2024) "Product Information. Vafseo (vadadustat)." Akebia Therapeutics
3. (2024) "Product Information. Vafseo (vadadustat)." Medice UK Ltd
More about vadadustat
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- During pregnancy
- Drug class: miscellaneous uncategorized agents
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Further information
Vadadustat side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.