Aprocitentan Side Effects
Medically reviewed by Drugs.com. Last updated on Jan 10, 2025.
Applies to aprocitentan: oral tablets film-coated.
Important warnings
This medicine can cause some serious health issues
REMS:
FDA approved a REMS for aprocitentan to ensure that the benefits outweigh the risks.
The REMS may apply to one or more preparations of aprocitentan and consists of the following: elements to assure safe use and implementation system.
See the FDA REMS page at [Web]
Side effects include:
Adverse effects reported in ≥2% of patients receiving aprocitentan include edema/fluid retention and anemia.
For healthcare professionals
Applies to aprocitentan: oral tablet.
General adverse events
The most frequently reported side effects included anemia, edema, and fluid retention.[Ref]
Dermatologic
- Frequency not reported: Allergic dermatitis, erythema, rash
Hematologic
- Common (1% to 10%): Anemia/decreased hemoglobin
- Frequency not reported: Decreased hematocrit
Hepatic
- Frequency not reported: Hepatotoxicity, increased aminotransferases, increased ALT, increased AST
Hypersensitivity
- Uncommon (0.1% to 1%): Hypersensitivity
- Frequency not reported: Allergic edema
Hypersensitivity included rash, erythema, and allergic edema.
Metabolic
- Common (1% to 10%): Edema/fluid retention
Renal
- Frequency not reported: Decrease in estimated GFR
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References
1. (2024) "Product Information. Tryvio (aprocitentan)." Idorsia Pharmaceuticals US Inc.
More about aprocitentan
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- During pregnancy
- Drug class: miscellaneous cardiovascular agents
- Breastfeeding
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Further information
Aprocitentan 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.
