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

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.

Medical Disclaimer