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Opsynvi Side Effects

Generic name: macitentan / tadalafil

Medically reviewed by Drugs.com. Last updated on Feb 10, 2025.

Note: This document provides detailed information about Opsynvi Side Effects associated with macitentan / tadalafil. Some dosage forms listed on this page may not apply specifically to the brand name Opsynvi.

Applies to macitentan / tadalafil: oral tablets.

Important warnings This medicine can cause some serious health issues

REMS:

FDA approved a REMS for macitentan-containing products to ensure that the benefits outweigh the risks.1 The REMS consists of the following: elements to assure safe use and implementation system.1 See the FDA REMS page ([Web]).

Side effects include:

Most common adverse reactions (≥10%): edema/fluid retention, anemia, headache/migraine.

For healthcare professionals

Applies to macitentan/tadalafil: oral tablet.

General adverse events

The most commonly reported side effects included edema/fluid retention, anemia, and headache/migraine.[Ref]

Cardiovascular

Macitentan:

Tadalafil:

Dermatologic

Macitentan:

Tadalafil:

Gastrointestinal

Tadalafil:

Genitourinary

Macitentan:

Tadalafil:

Hematologic

Hypersensitivity

Macitentan:

Tadalafil:

Metabolic

Musculoskeletal

Ocular

Tadalafil:

Other

Tadalafil:

Respiratory

Macitentan:

Tadalafil:

Hepatic

Macitentan:

Endothelin receptor antagonists:

Elevated aminotransferases at least 3 times the upper limit of normal (3 x ULN) and at least 8 x ULN have been reported in up to 3.4% and 1.1% of patients, respectively.[Ref]

Nervous system

Tadalafil:

See also:

References

1. (2024) "Product Information. Opsynvi (macitentan-tadalafil)." Actelion Pharmaceuticals US Inc

Further information

Opsynvi 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.