FDA label
What is Opsumit used for?
Opsumit contains macitentan. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Opsumit lists this use: Pulmonary Arterial Hypertension.
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Opsumit, tablet, film coated
Indications and Usage, quoted from the label by Actelion Pharmaceuticals US, Inc. (NDA204410). Cross-references to other label sections are left out.
Pulmonary Arterial Hypertension
OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH.
Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II–III symptoms treated for an average of 2 years. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%) [see Clinical Studies].
Source: DailyMed label, set id 1e484a50-55db-4b85-8c57-6cd1b0353abd, version 35, effective April 11, 2025. NDC 66215-501, one of 1 listing for this product.
Questions
What is Opsumit used for?
The FDA label for Opsumit lists this use: Pulmonary Arterial Hypertension.
What drug class is Opsumit?
FDA lists macitentan in the Endothelin Receptor Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.