FDA label
What is ambrisentan used for?
The FDA-approved uses of ambrisentan, 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 says: “Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening.”
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Ambrisentan, tablet, film coated
Indications and Usage, quoted from the label by Mylan Pharmaceuticals Inc. (ANDA208441). Cross-references to other label sections are left out.
Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients:
- To improve exercise ability and delay clinical worsening.
Studies establishing effectiveness included predominantly patients with WHO Functional Class II-III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).
Source: DailyMed label, set id 8080b009-361b-4505-b09a-0d91a0e4a2c0, version 7, effective December 5, 2025. NDC 0378-4270, one of 24 listings for this product.
Questions
What is ambrisentan used for?
The FDA label says: “Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening.”
What drug class is ambrisentan?
FDA lists ambrisentan 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.