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These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 2013
Medication labelWhy this: Advisory · dailymed-prescription
Macitentan tablets are 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 to 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 (14.1)].
- generic_name
- macitentan
- product_names
- Macitentan
- ndc
- 42385-907, 42385-907-30, 42385-907-15
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en