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These highlights do not include all the information needed to use BOSENTAN TABLETS safely and effectively. See full prescribing information for BOSENTAN TABLETS. BOSENTAN tablets, for oral use Initial U.S. Approval: 2001
Medication labelWhy this: Advisory · dailymed-prescription
Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]. in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.
- generic_name
- bosentan
- product_names
- bosentan
- ndc
- 0591-2511, 0591-2511-60, 0591-2512, 0591-2512-60
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en