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These highlights do not include all the information needed to use TRACLEER safely and effectively. See full prescribing information for TRACLEER. TRACLEER ®(bosentan) tablets, for oral use TRACLEER ®(bosentan) tablets for oral suspension Initial U.S. Approval: 2001
Medication labelWhy this: Advisory · dailymed-prescription
TRACLEER is 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
- 66215-232, 66215-101, 66215-102, 66215-101-06, 66215-101-03, 66215-102-06, 66215-102-03, 66215-232-14, 66215-232-56
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en