Quick answers
- What is Bosentan used for?
- The FDA-approved label (Tracleer, Actelion Pharmaceuticals US, Inc., November 17, 2025) says: “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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bosentan have a boxed warning?
- Yes. The FDA label for Tracleer has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Bosentan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bosentan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Bosentan?
- 6 companies list prescription products of Bosentan in the FDA NDC Directory, including Actelion Pharmaceuticals US, Inc., Zydus Pharmaceuticals USA Inc. and Zydus Lifesciences Limited.
What Bosentan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 …
— FDA label: Tracleer, Actelion Pharmaceuticals US, Inc., effective November 17, 2025. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
6 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, for suspension · Tablet, coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 14 in the FDA NDC Directory |
| Brand names | Tracleer |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Actelion Pharmaceuticals US, Inc.3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Zydus Lifesciences Limited3 products
- Actavis Pharma, Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Lupin Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021290 TRACLEER | Actelion | November 20, 2001 | 33, latest March 3, 2026 2026: REMS · 2025: Labeling · 2025: Labeling |
| NDA209279 TRACLEER | Actelion | September 5, 2017 | 12, latest March 3, 2026 2026: REMS · 2025: Labeling · 2025: Labeling |
Generic approvals (5)
- ANDA207110Watson Labs Inc · April 26, 2019
- ANDA207760Zydus Pharms · April 26, 2019
- ANDA209324Sun Pharm · April 26, 2019
- ANDA213154Natco Pharma Ltd · February 5, 2025
- ANDA213981Zydus Pharms · February 17, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tracleer, Actelion Pharmaceuticals US, Inc., effective November 17, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →