Prescription medicine
Bosentan Brand names: Tracleer
Bosentan (Tracleer) is a prescription medicine with an FDA approval on record since 2001. FDA's NDC Directory lists it from 5 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the bosentan FDA label on DailyMed (effective November 17, 2025, Actelion Pharmaceuticals US, Inc.); the NDA 21290 record on Drugs@FDA; every bosentan label on DailyMed.
Highlights of the record
FDA label of November 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISKS OF HEPATOTOXICITY and EMBRYO-FETAL TOXICITY Because of the risk of hepatotoxicity, TRACLEER is available only through a restricted program called the Bosentan Risk Evaluation and Mitigation Strategy (REMS). Under the Bosentan REMS, prescribers, patients, and pharmacies must enroll in the program [see Warnings and Precautions (5.2) ]. WARNING: RISKS OF HEPATOTOXICITY and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. TRACLEER is available only through a restricted distribution program called the Bosentan Risk Evaluation and Mitigation Strategy (REMS) because of the risk of hepatotoxicity ( 5.2 ): Elevations of liver aminotransferases (ALT, AST) and liver failure have been reported with TRACLEER ( 5.1 ). Measure liver aminotransferases prior to initiation of treatment and then monthly ( 2.1 , 5.1 ). Discontinue TRACLEER if aminotransferase elevations are accompanied by signs or symptoms of liver dysfunction or injury or increases in bilirubin ≥2×ULN ( 2.4 , 5.1 ). Based on animal data, TRACLEER may cause fetal harm if used during pregnancy ( 4.1 , 5.3 , 8.1 ). Females of reproductive potential: Exclude pregnancy before initiating treatment. Use effective contraception prior to initiation of treatment, during treatment and for one month after stopping TRACLEER ( 2.1 , 4.1 , 5.3 , 8.1 , 8.3 ). […]
Used for
From the label: indications and usageTRACLEER is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening.
Forms and strengths
- 32 mg
- 62.5 mg
- 125 mg
Film-coated tablet; tablet for suspension; tablet; coated tablet.
On the market
- Earliest approval on file
- November 20, 2001 Tracleer, Actelion; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first April 26, 2019; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 5 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 28, 2027 Tracleer tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 50,111 through July 30, 2026
What is bosentan used for?
From the label: indications and usageTRACLEER 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. […]
Conditions named in the indications of bosentan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Endothelin Receptor Antagonist.
Source: FDA drug label (Tracleer), Actelion Pharmaceuticals US, Inc., effective November 17, 2025 (SPL set 749e42fb-2fe0-45dd-9268-b43bb3f4081c), via openFDA; the full label on DailyMed
What does the patient leaflet for bosentan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TRACLEER?TRACLEER can cause serious side effects including: Liver damage. Liver damage may not cause symptoms at first. Only a blood test can show if you have early liver damage. You must have your blood tested to check your liver function before you start TRACLEER and each month after that. Your healthcare provider will order these tests. Regular blood tests are important because they will help your healthcare provider adjust or stop your treatment before there is permanent damage. Tell your healthcare provider if you have had liver problems, including liver problems while taking other medicines. Call your healthcare provider right away if you have any of these symptoms of liver problems while taking TRACLEER: nausea vomiting fever unusual tiredness stomach area (abdominal) pain yellowing of the skin or the whites of your eyes (jaundice) Because of the risk for liver damage, TRACLEER is only available through a restricted program called the Bosentan REMS. Before you begin taking TRACLEER, you must read and agree to all of the requirements of the Bosentan REMS. Serious birth defects. TRACLEER can cause serious birth defects if taken during pregnancy. You should not be pregnant when you start taking TRACLEER or during TRACLEER treatment. Serious birth defects from TRACLEER may happen early in pregnancy. Females who are able to get pregnant should have a negative pregnancy test before starting treatment with TRACLEER. Talk to your healthcare provider about your menstrual cycle. Your healthcare provider will decide when to do a pregnancy test and will order a pregnancy test for you depending on your menstrual cycle. […]
From the patient leaflet: How should I store TRACLEER?Store TRACLEER at room temperature between 68 °F to 77 °F (20 °C to 25 °C). Dispersible tablets that have been broken to adjust the dose of medicine can be stored at room temperature, between 68 °F to 77 °F (20 °C to 25 °C), and should be used within 7 days of having been broken. Tablet pieces may be returned to the opened blister and stored there out of reach of children for up to 7 days. Keep TRACLEER and all medicines out of the reach of children.
Source: FDA drug label (Tracleer), Actelion Pharmaceuticals US, Inc., effective November 17, 2025 (SPL set 749e42fb-2fe0-45dd-9268-b43bb3f4081c), via openFDA; the full label on DailyMed
Is there a generic for bosentan (Tracleer)?
The FDA approved the first generic bosentan on April 26, 2019. 13 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists bosentan from 5 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Tracleer tablets; a patent listed only for Tracleer tablets runs to December 28, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2001 earliest approval on file
- 2019 first generic approved
- 2027 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the bosentan label say about other medicines?
The bosentan label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 46 other medicines name bosentan. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Concomitant administration of both a CYP2C9 inhibitor (such as fluconazole or amiodarone) and a strong CYP3A inhibitor (e.g., ketoconazole, itraconazole) or a moderate CYP3A inhibitor (e.g., amprenavir, erythromycin, fluconazole, diltiazem) with TRACLEER will likely lead to large increases in plasma concentrations of … |
| Cyclosporine | contraindications | Use with Cyclosporine A Co-administration of cyclosporine A and bosentan resulted in markedly increased plasma concentrations of bosentan. |
| Diltiazem | drug interactions | Concomitant administration of both a CYP2C9 inhibitor (such as fluconazole or amiodarone) and a strong CYP3A inhibitor (e.g., ketoconazole, itraconazole) or a moderate CYP3A inhibitor (e.g., amprenavir, erythromycin, fluconazole, diltiazem) with TRACLEER will likely lead to large increases in plasma concentrations of … |
| Erythromycin | drug interactions | Concomitant administration of both a CYP2C9 inhibitor (such as fluconazole or amiodarone) and a strong CYP3A inhibitor (e.g., ketoconazole, itraconazole) or a moderate CYP3A inhibitor (e.g., amprenavir, erythromycin, fluconazole, diltiazem) with TRACLEER will likely lead to large increases in plasma concentrations of … |
| Fluconazole | drug interactions | Concomitant administration of both a CYP2C9 inhibitor (such as fluconazole or amiodarone) and a strong CYP3A inhibitor (e.g., ketoconazole, itraconazole) or a moderate CYP3A inhibitor (e.g., amprenavir, erythromycin, fluconazole, diltiazem) with TRACLEER will likely lead to large increases in plasma concentrations of … |
| Glyburide | contraindications | An increased risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. |
| Itraconazole | drug interactions | Concomitant administration of both a CYP2C9 inhibitor (such as fluconazole or amiodarone) and a strong CYP3A inhibitor (e.g., ketoconazole, itraconazole) or a moderate CYP3A inhibitor (e.g., amprenavir, erythromycin, fluconazole, diltiazem) with TRACLEER will likely lead to large increases in plasma concentrations of … |
| Ketoconazole | drug interactions | Concomitant administration of both a CYP2C9 inhibitor (such as fluconazole or amiodarone) and a strong CYP3A inhibitor (e.g., ketoconazole, itraconazole) or a moderate CYP3A inhibitor (e.g., amprenavir, erythromycin, fluconazole, diltiazem) with TRACLEER will likely lead to large increases in plasma concentrations of … |
| Norethindrone | drug interactions | An interaction study demonstrated that co-administration of bosentan and a combination oral hormonal contraceptive produced average decreases of norethindrone and ethinyl estradiol levels of 14% and 31%, respectively. |
Other labels that name bosentan
- Atazanavir
- Axitinib
- Cobicistat
- Darunavir
- Dienogest and estradiol
- Drospirenone
- Elbasvir and grazoprevir
- Eltrombopag
- Ethinyl estradiol and ferrous bisglycinate and levonorgestrel
- Ethinyl estradiol and ferrous fumarate and levonorgestrel
- Ethinyl estradiol and levonorgestrel
- Ethinyl estradiol and norelgestromin
- Ethinyl estradiol and norgestimate
- Etonogestrel
- Fosamprenavir
- Gemfibrozil
- Lemborexant
- Letermovir
- Lurasidone
- Macimorelin
- Nelfinavir
- Ritonavir
- Sildenafil
Source: FDA drug label (Tracleer), Actelion Pharmaceuticals US, Inc., effective November 17, 2025 (SPL set 749e42fb-2fe0-45dd-9268-b43bb3f4081c), via openFDA; the full label on DailyMed
What do FAERS reports show for bosentan?
The FDA Adverse Event Reporting System holds 50,111 reports that list bosentan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 15,952 are coded as a death and 25,004 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as bosentan?
6 other medicines are given the same way (oral) and in the same FDA class as bosentan or labeled mainly for the same use (pulmonary arterial hypertension), the same class first. Pulmonary arterial hypertension lists all 11 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ambrisentan | Pulmonary arterial hypertension | 12 labelers | $8.02 per tablet 10 mg tablet | No current entry |
| Macitentan | Pulmonary arterial hypertension | 13 labelers | n/a | No current entry |
| Macitentan and tadalafil | Pulmonary arterial hypertension | none listed | n/a | No current entry |
| Selexipag | Pulmonary arterial hypertension | 2 labelers | n/a | No current entry |
| Treprostinil | Pulmonary arterial hypertension | none listed | n/a | No current entry |
| Riociguat | Pulmonary arterial hypertension | 1 labeler | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does bosentan compare with medicines for the same use?
1 side-by-side page set bosentan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to bosentan
- 6 medicines for the same use
- Other endothelin receptor antagonists
- the pharmacologic class, with prices and generics
- Bosentan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other