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Tracleer
Bosentan
$6165.00
62.5mg · 3 × 60 tablets · 3 months supply
BrandBranded medicine· By Actelion
$2055.00 per month
Strength
How long a supply?
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Annual cost
$24660a year at this pack size
Prescription required
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62.5mg
125mg
FDA boxed warningRisks 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
TRACLEER is available only through a restricted distribution program called the Bosentan Risk Evaluation and Mitigation Strategy (REMS) because of the risk of hepatotoxicity:
Elevations of liver aminotransferases (ALT, AST) and liver failure have been reported with TRACLEER.
Measure liver aminotransferases prior to initiation of treatment and then monthly.
Discontinue TRACLEER if aminotransferase elevations are accompanied by signs or symptoms of liver dysfunction or injury or increases in bilirubin ≥2×ULN.
Based on animal data, TRACLEER may cause fetal harm if used during pregnancy.
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.
When pregnancy is detected, discontinue TRACLEER as soon as possible.
About Tracleer
Overview
Tracleer contains bosentan, an endothelin receptor antagonist available as film-coated tablets. It treats pulmonary arterial hypertension (PAH, WHO Group 1) in adults to improve exercise ability and reduce clinical worsening. It is also indicated for children aged 3 years and older with idiopathic or congenital PAH to reduce resistance to blood flow through the lungs, which is expected to improve exercise ability. Bosentan works by blocking the receptors that endothelin-1 acts on in blood vessels.
What it treats
- Pulmonary arterial hypertension (PAH, WHO Group 1) in adults, to improve exercise ability and reduce clinical worsening. - Idiopathic or congenital PAH in children aged 3 years and older, to reduce resistance to blood flow in the lungs, which is expected to improve exercise ability.
Safety information
Side effects
Common side effects include respiratory tract infections and anemia (low red blood cell levels). Serious risks include liver injury, harm to an unborn baby, fluid retention and pulmonary edema (fluid in the lungs). Contact your doctor if you develop fluid retention or signs of fluid in the lungs, or if you become pregnant during treatment. Fluid in the lungs may indicate an associated condition called pulmonary veno-occlusive disease and may require stopping Tracleer under medical guidance. Tracleer can also decrease sperm counts and lower hemoglobin and hematocrit levels. Hemoglobin should be checked after 1 and 3 months of treatment, then every 3 months.
FDA boxed warning
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
TRACLEER is available only through a restricted distribution program called the Bosentan Risk Evaluation and Mitigation Strategy (REMS) because of the risk of hepatotoxicity:
Elevations of liver aminotransferases (ALT, AST) and liver failure have been reported with TRACLEER.
Measure liver aminotransferases prior to initiation of treatment and then monthly.
Discontinue TRACLEER if aminotransferase elevations are accompanied by signs or symptoms of liver dysfunction or injury or increases in bilirubin ≥2×ULN.
Based on animal data, TRACLEER may cause fetal harm if used during pregnancy.
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.
When pregnancy is detected, discontinue TRACLEER as soon as possible.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not take Tracleer (bosentan) if you are pregnant, are allergic to bosentan, or take cyclosporine A or glyburide. Tracleer can cause fluid retention, which may need treatment. If fluid builds up in the lungs, your doctor should consider pulmonary veno-occlusive disease (PVOD) and whether to stop Tracleer. Tracleer may reduce sperm counts and lower hemoglobin and hematocrit levels. Hemoglobin should be checked after 1 and 3 months of treatment, then every 3 months. If you are breastfeeding, you and your doctor must choose between breastfeeding and taking Tracleer.
Interactions
Tracleer can interact with medicines processed by the liver enzymes CYP2C9 and CYP3A, increasing levels of Tracleer and/or the other medicine in the body. Ask your doctor to check for interactions with your other medicines. Tracleer can reduce the effectiveness of hormonal contraceptives. If you use hormonal birth control, discuss contraception with your doctor.
Using Tracleer
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label TRACLEER (BOSENTAN) TABLET, FILM COATED TRACLEER (BOSENTAN) TABLET, FOR SUSPENSION [ACTELION PHARMACEUTICALS US, INC.] (DailyMed, retrieved 19 September 2026).
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