Key facts about Tracleer
What is Tracleer?
Tracleer is the brand name for bosentan and is available as an oral tablet and suspension.
What dosages is Tracleer available in?
Tracleer is available as a 62.5 mg and 125 mg oral tablet and a 32 mg oral suspension.
What is Tracleer used for?
- Tracleer is an endothelin receptor antagonist that is used to treat pulmonary arterial hypertension (PAH)
How does Tracleer work?
Tracleer is an endothelin receptor antagonist. It works on proteins in your body that control the blood flow going to your lungs. This medication relaxes the arteries in your lung and allows more blood to flow through. As a result, your heart is able to pump better, your body gets more oxygen, and you should be able to breathe and exercise easier.
How do I take Tracleer?
Tracleer is dosed as follows:
- Adults and children over 12 years old: Start with 62.5 mg by mouth twice daily. After 4 weeks, if you weigh over 40 kg (88 pounds), your provider might increase your dose to 125 mg by mouth twice daily
- Children ages 3 to 12 years old: Depending on your child’s weight, they can take between 16 mg and 64 mg by mouth twice daily
Is it safe for me to take Tracleer?
Tracleer is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:
- Pregnancy
- Use with Cyclosporine A
- Use with Glyburide
- Hypersensitivity
Tracleer Common Side Effects
Common side effects of Tracleer:
- Common cold symptoms or lung infection
- Headache
- Swelling due to fluid buildup
- Chest pain
- Fainting
- Warmth and redness in the face, neck, or chest
- Low blood pressure
- Sinus inflammation
Tracleer Serious Side Effects
Serious side effects are rare with Tracleer. Contact your healthcare provider immediately if you experience any of the following.
- Liver failure
- Heart failure
- Allergic reactions
Effects of other drugs, drug classes and over-the-counter products on Tracleer
- The following medications may interact with Tracleer:
- Cytochrome P450: Coadministration of Tracleer with drugs metabolized by CYP2C9 and CYP3A can increase exposure to Tracleer and/or the coadministered drug
- Hormonal contraceptives: Tracleer use decreases contraceptive exposure and reduces effectiveness
Who makes Tracleer?
Janssen Pharmaceuticals
Is Tracleer safe in pregnancy?
Based on animal data, Tracleer is likely to cause major birth defects if used during pregnancy. Must exclude pregnancy before and during treatment. To prevent pregnancy, females of reproductive potential must use two reliable forms of contraception during treatment and for one month after stopping Tracleer.













