TRACLEER- bosentan tablet, film coated 
Actelion Pharmaceuticals US, Inc.


Medication Guide

Tracleer® (tra-KLEER)

Read the Medication Guide that comes with Tracleer before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Tracleer?

Tracleer is only available through the Tracleer REMS Program. Before you begin taking Tracleer, you must read and agree to all of the instructions in the Tracleer REMS Program.

Tracleer can cause serious side effects including:

Liver damage.

Serious birth defects.


See "What are the possible side effects of Tracleer?" for more information about side effects.

What is Tracleer?

Tracleer is a prescription medicine used to treat people with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of the lungs.

Tracleer can improve your ability to exercise and can slow the worsening of your physical condition and symptoms. Tracleer lowers high blood pressure in your lungs and lets your heart pump blood more efficiently.

Tracleer is only:

Prescribed by healthcare providers who are enrolled in the Tracleer REMS Program.

Available to people who understand and agree to enroll in the Tracleer REMS Program.

It is not known if Tracleer is safe and works in children below 12 years of age.

Who should not take Tracleer?

Do not take Tracleer if you:

What should I tell my healthcare provider before taking Tracleer?

Tracleer may not be right for you. Tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tracleer and other medicines may affect how each other works and cause side effects. Especially tell your healthcare provider if you take:

  • hormone-based birth control, such as pills, shots, patches, and implants. These birth control methods may not work as well when taken with Tracleer.
  • simvastatin or other "-statin" medicines used to lower cholesterol
  • rifampin used for tuberculosis
  • tacrolimus used to prevent rejection of liver or kidney transplant
  • ketoconazole, fluconazole, itraconazole, or voriconazole used for fungal infections
  • warfarin sodium used to prevent blood clots
  • ritonavir used to treat HIV

There may be more than one brand name medicine. Ask your healthcare provider if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine.

How should I take Tracleer?

Your healthcare provider will give you detailed information about the Tracleer REMS Program.

What are the possible side effects of Tracleer?

Tracleer can cause serious side effects, including:

The most common side effects of Tracleer include:

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Tracleer. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Tracleer?

Keep Tracleer and all medicines out of the reach of children.

General information about Tracleer

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Tracleer for a condition for which it was not prescribed. Do not give Tracleer to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Tracleer. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Tracleer that is written for health professionals. For more information, go to or call 1-866-228-3546.

What are the ingredients in Tracleer?

Active ingredient: bosentan

Inactive ingredients: corn starch, pregelatinized starch, sodium starch glycolate, povidone, glyceryl behenate, magnesium stearate, hydroxypropylmethylcellulose, triacetin, talc, titanium dioxide, iron oxide yellow, iron oxide red, ethylcellulose.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for:
Actelion Pharmaceuticals US, Inc.
South San Francisco, CA 94080, USA

Revised: October 2016

Revised: 11/2016
Actelion Pharmaceuticals US, Inc.