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Medications and Drugs

Brand Names: Tracleer

Generic Name: bosentan (Pronunciation: boe SEN tan)

What is Bosentan (Tracleer)?

Bosentan prevents thickening of the blood vessels, especially those in the lungs and heart. Bosentan also lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Bosentan is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

Bosentan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of bosentan (Tracleer)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • nausea, stomach pain, loss of appetite;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

Your doctor may have you take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.

Do not use this medication if you are allergic to bosentan, or if you are also taking cyclosporine (Sandimmune, Neoral, Gengraf), glyburide (Micronase, DiaBeta, Glynase Pres Tab), or HIV/AIDS medication that contains lopinavir or ritonavir (Kaletra, Norvir).

Bosentan can cause severe liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking bosentan, and again each month during your treatment.

Do not stop taking bosentan without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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