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GENERIC NAME: BOSENTAN - ORAL (boh-SEN-tan)

BRAND NAME(S): Tracleer

Warning | Medication Uses | How To Use | Side Effects | Precautions | Drug Interactions | Overdose | Notes | Missed Dose | Storage | Medical Alert

WARNING: This medication may cause serious liver problems. Your doctor should monitor your liver function closely to decrease your risk of liver-related side effects. Tell your doctor immediately if you notice any of these symptoms of liver problems: nausea, vomiting, stomach pain, unusual tiredness, and yellowing eyes or skin. These effects, if they occur, may go away over time (are reversible). This medication must not be used during pregnancy because it can cause fetal harm (e.g., birth defects). See the pregnancy warning information below (in Precautions section).

USES: Bosentan is used to treat a condition of high blood pressure in the lungs (pulmonary arterial hypertension). It works by causing the blood vessels (arteries) in the lungs to relax and expand, thus decreasing the pressure.

HOW TO USE: Before using, review the bosentan Medication Guide for information on the safe use of this medicine. Take this medication by mouth usually twice daily in the morning and evening with or without food; or as directed by your doctor. The dosage is based on your medical condition and response to therapy. Your doctor may recommend to gradually increase your dose over time so your body may better adjust to the effects of this drug. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.

SIDE EFFECTS: Headache, nose/throat irritation, itching, flushing, or stomach upset may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: irregular heartbeat, unusual tiredness and weakness, swelling of the feet or ankles, trouble breathing, dizziness or lightheadedness. If you notice any of the following very serious side effects of liver problems, stop taking bosentan and consult your doctor immediately: vomiting, stomach pain, yellowing eyes or skin. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, severe trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.




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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