Tracleer (Bosentan) Drug Overview of Side Effects and Precautions for Patients and Caregivers at RxList

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May 27, 2012

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High blood pressure facts

High blood pressure (hypertension) is designated as either essential (primary) hypertension or secondary hypertension and is defined as a consistently elevated blood pressure exceeding 140/90 mm Hg.
High blood pressure is called "the silent killer" because it often causes no symptoms for many years, even decades, until it finally damages certain critical organs.
Poorly controlled high blood pressure ultimately can cause damage to blood vessels in the eye, thickening of the heart muscle and heart attacks, hardening of the arteries (arteriosclerosis), kidney failure, and strokes.
Most antihypertensive medications can be used alone or in combination. Some are used only in combination. Some are preferred over others in certain specific medical situations. And some are not to be used (contraindicated) in other situations.
Several classes of antihypertensive medications are available, including ACE i...

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SIDE EFFECTS: See also Warning section.

Dizziness, flushing, upset stomach, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding heartbeat, extreme tiredness, swelling of the ankles/feet, sudden/unexplained weight gain.

Tell your doctor immediately if any of these rare but very serious side effects occur: fainting, shortness of breath, coughing up blood.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking bosentan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, anemia.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages since they can increase the effects of dizziness and also increase the risk of serious liver problems.

This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Women of child-bearing age must have a negative pregnancy test before starting this medication and monthly while taking it. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women using this medication use 2 effective forms of birth control (e.g., condoms and diaphragm with spermicide) while taking this medication. (See also Drug Interactions section.)

It is not known whether this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.