Tracleer Oral

Tracleer Oral Warning

Bosentan has rarely caused very serious liver problems. Your doctor will monitor your liver function blood tests monthly. Tell your doctor immediately if you develop symptoms of liver disease, including persistent nausea/vomiting, stomach/abdominal pain, extreme tiredness, dark urine, yellowing eyes/skin.

This medication must not be used during pregnancy because it can cause harm to a fetus/unborn baby. See also Precautions section.

Tracleer Oral 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.

Tracleer Oral 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:

Previous Section

Dosage and Storage

Next Section

Drug Interactions