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Tracleer (Bosentan Tablets)

Generic Name: Bosentan Tablets (boe SEN tan)
Brand Name: Tracleer

Medically reviewed on July 4, 2018

Warning

  • Liver problems have happened. Call your doctor right away if you get signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • You will be watched closely by your doctor.
  • If you have liver disease, talk with your doctor.
  • This medicine may cause birth defects if you take it while you are pregnant.
  • Do not take Tracleer (bosentan tablets) if you are pregnant. A pregnancy test will be done to show that you are NOT pregnant before starting Tracleer (bosentan tablets).
  • A pregnancy test will be done every month during care and for 1 month after care ends.
  • Use 2 kinds of birth control that you can trust during care and for 1 month after care ends.
  • Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Tracleer (bosentan tablets).
  • If you get pregnant while taking Tracleer (bosentan tablets) or within 1 month after your last dose, call your doctor right away.
  • You may only get Tracleer (bosentan tablets) through a special program. Talk with your doctor.

Uses of Tracleer:

What do I need to tell my doctor BEFORE I take Tracleer?

  • If you have an allergy to bosentan or any other part of Tracleer (bosentan tablets).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have liver disease or raised liver enzymes.
  • If you are taking any of these drugs: Cyclosporine or glyburide.
  • If you are breast-feeding. Do not breast-feed while you take Tracleer (bosentan tablets).

This is not a list of all drugs or health problems that interact with Tracleer (bosentan tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Tracleer (bosentan tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tracleer?

For all patients taking Tracleer (bosentan tablets):

  • Tell all of your health care providers that you take Tracleer (bosentan tablets). This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Tracleer (bosentan tablets) affects you.
  • Do not stop taking Tracleer (bosentan tablets) all of a sudden without calling your doctor. Signs of high pressure in the lungs like shortness of breath, dizziness, or weakness may get worse. Talk with your doctor.
  • Talk with your doctor before you drink alcohol.
  • A very bad and sometimes deadly reaction has happened with Tracleer (bosentan tablets). Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
  • This medicine may affect being able to father a child. It is not known how long this effect lasts. Talk with the doctor.
  • If you are a woman and you miss a period, have unprotected sex, or think that your birth control has not worked, call your doctor right away.

Children:

  • If your child starts puberty while taking Tracleer (bosentan tablets), talk with your child's doctor. Your child may be able to get pregnant, even if she has not started her menstrual period.

How is this medicine (Tracleer) best taken?

Use Tracleer (bosentan tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • To gain the most benefit, do not miss doses.
  • Keep taking Tracleer (bosentan tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

See also: Dosage Information (in more detail)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Feeling very tired or weak.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Very bad dizziness or passing out.
  • A heartbeat that does not feel normal.
  • Joint pain.

What are some other side effects of Tracleer?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tracleer?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Tracleer (bosentan tablets) is refilled. If you have any questions about Tracleer (bosentan tablets), please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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