Tracleer ratings & reviews

Tracleer contains the active ingredient bosentan monohydrate, which is an endothelin receptor antagonist. It is available as film-coated tablets in 62.5 mg and 125 mg strengths for oral administration. Key inactive ingredients include corn starch, ethylcellulose, and iron oxide. Bosentan belongs to a class of highly substituted pyrimidine derivatives and is intended to be taken orally.

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Leave the tablet in the sealed pack until you are ready to take it. With dry hands, open the pack and gently remove the tablet. Do not try to push the tablet through the foil backing. If the tablet breaks or crumbles, throw it away. Use a new tablet. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 3 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Divided tablet pieces may be returned to the opened pack and stored under the same conditions for up to 7 days. Throw away any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• New or worsening shortness of breath
• Swelling of the ankles, hands, or feet
• Sudden weight gain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dizziness
• Facial flushing, redness
• Headache
• Runny or stuffy nose
• Sinus pain or pressure around the face or forehead

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Liver disease
• Phenylketonuria
• An unusual or allergic reaction to bosentan, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Cyclosporine
• Estrogen and progestin hormones
• Glyburide

This medication may also interact with the following:

• Amiodarone
• Amprenavir
• Certain medications for cholesterol, such as atorvastatin, lovastatin, and simvastatin
• Certain medications for fungal infections, such as fluconazole, ketoconazole, and itraconazole
• Diltiazem
• Erythromycin
• Rifampin
• Ritonavir

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

This product may contain aspartame, which is a source of phenylalanine. If you have phenylketonuria (PKU), contact your care team for advice.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 1 month after your last dose. You will need a negative pregnancy test before, during, and after taking this medication. Estrogen and progestin hormones may not work as well while you are taking this medication. Contraception is recommended while taking this medication and for 1 month after your last dose. Your care team can help find the option that works for you.

Do not breastfeed while taking this medication.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What are the most serious risks of this medication?

This medication may cause serious birth defects if taken during pregnancy. Do not take this medication if you are pregnant.

This medicine can cause serious, life-threatening liver damage.