- 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 drug may cause birth defects if you take it while you are pregnant.
- Do not take this drug if you are pregnant. A pregnancy test will be done to show that you are NOT pregnant before starting this drug.
- 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 this drug.
- If you get pregnant while taking this drug or within 1 month after your last dose, call your doctor right away.
- You may only get this drug through a special program. Talk with your doctor.
- It is used to treat high blood pressure in the lungs.
- If you have an allergy to bosentan or any other part of this drug.
- 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 this drug.
- Tell all of your health care providers that you take this drug. 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 this drug affects you.
- Do not stop taking this drug 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 this drug. 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 drug 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.
- If your child starts puberty while taking this drug, talk with your child’s doctor. Your child may be able to get pregnant, even if she has not started her menstrual period.
Tablets for suspension:
- If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
- 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.
- Nose irritation.
- Signs of a common cold.
- Take with or without food.
- To gain the most benefit, do not miss doses.
- Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
Tablets for suspension:
- Mix with water as you have been told before drinking.
- The tablets may be broken in half. Do not break into quarters.
- 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.
- 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.
Tablets for suspension:
- If you have broken tablets, store the tablet pieces in the opened blister for up to 7 days.
- 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.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, 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.