Adult Medication

Brand Names: US


Brand Names: Canada



  • Very bad and sometimes deadly liver problems have happened with leflunomide, a drug like this one. Tell your doctor if you have liver disease. This drug must not be used in people with certain liver problems. Have your liver function checked as you were told by your doctor.
  • Tell your doctor if you are taking any drugs that can raise the chance of liver problems. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • This drug may cause harm to the unborn baby 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.
  • Do not take this drug if you are able to get pregnant and are not using birth control to prevent pregnancy. Use birth control that you can trust to prevent pregnancy while taking this drug. Keep using this birth control until you go through a process to get rid of extra teriflunomide in your body. Talk with your doctor if you get pregnant or want to get pregnant within 2 years after you stop taking this drug. You will need to have blood tests showing that your body is free of teriflunomide before you stop taking birth control.

What is this drug used for?

  • It is used to treat MS (multiple sclerosis).

What do I need to tell my doctor BEFORE I take this drug?

  • If you have an allergy to teriflunomide 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 a weak immune system.
  • If you have any of these health problems: Bone marrow disease (like low white blood cell count, low platelet count, or anemia).
  • If you have an infection.
  • If you have liver disease.
  • If you are taking leflunomide.
  • If you are breast-feeding or plan to breast-feed.
This is not a list of all drugs or health problems that interact with this drug.
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 this drug 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 this drug?

  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • High blood pressure has happened with this drug. Have your blood pressure checked as you have been told by your doctor.
  • You may have more chance of getting an infection. Some infections have been deadly. Wash hands often. Stay away from people with infections, colds, or flu.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • You will need a TB (tuberculosis) test before starting this drug.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this drug.
  • Talk with your doctor before getting any vaccines while you take this drug and after you stop taking it. Vaccine use with this drug may either raise the chance of an infection or make this drug not work as well. Talk with your doctor.
  • Nerve problems have happened with this drug. Most of the time, these nerve problems went away after this drug was stopped. Sometimes, people had nerve problems that did not go away even after this drug was stopped. Talk with the doctor.
  • 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.
  • If you are 60 or older, use this drug with care. You could have more side effects.
  • If you are a man and have sex with a female who could get pregnant, protect her from pregnancy. Do this during care and for at least 2 years after your last dose unless you have gone through the process to remove this drug from your body. Talk with your doctor. Call the doctor right away if your partner gets pregnant.
  • If you are a man and have sex with a female who plans to get pregnant, talk with your 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.

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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • 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.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Any unexplained bruising or bleeding.
  • Feeling very tired or weak.
  • Swollen gland.
  • A burning, numbness, or tingling feeling that is not normal.
  • Shortness of breath.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Very bad and sometimes deadly lung problems have happened with this drug. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.

What are some other side effects of this drug?

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:
  • Headache.
  • Upset stomach.
  • Loose stools (diarrhea).
  • Hair loss.
  • Hair thinning.
  • Joint pain.
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 your national health agency.

How is this drug best taken?

Use this drug 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 this drug 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.

How do I store and/or throw out this drug?

  • 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.
  • Check with your pharmacist about how to throw out unused drugs.

General drug facts

  • 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.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

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