Drug Notebook

FDA Alerts

  • Contraindicated in pregnant women and women of childbearing potential who are not using a reliable form of contraception. (See Fetal/Neonatal Morbidity and Mortality and also Contraindications under Cautions.)
  • Pregnancy must be excluded prior to initiation of therapy.
  • Pregnancy must be avoided while the woman is receiving leflunomide and prior to completion of the drug elimination procedure following discontinuance of the drug. (See Drug Elimination Procedures Following Leflunomide Discontinuance under Dosage and Administration.)

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leflunomide
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(le FLOO noe mide)

What is the most important information I should know about leflunomide?

This medication can cause birth defects. Do not use if you are pregnant. Your doctor may want you to have a pregnancy test to make sure you are not pregnant before you start taking leflunomide. Stop taking leflunomide and tell your doctor right away if you become pregnant during treatment. You will need to receive medications to help your body eliminate the drug quickly and reduce the risk of harm to your unborn baby. Use effective birth control while you are taking leflunomide, whether you are a man or a woman. After your treatment ends, continue using birth control until you have received the drug elimination medications.

Before taking leflunomide, tell your doctor if you have liver disease, a history of hepatitis, any type of infection, a bone marrow disorder, or if you are using any drugs that weaken your immune system (such as cancer medicine or steroids).

Leflunomide can make it easier for you to get sick. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with leflunomide, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

What is leflunomide?

Leflunomide affects the immune system and reduces swelling and inflammation in the body.

Leflunomide is used to treat the symptoms of rheumatoid arthritis. Leflunomide also helps reduce joint damage and improves physical functioning.

Leflunomide may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking leflunomide?

You should not use this medication if you are allergic to leflunomide, or if you are pregnant or may become pregnant.

Before taking leflunomide, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease or a history of hepatitis;
  • any type of infection;

  • a weak immune system or a bone marrow disorder; or

  • if you are using any drugs that weaken your immune system (such as cancer medicine or steroids).

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category X. This medication can cause birth defects. Do not use leflunomide if you are pregnant. Your doctor may want you to have a pregnancy test to make sure you are not pregnant before you start taking leflunomide. Stop taking leflunomide if you miss a period, and tell your doctor right away if you become pregnant during treatment. If you become pregnant while taking leflunomide, you will need to receive medications to help your body eliminate the drug quickly. This will reduce the risk of harm to your unborn baby. You will also need to go through this drug elimination procedure if you plan to become pregnant after you stop taking leflunomide. Use effective birth control while you are taking leflunomide. After your treatment ends, continue using birth control until you have received the drug elimination medications. If a man fathers a child during or after leflunomide treatment, the baby may have birth defects. Use a condom to prevent pregnancy while you are taking leflunomide. After your treatment ends, continue using condoms until you have received the medications to help your body eliminate leflunomide. It is not known whether leflunomide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
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