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
(le FLOO noe mide)

Before taking leflunomide, tell your doctor if you are taking cholestyramine (Questran, Prevalite, LoCHOLEST) or rifampin (Rifadin, Rimactane).

Also tell your doctor if you are using medications that can weaken your immune system, such as:

  • methotrexate (Rheumatrex);

  • cyclosporine (Neoral, Sandimmune, Gengraf);

  • sirolimus (Rapamune), tacrolimus (Prograf);

  • basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);

  • mycophenolate mofetil (CellCept); or

  • azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel).

This list is not complete and there may be other drugs that can interact with leflunomide. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using leflunomide and call your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;

  • white patches or sores inside your mouth or on your lips;

  • chest pain;

  • cough, trouble breathing (you may also have a fever);

  • pain or burning when you urinate;

  • pale skin, easy bruising or bleeding, unusual weakness;

  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • weakness;

  • nausea, stomach pain, diarrhea, loss of appetite;

  • weight loss;

  • headache, dizziness;

  • numbness or tingling;

  • sore throat, runny or stuffy nose; or

  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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