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Brand Name: Arava®
Active Ingredient:   leflunomide
Strength(s): 10mg, 20mg, and 100mg
Dosage Form(s):   Tablets
Company Name:    Hoechst Marion Roussel
Prescription only
*Date Approved by the FDA:   September 10, 1998
*Approval by FDA does not mean that the drug is
available for consumers at this time.

What is Arava used for? Arava is used to treat active
rheumatoid arthritis in adults to reduce signs and symptoms and to slow down damage to

Who should not take Arava? You must not take
Arava if you are pregnant or a woman of childbearing age not using reliable contraception.

Special Warnings with Arava:

For Women:

  • You must not take Arava if you are pregnant or a woman of childbearing
    age not using reliable contraception, because in animal studies Arava has been shown to
    cause birth defects to the fetus.
  • You must avoid becoming pregnant while being treated with Arava. If you suspect
    or find out that you are pregnant while taking Arava call you health care provider right
  • After stopping Arava treatment you must complete the drug elimination procedure
    before becoming pregnant because Arava stays in the body a long time.
  • You should not breast-feed if you are taking Arava.

For Men:

  • If there is any possibility your partner could become pregnant, you should stop
    Arava treatment and go through the drug elimination procedure prescribed by your doctor.

For All Patients:

Your doctor will conduct liver tests before you start taking Arava and will
check your liver’s response to Arava every month at first.

General Precautions with Arava:

If you have the following conditions or if you are being treated with
medications that can be harmful to your liver Arava may not be right for you:

  • Liver disease including hepatitis B or C
  • Kidney problems
  • Severe immune system disorders, bone marrow disorders or severe uncontrolled

What are some possible side effects of Arava? (This is NOT
a complete list of side effects reported with Arava. Your health care provider can discuss
with you a more complete list of side effects.

  • Diarrhea
  • Elevated liver enzymes
  • Hair loss
  • Rash
  • In postmarketing experience worldwide, rare, serious hepatic (liver) injury, including cases with fatal outcome, have been reported during treatment with Arava.

For more detailed information about Arava, ask your health care provider.    Link to
Arava’s Labeling 

Posted: 2/17/99

Revised: 7/25/00


Back to Drug Side Effects

source: FDA

last update: December 2004

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