Arava (leflunomide)

Reviewed by: HU Medical Review Board | Last reviewed: May 2023

Arava® (leflunomide) is a disease-modifying anti-rheumatic drug (DMARD) approved for the treatment of adults with RA to reduce signs and symptoms of the disease, inhibit structural damage, and improve physical functioning.1

This drug works by decreasing inflammation and slowing the progress of the condition, which can help improve the physical activity of people with rheumatoid arthritis.2

Leflunomide provides efficacy similar to methotrexate, including similar ACR20 disease control, slowing of disease progression (as shown by x-ray), and improvement of functioning. It is associated with greater improvement in quality of life compared with methotrexate. Its use is based on patient-specific levels of disease activity.3,4

Arava is available in generic forms.

What are the ingredients in Arava?

The active ingredient in Arava is leflunomide.

How does Arava work?

Leflunomide is an immunodulatory drug that inhibits the production of immune system cells that are responsible for swelling. Leflunomide inhibits the production of chemical compounds that are necessary for synthesis of lymphocytes.3

What are the possible side effects?

Common side effects of Arava include:2

  • Diarrhea
  • Vomiting
  • Heartburn
  • Headache
  • Dizziness
  • Weight loss
  • Back pain
  • Muscle pain or weakness
  • Pain, burning, numbness, or tingling in the hands or feet
  • Hair loss
  • Leg cramps
  • Dry skin

Arava has a boxed warning, the strictest warning from the US Food and Drug Administration (FDA). It has this warning because it may:1

  • Harm an unborn baby. If you can become pregnant, you should use birth control during treatment and for some time after the last dose of Arava. Talk to your doctor about your options for birth control while taking Arava.
  • Cause severe liver damage, including liver failure.

These are not all the possible side effects of Arava. Talk to your doctor about what to expect when taking Arava. You also should call your doctor if you have any changes that concern you when taking Arava.

Other things to know

Before taking Arava, tell your doctor if you:1

  • Are pregnant or plan to become pregnant within two years of taking the medicine or are breastfeeding
  • Have liver disease or drink or large amounts of alcohol

You should not take Arava if you are allergic to the drug or any of its ingredients. Some people can also experience severe infections as a result of taking Arava. It is important to tell your doctor immediately if you develop an infection while on this drug or if you have an immunodeficiency condition like HIV or have ever tested positive for tuberculosis.1

Before beginning treatment for RA, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information for Arava.

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