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Arava (Leflunomide)

Leflunomide (Arava) 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 medication 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 was introduced about two decades ago and is considered a second choice to methotrexate. It 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.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. Specifically, leflunomide inhibits the production of chemical compounds that are necessary for synthesis of lymphocytes.3

What are the possible side effects of Arava?

Common side effects with Arava include2:

  • 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

In some patients, Arava can cause serious side effects. These include rash, hives, difficulty breathing, chest pain, new or worsening cough, skin peeling or blistering, and pale skin. If you experience any of these, or nausea, extreme tiredness, unusual bleeding or bruising, lack of energy, appetite loss, pain affecting the upper right part of the stomach, yellowing of the skin or eyes, dark-colored urine, or flu-like symptoms, contact your doctor immediately.2

This is not an exhaustive list of all potential side effects of Arava. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects, contact your doctor or healthcare provider immediately.

Things to note about Arava

Before taking Arava, tell your doctor if you:

  • Are pregnant or plan to become pregnant within two years of taking the medicine or are breastfeeding. Arava can cause harm to a fetus.
  • Have liver disease or drink or have ever drunk large amounts of alcohol. Arava can cause liver damage that can be fatal.1

You should not take Arava if you are allergic to the drug or any of its ingredients.1 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

Other serious side effects include severe skin conditions, peripheral nerve damage, and potentially fatal lung complications. Arava can sometimes increase blood pressure, so it is important to monitor your blood pressure before and during treatment and to address any problems that arise. Certain drugs do not mix well with Arava, so tell your doctor about any other medications or supplements you are taking.1

After stopping Arava, doctors recommend taking medications to speed the elimination of the drug from your body.1

Dosing information

Arava is taken orally as a tablet. Daily dosing of Arava in patients with RA typically ranges from 10 mg to 20 mg. Your doctor will determine which dose is appropriate for you based on how well you tolerate and respond to the medication.

Treatment with Arava is usually started with a large initial dose, called a loading dose, so the medicine has a chance to build up in your body. This is usually 100mg a day for 3 days. Arava should be taken with food.5

Because it takes time for Arava (as well as most other conventional DMARDs) to build-up in the body, it may take several weeks before the drug takes full effect. You may not experience the full benefits of Arava until 6 to 12 weeks after you start therapy.5

Written by: Sara Finkelstein | Last reviewed: September 2019.
  1. Arava (leflunomide) Prescribing Information. Sanofi-Aventis US, LLC; Bridgewater, NJ: February 2016. Accessed May 16, 2018.
  2. Lefluonamide. MedlinePlus. US National Library of Medicine. Bethesda, MD. Published August 15, 2015. Accessed May 16, 2018.
  3. Scott DL. Leflunomide. In: Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH, eds. Rheumatoid Arthritis. Philadelphia, Penn: Mosby Elsevier; 2009:315-324. Gibofsky A. Comparative effectiveness of current treatments for rheumatoid arthritis. Am J Manag Care 2012;18:S303-14.
  4. Leflunomide (Arava). American College of Rheumatology. Updated March 2017. Accessed May 16, 2018.