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Medications and Drugs

Brand Names: Arava

Generic Name: leflunomide (Pronunciation: le FLOO noe mide)

What is leflunomide (Arava)?

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.

Arava 20 mg

triangular, yellow, imprinted with ZBO

Leflunomide 10 mg-APO

round, white, imprinted with APO, LE 10

Leflunomide 10 mg-BAR

round, white, imprinted with 10, b 351

Leflunomide 10 mg-TEV

round, white, imprinted with 173, 93

Leflunomide 20 mg-APO

triangular, white, imprinted with APO, LE 20

Leflunomide 20 mg-BAR

round, yellow, imprinted with 20, B352

Leflunomide 20 mg-TEV

round, yellow, imprinted with 174, 93

What are the possible side effects of leflunomide (Arava)?

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;
  • chest pain, dry cough, wheezing, feeling short of breath (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:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Leflunomide can harm an unborn baby or 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 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 a history of liver disease or hepatitis, kidney disease, any type of infection, a history of tuberculosis, a blood cell disorder such as anemia or low platelets, 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.

After you stop taking leflunomide, you may need to be treated with other medications to help your body eliminate leflunomide quickly. Without receiving this drug elimination procedure, leflunomide could stay in your body for up to 2 years. Follow your doctor's instructions.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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