October 6, 2015
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(leflunomide) 10 mg, 20 mg, 100 mg Tablets



Embryo-Fetal Toxicity

ARAVA is contraindicated for use in pregnant women because of the potential for fetal harm. Teratogenicity and embryo-lethality occurred in animals administered leflunomide at doses lower than the human exposure level. Exclude pregnancy before the start of treatment with ARAVA in females of reproductive potential. Advise females of reproductive potential to use effective contraception during ARAVA treatment and during an accelerated drug elimination procedure after ARAVA treatment. Stop ARAVA and use an accelerated drug elimination procedure if the patient becomes pregnant. [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Use in Special Populations, and CLINICAL PHARMACOLOGY]


Severe liver injury, including fatal liver failure, has been reported in patients treated with ARAVA. ARAVA is contraindicated in patients with severe hepatic impairment. Concomitant use of ARAVA with other potentially hepatotoxic drugs may increase the risk of liver injury. Patients with pre-existing acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) > 2xULN before initiating treatment, are at increased risk and should not be treated with ARAVA. Monitor ALT levels at least monthly for six months after starting ARAVA, and thereafter every 6-8 weeks. If leflunomide-induced liver injury is suspected, stop ARAVA treatment, start an accelerated drug elimination procedure, and monitor liver tests weekly until normalized. [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Use in Special Populations]


ARAVA® (leflunomide) is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an empirical formula C12H9F3N2O2, a molecular weight of 270.2 and the following structural formula:

ARAVA (leflunomide) Structural Formula Illustration

ARAVA is available for oral administration as tablets containing 10, 20, or 100 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, talc, titanium dioxide, and yellow ferric oxide (20 mg tablet only).

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...

Read All Potential Side Effects and See Pictures of Arava »

What are the precautions when taking leflunomide (Arava)?

Before taking leflunomide, tell your doctor or pharmacist if you are allergic to it; or to teriflunomide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system disorder (e.g., HIV infection), current/recent infection (e.g., tuberculosis), cancer, bone marrow/blood disorder, kidney disease, liver disease (e.g., hepatitis B or C), alcohol abuse, heart disease (e.g., congestive heart failure), high blood pressure, lung disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are...

Read All Potential Precautions of Arava »

Last reviewed on RxList: 9/15/2015
This monograph has been modified to include the generic and brand name in many instances.

Arava - User Reviews

Arava User Reviews

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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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