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Arava
Leflunomide
$282.00
10mg · 3 × 30 tablets · 3 months supply
BrandBranded medicine
$94.00 per month
Strength
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Annual cost
$1128a year at this pack size
Prescription required
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10mg
20mg
FDA boxed warningEmbryo-fetal toxicity and hepatotoxicity
Embryo-Fetal Toxicity
Teratogenicity and embryo-lethality occurred in animals administered leflunomide.
Exclude pregnancy prior to initiating ARAVA therapy.
Advise use of effective contraception in females of reproductive potential during treatment and during a drug elimination procedure.
Stop ARAVA and use an accelerated drug elimination procedure if the patient becomes pregnant.
Hepatotoxicity
Severe liver injury and fatal liver failure have been reported.
Avoid ARAVA use in patients with pre-existing liver disease, or those with serum alanine aminotransferase (ALT) >2 × ULN.
Use caution when ARAVA is given with other potentially hepatotoxic drugs.
Monitor ALT levels. Interrupt ARAVA treatment if ALT elevation >3-fold ULN. If likely leflunomide-induced, start accelerated drug elimination procedure and monitor liver tests weekly until normalized.
About Arava
Overview
Arava is a medicine containing leflunomide, taken as an oral tablet. It is used to treat adults with active rheumatoid arthritis. It works by blocking an enzyme involved in making substances that cells need to multiply.
What it treats
Active rheumatoid arthritis in adults.
Safety information
Side effects
The most commonly reported side effects were diarrhoea, respiratory infections, nausea, headache, rash, abnormal liver enzyme tests and indigestion. These were reported in at least 10% of patients, whether or not they were related to Arava. Contact a doctor promptly about serious side effects, including liver damage, suppression of the immune system, serious infections including sepsis, and bone marrow suppression with low blood cell counts. Severe skin reactions include Stevens–Johnson syndrome, toxic epidermal necrolysis and DRESS, a drug reaction that can affect the skin and internal organs. Skin ulcers, damage to nerves outside the brain and spinal cord (peripheral neuropathy), and interstitial lung disease can also occur. Interstitial lung disease may be fatal. Arava can increase blood pressure. Blood pressure and blood cell counts need monitoring during treatment. Serious reactions may require stopping Arava and a medically supervised procedure to remove its active breakdown product from the body more quickly.
FDA boxed warning
Embryo-fetal toxicity and hepatotoxicity
Embryo-Fetal Toxicity
Teratogenicity and embryo-lethality occurred in animals administered leflunomide.
Exclude pregnancy prior to initiating ARAVA therapy.
Advise use of effective contraception in females of reproductive potential during treatment and during a drug elimination procedure.
Stop ARAVA and use an accelerated drug elimination procedure if the patient becomes pregnant.
Hepatotoxicity
Severe liver injury and fatal liver failure have been reported.
Avoid ARAVA use in patients with pre-existing liver disease, or those with serum alanine aminotransferase (ALT) >2 × ULN.
Use caution when ARAVA is given with other potentially hepatotoxic drugs.
Monitor ALT levels. Interrupt ARAVA treatment if ALT elevation >3-fold ULN. If likely leflunomide-induced, start accelerated drug elimination procedure and monitor liver tests weekly until normalized.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not take Arava if you are pregnant, have severe liver impairment, are allergic to leflunomide or any other ingredient in Arava, or are currently taking teriflunomide. Allergic reactions may include anaphylaxis. Arava may harm an unborn baby. If you become pregnant while taking it, stop treatment and contact your prescriber promptly so a drug elimination procedure can be started. Do not start Arava if you have an active infection. Serious infections, including sepsis, and severe reductions in blood cell counts require treatment to be stopped and an accelerated drug elimination procedure. Blood counts should be monitored during treatment. Severe skin reactions, including Stevens–Johnson syndrome, toxic epidermal necrolysis and DRESS, also require stopping Arava and an accelerated drug elimination procedure. Suspected skin ulcers require stopping treatment and consideration of this procedure. Symptoms of nerve damage need evaluation and may require stopping treatment. New or worsening lung symptoms may signal interstitial lung disease, which can be fatal, and may require stopping Arava and an accelerated drug elimination procedure. Blood pressure should be monitored and treated if raised. An accelerated drug elimination procedure is recommended after stopping Arava to reduce levels of its active metabolite. Breastfeeding should be discontinued. Safety and effectiveness in children under 12 years have not been established.
Interactions
Tell your doctor about all medicines you take, especially warfarin, rosuvastatin and oral contraceptives containing ethinylestradiol or levonorgestrel. Arava’s active metabolite, teriflunomide, may lower INR in people taking warfarin, so INR monitoring is needed. It may increase exposure to rosuvastatin, so your prescriber must limit the rosuvastatin dose. It may also increase exposure to ethinylestradiol and levonorgestrel; your doctor should review which oral contraceptive is appropriate. Teriflunomide may increase levels of medicines affected by CYP2C8, OAT3, BCRP or OATP1B1/B3, and decrease levels of medicines affected by CYP1A2. Your doctor may need to monitor you if you take these medicines.
Using Arava
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] (DailyMed, retrieved 19 September 2026).
Patient information and references
Official and supporting information to read alongside advice from your prescriber or pharmacist.
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