Leflunomide (marketed as Arava) Information

Arava (leflunomide) is indicated in adults for the treatment of active rheumatoid arthritis (RA):

 

1. to reduce signs and symptoms
2. to inhibit structural damage as evidenced by X-ray erosions and joint space narrowing
3. to improve physical function.

 

To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this page.

Related Information

• FDA Drug Safety Communication: New boxed warning for severe liver injury with arthritis drug Arava (leflunomide)
• FDA Drug Safety Podcast for Healthcare Professionals: New boxed warning for severe liver injury with arthritis drug Arava (leflunomide)

Labeling and Regulatory History from Drugs@FDA

• Leflunomide (marketed as Arava) Prescribing and Labeling Information
• Arava Tablets Label - 09/09/2010