Azathioprine: clinical trials recruiting now

FDA drug label

FDA-approved

Yes. Azathioprine appears in the FDA drug-label database. Marketed as Azathioprine.

Drug class

Purine Antimetabolite (FDA established pharmacologic class)

Mechanism of action

Nucleic Acid Synthesis Inhibitors (as stated on the FDA label)

Boxed warning

The FDA label for Azathioprine carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

Azathioprine tablets, USP are indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation Azathioprine tablets, USP are indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of azathioprine tablets on these variables has not been tested in controlled trials. Rheumatoid Arthritis Azathioprine tablets, USP are indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with azathioprine tablets. The combined use of azathioprine tablets with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of azathioprine tablets with these agents cannot be recommended.…

FDA label via openFDA