Effective July 29, 2026, FDA no longer requires a REMS for mycophenolate products. As a result, the Mycophenolate REMS (MREMS) program has been discontinued. The FDA determined that the elements to assure safe use are no longer necessary to ensure the benefits of the drug outweigh the risk of embryofetal toxicity associated with the use of mycophenolate during pregnancy.

For pregnancy exposure or adverse event reporting, please contact the manufacturer of the applicable product.