FDA label
What is mycophenolate used for?
The FDA-approved uses of mycophenolate, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for mycophenolate lists this use: Prophylaxis of Organ Rejection in Kidney Transplant.
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Mycophenolic Acid, tablet, delayed release
Indications and Usage, quoted from the label by Accord Healthcare Inc. (ANDA202555). Cross-references to other label sections are left out.
Prophylaxis of Organ Rejection in Kidney Transplant
Mycophenolic acid delayed release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Mycophenolic acid delayed release tablets are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.
Mycophenolic acid delayed release tablet is to be used in combination with cyclosporine and corticosteroids.
Limitations of Use
Mycophenolic acid delayed release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
Source: DailyMed label, set id dc24aa15-330c-4698-872f-159d7e582b4b, version 8, effective September 25, 2026. NDC 16729-189, one of 33 listings for this product.
Questions
What is mycophenolate used for?
The FDA label for mycophenolate lists this use: Prophylaxis of Organ Rejection in Kidney Transplant.
What drug class is mycophenolate?
FDA lists mycophenolate in the Antimetabolite Immunosuppressant established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.