WELCOME TO THE MYCOPHENOLATE REMS (Risk Evaluation and Mitigation Strategy)

What is the Mycophenolate REMS?

The Mycophenolate REMS is a program to tell doctors, nurses, pharmacists, and patients about the increased risks of taking mycophenolate during pregnancy. It was required by the Food and Drug Administration (FDA).

What are the risks of mycophenolate during pregnancy?

  • Higher risk of miscarriage in the first 3 months.
  • Higher risk that the baby will have birth defects.

Who should be informed about the Mycophenolate REMS?


What is the goal of the Mycophenolate REMS?

The goal of the Mycophenolate REMS is to mitigate the risk of embryofetal toxicity associated with the use of mycophenolate during pregnancy by:
  1. Educating healthcare providers on the following:
    • The increased risks of miscarriage and birth defects associated with exposure to mycophenolate during pregnancy.
    • The need to counsel females of reproductive potential on the importance of pregnancy prevention and planning when taking mycophenolate.
    • The need to report pregnancies to the Mycophenolate Pregnancy Registry.
  2. Informing females of reproductive potential who are prescribed mycophenolate about:
    • The increased risks of pregnancy loss (miscarriage) and birth defects.
    • The importance of pregnancy prevention and planning when taking mycophenolate.

What medications contain mycophenolate?

Mycophenolate Mofetil
CellCept® by Genentech USA, Inc.

Generic formulations by >>
Accord Healthcare, Inc.
Akorn, Inc.
Alkem Laboratories, Ltd.
Amneal Pharmaceuticals LLC
Concord Biotech Limited
Hikma Pharmaceuticals USA Inc.
Hisun Pharmaceuticals USA, Inc.
Jubilant Cadista Pharmaceuticals Inc.
Meitheal Pharmaceuticals Inc.
Mylan Pharmaceuticals, Inc.
Par Pharmaceutical.
Sandoz Incorporated.
Strides Pharma Inc.
Teva Pharmaceuticals USA, Inc.
Vintage Pharmaceuticals, LLC.
VistaPharm, Inc.
Zydus Pharmaceuticals (USA) Inc.
Mycophenolic Acid
Myfortic® by Novartis Pharmaceuticals Corporation.

Generic formulations by >>
Accord Healthcare, Inc.
Apotex Corp.
Mylan Pharmaceuticals, Inc.
Teva Pharmaceuticals USA, Inc.

*Females of reproductive potential include girls who have entered puberty and all women who have a uterus and have not passed through menopause.