Last reviewed 2026-04-20 · How we verify

Mycophenolate (MYCOPHENOLIC ACID)

Mycophenolate, also known as Mycophenolic Acid, is a small molecule antimetabolite immunosuppressant developed by Novartis. It targets inosine-5'-monophosphate dehydrogenase 2, an enzyme involved in the synthesis of guanine nucleotides. Mycophenolate is FDA-approved for preventing rejection in cardiac, kidney, and liver transplant patients. It has a half-life of 9.7 hours and is still patented by Novartis. Key safety considerations include gastrointestinal and hematologic side effects.

At a glance

Approved indications

• Prevention of Cardiac Transplant Rejection
• Prevention of Kidney Transplant Rejection
• Prevention of Liver Transplant Rejection

Boxed warnings

• WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ]. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolic acid. Patients receiving mycophenolic acid should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Warnings and Precautions (5.2) ]. Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions (5.3) ]. Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see Warnings and Precautions (5.4 , 5.5) ]. WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, and SERIOUS INFECTIONS See full prescribing information for complete boxed warning Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning. (5.1 , 8.1 , 8.3) Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolic acid delayed-release tablets. (5.2) Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression. (5.3) Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections. (5.4 , 5.5)

Common side effects

• Anemia
• Leukopenia
• Constipation
• Nausea
• Diarrhea
• Vomiting
• Dyspepsia
• Urinary Tract Infection
• CMV Infection
• Insomnia
• Postoperative Pain
• Edema

Drug interactions

• dexlansoprazole
• esomeprazole
• estradiol
• ethinylestradiol
• lansoprazole
• levonorgestrel
• norethisterone
• omeprazole
• pantoprazole

Key clinical trials

• Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies (PHASE2)
• Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis (PHASE2)
• Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita (PHASE2)
• Tocilizumab in Lung Transplantation (PHASE2)
• A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation (PHASE2,PHASE3)
• MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases (PHASE2)
• Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis (NA)
• Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis (PHASE4)

Primary sources

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