Mycophenolate Mofetil

Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. MPA is a selective uncompetitive inhibitor of the two isoforms (type I and type II) of inosine monophosphate dehydrogenase (IMPDH) leading to inhibition of the de novo pathway of guanosine nucleotide synthesis and blocks DNA synthesis.

• Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1) ] , heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ], in combination with other immunosuppressants.

• Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product.contraindicated

ADULTS DOSAGE Kidney Transplant 1 g twice daily, orally ( 2.2 ) Heart Transplant 1.5 g twice daily orally ( 2.3 ) Liver Transplant 1.5 g twice daily orally ( 2.4 ) PEDIATRICS Kidney Transplant 600 mg/m 2 orally twice daily, up to maximum of 2 g daily ( 2.2 ) Heart Transplant 600 mg/m 2 orally twice daily, (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g) ( 2.3 ) Liver Transplant 600 mg/m 2 orally twice daily,daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g) ( 2.4 ) Reduce or interrupt dosing in the event of neutropenia. ( 2.5 ) See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia ( 2.5 ) 2.1 Important Administration Instructions Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy. Mycophenolate Mofetil Capsules and Tablets Mycophenolate mofetil oral dosage forms (capsules or tablets) should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision of a physician with experience in immunosuppressive therapy because the rates of absorption following the administration of mycophenolate mofetil oral dosage forms and mycophenolic acid delayed-release tablets are not equivalent. Mycophenolate mofetil tablets should not be crushed and mycophenolate mofetil capsules should not be opened or crushed. Patients should avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil capsules and oral suspension.

Blood Dyscrasias (Neutropenia, Red Blood Cell Aplasia): Monitor with blood tests; consider treatment interruption or dose reduction. ( 5.4 ) Gastrointestinal Complications: Monitor for complications such as bleeding, ulceration and perforations, particularly in patients with underlying gastrointestinal disorders. ( 5.5 ) Hypoxanthine-Guanine Phosphoribosyl-Transferase Deficiency: Avoid use of mycophenolate mofetil. ( 5.6 ) Acute Inflammatory Syndrome Associated with Mycophenolate Products: Monitor for this paradoxical inflammatory reaction. ( 5.7 ) Immunizations: Avoid live attenuated vaccines. ( 5.8 ) Blood Donation: Avoid during therapy and for 6 weeks thereafter. ( 5.11 ) Semen Donation: Avoid during therapy and for 90 days thereafter. ( 5.12 ) Potential Impairment on Driving and Use of Machinery: Mycophenolate mofetil may affect ability to drive or operate machinery. ( 5.14 ) 5.1 Embryofetal Toxicity Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney and nervous system. Females of reproductive potential must be made aware of these risks and must be counseled regarding pregnancy prevention and planning. Avoid use of MMF during pregnancy if safer treatment options are available [see Use in Specific Populations (8.1 , 8.3) ].

The following adverse reactions are discussed in greater detail in other sections of the label: Embryofetal Toxicity [see Warnings and Precautions (5.1) ] Lymphomas and Other Malignancies [see Warnings and Precautions 5.2) ] Serious Infections [see Warnings and Precautions (5.3) ] Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia [see Warnings and Precautions (5.4) ] Gastrointestinal Complications [see Warnings and Precautions (5.5) ] Acute Inflammatory Syndrome Associated with Mycophenolate Products s [see Warnings and Precautions (5.7) ] The most common adverse reactions in clinical trials (20 % or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections e.g., opportunistic infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. An estimated total of 1557 adult patients received mycophenolate mofetil during pivotal clinical trials in the prevention of acute organ rejection. Of these, 991 were included in the three renal studies, 277 were included in one hepatic study, and 289 were included in one cardiac study. Patients in all study arms also received cyclosporine and corticosteroids.

Pediatric Use: Safety and effectiveness in allogenic heart or liver transplants has not been established ( 8.4 ) Male Patients: Sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment ( 8.3 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. To report a pregnancy or obtain information about the registry, visit www.mycophenolateREMS.com or call 1-800-617-8191. Risk Summary Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see Human Data ]. Oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.01 to 0.05 times the recommended clinical doses in kidney and heart transplant patients) [see Animal Data ] . Consider alternative immunosuppressants with less potential for embryofetal toxicity.

Metabolism

Absorption Following oral and intravenous administration, MMF undergoes complete conversion to MPA, the active metabolite. In 12 healthy volunteers, the mean absolute bioavailability of oral MMF relative to intravenous MMF was 94%.

Possible signs and symptoms of acute overdose include hematological abnormalities such as leukopenia and neutropenia, and gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, vomiting, and dyspepsia. The experience with overdose of mycophenolate mofetil in humans is limited. The reported effects associated with overdose fall within the known safety profile of the drug. The highest dose administered to kidney transplant patients in clinical trials has been 4 g/day. In limited experience with heart and liver transplant patients in clinical trials, the highest doses used were 4 g/day or 5 g/day. At doses of 4 g/day or 5 g/day, there appears to be a higher rate, compared to the use of 3 g/day or less, of gastrointestinal intolerance (nausea, vomiting, and/or diarrhea), and occasional hematologic abnormalities, particularly neutropenia [see Warnings and Precautions (5.4) ] . Treatment and Management MPA and the phenolic glucuronide metabolite of MPA (MPAG) are usually not removed by hemodialysis. However, at high MPAG plasma concentrations (>100 µg/mL), small amounts of MPAG are removed.

• May 3, 1995NDANDA050722Roche Palo
• Jun 19, 1997NDANDA050723Roche Palo
• Aug 12, 1998NDANDA050758Roche Palo
• Oct 1, 1998NDANDA050759Roche Palo
• Jul 29, 2008ANDAANDA065410Hikma
• Jul 29, 2008ANDAANDA065413Hikma
• Oct 15, 2008ANDAANDA065379Sandoz
• May 1, 2024NDANDA216482Azurity

1. 1Off Label Use18,83414%
2. 2Drug Ineffective11,0038.4%
3. 3Product Use In Unapproved Indication7,1955.5%
4. 4Diarrhoea6,7865.2%
5. 5Pyrexia5,5784.2%
6. 6Pneumonia5,1673.9%
7. 7Cytomegalovirus Infection4,8213.7%
8. 8Fatigue4,4283.4%
9. 9Nausea4,4033.3%
10. 10Condition Aggravated4,3413.3%
11. 11Transplant Rejection4,0733.1%
12. 12Dyspnoea4,0623.1%
13. 13Vomiting3,9833.0%
14. 14Headache3,8502.9%
15. 15Acute Kidney Injury3,7302.8%

Recent PubMed references pinned to Mycophenolate Mofetil as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Insufficient mycophenolate mofetil maintenance dosage increases the relapse risk in neuromyelitis optica spectrum disorders.
  Frontiers in immunology · 2026 · Zhou X, Du J, Duan Y, et al.
  PMID 42253959DOI 10.3389/fimmu.2026.1815301
• Refractory immune cytopenia successfully treated with mycophenolate mofetil in four adolescents with del22q11.2 syndrome.
  Frontiers in immunology · 2026 · Cifaldi C, Pacillo L, Rossetti C, et al.
  PMID 42212148DOI 10.3389/fimmu.2026.1819182
• Stoichiometric simultaneous quantification of mycophenolate mofetil and mycophenolic acid in paired culture medium and cell extracts by common product ion LC-MS/MS.
  Journal of pharmaceutical and biomedical analysis · 2026 · Ishikawa UW, Kanoh HX, Irie K, et al.
  PMID 42202755DOI 10.1016/j.jpba.2026.117552
• Epstein-Barr Virus-Positive Primary CNS Lymphoma in a Patient Receiving Mycophenolate Mofetil: Diagnostic and Therapeutic Considerations.
  Viruses · 2026 · Burner DN, López GY, Low JT, et al.
  PMID 42198688DOI 10.3390/v18050485
• Pharmacogenetics and pharmacokinetics of immunosuppressants: clinical correlations and disease activity control in Egyptian female patients with lupus nephritis.
  Molecular biology reports · 2026 · Elmowafy AY, Elwasif S, Shemies R, et al.
  PMID 42142189DOI 10.1007/s11033-026-11881-0
• Pharmacogenetics of Mycophenolic Acid in Patients of African Descent: Underrepresentation of African Data.
  Clinical and translational science · 2026 · Mouton M, Davidson B, Taylor J, et al.
  PMID 42137999DOI 10.1111/cts.70599
• [Efficacy analysis of maintenance therapy with levamisole compared to mycophenolate mofetil after rituximab treatment in children].
  Zhonghua er ke za zhi = Chinese journal of pediatrics · 2026 · He QQ, Zhao GP, Li JT, et al.
  PMID 41986267DOI 10.3760/cma.j.cn112140-20251208-01085
• Evaluation of hematocrit-adjusted conversion strategies for mycophenolic acid and tacrolimus monitoring using volumetric absorptive microsampling in lung and renal transplant recipients.
  Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2026 · Juan L, Cheng CN, Chang WC, et al.
  PMID 41970245DOI 10.3389/jpps.2026.16123

The 10 most recently updated of 1,256 ClinicalTrials.gov registrations naming Mycophenolate Mofetil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers
  Not yet recruiting · Phase 2 · Interventional · 98 enrolled · National Cancer Institute (NCI)
  NCT07524530updated 2026-06-12
• Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME)
  Completed · Phase 3 · Interventional · 88 enrolled · Centre Hospitalier Universitaire, Amiens
  NCT01595984updated 2026-06-12
• Evaluation of Efficacy and Safety of Rituximab and Mycophenolate Mofetil Combination in Patients With Interstitial Lung Disease Related to Systemic Sclerosis
  Recruiting · Phase 3 · Interventional · 102 enrolled · University Hospital, Tours
  NCT06549231updated 2026-06-12
• PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
  Recruiting · Phase 4 · Interventional · 150 enrolled · Aurinia Pharmaceuticals Inc.
  NCT07611214updated 2026-06-12
• Phase 2 Study of Rapcabtagene Autoleucel in Myositis
  Active not recruiting · Phase 2 · Interventional · 21 enrolled · Novartis Pharmaceuticals
  NCT06665256updated 2026-06-11
• Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies
  Recruiting · Phase 1 · Phase 2 · Interventional · 320 enrolled · National Cancer Institute (NCI)
  NCT04959175updated 2026-06-11
• The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
  Recruiting · Phase 1 · Phase 2 · Interventional · 260 enrolled · National Cancer Institute (NCI)
  NCT05436418updated 2026-06-11
• Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 74 enrolled · M.D. Anderson Cancer Center
  NCT03247088updated 2026-06-10
• COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
  Terminated · Phase 2 · Interventional · 258 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT05000216updated 2026-06-10
• Automated Total Marrow and Lymphoid Irradiation for Allogeneic Hematopoietic Cell Transplant
  Not yet recruiting · Phase 2 · Interventional · 30 enrolled · Stanford University
  NCT07634536updated 2026-06-09

Frequently asked questions

How does Mycophenolate Mofetil work?

Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. MPA is a selective uncompetitive inhibitor of the two isoforms (type I and type II) of inosine monophosphate dehydrogenase (IMPDH) leading to inhibition of the de novo pathway of guanosine nucleotide synthesis and blocks DNA synthesis.

What is Mycophenolate Mofetil used for?

According to FDA labeling, Mycophenolate Mofetil carries indications including: Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1) ] , heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ], in combination with other immunosuppressants.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Mycophenolate Mofetil?

Mycophenolate Mofetil is classified as Enzyme Inhibitors, Nucleic Acid Synthesis Inhibitors, Decreased Immunologically Active Molecule Activity, Decreased Lymphocyte Cell Production.

What are the brand names for Mycophenolate Mofetil?

Mycophenolate Mofetil is marketed under brand names including Cellcept, Myhibbin.

What are the contraindications for Mycophenolate Mofetil?

Mycophenolate Mofetil labeling lists contraindications including: Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product.. Always consult the full prescribing information and a clinician.