Mycophenolic Acid

Mechanism-of-action class: Nucleic Acid Synthesis Inhibitors.

• Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (1.1) Use in combination with cyclosporine and corticosteroids.

• Known hypersensitivity to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients. (4.1) 4.1 Hypersensitivity Reactions Mycophenolic acid delayed-release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients.contraindicated

In adults: 720 mg by mouth, twice daily (1,440 mg total daily dose) on an empty stomach, 1 hour before or 2 hours after food intake. (2.1) In children: 5 years of age and older (who are at least 6 months post kidney transplant), 400 mg/m 2 by mouth, twice daily (up to a maximum of 720 mg twice daily). (2.2) Do not crush, chew, or cut tablet prior to ingestion. (2.3) 2.1 Dosage in Adult Kidney Transplant Patients The recommended dose of mycophenolic acid delayed-release tablets are 720 mg administered twice daily (1,440 mg total daily dose). 2.2 Dosage in Pediatric Kidney Transplant Patients The recommended dose of mycophenolic acid in conversion (at least 6 months post-transplant) pediatric patients age 5 years and older is 400 mg/m 2 body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily). 2.3 Administration Mycophenolic acid delayed-release tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake [see Clinical Pharmacology (12.3) ]. Mycophenolic acid delayed-release tablets should not be crushed, chewed, or cut prior to ingesting. The tablets should be swallowed whole in order to maintain the integrity of the enteric coating. Pediatric patients with a BSA of 1.19 m 2 to 1.58 m 2 may be dosed either with three mycophenolic acid 180 mg tablets, or one 180 mg tablet plus one 360 mg tablet twice daily (1,080 mg daily dose). Patients with a BSA of > 1.58 m 2 may be dosed either with four mycophenolic acid 180 mg tablets, or two mycophenolic acid 360 mg tablets twice daily (1,440 mg daily dose).

New or Reactivated Viral Infections: Consider reducing immunosuppression. (5.5) Blood Dyscrasias including Pure Red Cell Aplasia (PRCA): Monitor for neutropenia or anemia; consider treatment interruption or dose reduction. (5.6) Serious GI Tract Complications (gastrointestinal bleeding, perforations and ulcers): Administer with caution to patients with active digestive system disease. (5.7) Immunizations: Avoid live attenuated vaccines. (5.9) Patients with Hereditary Deficiency of Hypoxanthine-guanine Phosphoribosyl-transferase (HGPRT): May cause exacerbation of disease symptoms; avoid use. (5.10) Blood Donation: Avoid during therapy and for 6 weeks thereafter. (5.11) Semen Donation: Avoid during therapy and for 90 days thereafter. (5.12) 5.1 Embryo-Fetal Toxicity Use of mycophenolic acid delayed-release tablets 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 aware of these risks and must be counseled regarding pregnancy prevention and planning. Avoid use of mycophenolic acid delayed-release tablets 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. Embryo-Fetal Toxicity [see Boxed Warning , Warnings and Precautions (5.1) ] Lymphomas and Other Malignancies [see Boxed Warning , Warnings and Precautions (5.3) ] Serious Infections [see Boxed Warning , Warnings and Precautions (5.4) ] New or Reactivated Viral Infections [see Warnings and Precautions (5.5) ] Blood Dyscrasias, Including Pure Red Cell Aplasia [see Warnings and Precautions (5.6) ] Serious GI Tract Complications [see Warnings and Precautions (5.7) ] Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions (5.8) ] Rare Hereditary Deficiencies [see Warnings and Precautions (5.10) ] Most common adverse reactions (≥ 20%): anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain. (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies 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. The data described below derive from two randomized, comparative, active-controlled, double-blind, double-dummy trials in prevention of acute rejection in de novo and converted stable kidney transplant patients.

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 mycophenolic acid treatment. To report a pregnancy or obtain information about the registry, visit www.mycophenolateREMS.com or call 1-800-617-8191. Risk Summary Following oral or intravenous (IV) administration, MMF is metabolized to mycophenolic acid (MPA), the active ingredient in mycophenolic acid delayed-release tablets and the active form of the drug. Use of 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 (0.05 and 1.1 times exposure at the recommended clinical doses in kidney transplant patients for rats and rabbits, respectively) (see Animal Data).

Signs and Symptoms There have been anecdotal reports of deliberate or accidental overdoses with mycophenolic acid delayed-release tablets, whereas not all patients experienced related adverse reactions. In those overdose cases in which adverse reactions were reported, the reactions fall within the known safety profile of the class. Accordingly, an overdose of mycophenolic acid delayed-release tablets could possibly result in oversuppression of the immune system and may increase the susceptibility to infection, including opportunistic infections, fatal infections and sepsis. If blood dyscrasias occur (e.g., neutropenia with absolute neutrophil count < 1.5 x 10 3 /mcL or anemia), it may be appropriate to interrupt or discontinue mycophenolic acid delayed-release tablets. Possible signs and symptoms of acute overdose could include the following: hematological abnormalities, such as leukopenia and neutropenia, and gastrointestinal symptoms, such as abdominal pain, diarrhea, nausea and vomiting, and dyspepsia. Treatment and Management General supportive measures and symptomatic treatment should be followed in all cases of overdosage.

• Feb 27, 2004NDANDA050791Novartis
• Aug 21, 2012ANDAANDA091558Apotex Inc
• Aug 23, 2017ANDAANDA202555Accord Hlthcare
• Dec 13, 2019ANDAANDA211173Concord Biotech Ltd
• Feb 10, 2021ANDAANDA214376Yichang Humanwell
• Sep 23, 2021ANDAANDA208315Alkem Labs Ltd
• Nov 3, 2021ANDAANDA214289Twi Pharms
• Nov 29, 2021ANDAANDA214630Biocon Pharma

1. 1Off Label Use2,7438.8%
2. 2Diarrhoea1,9356.2%
3. 3Drug Ineffective1,7745.7%
4. 4Death1,4044.5%
5. 5Pyrexia1,3274.3%
6. 6Acute Kidney Injury1,2684.1%
7. 7Nausea1,1293.6%
8. 8Covid-191,0373.3%
9. 9Fatigue9713.1%
10. 10Vomiting9533.1%
11. 11Product Use In Unapproved Indication9423.0%
12. 12Pneumonia9333.0%
13. 13Headache8912.9%
14. 14Dyspnoea8892.9%
15. 15Drug Interaction8792.8%

Recent PubMed references pinned to Mycophenolic Acid 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 1,367 ClinicalTrials.gov registrations naming Mycophenolic Acid 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

CPIC-curated drug–gene pairs for Mycophenolic Acid. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• HPRT1CPIC B (provisional)FDA label: Actionable PGx

Frequently asked questions

How does Mycophenolic Acid work?

Mechanism-of-action class: Nucleic Acid Synthesis Inhibitors.

What is Mycophenolic Acid used for?

According to FDA labeling, Mycophenolic Acid carries indications including: Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (1.1) Use in combination with cyclosporine and corticosteroids.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Mycophenolic Acid?

Mycophenolic Acid is classified as Selective immunosuppressants, Antimetabolite Immunosuppressant, Nucleic Acid Synthesis Inhibitors, Decreased Immunologically Active Molecule Activity, Decreased Lymphocyte Cell Production.

What are the brand names for Mycophenolic Acid?

Mycophenolic Acid is marketed under brand names including Myfortic.

What are the contraindications for Mycophenolic Acid?

Mycophenolic Acid labeling lists contraindications including: Known hypersensitivity to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients. (4.1) 4.1 Hypersensitivity Reactions Mycophenolic acid delayed-release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients.. Always consult the full prescribing information and a clinician.