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Mycophenolic acid

Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients recei.

Checked against the official label · Updated

Prescription medicine 口服 Safety alerts on record

Mycophenolic acid: quick answers

Used for
Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in.
Usual adult dose
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.
Children
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).
With food?
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.
Prescription
Prescription medicine in the United States; rules differ by country.

From the official label (Jul 2026). Your prescription and pharmacist come first.

How to use Mycophenolic acid

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Serious 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) ]. …
Who it is for

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. (1.1) Limitations of Use: Mycophenolic acid delayed release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. …

How to take it and how often
  • 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
  • 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)
  • Do not crush, chew, or cut tablet prior to ingestion
  • 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)
  • 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)
  • 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 ]
  • 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). …
Strengths it comes in

Mycophenolic acid delayed-release tablets, USP are available as 180 mg and 360 mg tablets. Table 1: Description of Mycophenolic Acid Delayed-Release Tablets, USP Dosage Strength 180 mg tablet 360 mg tablet Active ingredient mycophenolic acid as mycophenolate sodium mycophenolic acid as mycophenolate sodium Appearance Light green, round, slightly biconvex bevelled edge enteric coated tablet Light p …

Children
  • The safety and effectiveness of mycophenolic acid delayed-release tablets have been established
  • In pediatric kidney transplant patients 5 to 16 years of age who were initiated on mycophenolic acid delayed-release tablets at least 6 months post-transplant
  • Use of mycophenolic acid delayed-release tablets in this age group is supported by evidence from adequate and well-controlled studies of mycophenolic acid delayed-release tablets in a similar population of adult kidney transplant patients with additional pharmacokinetic data
  • In pediatric kidney transplant patients [see Dosage and Administrati …
Older adults

Clinical studies of mycophenolic acid delayed-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Of the 372 patients treated with mycophenolic acid delayed-release tablets in the clinical trials, 6% (N = 21) were 65 years of age and older and 0.3% (N = 1) were 75 years of age and older. …

While you are taking it
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide)
  • Embryo-Fetal Toxicity Pregnancy loss and malformations Inform pregnant women and females of reproductive potential that use of mycophenolic acid delayed-release tablets in pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations
  • Advise patients that they must use an acceptable form of contraception [see Warnings and Precautions , Use in Specific Populations ]
  • Encourage pregnant women to enroll in the Mycophenolate Pregnancy Registry (1-800-617-8191). …
Talk to a doctor first if
  • Mycophenolic acid delayed-release tablets are contraindicated in patients with history of hypersensitivity, including anaphylaxis, to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients. [see Warnings and Precautions , Adverse Reactions ]
  • History of hypersensitivity, including anaphylaxis, to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients
Medicines it may not mix with

Antacids with Magnesium and Aluminum Hydroxides: Decreases concentrations of MPA; concomitant use is not recommended. (7.1) Azathioprine: Competition for purine metabolism; concomitant administration is not recommended. (7.2) Cholestyramine, Bile Acid Sequestrates, Oral Activated Charcoal, and Other Drugs that Interfere with Enterohepatic Recirculation: May decrease MPA concentrations; concomitant use is not recommended. (7.3) Sevelamer: May decrease MPA concentrations; concomitant use is not recommended. (7.4) Cyclosporine: May decrease MPA concentrations; exercise caution when switching from cyclosporine to other drugs or from other drugs to cyclosporine. …

Warnings

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) Hypersensitivity Reactions: Discontinue Mycophenolic acid delayed-release tablets; treat and monitor until signs and symptoms resolve. (5.9) Immunizations: Avoid live attenuated vaccines. …

Possible side effects

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) ] Hypersensitivity Reactions [see …

Pregnancy and breastfeeding

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. …

If you take too much

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 you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2026-07-27.

How much Mycophenolic acid costs

In other countries

Prices in other countries are not what you will pay where you live; they show how prices compare.

Brands around the world

Products with Mycophenolic acid as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

Mycophenolic AcidMYCOPHENOLATE SODIUM 180 mg/1 · Tablet, Delayed Release · American Health Packaging
NDC 68084-907Label
Mycophenolic AcidMYCOPHENOLATE SODIUM 180 mg/1 · Tablet, Delayed Release · Accord Healthcare Inc.
NDC 16729-261Label
Mycophenolic AcidMYCOPHENOLIC ACID 1 kg/kg · Powder · Hisun Pharmaceutical (Hangzhou) Co., Ltd.
NDC 51187-0004Label
MyforticMYCOPHENOLATE SODIUM 180 mg/1 · Tablet, Delayed Release · Novartis Pharmaceuticals Corporation
NDC 0078-0385Label
Mycophenolic AcidMYCOPHENOLIC ACID 1 kg/kg · Powder · Chongqing Daxin Pharmaceutical Co. Ltd.
NDC 57885-0009Label

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, ParU.S. FDA Class II
3 Sep 2024 · Ascend Laboratories, LLC · OngoingFailed Dissolution Specifications
Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.U.S. FDA Class II
20 May 2015 · Mylan Lab Inc · TerminatedFailed Dissolution Specifications: Low out of specification dissolution results.
MYCOPHENOLIC ACID DR, Tablet, 180 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078038566.U.S. FDA Class II
2 Jul 2013 · Aidapak Services, LLC · TerminatedLabeling: Label Mixup: MYCOPHENOLIC ACID DR, Tablet, 180 mg may have potentially been mislabeled as the following drug: METHAZOLAMIDE, Tablet, 50 mg, NDC 00781107101, Pedigree: AD37072_11, EXP: 5/13/2014.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Mycophenolic acid

Type the registration number on the pack, or scan it with your camera.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Mycophenolic acid

What is Mycophenolic acid used for?

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. (1.1) Limitations of Use: Mycophenolic acid delayed release tablets and (From the official U.S. FDA label.)

How do I take Mycophenolic acid?

Follow your prescription or the leaflet in your pack. The official label says: 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 …

Should I take Mycophenolic acid with food?

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.

Do I need a prescription for Mycophenolic acid?

Usually yes. Mycophenolic acid is a prescription medicine in most countries. Rules differ by country.

What brands contain Mycophenolic acid?

Mycophenolic acid is sold under names such as Myfortic. Brand names differ between countries.

What are the side effects of Mycophenolic acid?

The official label lists: 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 Warning… Tell your doctor about any side effect that bothers you or does not go away.

Can children take Mycophenolic acid?

The safety and effectiveness of mycophenolic acid delayed-release tablets have been established in pediatric kidney transplant patients 5 to 16 years of age who were initiated on mycophenolic acid delayed-release tablets at least 6 months post-transplant. Use of mycophenolic acid delayed-release tablets in this age group is supported by evidence from adequate and well-controlle… Always use the dose for the child's age or weight on the pack or prescription.

Can I take Mycophenolic acid when pregnant or breastfeeding?

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. … Ask your doctor or midwife first.

What medicines interact with Mycophenolic acid?

Antacids with Magnesium and Aluminum Hydroxides: Decreases concentrations of MPA; concomitant use is not recommended. (7.1) Azathioprine: Competition for purine metabolism; concomitant administration is not recommended. (7.2) Cholestyramine, Bile Acid Sequestrates, Oral Activated Charcoal, and Other Drugs that Interfere with Enterohepatic Recirculation: May decrease MPA concent… Use the free interaction checker before combining medicines.

What happens if I take too much Mycophenolic acid?

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 k… Get medical help right away.

How can I check that my Mycophenolic acid is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.