Prescription medicine
Mycophenolic acid Brand names: Myfortic
Mycophenolic acid (Myfortic) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $0.0996 per mycophenolic acid DR 180 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the mycophenolic acid FDA label on DailyMed (effective July 29, 2026, Novartis Pharmaceuticals Corporation); the NDA 50791 record on Drugs@FDA; every mycophenolic acid label on DailyMed.
Highlights of the record
FDA label of July 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 Myfortic. Patients receiving Myfortic 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. […]
Used for
From the label: indications and usageMyfortic is 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.
Forms and strengths
- 180 mg
- 360 mg
Delayed-release tablet.
On the market
- Earliest approval on file
- February 27, 2004 Myfortic, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first August 21, 2012; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 16 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0996 per tablet Mycophenolic acid DR 180 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest September 3, 2024; 1 more by firms not listed as its makers
- FAERS reports
- 31,820 through July 30, 2026
What is mycophenolic acid used for?
From the label: indications and usageMyfortic is 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: Myfortic delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. ( 1.2 ) 1.1 Prophylaxis of Organ Rejection in Kidney Transplant Myfortic ® (mycophenolic acid) is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. […]
Conditions named in the indications of mycophenolic acid's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Antimetabolite Immunosuppressant.
Source: FDA drug label (Myfortic), Novartis Pharmaceuticals Corporation, effective July 29, 2026 (SPL set eed26501-890d-4ff6-88e7-6dbea4726e53), via openFDA; the full label on DailyMed
What does the patient leaflet for mycophenolic acid say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Myfortic?Myfortic can cause serious side effects, including: Increased risk of loss of pregnancy (miscarriage) and higher risk of birth defects. Females who take Myfortic during pregnancy, have a higher risk of miscarriage during the first 3 months (first trimester), and a higher risk that their baby will be born with birth defects. If you are a female who can become pregnant: your doctor must talk with you about acceptable birth control methods (contraceptive counseling) while taking Myfortic. you should have a pregnancy test immediately before starting Myfortic and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits with your doctor. Talk to your doctor about the results of all of your pregnancy tests. you must use acceptable birth control during your entire Myfortic therapy and for 6 weeks after stopping Myfortic, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. […] See “What are the possible side effects of Myfortic?” Call your doctor right away if you have any of these signs and symptoms of infection: Temperature of 100.5°F or greater Cold symptoms, such as a runny nose or sore throat Flu symptoms, such as an upset stomach, stomach pain, vomiting, or diarrhea Earache or headache Pain during urination or you need to urinate often White patches in the mouth or throat Unexpected bruising or bleeding Cuts, scrapes, or incisions that are red, warm, and oozing pus Increased risk of getting certain cancers. People who take Myfortic have a higher risk of getting lymphoma, and other cancers, especially skin cancer. […]
From the patient leaflet: What should I avoid while taking Myfortic?Avoid pregnancy. See “What is the most important information I should know about Myfortic?” Limit the amount of time you spend in sunlight. Avoid using tanning beds and sunlamps. People who take Myfortic have a higher risk of getting skin cancer. See “What is the most important information I should know about Myfortic?” Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen with a high sun protection factor (SPF 30 and above). This is especially important if your skin is fair (light colored) or you have a family history of skin cancer. You should not donate blood while taking Myfortic and for at least 6 weeks after stopping Myfortic. You should not donate sperm while taking Myfortic and for 90 days after stopping Myfortic. Elderly patients 65 years of age or older may have more side effects with Myfortic because of a weaker immune system.
From the patient leaflet: How should I store Myfortic?Store Myfortic tablets at room temperature, 59°F to 86°F (15°C to 30°C). Myfortic does not need to be refrigerated. Keep the container tightly closed. Store Myfortic in a dry place. Keep Myfortic and all medicines out of the reach of children.
Source: FDA drug label (Myfortic), Novartis Pharmaceuticals Corporation, effective July 29, 2026 (SPL set eed26501-890d-4ff6-88e7-6dbea4726e53), via openFDA; the full label on DailyMed
Is there a generic for mycophenolic acid (Myfortic)?
The FDA approved the first generic mycophenolic acid on August 21, 2012. 12 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists mycophenolic acid from 16 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2012 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for mycophenolic acid (Myfortic)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0996 per Mycophenolic acid DR 180 mg tablet, down 31% from $0.145 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Mycophenolic acid DR 180 mg tablet (generic)
- Myfortic 180 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Mycophenolic acid DR 180 mg tablet | Generic | $0.0996 per tablet | $2.99 | -31% |
| Mycophenolic acid DR 360 mg tablet | Generic | $0.222 per tablet | $6.65 | -13% |
| Myfortic 180 mg tablet | Brand | $7.43 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $222.99 | +3% |
| Myfortic 360 mg tablet | Brand | $14.93 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $448.03 | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has mycophenolic acid been recalled?
The FDA's Enforcement Report lists 3 recalls naming mycophenolic acid since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of mycophenolic acid and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 3, 2024 | Class II | Ascend Laboratories, LLC | Failed Dissolution Specifications |
| May 20, 2015 | Class II | Mylan Lab Inc | Failed Dissolution Specifications: Low out of specification dissolution results. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: MYCOPHENOLIC ACID DR, Tablet, 180 mg may have potentially been mislabeled as the following drug: METHAZOLAMIDE, Tablet, 50 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the mycophenolic acid label say about other medicines?
The mycophenolic acid label names 15 other medicines in its interaction, contraindication or warning sections. The labels of 16 other medicines name mycophenolic acid. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acyclovir | drug interactions | Acyclovir (Valacyclovir), Ganciclovir (Valganciclovir), and Other Drugs That Undergo Renal Tubular Secretion The coadministration of MMF and acyclovir or ganciclovir may increase plasma concentrations of mycophenolic acid glucuronide (MPAG) and acyclovir/valacyclovir/ganciclovir/valganciclovir as their coexistence … |
| Amoxicillin | drug interactions | Acid and Other Drugs That Alter the Gastrointestinal Flora Drugs that alter the gastrointestinal flora, such as ciprofloxacin or amoxicillin plus clavulanic acid may interact with MMF by disrupting enterohepatic recirculation. |
| Azathioprine | drug interactions | Given that azathioprine and MMF inhibit purine metabolism, it is recommended that Myfortic not be administered concomitantly with azathioprine or MMF. |
| Cholestyramine | drug interactions | 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: |
| Ciprofloxacin | drug interactions | Acid and Other Drugs That Alter the Gastrointestinal Flora Drugs that alter the gastrointestinal flora, such as ciprofloxacin or amoxicillin plus clavulanic acid may interact with MMF by disrupting enterohepatic recirculation. |
| Cyclosporine | drug interactions | May decrease MPA concentrations; exercise caution when switching from cyclosporine to other drugs or from other drugs to cyclosporine. ( 7.5 ) Norfloxacin and Metronidazole: |
| Ganciclovir | drug interactions | Acyclovir (Valacyclovir), Ganciclovir (Valganciclovir), and Other Drugs That Undergo Renal Tubular Secretion The coadministration of MMF and acyclovir or ganciclovir may increase plasma concentrations of mycophenolic acid glucuronide (MPAG) and acyclovir/valacyclovir/ganciclovir/valganciclovir as their coexistence … |
| Levonorgestrel | drug interactions | In a drug interaction study, mean levonorgestrel AUC was decreased by 15% when coadministered with MMF. |
| Metronidazole | drug interactions | May decrease MPA concentrations; exercise caution when switching from cyclosporine to other drugs or from other drugs to cyclosporine. ( 7.5 ) Norfloxacin and Metronidazole: |
| Mycophenolate mofetil | contraindications | CONTRAINDICATIONS Myfortic is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients [see Warnings and Precautions (5.9), Adverse Reactions (6.2)]. |
| Pantoprazole | drug interactions | Administration of pantoprazole at a dose of 40 mg twice daily for 4 days to healthy volunteers did not alter the pharmacokinetics of a single dose of Myfortic [see Clinical Pharmacology (12.3)]. |
| Rifampin | drug interactions | The concomitant administration of MMF and rifampin may decrease MPA plasma concentrations. |
| Sevelamer | drug interactions | May decrease MPA concentrations; concomitant use is not recommended. ( 7.3 ) Sevelamer: May decrease MPA concentrations; concomitant use is not recommended. |
| Valacyclovir | drug interactions | Acyclovir (Valacyclovir), Ganciclovir (Valganciclovir), and Other Drugs That Undergo Renal Tubular Secretion The coadministration of MMF and acyclovir or ganciclovir may increase plasma concentrations of mycophenolic acid glucuronide (MPAG) and acyclovir/valacyclovir/ganciclovir/valganciclovir as their coexistence … |
Every other medicine the mycophenolic acid label names
| Medicine named | Section | What the label says |
|---|---|---|
| Valganciclovir | drug interactions | Acyclovir (Valacyclovir), Ganciclovir (Valganciclovir), and Other Drugs That Undergo Renal Tubular Secretion The coadministration of MMF and acyclovir or ganciclovir may increase plasma … |
Other labels that name mycophenolic acid
Source: FDA drug label (Myfortic), Novartis Pharmaceuticals Corporation, effective July 29, 2026 (SPL set eed26501-890d-4ff6-88e7-6dbea4726e53), via openFDA; the full label on DailyMed
What do FAERS reports show for mycophenolic acid?
The FDA Adverse Event Reporting System holds 31,820 reports that list mycophenolic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,426 are coded as a death and 13,782 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as mycophenolic acid?
5 other medicines are given the same way (oral) and in the same FDA class as mycophenolic acid or labeled mainly for the same use (organ transplant rejection), the same class first. Organ transplant rejection lists all 13 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Mycophenolate mofetil | Organ transplant rejection | 30 labelers | $0.138 per capsule 250 mg capsule | No current entry |
| Tacrolimus | Organ transplant rejection | 30 labelers | $0.123 per capsule 0.5 mg capsule (immediate release) | No current entry |
| Sirolimus | Organ transplant rejection | 18 labelers | $0.723 per tablet 1 mg tablet | No current entry |
| Azathioprine | Organ transplant rejection | 16 labelers | $0.124 per tablet 50 mg tablet | No current entry |
| Cyclosporine | Organ transplant rejection | 8 labelers | $0.314 per unit 25 mg | No current entry |
Every medicine labeled for the same conditions as mycophenolic acid
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does mycophenolic acid compare with medicines for the same use?
1 side-by-side page set mycophenolic acid beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to mycophenolic acid
- 5 medicines for the same use
- Other antimetabolite immunosuppressants
- the pharmacologic class, with prices and generics
- Mycophenolic acid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other