Prescription medicine
Mycophenolate mofetil Brand names: Cellcept, Myhibbin
Mycophenolate mofetil (Cellcept) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 36 generic labelers, and pharmacies paid $0.138 per mycophenolate 250 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the mycophenolate mofetil FDA label on DailyMed (effective August 5, 2026, Genentech, Inc.); the NDA 50722 record on Drugs@FDA; every mycophenolate mofetil label on DailyMed.
Highlights of the record
FDA label of August 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
EMBRYOFETAL TOXICITY,.
MALIGNANCIES and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of first trimester 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 Special Populations (8.1 , 8.3) ]. Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ]. Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see Warnings and Precautions (5.3) ]. WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS See full prescribing information for complete boxed warning Use during pregnancy is associated with increased risks of first trimester 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) ]. Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ]. […]
Used for
From the label: indications and usageCELLCEPT [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.
Forms and strengths
- 250 mg
- 500 mg
- 200 mg/ml
- 500 mg/20ml
Capsule; film-coated tablet; powder for suspension; injection (powder) (lyophilized) for solution; tablet.
On the market
- Earliest approval on file
- May 3, 1995 Cellcept, Roche Palo; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 50 first July 29, 2008; 33 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 38 of which 36 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- August 16, 2039 Myhibbin oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.138 per capsule Mycophenolate 250 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2012 1 Class I among all firms' recalls; latest August 26, 2026; 6 more by firms not listed as its makers
- FAERS reports
- 135,260 through July 30, 2026
What is mycophenolate mofetil used for?
From the label: indications and usageCELLCEPT [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. CELLCEPT is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.
Conditions named in the indications of mycophenolate mofetil's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Antimetabolite Immunosuppressant.
Source: FDA drug label (CellCept), NDA050722 (Roche Palo), as published by Genentech, Inc., effective August 5, 2026 (SPL set 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40), via openFDA; the full label on DailyMed
What does the patient leaflet for mycophenolate mofetil 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 CELLCEPT?CELLCEPT can cause serious side effects, including: Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take CELLCEPT 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) to use while taking CELLCEPT. You should have 1 pregnancy test immediately before starting CELLCEPT 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 CELLCEPT treatment and for 6 weeks after stopping CELLCEPT, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. […] Call your doctor right away if you have any of the following 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 white patches in the mouth or throat unexpected bruising or bleeding cuts, scrapes or incisions that are red, warm and oozing pus See " What are the possible side effects of CELLCEPT? " for information about other serious side effects. […]
From the patient leaflet: What should I avoid while taking CELLCEPT?Avoid becoming pregnant. (See " What is the most important information I should know about CELLCEPT? "). Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. People who take CELLCEPT have a higher risk of getting skin cancer (See " What is the most important information I should know about CELLCEPT? " ). Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen with a high protection factor. This is especially important if your skin is very fair or if you have a family history of skin cancer. You should not donate blood while taking CELLCEPT and for at least 6 weeks after stopping CELLCEPT. You should not donate sperm while taking CELLCEPT and for 90 days after stopping CELLCEPT. CELLCEPT may influence your ability to drive and use machines (See " What are the possible side effects of CELLCEPT? ". […]
From the patient leaflet: How should I store CELLCEPT?Store CELLCEPT capsules and tablets at room temperature between 59°F to 86°F (15°C to 30°C). Keep CELLCEPT tablets in the light resistant container that it comes in. Store CELLCEPT Oral Suspension at room temperature between 59°F to 86°F (15°C to 30°C), for up to 60 days. You can also store CELLCEPT Oral Suspension in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze. Keep CELLCEPT and all medicines out of the reach of children.
Source: FDA drug label (CellCept), NDA050722 (Roche Palo), as published by Genentech, Inc., effective August 5, 2026 (SPL set 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40), via openFDA; the full label on DailyMed
Is there a generic for mycophenolate mofetil (Cellcept)?
The FDA approved the first generic mycophenolate mofetil on July 29, 2008. 50 generic applications are approved; 33 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists mycophenolate mofetil from 36 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Cellcept capsules; a patent listed only for Myhibbin oral suspension runs to August 16, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1995 earliest approval on file
- 2008 first generic approved
- 2039 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for mycophenolate mofetil (Cellcept)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.138 per Mycophenolate 250 mg capsule, up 4% from $0.133 on October 8, 2025. 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.
- Mycophenolate 250 mg capsule (generic)
- Cellcept 250 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Mycophenolate 200 mg/mL suspension | Generic | $0.982 per mL | n/a | -23% |
| Mycophenolate 250 mg capsule | Generic | $0.138 per capsule | $4.15 | +4% |
| Mycophenolate 500 mg tablet | Generic | $0.263 per tablet | $7.90 | -2% |
| Cellcept 200 mg/mL oral suspension | Brand | $8.31 per mL | n/a | -0.2% |
| Cellcept 250 mg capsule | Brand | $8.65 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $259.47 | -0.2% |
| Cellcept 500 mg tablet | Brand | $17.34 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $520.18 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has mycophenolate mofetil been recalled?
The FDA's Enforcement Report lists 10 recalls naming mycophenolate mofetil since 2012: 1 Class I (the most serious), 6 Class II, 3 Class III; 2 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of mycophenolate mofetil and that hold 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 |
|---|---|---|---|
| August 26, 2026 | Class II | Mylan Pharmaceuticals Inc | Failed Dissolution Specifications |
| July 2, 2026 | Class II | MYLAN PHARMACEUTICALS INC | Presence of precipitate |
| October 26, 2023 | Class III | VistaPharm LLC | Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water. |
| April 30, 2019 | Class I | Par Pharmaceutical, Inc. not a listed maker | Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product |
| May 18, 2016 | Class III | Attix Pharmaceuticals Inc not a listed maker | cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may be potentially mis-labeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Tablet, 500 mg may be potentially mis-labeled as the following drug: MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the mycophenolate mofetil label say about other medicines?
The mycophenolate mofetil label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 26 other medicines name mycophenolate mofetil. 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 | Examples; Acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir |
| Cholestyramine | drug interactions | Examples; Cyclosporine A, trimethoprim/sulfamethoxazole, bile acid sequestrants (cholestyramine), rifampin as well as aminoglycoside, cephalosporin, fluoroquinolone and penicillin classes of antimicrobials |
| Cyclosporine | drug interactions | Examples; Cyclosporine A, trimethoprim/sulfamethoxazole, bile acid sequestrants (cholestyramine), rifampin as well as aminoglycoside, cephalosporin, fluoroquinolone and penicillin classes of antimicrobials |
| Ganciclovir | drug interactions | Examples; Acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir |
| Lansoprazole | drug interactions | Examples; Lansoprazole, pantoprazole |
| Levonorgestrel | drug interactions | Clinical Impact; Concomitant use with CELLCEPT decreased the systemic exposure to levonorgestrel, but did not affect the systemic exposure to ethinylestradiol [see ], which may result in reduced combination oral contraceptive effectiveness. |
| Mycophenolic acid | contraindications | CONTRAINDICATIONS CELLCEPT is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product [see Warnings and Precautions (5.8) ]. |
| Pantoprazole | drug interactions | Examples; Lansoprazole, pantoprazole |
| Probenecid | drug interactions | Examples; Acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir |
| Rifampin | drug interactions | Examples; Cyclosporine A, trimethoprim/sulfamethoxazole, bile acid sequestrants (cholestyramine), rifampin as well as aminoglycoside, cephalosporin, fluoroquinolone and penicillin classes of antimicrobials |
| Sulfamethoxazole and trimethoprim | drug interactions | Examples Cyclosporine A, trimethoprim/sulfamethoxazole, bile acid sequestrants (cholestyramine), rifampin as well as aminoglycoside, cephalosporin, fluoroquinolone and penicillin classes of antimicrobials Drugs Modulating Glucuronidation Clinical Impact Concomitant use with drugs inducing glucuronidation decreases MPA … |
| Telmisartan | drug interactions | Examples; Telmisartan (induces glucuronidation); isavuconazole (inhibits glucuronidation). |
| Valacyclovir | drug interactions | Examples; Acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir |
| Valganciclovir | drug interactions | Examples; Acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir |
Other labels that name mycophenolate mofetil
Source: FDA drug label (CellCept), NDA050722 (Roche Palo), as published by Genentech, Inc., effective August 5, 2026 (SPL set 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40), via openFDA; the full label on DailyMed
What do FAERS reports show for mycophenolate mofetil?
The FDA Adverse Event Reporting System holds 135,260 reports that list mycophenolate mofetil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 24,305 are coded as a death and 51,893 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 mycophenolate mofetil?
5 other medicines are given the same way (oral) and in the same FDA class as mycophenolate mofetil 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 |
|---|---|---|---|---|
| Mycophenolic acid | Organ transplant rejection | 16 labelers | $0.0996 per tablet 180 mg tablet | 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 mycophenolate mofetil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does mycophenolate mofetil compare with medicines for the same use?
2 side-by-side pages set mycophenolate mofetil beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to mycophenolate mofetil
- 5 medicines for the same use
- Other antimetabolite immunosuppressants
- the pharmacologic class, with prices and generics
- Mycophenolate mofetil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other