Two medicines, side by side
Mycophenolate mofetil vs mycophenolic acid
Mycophenolate mofetil and mycophenolic acid are both labeled for organ transplant rejection. Drugs@FDA records approvals of mycophenolate mofetil since 1995 and of mycophenolic acid since 2004. Pharmacies paid $0.138 per mycophenolate 250 mg capsule and $0.0996 per mycophenolic acid DR 180 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Mycophenolate mofetil, “Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite.”; Mycophenolic acid, “Mycophenolic acid (MPA), an immunosuppressant, is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine …”
Check it at the source: the mycophenolate mofetil FDA label on DailyMed (effective August 5, 2026); the mycophenolic acid FDA label on DailyMed (effective July 29, 2026).
Highlights of the mycophenolate mofetil record
Mycophenolate mofetil (Cellcept) · label of August 5, 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) ].
Used for
From the label: indicationsCELLCEPT [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. […]
On the market
- Earliest approval on file
- May 3, 1995
- Generic labelers
- 36 labelers
- Pharmacy cost
- $0.138 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 4
Highlights of the mycophenolic acid record
Mycophenolic acid (Myfortic) · label of July 29, 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)].
Used for
From the label: indicationsMyfortic 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. […]
On the market
- Earliest approval on file
- February 27, 2004
- Generic labelers
- 16 labelers
- Pharmacy cost
- $0.0996 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 2
Source: FDA drug labels via openFDA (Mycophenolate mofetil label of August 5, 2026, Mycophenolic acid label of July 29, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do mycophenolate mofetil and mycophenolic acid differ on the record?
How each works, in its label's words: Mycophenolate mofetil, “Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite.”; Mycophenolic acid, “Mycophenolic acid (MPA), an immunosuppressant, is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine …”
Both are in FDA's class antimetabolite immunosuppressants.
Both labels carry a boxed warning; the records quote them.
Generics: mycophenolate mofetil since 2008; mycophenolic acid since 2012 (Drugs@FDA).
| Mycophenolate mofetil | Mycophenolic acid | |
|---|---|---|
| Labeled for | Organ transplant rejection | Organ transplant rejection |
| Pharmacologic class | Antimetabolite Immunosuppressant | Antimetabolite Immunosuppressant |
| How it works (label) | Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. | Mycophenolic acid (MPA), an immunosuppressant, is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation … |
| Half-life (label) | n/a | The mean elimination half-life of MPA and MPAG ranged between 8 and 16 hours, and 13 and 17 hours, respectively. |
| Earliest approval on file (Drugs@FDA) | May 3, 1995 | February 27, 2004 |
| First generic approved | July 29, 2008 | August 21, 2012 |
| Generic labelers (NDC) | 36 labelers | 16 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.138 per capsule (Mycophenolate 250 mg capsule) | $0.0996 per tablet (Mycophenolic acid DR 180 mg tablet) |
| 12-month price change | +4% | -31% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 4 | 2 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 135,260 | 31,820 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Mycophenolate mofetil label, contraindicationsCONTRAINDICATIONS 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) ].
Mycophenolate mofetil label, drug interactionsDrugs on CELLCEPT Table 7 Drug Interactions with CELLCEPT that Affect Mycophenolic Acid (MPA) Exposure Antacids with Magnesium or Aluminum Hydroxide Clinical Impact Concomitant use with an antacid containing magnesium or aluminum hydroxide decreases MPA systemic exposure [see Clinical Pharmacology (12.3) ], which may reduce CELLCEPT efficacy. …
Mycophenolic acid label, contraindicationsCONTRAINDICATIONS 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)].
Source: FDA drug labels via openFDA
What next?
- Alternatives to mycophenolate mofetil
- every medicine labeled for the same conditions