Two medicines, side by side
Azathioprine vs mycophenolate mofetil
Azathioprine and mycophenolate mofetil are both labeled for organ transplant rejection. Drugs@FDA records approvals of azathioprine since 1968 and of mycophenolate mofetil since 1995. Pharmacies paid $0.124 per azathioprine 50 mg tablet and $0.138 per mycophenolate 250 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, azathioprine is a purine antimetabolite and mycophenolate mofetil an antimetabolite immunosuppressant.
Check it at the source: the azathioprine FDA label on DailyMed (effective November 8, 2025); the mycophenolate mofetil FDA label on DailyMed (effective August 5, 2026).
Highlights of the azathioprine record
Azathioprine (Imuran) · label of November 8, 2025
MALIGNANCY Chronic immunosuppression with IMURAN, a purine antimetabolite increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. Physicians should inform patients of the risk of malignancy with IMURAN.
Used for
From the label: indicationsIMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. […]
On the market
- Earliest approval on file
- March 20, 1968
- Generic labelers
- 17 labelers
- Pharmacy cost
- $0.124 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 1
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
Source: FDA drug labels via openFDA (Azathioprine label of November 8, 2025, Mycophenolate mofetil label of August 5, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do azathioprine and mycophenolate mofetil differ on the record?
In FDA's classes, azathioprine is a purine antimetabolite and mycophenolate mofetil an antimetabolite immunosuppressant.
Both labels carry a boxed warning; the records quote them.
Generics: azathioprine since 1995; mycophenolate mofetil since 2008 (Drugs@FDA).
| Azathioprine | Mycophenolate mofetil | |
|---|---|---|
| Labeled for | Organ transplant rejection, Rheumatoid arthritis | Organ transplant rejection |
| Pharmacologic class | Purine Antimetabolite | Antimetabolite Immunosuppressant |
| How it works (label) | n/a | Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. |
| Half-life (label) | Maximum serum radioactivity occurs at 1 to 2 hours after oral 35 S-azathioprine and decays with a half-life of 5 hours. | n/a |
| Earliest approval on file (Drugs@FDA) | March 20, 1968 | May 3, 1995 |
| First generic approved | March 31, 1995 | July 29, 2008 |
| Generic labelers (NDC) | 17 labelers | 36 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.124 per tablet (Azathioprine 50 mg tablet) | $0.138 per capsule (Mycophenolate 250 mg capsule) |
| 12-month price change | -10% | +4% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 1 | 4 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 89,586 | 135,260 |
| 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)
What next?
- Alternatives to azathioprine
- every medicine labeled for the same conditions