Drugs › Antimetabolite immunosuppressant
Generic name
Mycophenolate mofetil: adverse event reports filed with FDA
82,125 reports list it as a suspect or interacting product, 2004–2026. Class: Antimetabolite immunosuppressant. Also reported as Mycophenolate Mofetil Capsule, Mycophenolate Mofetil Tablets, Mycophenolate Mofetil Capsules.
- 82,125
- reports as suspect product
- 0.4% of all reports · about 3,651 a year
- 9,692
- reports, 12 months to June 2026
- 9,180 in the 12 months before
- 93.7%
- marked serious by the reporter
- 92.4% across the class
- 20.3%
- record death among outcomes, as reported
- 16,683 reports · not verified by FDA
82,125 adverse event reports received by FDA list mycophenolate mofetil, a generic name as a suspect or interacting product, from January 2004 to June 2026. A further 24,397 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 9,692 reports listed it, close to the 9,180 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 3,651 reports a year and 0.4% of the 20,646,523 reports in the database, and 67.4% of the reports for the antimetabolite immunosuppressant class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded off label use (16.3%), drug ineffective (10.6%) and product use in unapproved indication (7.5%). A report can list several reactions, so shares add to more than 100%; 4,990 different terms appear across these reports. Off label use is recorded in 16.3% of these reports, a larger share than in the median antimetabolite immunosuppressant drug (13%).
93.7% of the reports are marked serious by the reporter (92.4% across the class); 20.3% record death among the outcomes and 36.2% record hospitalisation, as reported. 59.1% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (29%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Mycophenolate mofetil reports recording the termmedian drug in antimetabolite immunosuppressant
- Off label useused for a purpose or in a way not on the label16.3%13,417
- Drug ineffectivethe medicine did not work as expected10.6%8,700
- Product use in unapproved indicationused for a purpose not on the label7.5%6,186
- Diarrhoealoose or frequent stools4.9%4,029
- Cytomegalovirus infection4.8%3,928
- Pyrexiafever4.4%3,637
- Pneumonialung infection4.3%3,497
- Condition aggravatedthe condition being treated got worse4%3,252
- Transplant rejection3.7%3,022
- Infectionan infection, type not specified3.5%2,875
- Covid-19COVID-19 infection3.2%2,652
- Fatiguetiredness3%2,502
- Treatment failurethe treatment did not work3%2,477
- Nauseafeeling sick2.9%2,376
- Vomitingbeing sick2.9%2,372
- Sepsisa severe body-wide response to infection2.9%2,371
- Hypertensionhigh blood pressure2.8%2,276
- Acute kidney injurysudden loss of kidney function2.7%2,221
- Drug intolerancethe medicine was not tolerated2.6%2,175
- Dyspnoeashortness of breath2.6%2,133
- Rashskin rash2.6%2,129
- Headachehead pain2.5%2,079
- Post transplant lymphoproliferative disorder2.4%1,976
- Intentional product use issuedeliberate use not as intended2.4%1,933
- Arthralgiajoint pain2.3%1,862
- Neutropenialow neutrophils, a type of white blood cell2.2%1,771
- Respiratory failurethe lungs could not supply enough oxygen2.1%1,750
- Alopeciahair loss2.1%1,747
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease2.1%1,731
Top 30 of 4,990 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the antimetabolite immunosuppressant class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 121,804 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 31.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Immunosuppressant drug therapy | 16,637 | 20.3% |
| Immunosuppression | 6,560 | 8% |
| Prophylaxis against graft versus host disease | 6,306 | 7.7% |
| Prophylaxis against transplant rejection | 5,932 | 7.2% |
| Renal transplant | 5,224 | 6.4% |
| Systemic lupus erythematosus | 2,313 | 2.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 82,125 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Mycophenolate mofetil reports |
|---|---|---|
| Tacrolimus | 36,516 | 44.5% |
| Prednisone | 26,092 | 31.8% |
| Prednisolone | 16,542 | 20.1% |
| Rituximab | 12,808 | 15.6% |
| Methylprednisolone | 12,430 | 15.1% |
| Cyclosporine | 11,280 | 13.7% |
| Cyclophosphamide | 9,329 | 11.4% |
| Methotrexate | 9,008 | 11% |
| Azathioprine | 6,319 | 7.7% |
| Hydroxychloroquine | 5,156 | 6.3% |
Other products listed in reports where Mycophenolate mofetil is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Mycophenolate mofetil | Antimetabolite immunosuppressant | All reports |
|---|---|---|---|
| Reports as suspect product | 82,125 | 121,804 | 20,646,523 |
| Share of that pool | — | 67.4% | 0.4% |
| Reports, latest 12 months | 9,692 | — | 1,332,454 |
| Marked serious | 93.7% | 92.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 203 | 188 | 91 |
| Hospitalisation recorded, per 1,000 reports | 362 | 384 | 213 |
| Consumer-filed share | 6.1% | 12% | 45.8% |
| Top term, share of reports | Off label use 16.3% | median 13% | 4.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the antimetabolite immunosuppressant class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| CellCept | brand | 17,983 | 941 | 88% |
| Mycophenolic acid | generic | 13,844 | 1,632 | 96.3% |
| Myfortic | brand | 7,852 | 319 | 82% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Mycophenolate mofetil reports
How many adverse event reports has FDA received for Mycophenolate mofetil?
82,125 reports list Mycophenolate mofetil as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 9,692 of them arrived in the latest 12 months. Another 24,397 list it only as a concomitant medication.
What reactions are recorded in Mycophenolate mofetil reports?
off label use (16.3%), drug ineffective (10.6%), product use in unapproved indication (7.5%), diarrhoea (4.9%) and cytomegalovirus infection (4.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Mycophenolate mofetil was responsible.
How serious are the reports?
93.7% are marked serious by the reporter. Among the outcomes recorded, 20.3% of reports include death and 36.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (59.1%), physician (29.9%) and consumer or non-health professional (6.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Mycophenolate mofetil rising?
9,692 reports in the 12 months to June 2026, close to the 9,180 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Mycophenolate mofetil was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Mycophenolate mofetil?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Mycophenolate mofetil as a suspect or interacting product; reports listing it only as a concomitant medication (24,397) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.