Mycophenolic acid: adverse event reports filed with FDA

13,844

reports as suspect product

0.1% of all reports · about 620 a year

1,632

reports, 12 months to June 2026

1,922 in the 12 months before

96.3%

marked serious by the reporter

92.4% across the class

17.3%

record death among outcomes, as reported

2,390 reports · not verified by FDA

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 Mycophenolic acid reports recording the termmedian drug in antimetabolite immunosuppressant

1. Off label useused for a purpose or in a way not on the label9.6%1,323
2. Drug ineffectivethe medicine did not work as expected8.1%1,121
3. Diarrhoealoose or frequent stools4.9%683
4. Covid-19COVID-19 infection4.4%616
5. Pyrexiafever4.2%579
6. Product use in unapproved indicationused for a purpose not on the label4.1%565
7. Acute kidney injurysudden loss of kidney function4%559
8. Cytomegalovirus infection3.9%542
9. Deaththe patient died; cause not stated by this term3.4%469
10. Sepsisa severe body-wide response to infection3.2%440
11. Nauseafeeling sick3.1%425
12. Pneumonialung infection2.8%384
13. Vomitingbeing sick2.7%375
14. Drug interactionan interaction between medicines2.7%373
15. Post transplant lymphoproliferative disorder2.7%373
16. Transplant rejection2.6%362
17. Dyspnoeashortness of breath2.6%356
18. Abdominal painstomach or belly pain2.5%351
19. Headachehead pain2.5%347
20. Condition aggravatedthe condition being treated got worse2.4%335
21. Renal impairmentreduced kidney function2.4%333
22. Fatiguetiredness2.4%326
23. Neutropenialow neutrophils, a type of white blood cell2.3%315
24. Respiratory failurethe lungs could not supply enough oxygen2.3%312
25. Leukopenialow white blood cells2.1%291
26. Kidney transplant rejection2.1%288
27. Septic shockshock arising from infection2%281
28. Urinary tract infectionbladder or urinary infection1.9%260
29. Multiple organ dysfunction syndromeseveral organs failing1.9%259
30. Coughcough1.9%257

Top 30 of 2,037 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 47.3% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 13,844 reports.

Drugs most often listed in the same reports

Other products listed in reports where Mycophenolic acid 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

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

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.

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 Mycophenolic acid as a suspect or interacting product; reports listing it only as a concomitant medication (6,813) 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.