CellCept: adverse event reports filed with FDA

17,983

reports as suspect product

0.1% of all reports · about 799 a year

941

reports, 12 months to June 2026

1,079 in the 12 months before

88%

marked serious by the reporter

92.4% across the class

15.6%

record death among outcomes, as reported

2,810 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 CellCept reports recording the termmedian drug in antimetabolite immunosuppressant

1. Off label useused for a purpose or in a way not on the label16.7%3,002
2. Diarrhoealoose or frequent stools5.9%1,057
3. Deaththe patient died; cause not stated by this term5.7%1,021
4. Intentional product use issuedeliberate use not as intended3.8%682
5. Drug ineffectivethe medicine did not work as expected3.7%674
6. Pneumonialung infection3.5%635
7. Pyrexiafever3.4%615
8. Nauseafeeling sick3.2%580
9. Fatiguetiredness3.1%554
10. Vomitingbeing sick2.8%506
11. Dyspnoeashortness of breath2.7%485
12. Malaisegeneral feeling of being unwell2.6%475
13. Transplant rejection2.6%461
14. Acute kidney injurysudden loss of kidney function2.5%445
15. Neutropenialow neutrophils, a type of white blood cell2.4%437
16. Agranulocytosis2.4%436
17. Anaemialow red blood cells2.4%426
18. Headachehead pain2.2%398
19. No adverse eventno adverse event was reported2.2%394
20. Cytomegalovirus infection2.2%393
21. Painpain, site not specified2.2%392
22. Condition aggravatedthe condition being treated got worse2.2%388
23. Renal failurekidney failure2.1%382
24. Blood creatinine increasedraised creatinine, a kidney test2.1%372
25. Leukopenialow white blood cells2.1%372
26. Urinary tract infectionbladder or urinary infection2.1%371
27. Weight decreasedweight loss2%362
28. Arthralgiajoint pain2%357
29. Astheniaweakness or lack of energy1.9%348
30. Drug interactionan interaction between medicines1.9%342

Top 30 of 2,232 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. 37.4% 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 17,983 reports.

Drugs most often listed in the same reports

Other products listed in reports where CellCept 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 CellCept as a suspect or interacting product; reports listing it only as a concomitant medication (15,226) 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.