Prograf: adverse event reports filed with FDA

20,427

reports as suspect product

0.1% of all reports · about 908 a year

415

reports, 12 months to June 2026

352 in the 12 months before

89.6%

marked serious by the reporter

79.1% across the class

22.2%

record death among outcomes, as reported

4,527 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 Prograf reports recording the termmedian drug in calcineurin inhibitor immunosuppressant

1. Off label useused for a purpose or in a way not on the label8.4%1,722
2. Drug ineffectivethe medicine did not work as expected6.7%1,361
3. Deaththe patient died; cause not stated by this term5.9%1,208
4. Transplant rejection3.8%785
5. Diarrhoealoose or frequent stools3.7%748
6. Pneumonialung infection3.4%693
7. Drug interactionan interaction between medicines3.3%683
8. Pyrexiafever2.9%586
9. Alopeciahair loss2.7%542
10. Renal failurekidney failure2.6%535
11. Renal impairmentreduced kidney function2.6%534
12. Immunosuppressant drug level increased2.3%480
13. Transplant dysfunction2.3%471
14. Sepsisa severe body-wide response to infection2.2%453
15. Acute graft versus host disease2.1%438
16. Vomitingbeing sick2.1%436
17. Cytomegalovirus infection2.1%426
18. Thrombotic microangiopathy2.1%423
19. Blood creatinine increasedraised creatinine, a kidney test2%418
20. Condition aggravatedthe condition being treated got worse2%414
21. Hospitalisationadmission to hospital2%413
22. Nauseafeeling sick2%407
23. Hypertensionhigh blood pressure2%405
24. Anaemialow red blood cells2%402
25. Kidney transplant rejection2%402
26. Ovarian cysta cyst on an ovary2%399
27. Acneacne1.9%397
28. Acute kidney injurysudden loss of kidney function1.8%361
29. Diabetes mellitusdiabetes1.8%359
30. Tremorshaking1.7%357

Top 30 of 2,273 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 11 drugs in the calcineurin inhibitor 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 206,378 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. 41.6% 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 20,427 reports.

Drugs most often listed in the same reports

Other products listed in reports where Prograf 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 calcineurin inhibitor 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 Prograf as a suspect or interacting product; reports listing it only as a concomitant medication (9,078) 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.