Tacrolimus: adverse event reports filed with FDA

95,165

reports as suspect product

0.5% of all reports · about 4,231 a year

9,301

reports, 12 months to June 2026

9,903 in the 12 months before

93.5%

marked serious by the reporter

79.1% across the class

16.7%

record death among outcomes, as reported

15,919 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 Tacrolimus reports recording the termmedian drug in calcineurin inhibitor immunosuppressant

1. Off label useused for a purpose or in a way not on the label9.9%9,385
2. Drug ineffectivethe medicine did not work as expected7%6,659
3. Drug interactionan interaction between medicines5.5%5,217
4. Product use in unapproved indicationused for a purpose not on the label5.3%5,019
5. Acute kidney injurysudden loss of kidney function4.6%4,420
6. Transplant rejection3.8%3,591
7. Cytomegalovirus infection3.7%3,568
8. Toxicity to various agentspoisoning or toxic effect of one or more substances3.5%3,369
9. Covid-19COVID-19 infection3.4%3,225
10. Diarrhoealoose or frequent stools3.1%2,959
11. Post transplant lymphoproliferative disorder2.9%2,734
12. Pneumonialung infection2.9%2,728
13. Pyrexiafever2.9%2,722
14. Deaththe patient died; cause not stated by this term2.8%2,687
15. Sepsisa severe body-wide response to infection2.4%2,324
16. Renal impairmentreduced kidney function2.4%2,294
17. Thrombotic microangiopathy2.3%2,185
18. Condition aggravatedthe condition being treated got worse2.1%2,016
19. Respiratory failurethe lungs could not supply enough oxygen2.1%1,997
20. Multiple organ dysfunction syndromeseveral organs failing2.1%1,952
21. Septic shockshock arising from infection2%1,890
22. Immunosuppressant drug level increased1.9%1,805
23. Blood creatinine increasedraised creatinine, a kidney test1.8%1,674
24. Urinary tract infectionbladder or urinary infection1.7%1,661
25. Anaemialow red blood cells1.7%1,625
26. Polyomavirus-associated nephropathy1.7%1,610
27. Neutropenialow neutrophils, a type of white blood cell1.7%1,574
28. Leukopenialow white blood cells1.6%1,518
29. Drug level increaseda raised blood level of the medicine1.5%1,458
30. Cytomegalovirus viraemia1.5%1,450

Top 30 of 5,235 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. 39.3% 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 95,165 reports.

Drugs most often listed in the same reports

Other products listed in reports where Tacrolimus 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 Tacrolimus as a suspect or interacting product; reports listing it only as a concomitant medication (32,655) 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.