Afinitor: adverse event reports filed with FDA

30,706

reports as suspect product

0.2% of all reports · about 1,723 a year

161

reports, 12 months to June 2026

229 in the 12 months before

71.3%

marked serious by the reporter

70.8% across the class

25.5%

record death among outcomes, as reported

7,836 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 Afinitor reports recording the termmedian drug in kinase inhibitor

1. Deaththe patient died; cause not stated by this term17.2%5,284
2. Malignant neoplasm progression9.9%3,048
3. Fatiguetiredness8.8%2,712
4. Stomatitissore mouth8.6%2,640
5. Diarrhoealoose or frequent stools8.2%2,524
6. Dyspnoeashortness of breath6.1%1,880
7. Nauseafeeling sick6%1,855
8. Rashskin rash5%1,541
9. Malaisegeneral feeling of being unwell5%1,538
10. Decreased appetitereduced appetite4.9%1,506
11. Coughcough4.7%1,441
12. Pyrexiafever4.6%1,426
13. Weight decreasedweight loss4.5%1,368
14. Vomitingbeing sick4.4%1,351
15. Astheniaweakness or lack of energy4.3%1,334
16. Drug ineffectivethe medicine did not work as expected4.2%1,293
17. Painpain, site not specified3.9%1,185
18. Pneumonialung infection3.3%1,011
19. Headachehead pain3.3%1,010
20. Anaemialow red blood cells2.8%845
21. Neoplasm progression2.5%782
22. Abdominal painstomach or belly pain2.5%764
23. Pneumonitis2.5%762
24. General physical health deteriorationgeneral decline in health2.4%747
25. Oedema peripheralswelling of the legs, ankles or hands2.4%729
26. Disease progressionthe disease advanced2.3%715
27. Dizzinesslight-headedness or unsteadiness2.3%709
28. Metastases to liver2.3%704
29. Blood pressure increaseda raised blood pressure reading2.3%697
30. Peripheral swellingswelling of the arms or legs2.3%692

Top 30 of 2,117 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 100 drugs in the kinase inhibitor 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 849,161 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. 63.1% 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 30,706 reports.

Drugs most often listed in the same reports

Other products listed in reports where Afinitor 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 kinase inhibitor 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 Afinitor as a suspect or interacting product; reports listing it only as a concomitant medication (1,900) 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.