Gleevec: adverse event reports filed with FDA

23,132

reports as suspect product

0.1% of all reports · about 1,028 a year

81

reports, 12 months to June 2026

158 in the 12 months before

74.7%

marked serious by the reporter

70.8% across the class

24.4%

record death among outcomes, as reported

5,638 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 Gleevec reports recording the termmedian drug in kinase inhibitor

1. Deaththe patient died; cause not stated by this term17.5%4,043
2. Nauseafeeling sick7.8%1,803
3. Diarrhoealoose or frequent stools6.3%1,452
4. Fatiguetiredness5.5%1,262
5. Drug ineffectivethe medicine did not work as expected4.9%1,145
6. Vomitingbeing sick4.7%1,092
7. Malaisegeneral feeling of being unwell4.1%954
8. Rashskin rash3.8%881
9. Muscle spasmsmuscle cramps3.4%785
10. Dyspnoeashortness of breath3.4%779
11. Neoplasm malignanta cancer, type not specified3%704
12. Astheniaweakness or lack of energy2.7%631
13. Anaemialow red blood cells2.7%628
14. Pyrexiafever2.5%588
15. Malignant neoplasm progression2.5%585
16. Painpain, site not specified2.4%553
17. Oedema peripheralswelling of the legs, ankles or hands2.3%524
18. Pneumonialung infection2.2%499
19. Arthralgiajoint pain2.1%485
20. Headachehead pain2.1%479
21. Haemoglobin decreasedlow haemoglobin2%469
22. Pleural effusionfluid around the lung1.9%446
23. Fluid retentionthe body holding extra fluid1.8%420
24. Gastrointestinal stromal tumour1.8%413
25. Abdominal painstomach or belly pain1.8%411
26. Falla fall1.8%411
27. Dizzinesslight-headedness or unsteadiness1.7%388
28. Myalgiamuscle pain1.6%374
29. Pain in extremitypain in an arm or leg1.6%371
30. Chronic myeloid leukaemia1.6%363

Top 30 of 1,893 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. 70.5% 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 23,132 reports.

Drugs most often listed in the same reports

Other products listed in reports where Gleevec 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 Gleevec as a suspect or interacting product; reports listing it only as a concomitant medication (994) 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.