Imatinib: adverse event reports filed with FDA

13,822

reports as suspect product

0.1% of all reports · about 614 a year

1,030

reports, 12 months to June 2026

1,200 in the 12 months before

87.1%

marked serious by the reporter

70.8% across the class

14.6%

record death among outcomes, as reported

2,023 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 Imatinib reports recording the termmedian drug in kinase inhibitor

1. Drug ineffectivethe medicine did not work as expected10.2%1,408
2. Drug resistance6.8%944
3. Drug intolerancethe medicine was not tolerated5.9%814
4. Nauseafeeling sick5.8%803
5. Diarrhoealoose or frequent stools5.8%799
6. Malignant neoplasm progression5.3%738
7. Fatiguetiredness4.6%642
8. Disease progressionthe disease advanced4.4%603
9. Off label useused for a purpose or in a way not on the label4.1%560
10. Vomitingbeing sick4%557
11. Dyspnoeashortness of breath3.6%502
12. Deaththe patient died; cause not stated by this term3.5%485
13. Pleural effusionfluid around the lung3.3%458
14. Headachehead pain3.1%427
15. Rashskin rash3.1%422
16. Thrombocytopenialow platelets3%412
17. Anaemialow red blood cells3%410
18. Pyrexiafever3%409
19. Treatment failurethe treatment did not work3%409
20. Astheniaweakness or lack of energy2.9%405
21. Drug interactionan interaction between medicines2.9%401
22. Abdominal painstomach or belly pain2.9%399
23. Arthralgiajoint pain2.9%399
24. Myalgiamuscle pain2.8%391
25. Chronic myeloid leukaemia2.8%387
26. Product use in unapproved indicationused for a purpose not on the label2.7%380
27. Neutropenialow neutrophils, a type of white blood cell2.5%349
28. Pruritusitching2.4%333
29. Toxicity to various agentspoisoning or toxic effect of one or more substances2.4%332
30. Decreased appetitereduced appetite2.4%328

Top 30 of 1,801 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. 29.7% 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 13,822 reports.

Drugs most often listed in the same reports

Other products listed in reports where Imatinib 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 Imatinib as a suspect or interacting product; reports listing it only as a concomitant medication (853) 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.