Gleevecimatinib
According to the FDA label: Imatinib mesylate tablets are a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy.
27,600 adverse event reports submitted to the FDA (2001–2026)
Top Reported Adverse Events
The most frequently reported events in association with Gleevec in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
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Death 4,629 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Nausea 2,125 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 1,763 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Fatigue 1,517 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 1,391 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Vomiting 1,283 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Malaise 1,078 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Rash 999 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 987 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Muscle Spasms 857 reports
Sudden, involuntary tightening of a muscle, often called cramps.
Full definition in the glossary → See all drugs reporting this event →Neoplasm Malignant 846 reports
The medical term for a cancerous growth. It may appear in reports as a condition being treated or monitored.
Full definition in the glossary →Asthenia 797 reports
Physical weakness or lack of strength.
Full definition in the glossary →Pyrexia 767 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Anaemia 716 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →Malignant Neoplasm Progression 677 reports
A report that a cancer grew or spread. This describes the course of the illness, not necessarily an effect of the drug. Malignant neoplasm is the medical term for a cancerous growth.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 12,606 |
| Male | 12,522 |
| Unknown | 108 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 382 |
| 18-34 | 618 |
| 35-49 | 1,328 |
| 50-64 | 3,036 |
| 65-74 | 2,380 |
| 75+ | 2,174 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Gleevec. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 11,090 |
| Death | 6,777 |
| Non-Serious | 6,770 |
| Hospitalization | 6,088 |
| Life-Threatening | 722 |
| Disability | 484 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Gleevec. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 638 |
| 2005 | 712 |
| 2006 | 687 |
| 2007 | 717 |
| 2008 | 727 |
| 2009 | 1,136 |
| 2010 | 1,568 |
| 2011 | 3,282 |
| 2012 | 3,332 |
| 2013 | 1,010 |
| 2014 | 619 |
| 2015 | 1,009 |
| 2016 | 1,668 |
| 2017 | 1,518 |
| 2018 | 1,567 |
| 2019 | 1,761 |
| 2020 | 1,390 |
| 2021 | 1,147 |
| 2022 | 1,012 |
| 2023 | 1,022 |
| 2024 | 624 |
| 2025 | 362 |
| 2026 (partial) | 87 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Gleevec
In FDA adverse event reports that mention Gleevec, these medications appeared most often in the same report.
- Nilotinib (1,091 reports)
- Dasatinib (938 reports)
- Aspirin (787 reports)
- Furosemide (765 reports)
- Omeprazole (557 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026