Product name as reported
Gleevec Unknown: adverse event reports filed with FDA
360 reports list it as a suspect or interacting product, 2010–2013.
- 360
- reports as suspect product
- 0% of all reports · about 22 a year
- 0
- reports, 12 months to June 2026
- 0 in the 12 months before
- 98.9%
- marked serious by the reporter
- 57.4% across all reports
- 1.4%
- record death among outcomes, as reported
- 5 reports · not verified by FDA
Between June 2010 and July 2013, 360 adverse event reports received by FDA list the product name "Gleevec Unknown" as reporters wrote it as a suspect or interacting product. Reports that mention it only as a concomitant medication (0) are left out of every figure here.
In the 12 months to June 2026, 0 reports listed it, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 22 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded nausea (12.2%), gastrointestinal stromal tumour (9.7%) and neoplasm recurrence (9.7%). A report can list several reactions, so shares add to more than 100%; 132 different terms appear across these reports. Nausea is recorded in 12.2% of these reports, against 3.8% of all reports in the database.
98.9% of the reports are marked serious by the reporter; 1.4% record death among the outcomes and 29.4% record hospitalisation, as reported. 41.4% of the reports came from consumers, and the largest patient age group is 45 to 64 (23.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
No report listing Gleevec Unknown was received in the five years to June 2026; the latest was received in July 2013.
By year received
Reactions recorded in the reports
share of Gleevec Unknown reports recording the termall reports in the database
- Nauseafeeling sick12.2%44
- Gastrointestinal stromal tumour9.7%35
- Neoplasm recurrence9.7%35
- Diarrhoealoose or frequent stools8.6%31
- Fatiguetiredness8.6%31
- Neoplasm progression8.6%31
- Vomitingbeing sick8.3%30
- Chronic myeloid leukaemia8.1%29
- Drug ineffectivethe medicine did not work as expected7.2%26
- Neoplasm malignanta cancer, type not specified7.2%26
- Anaemialow red blood cells5.8%21
- Muscle spasmsmuscle cramps5.6%20
- Pneumonialung infection5.6%20
- Fluid retentionthe body holding extra fluid4.2%15
- Dehydrationdehydration3.9%14
- Oedema peripheralswelling of the legs, ankles or hands3.9%14
- Rashskin rash3.9%14
- Astheniaweakness or lack of energy3.6%13
- Leukaemia recurrent3.6%13
- Malaisegeneral feeling of being unwell3.6%13
- Weight increasedweight gain3.6%13
- White blood cell count decreasedlow white cell count3.3%12
- Dyspnoeashortness of breath3.1%11
- Pruritusitching3.1%11
- Haemoglobin decreasedlow haemoglobin2.8%10
- Haemorrhagebleeding2.8%10
- Pleural effusionfluid around the lung2.8%10
- Pyrexiafever2.8%10
Top 30 of 132 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 share of all reports in the database; 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 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 100% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Chronic myeloid leukaemia | 135 | 37.5% |
| Gastrointestinal stromal tumour | 70 | 19.4% |
| Gastric cancer | 25 | 6.9% |
| Soft tissue cancer | 20 | 5.6% |
| Acute lymphocytic leukaemia | 13 | 3.6% |
| Leukaemia | 5 | 1.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 360 reports.
In context
| Measure | Gleevec Unknown | All reports |
|---|---|---|
| Reports as suspect product | 360 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 0 | 1,332,454 |
| Marked serious | 98.9% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 14 | 91 |
| Hospitalisation recorded, per 1,000 reports | 294 | 213 |
| Consumer-filed share | 41.4% | 45.8% |
| Top term, share of reports | Nausea 12.2% | 3.8% |
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."
Questions about Gleevec Unknown reports
How many adverse event reports has FDA received for Gleevec Unknown?
360 reports list Gleevec Unknown as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 0 list it only as a concomitant medication.
What reactions are recorded in Gleevec Unknown reports?
nausea (12.2%), gastrointestinal stromal tumour (9.7%), neoplasm recurrence (9.7%), diarrhoea (8.6%) and fatigue (8.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Gleevec Unknown was responsible.
How serious are the reports?
98.9% are marked serious by the reporter. Among the outcomes recorded, 1.4% of reports include death and 29.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (41.4%), physician (39.7%) and other health professional (12.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Gleevec Unknown rising?
0 reports in the 12 months to June 2026, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Gleevec Unknown was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Gleevec Unknown?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Unknown as a suspect or interacting product; reports listing it only as a concomitant medication (0) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.