Generic name
Gilteritinib: adverse event reports filed with FDA
1,123 reports list it as a suspect or interacting product, 2016–2026.
- 1,123
- reports as suspect product
- 0% of all reports · about 112 a year
- 143
- reports, 12 months to June 2026
- 172 in the 12 months before
- 98.1%
- marked serious by the reporter
- 57.4% across all reports
- 25.1%
- record death among outcomes, as reported
- 282 reports · not verified by FDA
Between July 2016 and June 2026, 1,123 adverse event reports received by FDA list gilteritinib, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (200) are left out of every figure here.
In the 12 months to June 2026, 143 reports listed it, down 17% from 172 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 112 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 off label use (13%), febrile neutropenia (11.9%) and product use issue (7.7%). A report can list several reactions, so shares add to more than 100%; 340 different terms appear across these reports. Off label use is recorded in 13% of these reports, against 4.1% of all reports in the database.
98.1% of the reports are marked serious by the reporter; 25.1% record death among the outcomes and 38.1% record hospitalisation, as reported. 53% of the reports came from physicians, and the largest patient age group is 45 to 64 (28.8%). 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
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 Gilteritinib reports recording the termall reports in the database
- Off label useused for a purpose or in a way not on the label13%146
- Febrile neutropeniafever with low white blood cells11.9%134
- Product use issuea problem in how the product was used7.7%87
- Thrombocytopenialow platelets7.3%82
- Pneumonialung infection6.9%77
- Acute myeloid leukaemia6.6%74
- Pyrexiafever6.6%74
- Drug ineffectivethe medicine did not work as expected5.9%66
- Anaemialow red blood cells5.7%64
- Deaththe patient died; cause not stated by this term5.4%61
- Neutropenialow neutrophils, a type of white blood cell5.4%61
- Cytopenia5.3%60
- Sepsisa severe body-wide response to infection5.1%57
- Acute myeloid leukaemia recurrent4.1%46
- Pancytopenialow counts of all blood cells4.1%46
- Septic shockshock arising from infection3.9%44
- Myelosuppression3.7%42
- Platelet count decreasedlow platelet count3.7%42
- Electrocardiogram QT prolongeda QT prolongation on the ECG3.3%37
- Respiratory failurethe lungs could not supply enough oxygen3.3%37
- Bacteraemia3.1%35
- Infectionan infection, type not specified3%34
- Differentiation syndrome2.9%33
- Underdoseless than the intended dose2.7%30
- Blood disorder2.6%29
- Acute kidney injurysudden loss of kidney function2.4%27
- Condition aggravatedthe condition being treated got worse2.1%24
- Multiple organ dysfunction syndromeseveral organs failing1.9%21
Top 30 of 340 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. 30.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Acute myeloid leukaemia | 622 | 55.4% |
| Acute myeloid leukaemia recurrent | 119 | 10.6% |
| Acute myeloid leukaemia refractory | 92 | 8.2% |
| Flt3 gene mutation | 23 | 2% |
| Acute leukaemia | 9 | 0.8% |
| Acute myelomonocytic leukaemia | 9 | 0.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,123 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Gilteritinib reports |
|---|---|---|
| Azacitidine | 256 | 22.8% |
| Venetoclax | 251 | 22.4% |
| Cytarabine | 212 | 18.9% |
| Daunorubicin | 86 | 7.7% |
| Posaconazole | 70 | 6.2% |
| Fludarabine | 68 | 6.1% |
| Acyclovir | 66 | 5.9% |
| Decitabine | 51 | 4.5% |
| Voriconazole | 49 | 4.4% |
| Sorafenib | 48 | 4.3% |
Other products listed in reports where Gilteritinib 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
| Measure | Gilteritinib | All reports |
|---|---|---|
| Reports as suspect product | 1,123 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 143 | 1,332,454 |
| Marked serious | 98.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 251 | 91 |
| Hospitalisation recorded, per 1,000 reports | 381 | 213 |
| Consumer-filed share | 21% | 45.8% |
| Top term, share of reports | Off label use 13% | 4.1% |
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 Gilteritinib reports
How many adverse event reports has FDA received for Gilteritinib?
1,123 reports list Gilteritinib as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 143 of them arrived in the latest 12 months. Another 200 list it only as a concomitant medication.
What reactions are recorded in Gilteritinib reports?
off label use (13%), febrile neutropenia (11.9%), product use issue (7.7%), thrombocytopenia (7.3%) and pneumonia (6.9%). 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 Gilteritinib was responsible.
How serious are the reports?
98.1% are marked serious by the reporter. Among the outcomes recorded, 25.1% of reports include death and 38.1% 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?
physician (53%), other health professional (23.7%) and consumer or non-health professional (21%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Gilteritinib rising?
143 reports in the 12 months to June 2026, down 17% from 172 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 Gilteritinib 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 Gilteritinib?
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 Gilteritinib as a suspect or interacting product; reports listing it only as a concomitant medication (200) 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.