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Gilteritinib Side Effects

The most commonly reported side effects of gilteritinib include off label use, acute myeloid leukaemia, and platelet count decreased, based on 3,625 FDA adverse event reports from 2013 to 2025. 3.9% of reports found the drug to be ineffective.

Gilteritinib side effects

Percentages show how often each reaction appears relative to total reports for gilteritinib.

1
Off Label Use11.6%421
2
Acute Myeloid Leukaemia9.0%326
3
Platelet Count Decreased7.4%268
4
Myelosuppression7.0%252
5
Pneumonia6.8%246
6
Death6.6%241
7
Pyrexia6.6%238
8
Febrile Neutropenia6.3%227
9
Product Use Issue5.5%201
10
Acute Myeloid Leukaemia Recurrent4.4%159
11
Cytopenia4.0%146
12
Thrombocytopenia4.0%145
13
Infection3.9%142
14
Drug Ineffective3.9%142
15
Neutropenia3.5%128

These are voluntary reports and do not establish that gilteritinib caused these reactions.

Report severity

94.2%Serious3,415 reports
33.9%Hospitalizations1,228 reports
26.5%Fatal962 reports

Seriousness is determined by the reporter, not by OpenClaim.

Gilteritinib drug interactions

Other drugs that appear in adverse event reports alongside gilteritinib. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Venetoclax14.7%533
2
Azacitidine10.0%363
3
Cytarabine6.4%233
4
Daunorubicin2.7%98
5
Tacrolimus2.6%95
6
Fludarabine-phosphate1.8%67
7
Decitabine1.5%54
8
Idarubicin-hydrochloride1.5%53
9
Posaconazole1.4%51
10
Midostaurin1.2%45
11
Sorafenib-tosylate1.2%44
12
Voriconazole1.2%44
13
Ruxolitinib1.2%44
14
Etoposide1.2%43
15
Cyclosporine1.0%35

Taken alongside

1
Azacitidine7.5%272
2
Venetoclax7.3%265
3
Acyclovir7.1%259
4
Cytarabine5.5%201
5
Posaconazole4.5%163
6
Fluconazole4.2%151
7
Levofloxacin3.9%140
8
Allopurinol3.7%133
9
Ondansetron3.4%124
10
Pantoprazole-sodium3.1%114
11
Voriconazole3.0%107
12
Acetaminophen2.6%95
13
Hydroxyurea2.3%85
14
Amlodipine2.3%83
15
Levothyroxine-sodium2.1%77

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports gilteritinib side effects

44.1% of gilteritinib adverse event reports involve female patients and 45.8% involve male patients. The largest age group is elderly at 49%. These figures reflect who reports side effects, not underlying risk.

Sex

Female44.1%
Male45.8%
Unknown10.1%

Age group

< 2<0.1%
2–111.0%
12–171.9%
18–6448.0%
65+49.0%

What is gilteritinib used for

Conditions and purposes for which patients were taking gilteritinib when the adverse event was reported.

Acute LeukaemiaAcute Monocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia (in Remission)Acute Myeloid Leukaemia RecurrentAcute Myeloid Leukaemia RefractoryAcute Myelomonocytic LeukaemiaAllogenic Stem Cell TransplantationAcute Bilineal LeukaemiaAcute LeukaemiaAcute Leukaemia In RemissionAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Monocytic LeukaemiaAcute Myeloid Leukaemia

Showing 15 of 87 indications

Gilteritinib brand names and reporting trend

Gilteritinib is sold under the brand name Xospata.

Brand names

Xospata2,096

Quarterly reports (20132025)

2013202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking gilteritinib with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.