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Midostaurin Side Effects

The most commonly reported side effects of midostaurin include death, nausea, and febrile neutropenia, based on 3,134 FDA adverse event reports from 2008 to 2025. 5.5% of reports found the drug to be ineffective.

Midostaurin side effects

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

1
Death13.1%410
2
Nausea8.3%259
3
Febrile Neutropenia7.5%236
4
Diarrhoea6.6%208
5
Pyrexia6.1%192
6
Acute Myeloid Leukaemia Recurrent5.5%173
7
Drug Ineffective5.5%171
8
Pancytopenia5.3%166
9
Vomiting4.9%154
10
Thrombocytopenia4.7%147
11
Neutropenia4.2%131
12
Pneumonia4.0%125
13
Bone Marrow Failure3.6%112
14
Off Label Use3.4%107
15
Anaemia3.2%100

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

Report severity

82.0%Serious2,571 reports
30.2%Hospitalizations947 reports
23.0%Fatal722 reports

Seriousness is determined by the reporter, not by OpenClaim.

Midostaurin drug interactions

Other drugs that appear in adverse event reports alongside midostaurin. 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
Cytarabine22.6%707
2
Daunorubicin12.9%405
3
Fludarabine-phosphate5.2%164
4
Idarubicin-hydrochloride4.4%139
5
Venetoclax4.1%129
6
Azacitidine4.0%124
7
Cyclophosphamide3.8%119
8
Sorafenib-tosylate3.7%117
9
Filgrastim3.6%114
10
Busulfan3.3%104
11
Etoposide3.0%94
12
Decitabine2.8%87
13
Gemtuzumab-ozogamicin2.5%78
14
Gilteritinib-fumarate2.3%71
15
Methotrexate2.1%66

Taken alongside

1
Cytarabine6.8%214
2
Acyclovir5.8%182
3
Daunorubicin5.5%172
4
Posaconazole5.2%162
5
Ondansetron4.5%142
6
Acetaminophen3.6%113
7
Allopurinol3.2%101
8
Pantoprazole-sodium2.7%86
9
Furosemide2.7%85
10
Meropenem2.6%80
11
Omeprazole2.2%70
12
Levofloxacin2.0%63
13
Metoclopramide-hydrochloride2.0%63
14
Fluconazole1.9%59
15
Vancomycin1.8%55

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 midostaurin side effects

40.5% of midostaurin adverse event reports involve female patients and 46.0% involve male patients. The largest age group is adult at 62%. These figures reflect who reports side effects, not underlying risk.

Sex

Female40.5%
Male46.0%
Unknown13.5%

Age group

< 20.3%
2–113.5%
12–170.9%
18–6461.9%
65+33.4%

What is midostaurin used for

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

Abdominal DiscomfortAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Monocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia (in Remission)Acute Myeloid Leukaemia RecurrentAcute Myeloid Leukaemia RefractoryAcute Myelomonocytic LeukaemiaAmino Acid Level DecreasedAngiomyolipomaAscitesAcute Graft Versus Host Disease In SkinAcute LeukaemiaAcute Megakaryocytic Leukaemia

Showing 15 of 120 indications

Midostaurin brand names and reporting trend

Midostaurin is sold under the brand name Midostaurin.

Brand names

Midostaurin1,660

Quarterly reports (20082025)

2008201520202025

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

Taking midostaurin with another medication?

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