OpenClaim

Mitoxantrone Side Effects

The most commonly reported side effects of mitoxantrone include febrile neutropenia, off label use, and neutropenia, based on 8,413 FDA adverse event reports from 2004 to 2025. 5.4% of reports found the drug to be ineffective.

#1 Reported: Febrile NeutropeniaAll side effects ↓Top Co-Medication: CytarabineDrug interactions ↓60% of Reports Are AdultDemographics ↓

Mitoxantrone side effects

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

1
Febrile Neutropenia9.0%758
2
Off Label Use5.9%497
3
Drug Ineffective5.4%453
4
Neutropenia4.4%368
5
Pyrexia3.9%324
6
Thrombocytopenia3.7%312
7
Sepsis3.5%298
8
Disease Progression2.6%220
9
Product Use In Unapproved Indication2.6%220
10
Death2.6%219
11
Pneumonia2.6%216
12
Febrile Neutropenia2.5%211
13
Acute Myeloid Leukaemia2.4%201
14
Infection2.4%199
15
Acute Myeloid Leukaemia2.3%195

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

Report severity

97.0%Serious8,161 reports
37.6%Hospitalizations3,166 reports
26.6%Fatal2,235 reports

Seriousness is determined by the reporter, not by OpenClaim.

Mitoxantrone drug interactions

Other drugs that appear in adverse event reports alongside mitoxantrone. 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
Cytarabine34.6%2,915
2
Etoposide24.0%2,015
3
Cyclophosphamide17.7%1,488
4
Dexamethasone16.6%1,396
5
Vincristine-sulfate16.5%1,388
6
Methotrexate15.2%1,280
7
Fludarabine-phosphate14.8%1,244
8
Rituximab13.8%1,159
9
Doxorubicin-hydrochloride8.1%685
10
Prednisone7.9%664
11
Idarubicin-hydrochloride7.3%614
12
Daunorubicin7.1%594
13
Gemtuzumab-ozogamicin7.0%593
14
Interferon4.8%404
15
Pegaspargase4.7%398

Taken alongside

1
Cytarabine8.0%672
2
Acetaminophen6.3%532
3
Dexamethasone6.0%503
4
Etoposide5.6%471
5
Cyclophosphamide5.1%431
6
Ondansetron4.8%402
7
Vincristine-sulfate4.0%339
8
Fludarabine-phosphate3.9%325
9
Methotrexate3.8%322
10
Sulfamethoxazole3.8%322
11
Prednisone3.4%290
12
Acyclovir3.4%287
13
Amphotericin-b3.3%278
14
Vancomycin3.2%272
15
Trimethoprim3.1%257

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 mitoxantrone side effects

40.8% of mitoxantrone adverse event reports involve female patients and 41.7% involve male patients. The largest age group is adult at 60%. These figures reflect who reports side effects, not underlying risk.

Sex

Female40.8%
Male41.7%
Unknown17.6%

Age group

< 22.6%
2–1110.3%
12–178.3%
18–6459.6%
65+19.2%

What is mitoxantrone used for

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

Acute LeukaemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Lymphocytic Leukaemia RefractoryAcute Megakaryocytic LeukaemiaAcute Monocytic LeukaemiaAcute Myeloblastic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia RecurrentAcute Myeloid Leukaemia RefractoryAcute Myelomonocytic LeukaemiaAcute Promyelocytic LeukaemiaAdenoid Cystic CarcinomaAdjuvant TherapyAdult T-cell Lymphoma/leukaemia

Showing 15 of 386 indications

Mitoxantrone brand names and reporting trend

Mitoxantrone is sold under the brand name Novantrone.

Brand names

Novantrone22

Quarterly reports (2004–2025)

20052010201520202025

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

Taking mitoxantrone with another medication?

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