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Mitomycin Side Effects

The most commonly reported side effects of mitomycin include off label use, diarrhoea, and nausea, based on 3,927 FDA adverse event reports from 2004 to 2025. 3.7% of reports found the drug to be ineffective.

Mitomycin side effects

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

1
Off Label Use10.7%421
2
Diarrhoea4.2%166
3
Nausea4.2%163
4
Drug Ineffective3.7%146
5
Fatigue3.5%136
6
Thrombocytopenia3.4%135
7
Neutropenia3.4%134
8
Disease Progression3.4%132
9
Death2.8%111
10
Pancytopenia2.8%110
11
Vomiting2.6%102
12
Rash2.4%96
13
Pyrexia2.2%86
14
Febrile Neutropenia1.9%76
15
Pain1.9%75

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

Report severity

84.7%Serious3,325 reports
30.8%Hospitalizations1,209 reports
13.3%Fatal521 reports

Seriousness is determined by the reporter, not by OpenClaim.

Mitomycin drug interactions

Other drugs that appear in adverse event reports alongside mitomycin. 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
Fluorouracil22.5%884
2
Capecitabine10.6%418
3
Cisplatin9.5%372
4
Doxorubicin-hydrochloride7.4%291
5
Bevacizumab6.7%262
6
Gemcitabine5.7%225
7
Oxaliplatin5.1%202
8
Irinotecan-hydrochloride3.9%154
9
Docetaxel3.6%140
10
Epirubicin-hydrochloride3.1%123
11
Paclitaxel3.1%122
12
Carboplatin2.9%114
13
Ethiodized-oil2.9%113
14
Cyclophosphamide2.6%103
15
Trastuzumab2.5%97

Taken alongside

1
Fluorouracil5.2%204
2
Cisplatin3.1%122
3
Dexamethasone3.1%121
4
Ondansetron2.6%102
5
Acetaminophen2.3%89
6
Irinotecan-hydrochloride1.9%76
7
Paclitaxel1.9%74
8
Capecitabine1.8%71
9
Aspirin1.8%71
10
Levoleucovorin1.6%62
11
Doxorubicin-hydrochloride1.6%62
12
Furosemide1.5%60
13
Ethiodized-oil1.5%59
14
Lidocaine1.5%58
15
Omeprazole1.4%56

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 mitomycin side effects

34.9% of mitomycin adverse event reports involve female patients and 34.4% involve male patients. The largest age group is adult at 55%. These figures reflect who reports side effects, not underlying risk.

Sex

Female34.9%
Male34.4%
Unknown30.7%

Age group

< 2<0.1%
2–110.5%
12–170.1%
18–6454.6%
65+44.8%

What is mitomycin used for

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

Acinar Cell Carcinoma Of PancreasAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAdenocarcinomaAdenocarcinoma GastricAdenocarcinoma Of AppendixAdenocarcinoma Of ColonAdenocarcinoma Of The CervixAdenocarcinoma PancreasAdenoid Cystic CarcinomaAdenosquamous Carcinoma Of The CervixAdenosquamous Cell CarcinomaAdjuvant TherapyAnal CancerAnal Cancer Metastatic

Showing 15 of 406 indications

Mitomycin brand names and reporting trend

Mitomycin is sold under the brand name Mutamycin.

Brand names

Mutamycin3,648

Quarterly reports (20042025)

20052010201520202025

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

Taking mitomycin with another medication?

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