MITOMYCIN

N/A

Manufactured by UroGen Pharma, Inc.

4,566 FDA adverse event reports analyzed

Last updated: 2026-04-15

About MITOMYCIN

MITOMYCIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by UroGen Pharma, Inc.. The most commonly reported adverse reactions for MITOMYCIN include OFF LABEL USE, NAUSEA, DIARRHOEA, FATIGUE, THROMBOCYTOPENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MITOMYCIN.

Top Adverse Reactions

OFF LABEL USE372 reports
NAUSEA159 reports
DIARRHOEA146 reports
FATIGUE116 reports
THROMBOCYTOPENIA108 reports
DRUG INEFFECTIVE106 reports
NEUTROPENIA105 reports
RASH104 reports
VOMITING104 reports
PANCYTOPENIA100 reports
DISEASE PROGRESSION95 reports
PYREXIA95 reports
DEATH85 reports
PAIN79 reports
LEUKOPENIA74 reports
FEBRILE NEUTROPENIA72 reports
URINARY TRACT INFECTION67 reports
DYSPNOEA66 reports
DYSURIA65 reports
ANAEMIA62 reports
MUCOSAL INFLAMMATION58 reports
MALIGNANT NEOPLASM PROGRESSION57 reports
SEPSIS56 reports
ASTHENIA54 reports
RENAL FAILURE52 reports
DECREASED APPETITE51 reports
ABDOMINAL PAIN48 reports
HAEMATURIA47 reports
PRURITUS45 reports
PRODUCT USE IN UNAPPROVED INDICATION44 reports
PULMONARY VENO OCCLUSIVE DISEASE44 reports
INTERSTITIAL LUNG DISEASE42 reports
WHITE BLOOD CELL COUNT DECREASED41 reports
ADVERSE EVENT40 reports
INFECTION40 reports
POLLAKIURIA40 reports
METASTASES TO LIVER39 reports
FLANK PAIN37 reports
NEUROPATHY PERIPHERAL36 reports
SCLERAL THINNING36 reports
PLATELET COUNT DECREASED35 reports
RESPIRATORY FAILURE35 reports
URETERIC STENOSIS35 reports
BLADDER PERFORATION34 reports
DEHYDRATION34 reports
VISUAL ACUITY REDUCED34 reports
HEPATIC FAILURE32 reports
TOXICITY TO VARIOUS AGENTS32 reports
ENDOPHTHALMITIS31 reports
ERYTHEMA30 reports
ALOPECIA29 reports
CONDITION AGGRAVATED29 reports
HYPOTENSION29 reports
MALAISE29 reports
STOMATITIS29 reports
HYPERTENSION28 reports
HYPOTONY OF EYE28 reports
INCORRECT ROUTE OF DRUG ADMINISTRATION28 reports
CONSTIPATION27 reports
INTENTIONAL PRODUCT USE ISSUE27 reports
RADIATION SKIN INJURY27 reports
CHILLS26 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME26 reports
POST PROCEDURAL COMPLICATION26 reports
BONE MARROW FAILURE25 reports
CYSTITIS25 reports
ACUTE KIDNEY INJURY24 reports
HAEMOLYTIC URAEMIC SYNDROME24 reports
PNEUMONIA24 reports
THROMBOTIC MICROANGIOPATHY24 reports
ARTHRALGIA23 reports
BLEBITIS23 reports
CONJUNCTIVAL FILTERING BLEB LEAK23 reports
CARDIAC FAILURE22 reports
GENERAL PHYSICAL HEALTH DETERIORATION22 reports
HAEMORRHAGE22 reports
HEADACHE22 reports
PLEURAL EFFUSION22 reports
RENAL IMPAIRMENT22 reports
URTICARIA22 reports
WEIGHT DECREASED22 reports
HAEMATOTOXICITY21 reports
METASTASES TO CENTRAL NERVOUS SYSTEM21 reports
STAPHYLOCOCCAL INFECTION21 reports
ACUTE PROMYELOCYTIC LEUKAEMIA20 reports
DERMATITIS20 reports
DIZZINESS20 reports
RASH PRURITIC20 reports
SCLEROMALACIA20 reports
URINARY RETENTION20 reports
BLOOD CREATININE INCREASED19 reports
CHEST PAIN19 reports
DRY MOUTH19 reports
HYDRONEPHROSIS19 reports
HYPERSENSITIVITY19 reports
ASCITES18 reports
BACK PAIN18 reports
BACTERIAL INFECTION18 reports
GASTRIC PERFORATION18 reports
ILEUS18 reports

Report Outcomes

Out of 3,064 classified reports for MITOMYCIN:

Serious 83.6%Non-Serious 16.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male1,030 (49.2%)
Female1,018 (48.6%)
Unknown47 (2.2%)

Reports by Age

Age 6765 reports
Age 6864 reports
Age 5263 reports
Age 5961 reports
Age 7157 reports
Age 6255 reports
Age 5454 reports
Age 6554 reports
Age 6148 reports
Age 6646 reports
Age 7646 reports
Age 6345 reports
Age 6444 reports
Age 7244 reports
Age 7444 reports
Age 5841 reports
Age 7039 reports
Age 5538 reports
Age 5638 reports
Age 6038 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with MITOMYCIN?

This profile reflects 4,566 FDA FAERS reports that mention MITOMYCIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MITOMYCIN?

Frequently reported terms in FAERS include OFF LABEL USE, NAUSEA, DIARRHOEA, FATIGUE, THROMBOCYTOPENIA, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MITOMYCIN?

Labeling and FAERS entries often list UroGen Pharma, Inc. in connection with MITOMYCIN. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.