This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Mitomycin and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (133)
Death (26)
Life Threatening Events (6)
Disability (9)
Reports by Reaction Type
Off Label Use (40),
Incorrect Route of Drug Administration (24),
Hepatic Failure (20),
Hepatic Cirrhosis (10),
Diarrhoea (8),
Thrombocytopenia (6),
Anaemia (6),
Rash (6),
Interstitial Lung Disease (5),
Nausea (5),
Haematuria (5),
Palmar-Plantar Erythrodysaesthesia Syndrome (5)
Below are a few examples of reports where side effects / adverse reactions may be related to Mitomycin. For a complete list or a specific selection of reports, please use the links above.
Possible Mitomycin side effects in 48 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16
Patient: 48 year old female
Reactions: Pulmonary Veno-Occlusive Disease
Drug(s) suspected as cause:
Adriamycin PFS
Indication: Anal Cancer
Mitomycin
Indication: Anal Cancer
Mitomycin
Fluorouracil
Indication: Anal Cancer
Possible Mitomycin side effects in 81 year old male
Reported by a consumer/non-health professional from Japan on 2012-07-30
Patient: 81 year old male
Reactions: Rash, Urinary Retention
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mitomycin
Other drugs received by patient: Omeprazole; Trimetazidine; Valsartan; Metformin Hydrochloride
Possible Mitomycin side effects in 62 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 62 year old female
Reactions: Off Label Use, Incorrect Route of Drug Administration, Gastric Stenosis
Drug(s) suspected as cause:
Ethiodol
Indication: Hepatic Neoplasm Malignant
Doxorubicin HCL
Indication: Hepatic Neoplasm Malignant
Cisplatin
Indication: Hepatic Neoplasm Malignant
Mitomycin
Indication: Hepatic Neoplasm Malignant
Possible Mitomycin side effects in 63 year old female
Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-07-16
Patient: 63 year old female
Reactions: Necrotising Scleritis
Drug(s) suspected as cause:
Mitomycin
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from Chile on 2012-07-12
Patient:
Reactions: Off Label Use, Haematuria, Dysuria
Drug(s) suspected as cause:
Mitomycin
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from Chile on 2012-07-12
Patient:
Reactions: Off Label Use, Dysuria, Haematuria
Drug(s) suspected as cause:
Mitomycin
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from Chile on 2012-07-12
Patient:
Reactions: Off Label Use, Haematuria, Dysuria
Drug(s) suspected as cause:
Mitomycin
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-11
Patient:
Reactions: Off Label Use, Liver Abscess
Drug(s) suspected as cause:
Doxorubicin HCL
Indication: Hepatic Neoplasm Malignant
Start date: 2008-01-01
Gelfoam
Indication: Hepatic Neoplasm Malignant
Mitomycin
Indication: Hepatic Neoplasm Malignant
Start date: 2008-01-01
Cisplatin
Indication: Hepatic Neoplasm Malignant
Start date: 2008-01-01
Ethiodol
Indication: Hepatic Neoplasm Malignant
Possible Mitomycin side effects in 85 year old male
Reported by a consumer/non-health professional from Japan on 2012-07-09
Patient: 85 year old male
Reactions: Pruritus, Dyspnoea, Tachycardia, Pyrexia
Drug(s) suspected as cause:
Mitomycin
Possible Mitomycin side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-06
Patient: 49 year old female
Reactions: Neoplasm Malignant, Swelling, Pancytopenia, Rash, Neurological Symptom, Generalised Oedema
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Carboplatin
Dosage: 1df=auc5 also auc4
Indication: Peritoneal Carcinoma Metastatic
Cytarabine
Indication: Peritoneal Carcinoma Metastatic
Methotrexate
Indication: Peritoneal Carcinoma Metastatic
Mitomycin
Dosage: inj
Indication: Peritoneal Carcinoma Metastatic
Cyclophosphamide
Dosage: cyclophosphamide hydrate day1 also 600mg/m2
Indication: Peritoneal Carcinoma Metastatic
Prednisolone
Indication: Peritoneal Carcinoma Metastatic
Doxil
Indication: Peritoneal Carcinoma Metastatic
Irinotecan HCL
Dosage: on day 1, 15
Indication: Peritoneal Carcinoma Metastatic
Epirubicin Hydrochloride
Dosage: day1
Indication: Peritoneal Carcinoma Metastatic
Nedaplatin
Dosage: also 60mg/m2,12mg/m2(days1-15),120mg/m2
Indication: Peritoneal Carcinoma Metastatic
Paclitaxel
Indication: Peritoneal Carcinoma Metastatic
Docetaxel
Indication: Peritoneal Carcinoma Metastatic
Possible Mitomycin side effects in 71 year old male
Reported by a individual with unspecified qualification on 2012-07-06
Patient: 71 year old male
Reactions: Optic Nerve CUP / Disc Ratio Increased, Uveitis, Chorioretinal Disorder
Drug(s) suspected as cause:
Travoprost and Timolol
Indication: Ocular Hypertension
Azarga
Pred Forte
Start date: 2011-04-01
Mitomycin
Timolol Maleate
Administration route: Topical
Possible Mitomycin side effects in 62 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05
Patient: 62 year old female
Reactions: Off Label Use, Incorrect Route of Drug Administration, Gastric Stenosis
Drug(s) suspected as cause:
Doxorubicin HCL
Indication: Hepatic Neoplasm Malignant
Cisplatin
Indication: Hepatic Neoplasm Malignant
Mitomycin
Indication: Hepatic Neoplasm Malignant
Ethiodol
Indication: Hepatic Neoplasm Malignant
Possible Mitomycin side effects in 63 year old female
Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-07-03
Patient: 63 year old female
Reactions: Necrotising Scleritis
Drug(s) suspected as cause:
Mitomycin
Possible Mitomycin side effects in 83 year old male
Reported by a consumer/non-health professional from Japan on 2012-07-03
Patient: 83 year old male
Reactions: Urethritis, Cystitis
Drug(s) suspected as cause:
Mitomycin
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02
Patient:
Reactions: Liver Abscess
Drug(s) suspected as cause:
Mitomycin
Indication: Hepatic Neoplasm Malignant
Start date: 2008-01-01
Gelfoam
Indication: Hepatic Neoplasm Malignant
Doxorubicin HCL
Indication: Hepatic Neoplasm Malignant
Start date: 2008-01-01
Cisplatin
Indication: Hepatic Neoplasm Malignant
Start date: 2008-01-01
Ethiodol
Indication: Hepatic Neoplasm Malignant
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-29
Patient:
Reactions: Incorrect Route of Drug Administration, Off Label Use, Biliary Dilatation, Cholangitis, Biliary Sepsis, Biloma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mitomycin
Indication: Hepatic Neoplasm Malignant
Start date: 2008-01-01
Ethiodol
Indication: Hepatic Neoplasm Malignant
Doxorubicin HCL
Indication: Hepatic Neoplasm Malignant
Start date: 2008-01-01
Cisplatin
Indication: Hepatic Neoplasm Malignant
Start date: 2008-01-01
Gelfoam
Indication: Hepatic Neoplasm Malignant
Possible Mitomycin side effects in 35 year old male
Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-06-28
Patient: 35 year old male
Reactions: Retinal Detachment, Visual Acuity Reduced, Hypotony of Eye
Drug(s) suspected as cause:
Mitomycin
Other drugs received by patient: Antiglaucoma Preparateions and Miotics
Possible Mitomycin side effects in 74 year old male
Reported by a consumer/non-health professional from Japan on 2012-06-27
Patient: 74 year old male
Reactions: Jaundice, General Physical Health Deterioration
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mitomycin
Dosage: inj
Indication: Pancreatic Carcinoma Metastatic
Start date: 2012-05-25
Gemcitabine
Indication: Pancreatic Carcinoma Metastatic
Start date: 2012-05-25
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-27
Patient:
Reactions: Liver Abscess
Drug(s) suspected as cause:
Gelfoam
Indication: Hepatic Neoplasm Malignant
Cisplatin
Indication: Hepatic Neoplasm Malignant
Start date: 2008-01-01
Mitomycin
Indication: Hepatic Neoplasm Malignant
Start date: 2008-01-01
Ethiodol
Indication: Hepatic Neoplasm Malignant
Doxorubicin HCL
Indication: Hepatic Neoplasm Malignant
Start date: 2008-01-01
Possible Mitomycin side effects in 49 year old female
Reported by a consumer/non-health professional from Japan on 2012-06-25
Patient: 49 year old female
Reactions: Neoplasm Malignant, Swelling, Pancytopenia, Rash, Neurological Symptom, Generalised Oedema
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mitomycin
Dosage: inj
Indication: Peritoneal Carcinoma Metastatic
Nedaplatin
Dosage: also 60mg/m2,12mg/m2(days1-15),120mg/m2
Indication: Peritoneal Carcinoma Metastatic
Irinotecan HCL
Dosage: on day 1, 15
Indication: Peritoneal Carcinoma Metastatic
Cytarabine
Indication: Peritoneal Carcinoma Metastatic
Doxil
Indication: Peritoneal Carcinoma Metastatic
Epirubicin Hydrochloride
Dosage: day1
Indication: Peritoneal Carcinoma Metastatic
Docetaxel
Indication: Peritoneal Carcinoma Metastatic
Methotrexate
Indication: Peritoneal Carcinoma Metastatic
Prednisolone
Indication: Peritoneal Carcinoma Metastatic
Carboplatin
Dosage: 1df=auc5 also auc4
Indication: Peritoneal Carcinoma Metastatic
Paclitaxel
Indication: Peritoneal Carcinoma Metastatic
Cyclophosphamide
Dosage: cyclophosphamide hydrate day1 also 600mg/m2
Indication: Peritoneal Carcinoma Metastatic
Possible Mitomycin side effects in 57 year old male
Reported by a physician from Switzerland on 2012-06-25
Patient: 57 year old male
Reactions: Amniotic Membrane Graft, Conjunctival Hyperaemia, Post Procedural Complication, Ocular Hyperaemia, Ulcerative Keratitis, Anterior Chamber Cell, Anterior Chamber Fibrin
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tobradex
Dosage: (tid ophthalmic)
Indication: Postoperative Care
Ofloxacin
Dosage: (every 2 hours ophthalmic)
Indication: Infection Prophylaxis
Mitomycin
Dosage: (0.2 mg/ml for 2 min intraocular)
Indication: Surgery
Vitamin A
Dosage: (tid ophthalmic)
Indication: Postoperative Care
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21
Patient:
Reactions: Confusional State, Incorrect Route of Drug Administration, Off Label Use, Dehydration
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Doxorubicin HCL
Indication: Oesophageal Cancer Metastatic
Ethiodized OIL
Indication: Oesophageal Cancer Metastatic
Doxorubicin HCL
Mitomycin
Indication: Oesophageal Cancer Metastatic
Cisplatin
Indication: Oesophageal Cancer Metastatic
Polyvinyl Alcohol
Indication: Oesophageal Cancer Metastatic
Other drugs received by patient: Cefazolin; Fentanyl; Midazolam; Lidocaine; Diphenhydramine HCL; Ondansetron; Dexamethasone Sodium Posphate; Metronidazole; Lidocaine
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-15
Patient:
Reactions: Incorrect Route of Drug Administration, White Blood Cell Count Decreased, Device Related Sepsis, Pneumonia, Urinary Tract Infection, Anaemia, Off Label Use, Pleural Effusion, Venous Thrombosis, Neutropenia, Post Procedural Haemorrhage
Drug(s) suspected as cause:
Mitomycin
Indication: Peritoneal Mesothelioma Malignant
Doxorubicin HCL
Indication: Pseudomyxoma Peritonei
Doxorubicin HCL
Indication: Peritoneal Mesothelioma Malignant
Mitomycin
Indication: Pseudomyxoma Peritonei
Possible Mitomycin side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-15
Patient: 49 year old female, weighing 59.0 kg (129.8 pounds)
Reactions: Neoplasm Malignant, Drug Ineffective, Metastases To Meninges, Motor Dysfunction, Dizziness, Deafness, Neurological Symptom, Infrequent Bowel Movements
Adverse event resulted in: death
Drug(s) suspected as cause:
Carboplatin
Dosage: auc 4
Indication: Metastases To Central Nervous System
Epirubicin Hydrochloride
Dosage: 30 mg/m2, unk
Indication: Malignant Peritoneal Neoplasm
Mitomycin
Dosage: 7 mg/m2, unk
Carboplatin
Dosage: auc 5
Indication: Malignant Peritoneal Neoplasm
Docetaxel
Dosage: 70 mg/m2, unk
Indication: Malignant Peritoneal Neoplasm
Cyclophosphamide
Dosage: 600 mg/m2, unk
Indication: Metastases To Central Nervous System
Nedaplatin
Dosage: 60 mg/m2, unk
Indication: Malignant Peritoneal Neoplasm
Nedaplatin
Dosage: 12 mg/m2, unk
Cyclophosphamide
Dosage: 400 mg/m2, unk
Indication: Malignant Peritoneal Neoplasm
Irinotecan Hydrochloride
Dosage: 120 mg/m2, unk
Doxorubicin HCL
Dosage: 40 mg/m2, unk
Paclitaxel
Dosage: 175 mg/m2, unk
Indication: Malignant Peritoneal Neoplasm
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14
Patient:
Reactions: Off Label Use, Incorrect Route of Drug Administration, Hospitalisation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mitomycin
Indication: Peritoneal Mesothelioma Malignant
Doxorubicin Hydrochloride
Indication: Pseudomyxoma Peritonei
Doxorubicin Hydrochloride
Indication: Peritoneal Mesothelioma Malignant
Mitomycin
Indication: Pseudomyxoma Peritonei
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14
Patient:
Reactions: Incorrect Route of Drug Administration, Off Label Use, Anastomotic Leak
Drug(s) suspected as cause:
Mitomycin
Administration route: Oral
Indication: Pseudomyxoma Peritonei
Doxorubicin HCL
Indication: Pseudomyxoma Peritonei
Mitomycin
Administration route: Oral
Indication: Peritoneal Mesothelioma Malignant
Doxorubicin HCL
Indication: Peritoneal Mesothelioma Malignant
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14
Patient:
Reactions: Off Label Use, Incorrect Route of Drug Administration, Abdominal Abscess
Drug(s) suspected as cause:
Mitomycin
Indication: Pseudomyxoma Peritonei
Doxorubicin HCL
Indication: Pseudomyxoma Peritonei
Doxorubicin HCL
Indication: Peritoneal Mesothelioma Malignant
Mitomycin
Indication: Peritoneal Mesothelioma Malignant
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14
Patient:
Reactions: Off Label Use, Incorrect Route of Drug Administration, Renal Failure
Drug(s) suspected as cause:
Doxorubicin HCL
Indication: Pseudomyxoma Peritonei
Mitomycin
Indication: Pseudomyxoma Peritonei
Doxorubicin HCL
Indication: Peritoneal Mesothelioma Malignant
Mitomycin
Indication: Peritoneal Mesothelioma Malignant
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14
Patient:
Reactions: Off Label Use, Incorrect Route of Drug Administration, Adverse Drug Reaction
Drug(s) suspected as cause:
Mitomycin
Indication: Pseudomyxoma Peritonei
Doxorubicin Hydrochloride
Indication: Pseudomyxoma Peritonei
Doxorubicin Hydrochloride
Indication: Peritoneal Mesothelioma Malignant
Mitomycin
Indication: Peritoneal Mesothelioma Malignant
Possible Mitomycin side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14
Patient:
Reactions: Incorrect Route of Drug Administration, Off Label Use, Anastomotic Leak
Drug(s) suspected as cause:
Doxorubicin HCL
Indication: Pseudomyxoma Peritonei
Mitomycin
Indication: Peritoneal Mesothelioma Malignant
Doxorubicin HCL
Indication: Peritoneal Mesothelioma Malignant
Mitomycin
Indication: Pseudomyxoma Peritonei
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