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Mitomycin (Mitomycin) - Side Effect Reports to FDA

 
 



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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