MITOMYCIN

Mitomycin Adverse Events Reported to the FDA Over Time

How are Mitomycin adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Mitomycin, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Mitomycin is flagged as the suspect drug causing the adverse event.

Most Common Mitomycin Adverse Events Reported to the FDA

What are the most common Mitomycin adverse events reported to the FDA?

Off Label Use	77 (2.34%)
Diarrhoea	73 (2.22%)
Nausea	54 (1.64%)
Vomiting	45 (1.37%)
Pyrexia	40 (1.22%)
Anaemia	38 (1.16%)
Dehydration	36 (1.1%)
Thrombocytopenia	35 (1.07%)
Hepatic Failure	33 (1%)
Interstitial Lung Disease	32 (.97%)
Rash	30 (.91%)
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Abdominal Pain	28 (.85%)
Haemolytic Uraemic Syndrome	28 (.85%)
Neutropenia	28 (.85%)
Incorrect Route Of Drug Administrat...	26 (.79%)
Sepsis	25 (.76%)
Bladder Perforation	24 (.73%)
Febrile Neutropenia	24 (.73%)
Hypertension	24 (.73%)
Bone Marrow Failure	23 (.7%)
Dyspnoea	23 (.7%)
Fatigue	23 (.7%)
Pain	23 (.7%)
Pancytopenia	22 (.67%)
Dysuria	21 (.64%)
Endophthalmitis	21 (.64%)
Visual Acuity Reduced	21 (.64%)
Corneal Epithelium Defect	20 (.61%)
Bladder Necrosis	19 (.58%)
Decreased Appetite	17 (.52%)
Leukopenia	17 (.52%)
Pruritus	17 (.52%)
Liver Abscess	16 (.49%)
Myelodysplastic Syndrome	16 (.49%)
Nephrotic Syndrome	16 (.49%)
Platelet Count Decreased	16 (.49%)
White Blood Cell Count Decreased	16 (.49%)
Drug Toxicity	15 (.46%)
Radiation Skin Injury	15 (.46%)
Treatment Related Secondary Maligna...	15 (.46%)
Acute Myeloid Leukaemia	14 (.43%)
Asthenia	14 (.43%)
Proteinuria	14 (.43%)
Renal Failure Acute	14 (.43%)
Renal Impairment	14 (.43%)
Stomatitis	14 (.43%)
Eosinophilic Cystitis	13 (.4%)
Intestinal Obstruction	13 (.4%)
Palmar-plantar Erythrodysaesthesia ...	13 (.4%)
Pulmonary Fibrosis	13 (.4%)
Body Temperature Increased	12 (.37%)
Cystitis	12 (.37%)
Dermatitis	12 (.37%)
Erythema	12 (.37%)
Renal Failure	12 (.37%)
Respiratory Failure	12 (.37%)
Acute Promyelocytic Leukaemia	11 (.33%)
Arthralgia	11 (.33%)
Infection	11 (.33%)
Neutropenic Sepsis	11 (.33%)
Pneumonia	11 (.33%)
Pulmonary Haemorrhage	11 (.33%)
Skin Exfoliation	11 (.33%)
Blood Creatinine Increased	10 (.3%)
Drug Ineffective	10 (.3%)
Fall	10 (.3%)
Hepatic Cirrhosis	10 (.3%)
Ileus	10 (.3%)
Neoplasm Progression	10 (.3%)
Neutrophil Count Decreased	10 (.3%)
Pleural Effusion	10 (.3%)
Pollakiuria	10 (.3%)
Respiratory Distress	10 (.3%)
Stridor	10 (.3%)
Thrombotic Thrombocytopenic Purpura	10 (.3%)
Chills	9 (.27%)
Confusional State	9 (.27%)
Disease Progression	9 (.27%)
Iridocyclitis	9 (.27%)
Neoplasm Recurrence	9 (.27%)
Peripheral Embolism	9 (.27%)
Proctalgia	9 (.27%)
Pulmonary Embolism	9 (.27%)
Pulmonary Hypertension	9 (.27%)
Pulmonary Veno-occlusive Disease	9 (.27%)
Septic Shock	9 (.27%)
Blood Bilirubin Increased	8 (.24%)
Encephalopathy	8 (.24%)
Hypotension	8 (.24%)
Malaise	8 (.24%)
Neutropenic Colitis	8 (.24%)
Postoperative Wound Complication	8 (.24%)
Scleroderma	8 (.24%)
Urticaria	8 (.24%)
Adverse Drug Reaction	7 (.21%)
Ascites	7 (.21%)
Biliary Fistula	7 (.21%)
Conjunctival Hyperaemia	7 (.21%)
Dermatitis Bullous	7 (.21%)
Drug Effect Decreased	7 (.21%)
Erythema Multiforme	7 (.21%)

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This graph shows the top adverse events submitted to the FDA for Mitomycin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Mitomycin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Mitomycin

What are the most common Mitomycin adverse events reported to the FDA?

Infections - Pathogen Unspecified	171 (5.2%)
Epidermal And Dermal Conditions	161 (4.9%)
Gastrointestinal Signs	159 (4.84%)
Hepatic And Hepatobiliary	99 (3.01%)
Gastrointestinal Motility And Defec...	95 (2.89%)
Anemias Nonhemolytic And Marrow Dep...	87 (2.65%)
Respiratory	82 (2.5%)
Therapeutic Procedures And Supporti...	80 (2.43%)
Bladder And Bladder Neck Disorders	78 (2.37%)
White Blood Cell	77 (2.34%)
Hematology Investigations	74 (2.25%)
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Lower Respiratory Tract Disorders	74 (2.25%)
Urinary Tract Signs	62 (1.89%)
Renal Disorders	59 (1.8%)
Ocular Infections, Irritations And ...	51 (1.55%)
Neurological	49 (1.49%)
Medication Errors	47 (1.43%)
Electrolyte And Fluid Balance Condi...	45 (1.37%)
Platelet	45 (1.37%)
Anterior Eye Structural Change, Dep...	43 (1.31%)
Body Temperature Conditions	41 (1.25%)
Leukemias	41 (1.25%)
Injuries	40 (1.22%)
Gastrointestinal Inflammatory Condi...	37 (1.13%)
Gastrointestinal Stenosis And Obstr...	37 (1.13%)
Hemolyses And Related Conditions	36 (1.1%)
Therapeutic And Nontherapeutic Effe...	36 (1.1%)
Pulmonary Vascular	34 (1.03%)
Hepatobiliary	33 (1%)
Bacterial Infectious	32 (.97%)
Miscellaneous And Site Unspecified ...	32 (.97%)
Tissue	31 (.94%)
Vascular Hypertensive	31 (.94%)
Vision	30 (.91%)
Bile Duct	28 (.85%)
Procedural And Device Related Injur...	28 (.85%)
Chemical Injury And Poisoning	25 (.76%)
Fungal Infectious	25 (.76%)
Metastases	24 (.73%)
Upper Respiratory Tract Disorders	23 (.7%)
Appetite And General Nutritional	22 (.67%)
Injuries By Physical Agents	21 (.64%)
Neoplasm Related Morbidities	21 (.64%)
Oral Soft Tissue Conditions	21 (.64%)
Renal And Urinary Tract Investigati...	21 (.64%)
Physical Examination Topics	20 (.61%)
Skin And Subcutaneous Tissue	19 (.58%)
Cardiac Arrhythmias	18 (.55%)
Coronary Artery	18 (.55%)
Nephropathies	18 (.55%)
Embolism And Thrombosis	17 (.52%)
Encephalopathies	17 (.52%)
Gastrointestinal Hemorrhages	17 (.52%)
Eye	16 (.49%)
Joint	16 (.49%)
Anal And Rectal Conditions	15 (.46%)
Musculoskeletal And Connective Tiss...	15 (.46%)
Ocular Structural Change, Deposit A...	15 (.46%)
Penile And Scrotal Disorders	15 (.46%)
Peritoneal And Retroperitoneal Cond...	15 (.46%)
Allergic Conditions	14 (.43%)
Cardiac And Vascular Investigations	14 (.43%)
Central Nervous System Vascular	14 (.43%)
Gastrointestinal Ulceration And Per...	14 (.43%)
Skin Vascular Abnormalities	14 (.43%)
Decreased And Nonspecific Blood Pre...	13 (.4%)
Pleural	13 (.4%)
Gastrointestinal Neoplasms Malignan...	12 (.37%)
Water, Electrolyte And Mineral	12 (.37%)
Coagulopathies And Bleeding Diathes...	11 (.33%)
Heart Failures	11 (.33%)
Connective Tissue Disorders	10 (.3%)
Fatal Outcomes	10 (.3%)
Gastrointestinal Conditions	10 (.3%)
Muscle	10 (.3%)
Protein And Chemistry Analyses	10 (.3%)
Reproductive Tract	10 (.3%)
Seizures	10 (.3%)
Deliria	9 (.27%)
Microbiology And Serology	9 (.27%)
Retina, Choroid And Vitreous Hemorr...	9 (.27%)
Angiedema And Urticaria	8 (.24%)
Glucose Metabolism Disorders	8 (.24%)
Immunology And Allergy	8 (.24%)
Bronchial Disorders	7 (.21%)
Enzyme	7 (.21%)
Headaches	7 (.21%)
Immune	7 (.21%)
Peripheral Neuropathies	7 (.21%)
Skin Appendage Conditions	7 (.21%)
Administration Site Reactions	6 (.18%)
Hematological	6 (.18%)
Metabolic, Nutritional And Blood Ga...	6 (.18%)
Ureteric	6 (.18%)
Viral Infectious	6 (.18%)
Aneurysms And Artery Dissections	5 (.15%)
Hepatobiliary Neoplasms Malignant A...	5 (.15%)
Neurological, Special Senses And Ps...	5 (.15%)
Reproductive Neoplasms Female Malig...	5 (.15%)
Respiratory And Mediastinal Neoplas...	5 (.15%)
Arteriosclerosis, Stenosis, Vascula...	4 (.12%)

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This graph shows the top categories of adverse events submitted to the FDA for Mitomycin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Mitomycin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.