METALYSE

Metalyse Adverse Events Reported to the FDA Over Time

How are Metalyse adverse event reports trending over time?

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

Most Common Metalyse Adverse Events Reported to the FDA

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

Death	78 (14.34%)
Electrocardiogram St Segment Elevat...	25 (4.6%)
Chest Pain	22 (4.04%)
Drug Ineffective	22 (4.04%)
Cardiogenic Shock	18 (3.31%)
Ventricular Fibrillation	16 (2.94%)
Cardiac Arrest	12 (2.21%)
Cerebral Haemorrhage	12 (2.21%)
Myocardial Infarction	12 (2.21%)
Dysphagia	10 (1.84%)
Haematemesis	10 (1.84%)
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Haematoma	10 (1.84%)
Odynophagia	10 (1.84%)
Abdominal Pain Upper	9 (1.65%)
Cardiovascular Disorder	8 (1.47%)
Electrocardiogram Abnormal	8 (1.47%)
Haemorrhage Intracranial	8 (1.47%)
Mediastinal Haematoma	8 (1.47%)
Cardiac Failure	6 (1.1%)
Coronary Artery Occlusion	5 (.92%)
Oesophageal Mass	5 (.92%)
Product Quality Issue	5 (.92%)
Respiratory Disorder	5 (.92%)
Angina Pectoris	4 (.74%)
Atrial Fibrillation	4 (.74%)
Blood Pressure Decreased	4 (.74%)
Cardiac Disorder	4 (.74%)
Epistaxis	4 (.74%)
Infection	4 (.74%)
Neurological Decompensation	4 (.74%)
Thrombocytopenia	4 (.74%)
Thrombocytopenic Purpura	4 (.74%)
Bradycardia	3 (.55%)
Chest Discomfort	3 (.55%)
Foreign Body Trauma	3 (.55%)
Gastrointestinal Haemorrhage	3 (.55%)
Haemoglobin Decreased	3 (.55%)
Haemorrhage	3 (.55%)
Oesophageal Rupture	3 (.55%)
Pneumonia	3 (.55%)
Red Blood Cell Count Decreased	3 (.55%)
Acute Myocardial Infarction	2 (.37%)
Acute Respiratory Distress Syndrome	2 (.37%)
Arrhythmia	2 (.37%)
Atrophy	2 (.37%)
Cardio-respiratory Arrest	2 (.37%)
Cerebrovascular Accident	2 (.37%)
Condition Aggravated	2 (.37%)
Disease Recurrence	2 (.37%)
Drug Interaction	2 (.37%)
Electrocardiogram St Segment Abnorm...	2 (.37%)
Electrocardiogram St Segment Depres...	2 (.37%)
Gastric Perforation	2 (.37%)
Gastrointestinal Disorder	2 (.37%)
Haemoptysis	2 (.37%)
Haemorrhagic Stroke	2 (.37%)
Headache	2 (.37%)
Hypotension	2 (.37%)
Hypoxic Encephalopathy	2 (.37%)
Intestinal Ischaemia	2 (.37%)
Loss Of Consciousness	2 (.37%)
Medication Error	2 (.37%)
Multi-organ Failure	2 (.37%)
Oesophageal Disorder	2 (.37%)
Oesophageal Haemorrhage	2 (.37%)
Periorbital Haematoma	2 (.37%)
Pulmonary Embolism	2 (.37%)
Pulmonary Haemorrhage	2 (.37%)
Puncture Site Haemorrhage	2 (.37%)
Renal Disorder	2 (.37%)
Renal Failure Acute	2 (.37%)
Respiratory Arrest	2 (.37%)
Respiratory Tract Infection	2 (.37%)
Retroperitoneal Haemorrhage	2 (.37%)
Subdural Haematoma	2 (.37%)
Sudden Death	2 (.37%)
Wound Haemorrhage	2 (.37%)
Abdominal Pain	1 (.18%)
Acute Coronary Syndrome	1 (.18%)
Adverse Drug Reaction	1 (.18%)
Alanine Aminotransferase Increased	1 (.18%)
Amnesia	1 (.18%)
Anuria	1 (.18%)
Areflexia	1 (.18%)
Aspartate Aminotransferase Increase...	1 (.18%)
Blindness Unilateral	1 (.18%)
Blood Albumin Decreased	1 (.18%)
Blood Lactic Acid Increased	1 (.18%)
Brain Compression	1 (.18%)
Brain Death	1 (.18%)
Bulbar Palsy	1 (.18%)
Cardiac Aneurysm	1 (.18%)
Cerebellar Haematoma	1 (.18%)
Cerebral Haematoma	1 (.18%)
Circulatory Collapse	1 (.18%)
Coma	1 (.18%)
Coronary Artery Stenosis	1 (.18%)
Decubitus Ulcer	1 (.18%)
Dehydration	1 (.18%)
Diabetes Mellitus	1 (.18%)
Diplopia	1 (.18%)

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This graph shows the top adverse events submitted to the FDA for Metalyse, 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 Metalyse 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 Metalyse

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

Fatal Outcomes	81 (14.89%)
Cardiac And Vascular Investigations	43 (7.9%)
Cardiac Arrhythmias	41 (7.54%)
Central Nervous System Vascular	28 (5.15%)
Coronary Artery	25 (4.6%)
Therapeutic And Nontherapeutic Effe...	25 (4.6%)
Heart Failures	24 (4.41%)
Gastrointestinal Signs	21 (3.86%)
Gastrointestinal Hemorrhages	16 (2.94%)
Vascular Hemorrhagic	15 (2.76%)
Respiratory	13 (2.39%)
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Cardiac Disorder Signs	12 (2.21%)
Injuries	12 (2.21%)
Oral Soft Tissue Conditions	10 (1.84%)
Gastrointestinal Conditions	9 (1.65%)
Infections - Pathogen Unspecified	9 (1.65%)
Hematology Investigations	8 (1.47%)
Neurological	8 (1.47%)
Platelet	8 (1.47%)
Thoracic Disorders	8 (1.47%)
Renal Disorders	6 (1.1%)
Decreased And Nonspecific Blood Pre...	5 (.92%)
Gastrointestinal Ulceration And Per...	5 (.92%)
Product Quality Issues	5 (.92%)
Medication Errors	4 (.74%)
Upper Respiratory Tract Disorders	4 (.74%)
Administration Site Reactions	3 (.55%)
Vision	3 (.55%)
Arteriosclerosis, Stenosis, Vascula...	2 (.37%)
Embolism And Thrombosis	2 (.37%)
Encephalopathies	2 (.37%)
Gastrointestinal Vascular Condition...	2 (.37%)
Headaches	2 (.37%)
Hepatobiliary	2 (.37%)
Lower Respiratory Tract Disorders	2 (.37%)
Metabolic, Nutritional And Blood Ga...	2 (.37%)
Metastases	2 (.37%)
Movement Disorders	2 (.37%)
Myocardial	2 (.37%)
Neurological Disorders Of The Eye	2 (.37%)
Ocular Neuromuscular	2 (.37%)
Peritoneal And Retroperitoneal Cond...	2 (.37%)
Procedural And Device Related Injur...	2 (.37%)
Pulmonary Vascular	2 (.37%)
Tissue	2 (.37%)
Urinary Tract Signs	2 (.37%)
Cardiac And Vascular Disorders Cong...	1 (.18%)
Cranial Nerve Disorders	1 (.18%)
Electrolyte And Fluid Balance Condi...	1 (.18%)
Enzyme	1 (.18%)
Epidermal And Dermal Conditions	1 (.18%)
Exocrine Pancreas Conditions	1 (.18%)
Eye	1 (.18%)
Glucose Metabolism Disorders	1 (.18%)
Hematological And Lymphoid Tissue T...	1 (.18%)
Increased Intracranial Pressure And...	1 (.18%)
Investigations, Imaging And Histopa...	1 (.18%)
Mental Impairment	1 (.18%)
Neuromuscular	1 (.18%)
Ocular Hemorrhages And Vascular	1 (.18%)
Ocular Sensory Symptoms	1 (.18%)
Pericardial	1 (.18%)
Postpartum And Puerperal	1 (.18%)
Protein And Chemistry Analyses	1 (.18%)
Respiratory And Mediastinal Neoplas...	1 (.18%)
Skin Appendage Conditions	1 (.18%)
Skin Vascular Abnormalities	1 (.18%)
Sleep Disorders	1 (.18%)
Therapeutic Procedures And Supporti...	1 (.18%)
Vascular	1 (.18%)

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This graph shows the top categories of adverse events submitted to the FDA for Metalyse, 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 Metalyse 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.