TENECTEPLASE

Tenecteplase Adverse Events Reported to the FDA Over Time

How are Tenecteplase adverse event reports trending over time?

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

Most Common Tenecteplase Adverse Events Reported to the FDA

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

Cardiac Arrest	33 (2.85%)
Ventricular Fibrillation	28 (2.42%)
Haemorrhage Intracranial	26 (2.24%)
Haematemesis	24 (2.07%)
Pneumonia	22 (1.9%)
Hypotension	21 (1.81%)
Tachycardia	19 (1.64%)
Cardiogenic Shock	18 (1.55%)
Chest Pain	18 (1.55%)
Haematoma	18 (1.55%)
Cerebral Haemorrhage	16 (1.38%)
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Death	15 (1.29%)
Pulmonary Oedema	15 (1.29%)
Cardiac Tamponade	14 (1.21%)
Drug Ineffective	14 (1.21%)
Haemoglobin Decreased	13 (1.12%)
Pericardial Haemorrhage	13 (1.12%)
Agitation	12 (1.04%)
Anuria	12 (1.04%)
Hyperglycaemia	12 (1.04%)
Dysphagia	11 (.95%)
Meningitis Viral	11 (.95%)
Shock	11 (.95%)
Tachypnoea	11 (.95%)
Abdominal Pain Upper	10 (.86%)
Myocardial Infarction	10 (.86%)
Odynophagia	10 (.86%)
Pulmonary Embolism	10 (.86%)
Acute Myocardial Infarction	9 (.78%)
Obstructive Airways Disorder	9 (.78%)
Thrombocytopenia	9 (.78%)
Brain Herniation	8 (.69%)
Cardiac Failure	8 (.69%)
Cerebrovascular Accident	8 (.69%)
Electrocardiogram St Segment Elevat...	8 (.69%)
Mediastinal Haematoma	8 (.69%)
Subdural Haemorrhage	8 (.69%)
Cerebral Haematoma	7 (.6%)
Epistaxis	7 (.6%)
Haemorrhage	7 (.6%)
Headache	7 (.6%)
Mitral Valve Incompetence	7 (.6%)
Nausea	7 (.6%)
Pleural Effusion	7 (.6%)
Subarachnoid Haemorrhage	7 (.6%)
Aortic Arteriosclerosis	6 (.52%)
Aortic Valve Incompetence	6 (.52%)
Bacteraemia	6 (.52%)
Bronchiolitis	6 (.52%)
Cerebral Arteriosclerosis	6 (.52%)
Coma	6 (.52%)
Drug Interaction	6 (.52%)
Nephrosclerosis	6 (.52%)
Oesophageal Mass	6 (.52%)
Pleural Adhesion	6 (.52%)
Pneumonia Aspiration	6 (.52%)
Puncture Site Haemorrhage	6 (.52%)
Renal Cyst	6 (.52%)
Septic Shock	6 (.52%)
Spinal Epidural Haemorrhage	6 (.52%)
Sudden Death	6 (.52%)
Uterine Leiomyoma	6 (.52%)
Acute Respiratory Distress Syndrome	5 (.43%)
Arteriosclerosis Coronary Artery	5 (.43%)
Aspiration	5 (.43%)
Atelectasis	5 (.43%)
Bradycardia	5 (.43%)
Convulsion	5 (.43%)
Coronary Artery Dissection	5 (.43%)
Depressed Level Of Consciousness	5 (.43%)
Haemoptysis	5 (.43%)
Haemothorax	5 (.43%)
Hemiparesis	5 (.43%)
Hepatic Steatosis	5 (.43%)
Hyperplastic Cholecystopathy	5 (.43%)
Intracranial Pressure Increased	5 (.43%)
Ischaemic Stroke	5 (.43%)
Polyneuropathy	5 (.43%)
Pupils Unequal	5 (.43%)
Sputum Culture Positive	5 (.43%)
Tongue Haemorrhage	5 (.43%)
Atrial Fibrillation	4 (.35%)
Cardiomegaly	4 (.35%)
Coronary Artery Occlusion	4 (.35%)
Coronary Artery Stenosis	4 (.35%)
Facial Paresis	4 (.35%)
Foreign Body Trauma	4 (.35%)
Gastrointestinal Haemorrhage	4 (.35%)
Gingival Bleeding	4 (.35%)
Hypercapnia	4 (.35%)
Hyperhidrosis	4 (.35%)
Hypoxia	4 (.35%)
Leiomyoma	4 (.35%)
Loss Of Consciousness	4 (.35%)
Oesophageal Haemorrhage	4 (.35%)
Post Procedural Haemorrhage	4 (.35%)
Pulmonary Haemorrhage	4 (.35%)
Pyrexia	4 (.35%)
Reperfusion Arrhythmia	4 (.35%)
Serratia Infection	4 (.35%)
Staphylococcal Bacteraemia	4 (.35%)

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

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

Cardiac Arrhythmias	107 (9.23%)
Central Nervous System Vascular	97 (8.37%)
Coronary Artery	45 (3.88%)
Respiratory	39 (3.36%)
Infections - Pathogen Unspecified	38 (3.28%)
Gastrointestinal Hemorrhages	37 (3.19%)
Decreased And Nonspecific Blood Pre...	36 (3.11%)
Injuries	35 (3.02%)
Lower Respiratory Tract Disorders	33 (2.85%)
Gastrointestinal Signs	31 (2.67%)
Pericardial	31 (2.67%)
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Neurological	30 (2.59%)
Vascular Hemorrhagic	27 (2.33%)
Heart Failures	26 (2.24%)
Cardiac And Vascular Investigations	25 (2.16%)
Hematology Investigations	25 (2.16%)
Therapeutic And Nontherapeutic Effe...	24 (2.07%)
Fatal Outcomes	21 (1.81%)
Renal Disorders	21 (1.81%)
Pleural	18 (1.55%)
Viral Infectious	17 (1.47%)
Procedural And Device Related Injur...	16 (1.38%)
Anxiety Disorders	13 (1.12%)
Cardiac Valve	13 (1.12%)
Glucose Metabolism Disorders	13 (1.12%)
Tongue Conditions	13 (1.12%)
Bacterial Infectious	12 (1.04%)
Myocardial	12 (1.04%)
Pulmonary Vascular	12 (1.04%)
Platelet	11 (.95%)
Administration Site Reactions	10 (.86%)
Ocular Neuromuscular	10 (.86%)
Oral Soft Tissue Conditions	10 (.86%)
Arteriosclerosis, Stenosis, Vascula...	9 (.78%)
Bronchial Disorders	9 (.78%)
Gastrointestinal Conditions	9 (.78%)
Hepatic And Hepatobiliary	8 (.69%)
Increased Intracranial Pressure And...	8 (.69%)
Thoracic Disorders	8 (.69%)
Cranial Nerve Disorders	7 (.6%)
Gastrointestinal Neoplasms Malignan...	7 (.6%)
Headaches	7 (.6%)
Microbiology And Serology	7 (.6%)
Movement Disorders	7 (.6%)
Upper Respiratory Tract Disorders	7 (.6%)
Muscle	6 (.52%)
Nephropathies	6 (.52%)
Reproductive Neoplasms Female Benig...	6 (.52%)
Gallbladder	5 (.43%)
Medication Errors	5 (.43%)
Peripheral Neuropathies	5 (.43%)
Seizures	5 (.43%)
Body Temperature Conditions	4 (.35%)
Dental And Gingival Conditions	4 (.35%)
Gastrointestinal Ulceration And Per...	4 (.35%)
Skin Appendage Conditions	4 (.35%)
Skin Vascular Abnormalities	4 (.35%)
Soft Tissue Neoplasms Benign	4 (.35%)
Vision	4 (.35%)
Deliria	3 (.26%)
Embolism And Thrombosis	3 (.26%)
Fungal Infectious	3 (.26%)
Gastrointestinal Tract Disorders Co...	3 (.26%)
Metabolic, Nutritional And Blood Ga...	3 (.26%)
Vascular Therapeutic Procedures	3 (.26%)
Encephalopathies	2 (.17%)
Exocrine Pancreas Conditions	2 (.17%)
Eye	2 (.17%)
Gastrointestinal Vascular Condition...	2 (.17%)
Musculoskeletal And Connective Tiss...	2 (.17%)
Neurological, Special Senses And Ps...	2 (.17%)
Peritoneal And Retroperitoneal Cond...	2 (.17%)
Physical Examination Topics	2 (.17%)
Thyroid Gland	2 (.17%)
Tissue	2 (.17%)
Vascular	2 (.17%)
Aneurysms And Artery Dissections	1 (.09%)
Cardiac And Vascular Disorders Cong...	1 (.09%)
Cardiac Disorder Signs	1 (.09%)
Chemical Injury And Poisoning	1 (.09%)
Electrolyte And Fluid Balance Condi...	1 (.09%)
Epidermal And Dermal Conditions	1 (.09%)
Gastrointestinal Stenosis And Obstr...	1 (.09%)
Hematological And Lymphoid Tissue T...	1 (.09%)
Investigations, Imaging And Histopa...	1 (.09%)
Lipid Metabolism	1 (.09%)
Metastases	1 (.09%)
Neurological Disorders Of The Eye	1 (.09%)
Neuromuscular	1 (.09%)
Ocular Sensory Symptoms	1 (.09%)
Respiratory And Mediastinal Neoplas...	1 (.09%)
Structural Brain	1 (.09%)
Vascular Injuries	1 (.09%)
White Blood Cell	1 (.09%)

Share/Embed Graph Export Data

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