RILUTEK

Rilutek Adverse Events Reported to the FDA Over Time

How are Rilutek adverse event reports trending over time?

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

Most Common Rilutek Adverse Events Reported to the FDA

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

Death	43 (4.47%)
Pyrexia	41 (4.26%)
Dyspnoea	28 (2.91%)
Disease Progression	25 (2.6%)
Pneumonia	22 (2.28%)
Interstitial Lung Disease	19 (1.97%)
Alanine Aminotransferase Increased	17 (1.77%)
Cough	14 (1.45%)
Condition Aggravated	13 (1.35%)
Hepatic Function Abnormal	12 (1.25%)
Myalgia	11 (1.14%)
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Pulmonary Embolism	11 (1.14%)
Aspartate Aminotransferase Increase...	10 (1.04%)
Asthenia	10 (1.04%)
Fall	10 (1.04%)
Respiratory Failure	10 (1.04%)
Atrial Fibrillation	9 (.93%)
Blood Alkaline Phosphatase Increase...	9 (.93%)
Diarrhoea	8 (.83%)
Dysphagia	8 (.83%)
Gamma-glutamyltransferase Increased	8 (.83%)
Myocardial Infarction	8 (.83%)
Nausea	8 (.83%)
Off Label Use	8 (.83%)
Arthralgia	7 (.73%)
Loss Of Consciousness	7 (.73%)
Lung Infiltration	7 (.73%)
Amyotrophic Lateral Sclerosis	6 (.62%)
Drug Exposure During Pregnancy	6 (.62%)
Infection	6 (.62%)
Respiratory Disorder	6 (.62%)
Somnolence	6 (.62%)
Weight Decreased	6 (.62%)
Blood Bilirubin Increased	5 (.52%)
Cerebrovascular Accident	5 (.52%)
Hyperhidrosis	5 (.52%)
Hypokalaemia	5 (.52%)
International Normalised Ratio Incr...	5 (.52%)
Melaena	5 (.52%)
Pneumonia Aspiration	5 (.52%)
Rash	5 (.52%)
Agranulocytosis	4 (.42%)
Atelectasis	4 (.42%)
Completed Suicide	4 (.42%)
Cyanosis	4 (.42%)
Cytolytic Hepatitis	4 (.42%)
Fatigue	4 (.42%)
Gastric Ulcer Haemorrhage	4 (.42%)
Hepatitis	4 (.42%)
Hypertension	4 (.42%)
Increased Upper Airway Secretion	4 (.42%)
Inflammation	4 (.42%)
Motor Neurone Disease	4 (.42%)
Nasopharyngitis	4 (.42%)
Pain In Extremity	4 (.42%)
Pemphigoid	4 (.42%)
Respiratory Distress	4 (.42%)
Shock Haemorrhagic	4 (.42%)
Thyroid Disorder	4 (.42%)
Viral Infection	4 (.42%)
Vomiting	4 (.42%)
Weight Increased	4 (.42%)
White Blood Cell Count Decreased	4 (.42%)
Abdominal Pain	3 (.31%)
Abdominal Pain Upper	3 (.31%)
Acute Respiratory Distress Syndrome	3 (.31%)
Anaemia	3 (.31%)
Anorexia	3 (.31%)
Blood Creatine Phosphokinase Increa...	3 (.31%)
Blood Lactate Dehydrogenase Increas...	3 (.31%)
Blood Pressure Decreased	3 (.31%)
Cardio-respiratory Arrest	3 (.31%)
Cerebral Haemorrhage	3 (.31%)
Chest Pain	3 (.31%)
Choking	3 (.31%)
Coma	3 (.31%)
Delirium	3 (.31%)
Depressed Level Of Consciousness	3 (.31%)
Dizziness	3 (.31%)
Drug Interaction	3 (.31%)
Electrocardiogram Qt Prolonged	3 (.31%)
Eosinophilic Pneumonia	3 (.31%)
Exomphalos	3 (.31%)
General Physical Health Deteriorati...	3 (.31%)
Hepatitis Fulminant	3 (.31%)
Hyponatraemia	3 (.31%)
Hypotension	3 (.31%)
Intra-uterine Death	3 (.31%)
Jaundice	3 (.31%)
Jaundice Cholestatic	3 (.31%)
Liver Disorder	3 (.31%)
Lung Disorder	3 (.31%)
Muscle Spasms	3 (.31%)
Neck Pain	3 (.31%)
Pancreatitis Acute	3 (.31%)
Panic Attack	3 (.31%)
Prostate Cancer Metastatic	3 (.31%)
Rash Papular	3 (.31%)
Renal Failure Acute	3 (.31%)
Shock	3 (.31%)
Tachycardia	3 (.31%)

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

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

Respiratory	86 (8.93%)
Body Temperature Conditions	43 (4.47%)
Fatal Outcomes	43 (4.47%)
Hepatic And Hepatobiliary	42 (4.36%)
Hepatobiliary	42 (4.36%)
Infections - Pathogen Unspecified	41 (4.26%)
Lower Respiratory Tract Disorders	41 (4.26%)
Neurological	31 (3.22%)
Gastrointestinal Signs	29 (3.01%)
Cardiac Arrhythmias	23 (2.39%)
Epidermal And Dermal Conditions	22 (2.28%)
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Muscle	18 (1.87%)
Cardiac And Vascular Investigations	15 (1.56%)
Enzyme	15 (1.56%)
Decreased And Nonspecific Blood Pre...	13 (1.35%)
Hematology Investigations	13 (1.35%)
Neuromuscular	13 (1.35%)
Pulmonary Vascular	13 (1.35%)
Coronary Artery	12 (1.25%)
Physical Examination Topics	12 (1.25%)
Therapeutic And Nontherapeutic Effe...	12 (1.25%)
Central Nervous System Vascular	11 (1.14%)
Injuries	11 (1.14%)
Electrolyte And Fluid Balance Condi...	10 (1.04%)
Gastrointestinal Motility And Defec...	10 (1.04%)
Musculoskeletal And Connective Tiss...	10 (1.04%)
Therapeutic Procedures And Supporti...	10 (1.04%)
Viral Infectious	10 (1.04%)
Movement Disorders	9 (.93%)
Bone And Joint Injuries	8 (.83%)
Joint	7 (.73%)
Chemical Injury And Poisoning	6 (.62%)
Medication Errors	6 (.62%)
Abortions And Stillbirth	5 (.52%)
Anxiety Disorders	5 (.52%)
Appetite And General Nutritional	5 (.52%)
Cardiac Disorder Signs	5 (.52%)
Deliria	5 (.52%)
Exocrine Pancreas Conditions	5 (.52%)
Gastrointestinal Hemorrhages	5 (.52%)
Heart Failures	5 (.52%)
Skin Appendage Conditions	5 (.52%)
Skin Vascular Abnormalities	5 (.52%)
Urinary Tract Signs	5 (.52%)
Vascular	5 (.52%)
White Blood Cell	5 (.52%)
Anemias Nonhemolytic And Marrow Dep...	4 (.42%)
Gastrointestinal Ulceration And Per...	4 (.42%)
Hemolyses And Related Conditions	4 (.42%)
Musculoskeletal And Connective Tiss...	4 (.42%)
Myocardial	4 (.42%)
Renal Disorders	4 (.42%)
Suicidal And Self-injurious Behavio...	4 (.42%)
Thyroid Gland	4 (.42%)
Upper Respiratory Tract Disorders	4 (.42%)
Vascular Hypertensive	4 (.42%)
Bronchial Disorders	3 (.31%)
Coagulopathies And Bleeding Diathes...	3 (.31%)
Gastrointestinal Conditions	3 (.31%)
Gastrointestinal Stenosis And Obstr...	3 (.31%)
Gastrointestinal Tract Disorders Co...	3 (.31%)
Lifestyle Issues	3 (.31%)
Metabolic, Nutritional And Blood Ga...	3 (.31%)
Neurological Disorders Congenital	3 (.31%)
Platelet	3 (.31%)
Psychiatric	3 (.31%)
Renal And Urinary Tract Investigati...	3 (.31%)
Reproductive Neoplasms Male Maligna...	3 (.31%)
Salivary Gland Conditions	3 (.31%)
Acid-base	2 (.21%)
Angiedema And Urticaria	2 (.21%)
Embolism And Thrombosis	2 (.21%)
Gallbladder	2 (.21%)
Gastrointestinal Neoplasms Malignan...	2 (.21%)
Gastrointestinal Therapeutic Proced...	2 (.21%)
Headaches	2 (.21%)
Hematological And Lymphoid Tissue T...	2 (.21%)
Hypothalamus And Pituitary Gland	2 (.21%)
Respiratory Tract Therapeutic Proce...	2 (.21%)
Sleep Disorders	2 (.21%)
Tendon, Ligament And Cartilage	2 (.21%)
Thoracic Disorders	2 (.21%)
Toxicology And Therapeutic Drug Mon...	2 (.21%)
Vascular Hemorrhagic	2 (.21%)
Water, Electrolyte And Mineral	2 (.21%)
Administration Site Reactions	1 (.1%)
Arteriosclerosis, Stenosis, Vascula...	1 (.1%)
Bacterial Infectious	1 (.1%)
Bile Duct	1 (.1%)
Bone Disorders	1 (.1%)
Dental And Gingival Conditions	1 (.1%)
Fungal Infectious	1 (.1%)
Gastrointestinal Vascular Condition...	1 (.1%)
Hematological	1 (.1%)
Increased Intracranial Pressure And...	1 (.1%)
Lymphomas	1 (.1%)
Mental Impairment	1 (.1%)
Mood Disorders	1 (.1%)
Nervous System Neoplasms Benign	1 (.1%)
Oral Soft Tissue Conditions	1 (.1%)
Pregnancy, Labour, Delivery And Pos...	1 (.1%)

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