MEDIATOR

Mediator Adverse Events Reported to the FDA Over Time

How are Mediator adverse event reports trending over time?

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

Most Common Mediator Adverse Events Reported to the FDA

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

Aortic Valve Incompetence	52 (6.61%)
Mitral Valve Incompetence	50 (6.35%)
Pulmonary Arterial Hypertension	49 (6.23%)
Dyspnoea	25 (3.18%)
Dyspnoea Exertional	23 (2.92%)
Mitral Valve Disease	23 (2.92%)
Aortic Valve Disease	21 (2.67%)
Cardiac Valve Disease	17 (2.16%)
Tricuspid Valve Incompetence	16 (2.03%)
Tricuspid Valve Disease	13 (1.65%)
Hepatic Cirrhosis	11 (1.4%)
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Pulmonary Hypertension	11 (1.4%)
Chest Pain	10 (1.27%)
Ejection Fraction Decreased	10 (1.27%)
Fatigue	10 (1.27%)
Myocardial Infarction	9 (1.14%)
Pancreatitis Acute	9 (1.14%)
Hypertension	8 (1.02%)
Malaise	8 (1.02%)
Papilloedema	8 (1.02%)
Renal Failure Acute	7 (.89%)
Visual Acuity Reduced	7 (.89%)
Arrhythmia	6 (.76%)
Asthenia	6 (.76%)
Bradycardia	6 (.76%)
Diarrhoea	6 (.76%)
Dizziness	6 (.76%)
Hyponatraemia	6 (.76%)
Mitral Valve Stenosis	6 (.76%)
Pruritus	6 (.76%)
Anaemia	5 (.64%)
Bronchitis	5 (.64%)
Cardiac Failure	5 (.64%)
Epistaxis	5 (.64%)
Hypothermia	5 (.64%)
Interstitial Lung Disease	5 (.64%)
Oedema Peripheral	5 (.64%)
Pleural Effusion	5 (.64%)
Pulmonary Embolism	5 (.64%)
Ventricular Hypokinesia	5 (.64%)
Aortic Stenosis	4 (.51%)
Chronic Obstructive Pulmonary Disea...	4 (.51%)
Gait Disturbance	4 (.51%)
Left Ventricular Failure	4 (.51%)
Pericarditis	4 (.51%)
Altered State Of Consciousness	3 (.38%)
Arteriosclerosis Coronary Artery	3 (.38%)
Blood Creatinine Increased	3 (.38%)
Cardiac Murmur	3 (.38%)
Death	3 (.38%)
Hepatic Neoplasm Malignant	3 (.38%)
Hypoglycaemia	3 (.38%)
Left Atrial Dilatation	3 (.38%)
Left Ventricular Hypertrophy	3 (.38%)
Off Label Use	3 (.38%)
Proteinuria	3 (.38%)
Pulmonary Valve Disease	3 (.38%)
Tachycardia	3 (.38%)
Ventricular Extrasystoles	3 (.38%)
Weight Increased	3 (.38%)
Acute Generalised Exanthematous Pus...	2 (.25%)
Anorexia	2 (.25%)
Aortic Valve Replacement	2 (.25%)
Arterial Disorder	2 (.25%)
Arthralgia	2 (.25%)
Ascites	2 (.25%)
Atelectasis	2 (.25%)
Blood Glucose Increased	2 (.25%)
Cardiac Disorder	2 (.25%)
Condition Aggravated	2 (.25%)
Cough	2 (.25%)
Deep Vein Thrombosis	2 (.25%)
Dehydration	2 (.25%)
Depression	2 (.25%)
Dizziness Postural	2 (.25%)
Drug Exposure During Pregnancy	2 (.25%)
Duodenal Ulcer Perforation	2 (.25%)
Dyspnoea At Rest	2 (.25%)
General Physical Health Deteriorati...	2 (.25%)
Headache	2 (.25%)
Heart Valve Incompetence	2 (.25%)
Hepatojugular Reflux	2 (.25%)
Hyperkalaemia	2 (.25%)
Iatrogenic Injury	2 (.25%)
Insomnia	2 (.25%)
Ketonuria	2 (.25%)
Left Ventricular Dysfunction	2 (.25%)
Leukocytosis	2 (.25%)
Leukoencephalopathy	2 (.25%)
Mitral Valve Replacement	2 (.25%)
Nausea	2 (.25%)
Nephritis Allergic	2 (.25%)
Normal Pressure Hydrocephalus	2 (.25%)
Pemphigoid	2 (.25%)
Portal Hypertension	2 (.25%)
Pulmonary Arterial Pressure Increas...	2 (.25%)
Radiation Pericarditis	2 (.25%)
Rash Erythematous	2 (.25%)
Rash Maculo-papular	2 (.25%)
Rash Pustular	2 (.25%)
Sinus Tachycardia	2 (.25%)

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

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

Cardiac Valve	206 (26.18%)
Pulmonary Vascular	65 (8.26%)
Respiratory	55 (6.99%)
Cardiac Arrhythmias	25 (3.18%)
Epidermal And Dermal Conditions	24 (3.05%)
Cardiac And Vascular Investigations	23 (2.92%)
Myocardial	17 (2.16%)
Neurological	16 (2.03%)
Hepatic And Hepatobiliary	15 (1.91%)
Coronary Artery	14 (1.78%)
Exocrine Pancreas Conditions	12 (1.52%)
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Heart Failures	12 (1.52%)
Infections - Pathogen Unspecified	12 (1.52%)
Electrolyte And Fluid Balance Condi...	10 (1.27%)
Lower Respiratory Tract Disorders	10 (1.27%)
Anemias Nonhemolytic And Marrow Dep...	8 (1.02%)
Arteriosclerosis, Stenosis, Vascula...	8 (1.02%)
Ocular Structural Change, Deposit A...	8 (1.02%)
Renal Disorders	8 (1.02%)
Vascular Hypertensive	8 (1.02%)
Urinary Tract Signs	7 (.89%)
Vision	7 (.89%)
Bronchial Disorders	6 (.76%)
Gastrointestinal Motility And Defec...	6 (.76%)
Body Temperature Conditions	5 (.64%)
Physical Examination Topics	5 (.64%)
Pleural	5 (.64%)
Upper Respiratory Tract Disorders	5 (.64%)
Cardiac Therapeutic Procedures	4 (.51%)
Fatal Outcomes	4 (.51%)
Hematology Investigations	4 (.51%)
Metabolic, Nutritional And Blood Ga...	4 (.51%)
Nephropathies	4 (.51%)
Pericardial	4 (.51%)
Vascular	4 (.51%)
Water, Electrolyte And Mineral	4 (.51%)
Appetite And General Nutritional	3 (.38%)
Bacterial Infectious	3 (.38%)
Cardiac Disorder Signs	3 (.38%)
Encephalopathies	3 (.38%)
Glucose Metabolism Disorders	3 (.38%)
Hepatobiliary Neoplasms Malignant A...	3 (.38%)
Increased Intracranial Pressure And...	3 (.38%)
Movement Disorders	3 (.38%)
Renal And Urinary Tract Investigati...	3 (.38%)
Therapeutic Procedures And Supporti...	3 (.38%)
White Blood Cell	3 (.38%)
Anxiety Disorders	2 (.25%)
Cardiac And Vascular Disorders Cong...	2 (.25%)
Chemical Injury And Poisoning	2 (.25%)
Depressed Mood Disorders	2 (.25%)
Embolism And Thrombosis	2 (.25%)
Fungal Infectious	2 (.25%)
Gastrointestinal Signs	2 (.25%)
Gastrointestinal Stenosis And Obstr...	2 (.25%)
Gastrointestinal Ulceration And Per...	2 (.25%)
Headaches	2 (.25%)
Injuries	2 (.25%)
Injuries By Physical Agents	2 (.25%)
Joint	2 (.25%)
Leukemias	2 (.25%)
Lipid Analyses	2 (.25%)
Peritoneal And Retroperitoneal Cond...	2 (.25%)
Procedural And Device Related Injur...	2 (.25%)
Sleep Disorders	2 (.25%)
Structural Brain	2 (.25%)
Toxicology And Therapeutic Drug Mon...	2 (.25%)
Allergic Conditions	1 (.13%)
Angiedema And Urticaria	1 (.13%)
Bone, Calcium, Magnesium And Phosph...	1 (.13%)
Congenital And Hereditary	1 (.13%)
Developmental	1 (.13%)
Endocardial	1 (.13%)
Endocrine Gland Therapeutic Procedu...	1 (.13%)
Endocrine Neoplasms Malignant And U...	1 (.13%)
Eye Disorders Congenital	1 (.13%)
Gastrointestinal	1 (.13%)
Immunology And Allergy	1 (.13%)
Inner Ear And Viiith Cranial Nerve	1 (.13%)
Investigations, Imaging And Histopa...	1 (.13%)
Manic And Bipolar Mood Disorders	1 (.13%)
Medication Errors	1 (.13%)
Metabolism	1 (.13%)
Microbiology And Serology	1 (.13%)
Muscle	1 (.13%)
Neonatal And Perinatal Conditions	1 (.13%)
Psychiatric	1 (.13%)
Psychiatric And Behavioural Symptom...	1 (.13%)
Respiratory And Pulmonary Investiga...	1 (.13%)
Skin Vascular Abnormalities	1 (.13%)
Suicidal And Self-injurious Behavio...	1 (.13%)
Therapeutic And Nontherapeutic Effe...	1 (.13%)
Vascular Inflammations	1 (.13%)
Vascular Therapeutic Procedures	1 (.13%)
Viral Infectious	1 (.13%)

Share/Embed Graph Export Data

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