ACENOCOUMAROL

Acenocoumarol Adverse Events Reported to the FDA Over Time

How are Acenocoumarol adverse event reports trending over time?

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

Most Common Acenocoumarol Adverse Events Reported to the FDA

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

Drug Interaction	89 (6.6%)
International Normalised Ratio Incr...	58 (4.3%)
Renal Failure	36 (2.67%)
Anaemia	33 (2.45%)
Cardiogenic Shock	26 (1.93%)
Prothrombin Time Prolonged	21 (1.56%)
Overdose	17 (1.26%)
Gastrointestinal Haemorrhage	16 (1.19%)
Haematoma	14 (1.04%)
Death	13 (.96%)
Fall	13 (.96%)
	Show More
Hypotension	12 (.89%)
Loss Of Consciousness	12 (.89%)
Dyspnoea	11 (.82%)
Disorientation	10 (.74%)
Respiratory Failure	10 (.74%)
Activated Partial Thromboplastin Ti...	9 (.67%)
Cardiac Failure	9 (.67%)
Electrocardiogram Qt Prolonged	9 (.67%)
Haematuria	9 (.67%)
Haemoglobin Decreased	9 (.67%)
Pulmonary Embolism	9 (.67%)
Blood Creatinine Increased	8 (.59%)
Dizziness	8 (.59%)
Epistaxis	8 (.59%)
Haemoptysis	8 (.59%)
Ventricular Arrhythmia	8 (.59%)
Cardiac Tamponade	7 (.52%)
General Physical Health Deteriorati...	7 (.52%)
Haematemesis	7 (.52%)
Hyponatraemia	7 (.52%)
Melaena	7 (.52%)
Bradycardia	6 (.44%)
Cardio-respiratory Arrest	6 (.44%)
Electrocardiogram Qrs Complex Prolo...	6 (.44%)
Mydriasis	6 (.44%)
Renal Impairment	6 (.44%)
Skin Ulcer	6 (.44%)
Subdural Haematoma	6 (.44%)
Atrial Fibrillation	5 (.37%)
Blood Pressure Diastolic Decreased	5 (.37%)
Cerebral Haematoma	5 (.37%)
Coagulopathy	5 (.37%)
Dementia	5 (.37%)
Fatigue	5 (.37%)
Gastric Ulcer Haemorrhage	5 (.37%)
Intestinal Ischaemia	5 (.37%)
Lactic Acidosis	5 (.37%)
Leukocytosis	5 (.37%)
Multi-organ Failure	5 (.37%)
Myalgia	5 (.37%)
Shock	5 (.37%)
Torsade De Pointes	5 (.37%)
Ventricular Fibrillation	5 (.37%)
Vomiting	5 (.37%)
Alanine Aminotransferase Increased	4 (.3%)
Alopecia	4 (.3%)
Areflexia	4 (.3%)
Arrhythmia	4 (.3%)
Asthenia	4 (.3%)
Blood Lactate Dehydrogenase Increas...	4 (.3%)
Brain Oedema	4 (.3%)
Cerebral Haemorrhage	4 (.3%)
Condition Aggravated	4 (.3%)
Confusional State	4 (.3%)
Diarrhoea	4 (.3%)
Drug Toxicity	4 (.3%)
Ecchymosis	4 (.3%)
Haemodynamic Instability	4 (.3%)
Haemorrhage	4 (.3%)
Head Injury	4 (.3%)
Heart Rate Decreased	4 (.3%)
Hepatitis Cholestatic	4 (.3%)
Hyperkalaemia	4 (.3%)
Infection	4 (.3%)
Iron Deficiency Anaemia	4 (.3%)
Lung Disorder	4 (.3%)
Medication Error	4 (.3%)
Multiple Drug Overdose	4 (.3%)
Muscle Haemorrhage	4 (.3%)
Myocardial Infarction	4 (.3%)
Nausea	4 (.3%)
Pain	4 (.3%)
Pallor	4 (.3%)
Pemphigoid	4 (.3%)
Pericardial Haemorrhage	4 (.3%)
Rectal Haemorrhage	4 (.3%)
Rhabdomyolysis	4 (.3%)
Septic Shock	4 (.3%)
Subarachnoid Haemorrhage	4 (.3%)
Toxic Skin Eruption	4 (.3%)
Ventricular Tachycardia	4 (.3%)
Anuria	3 (.22%)
Arteritis	3 (.22%)
Aspartate Aminotransferase Increase...	3 (.22%)
Blood Alkaline Phosphatase Increase...	3 (.22%)
Blood Glucose Increased	3 (.22%)
Blood Urea Increased	3 (.22%)
Calciphylaxis	3 (.22%)
Cardiac Perforation	3 (.22%)
Decerebration	3 (.22%)

Share/Embed Graph Export Data

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

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

Hematology Investigations	123 (9.12%)
Therapeutic And Nontherapeutic Effe...	94 (6.97%)
Cardiac Arrhythmias	63 (4.67%)
Renal Disorders	50 (3.71%)
Respiratory	50 (3.71%)
Injuries	45 (3.34%)
Gastrointestinal Hemorrhages	44 (3.26%)
Anemias Nonhemolytic And Marrow Dep...	42 (3.11%)
Heart Failures	39 (2.89%)
Cardiac And Vascular Investigations	38 (2.82%)
Neurological	36 (2.67%)
	Show More
Medication Errors	34 (2.52%)
Central Nervous System Vascular	27 (2%)
Hepatic And Hepatobiliary	25 (1.85%)
Decreased And Nonspecific Blood Pre...	22 (1.63%)
Epidermal And Dermal Conditions	21 (1.56%)
Infections - Pathogen Unspecified	20 (1.48%)
Electrolyte And Fluid Balance Condi...	19 (1.41%)
Gastrointestinal Signs	19 (1.41%)
Vascular Hemorrhagic	18 (1.33%)
Muscle	17 (1.26%)
Deliria	16 (1.19%)
Fatal Outcomes	14 (1.04%)
Gastrointestinal Ulceration And Per...	14 (1.04%)
Skin Vascular Abnormalities	14 (1.04%)
Upper Respiratory Tract Disorders	14 (1.04%)
Renal And Urinary Tract Investigati...	13 (.96%)
White Blood Cell	13 (.96%)
Urinary Tract Signs	12 (.89%)
Coagulopathies And Bleeding Diathes...	11 (.82%)
Coronary Artery	11 (.82%)
Hepatobiliary	11 (.82%)
Pericardial	11 (.82%)
Pulmonary Vascular	10 (.74%)
Embolism And Thrombosis	9 (.67%)
Enzyme	9 (.67%)
Gastrointestinal Motility And Defec...	9 (.67%)
Vascular	9 (.67%)
Chemical Injury And Poisoning	8 (.59%)
Exocrine Pancreas Conditions	8 (.59%)
Gastrointestinal Vascular Condition...	8 (.59%)
Mental Impairment	7 (.52%)
Metabolic, Nutritional And Blood Ga...	7 (.52%)
Seizures	7 (.52%)
Toxicology And Therapeutic Drug Mon...	7 (.52%)
Cardiac Disorder Signs	6 (.44%)
Hematological And Lymphoid Tissue T...	6 (.44%)
Lower Respiratory Tract Disorders	6 (.44%)
Ocular Neuromuscular	6 (.44%)
Platelet	6 (.44%)
Skin And Subcutaneous Tissue	6 (.44%)
Abdominal Hernias And Other Abdomin...	5 (.37%)
Acid-base	5 (.37%)
Allergic Conditions	5 (.37%)
Bacterial Infectious	5 (.37%)
Bone And Joint Injuries	5 (.37%)
Administration Site Reactions	4 (.3%)
Bone, Calcium, Magnesium And Phosph...	4 (.3%)
Gastrointestinal Inflammatory Condi...	4 (.3%)
Glucose Metabolism Disorders	4 (.3%)
Increased Intracranial Pressure And...	4 (.3%)
Inner Ear And Viiith Cranial Nerve	4 (.3%)
Peripheral Neuropathies	4 (.3%)
Procedural And Device Related Injur...	4 (.3%)
Skin Appendage Conditions	4 (.3%)
Adrenal Gland	3 (.22%)
Appetite And General Nutritional	3 (.22%)
Arteriosclerosis, Stenosis, Vascula...	3 (.22%)
Benign Neoplasms Gastrointestinal	3 (.22%)
Central Nervous System Infections A...	3 (.22%)
Fungal Infectious	3 (.22%)
Gallbladder	3 (.22%)
Gastrointestinal Conditions	3 (.22%)
Headaches	3 (.22%)
Musculoskeletal And Connective Tiss...	3 (.22%)
Protein And Chemistry Analyses	3 (.22%)
Vascular Inflammations	3 (.22%)
Viral Infectious	3 (.22%)
Aneurysms And Artery Dissections	2 (.15%)
Anxiety Disorders	2 (.15%)
Autoimmune	2 (.15%)
Body Temperature Conditions	2 (.15%)
Cardiac Therapeutic Procedures	2 (.15%)
Depressed Mood Disorders	2 (.15%)
Disturbances In Thinking	2 (.15%)
Hearing	2 (.15%)
Iron And Trace Metal Metabolism	2 (.15%)
Joint	2 (.15%)
Lifestyle Issues	2 (.15%)
Movement Disorders	2 (.15%)
Nephropathies	2 (.15%)
Neurological, Special Senses And Ps...	2 (.15%)
Ocular Hemorrhages And Vascular	2 (.15%)
Peritoneal And Retroperitoneal Cond...	2 (.15%)
Prostatic Disorders	2 (.15%)
Respiratory And Mediastinal Neoplas...	2 (.15%)
Thyroid Gland	2 (.15%)
Vascular Hypertensive	2 (.15%)
Water, Electrolyte And Mineral	2 (.15%)
Aural	1 (.07%)
Bile Duct	1 (.07%)

Share/Embed Graph Export Data

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