REFLUDAN

Refludan Adverse Events Reported to the FDA Over Time

How are Refludan adverse event reports trending over time?

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

Most Common Refludan Adverse Events Reported to the FDA

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

Haemorrhage	28 (3.95%)
Heparin-induced Thrombocytopenia	22 (3.11%)
Deep Vein Thrombosis	20 (2.82%)
Renal Failure	16 (2.26%)
Disseminated Intravascular Coagulat...	15 (2.12%)
Activated Partial Thromboplastin Ti...	14 (1.98%)
Respiratory Failure	13 (1.84%)
Hypotension	12 (1.69%)
Loss Of Consciousness	12 (1.69%)
Cardio-respiratory Arrest	10 (1.41%)
Death	10 (1.41%)
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No Adverse Event	10 (1.41%)
Renal Failure Acute	10 (1.41%)
International Normalised Ratio Incr...	9 (1.27%)
Septic Shock	9 (1.27%)
Subdural Haemorrhage	9 (1.27%)
Coagulation Time Prolonged	8 (1.13%)
Coma	8 (1.13%)
Gangrene	8 (1.13%)
Leg Amputation	8 (1.13%)
Peripheral Ischaemia	8 (1.13%)
Thrombosis	8 (1.13%)
Vena Cava Thrombosis	8 (1.13%)
Anaphylactic Reaction	7 (.99%)
Angina Pectoris	7 (.99%)
Haemodialysis	7 (.99%)
Medication Error	7 (.99%)
Atrial Fibrillation	6 (.85%)
Bronchopulmonary Aspergillosis	6 (.85%)
Dialysis	6 (.85%)
Drug Interaction	6 (.85%)
Dyspnoea	6 (.85%)
Hepatic Haematoma	6 (.85%)
Multi-organ Failure	6 (.85%)
Thrombotic Thrombocytopenic Purpura	6 (.85%)
Abdominal Pain	5 (.71%)
Cardiac Tamponade	5 (.71%)
Cholangitis Sclerosing	5 (.71%)
Overdose	5 (.71%)
Post Procedural Haemorrhage	5 (.71%)
Pulmonary Oedema	5 (.71%)
Sepsis	5 (.71%)
Ventricular Fibrillation	5 (.71%)
Ventricular Tachycardia	5 (.71%)
Anaemia	4 (.56%)
Cardiac Arrest	4 (.56%)
Cerebral Infarction	4 (.56%)
Chest Discomfort	4 (.56%)
Confusional State	4 (.56%)
Drug Specific Antibody Present	4 (.56%)
Gastrointestinal Haemorrhage	4 (.56%)
Graft Thrombosis	4 (.56%)
Haematemesis	4 (.56%)
Lung Infiltration	4 (.56%)
Pericardial Effusion	4 (.56%)
Pleural Effusion	4 (.56%)
Primary Mediastinal Large B-cell Ly...	4 (.56%)
Prothrombin Level Decreased	4 (.56%)
Prothrombin Time Prolonged	4 (.56%)
Pulse Absent	4 (.56%)
Quadriplegia	4 (.56%)
Renal Impairment	4 (.56%)
Staphylococcal Sepsis	4 (.56%)
Thrombocytopenia	4 (.56%)
Vascular Insufficiency	4 (.56%)
Accidental Overdose	3 (.42%)
Aneurysm Ruptured	3 (.42%)
Cardiac Failure	3 (.42%)
Catheter Thrombosis	3 (.42%)
Cerebral Haemorrhage	3 (.42%)
Embolism	3 (.42%)
Haematoma	3 (.42%)
Haematuria	3 (.42%)
Haemoglobin Decreased	3 (.42%)
Hepatic Failure	3 (.42%)
Oedema Peripheral	3 (.42%)
Pharyngeal Oedema	3 (.42%)
Pulmonary Embolism	3 (.42%)
Subarachnoid Haemorrhage	3 (.42%)
Surgery	3 (.42%)
Urticaria	3 (.42%)
Wound Haemorrhage	3 (.42%)
Activated Partial Thromboplastin Ti...	2 (.28%)
Acute Respiratory Failure	2 (.28%)
Anaphylactic Shock	2 (.28%)
Anuria	2 (.28%)
Aortic Embolus	2 (.28%)
Aspiration	2 (.28%)
Blood Pressure Systolic Decreased	2 (.28%)
Brain Death	2 (.28%)
Cardiovascular Disorder	2 (.28%)
Chest Pain	2 (.28%)
Colon Cancer	2 (.28%)
Condition Aggravated	2 (.28%)
Convulsion	2 (.28%)
Depressed Level Of Consciousness	2 (.28%)
Dermatitis Exfoliative	2 (.28%)
Disease Progression	2 (.28%)
Drug Clearance Decreased	2 (.28%)
Erythema Of Eyelid	2 (.28%)
Eyelid Oedema	2 (.28%)

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

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

Hematology Investigations	49 (6.92%)
Embolism And Thrombosis	44 (6.21%)
Renal Disorders	35 (4.94%)
Vascular Hemorrhagic	35 (4.94%)
Cardiac Arrhythmias	32 (4.52%)
Platelet	32 (4.52%)
Respiratory	28 (3.95%)
Neurological	26 (3.67%)
Injuries	22 (3.11%)
Medication Errors	20 (2.82%)
Infections - Pathogen Unspecified	19 (2.68%)
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Central Nervous System Vascular	16 (2.26%)
Coagulopathies And Bleeding Diathes...	16 (2.26%)
Bacterial Infectious	15 (2.12%)
Procedural And Device Related Injur...	15 (2.12%)
Arteriosclerosis, Stenosis, Vascula...	13 (1.84%)
Decreased And Nonspecific Blood Pre...	13 (1.84%)
Hematological And Lymphoid Tissue T...	13 (1.84%)
Fatal Outcomes	12 (1.69%)
Allergic Conditions	10 (1.41%)
Coronary Artery	10 (1.41%)
Gastrointestinal Hemorrhages	10 (1.41%)
Lower Respiratory Tract Disorders	10 (1.41%)
Pericardial	9 (1.27%)
Bone And Joint Therapeutic Procedur...	8 (1.13%)
Therapeutic And Nontherapeutic Effe...	8 (1.13%)
Toxicology And Therapeutic Drug Mon...	8 (1.13%)
Administration Site Reactions	7 (.99%)
Cardiac And Vascular Investigations	7 (.99%)
Fungal Infectious	7 (.99%)
Gastrointestinal Signs	7 (.99%)
Hepatic And Hepatobiliary	7 (.99%)
Epidermal And Dermal Conditions	6 (.85%)
Therapeutic Procedures And Supporti...	6 (.85%)
Bile Duct	5 (.71%)
Cardiac Disorder Signs	5 (.71%)
Movement Disorders	5 (.71%)
Pleural	5 (.71%)
Pulmonary Vascular	5 (.71%)
Upper Respiratory Tract Disorders	5 (.71%)
Anemias Nonhemolytic And Marrow Dep...	4 (.56%)
Aneurysms And Artery Dissections	4 (.56%)
Deliria	4 (.56%)
Lymphomas Non-hodgkins B-cell	4 (.56%)
Ocular Infections, Irritations And ...	4 (.56%)
Angiedema And Urticaria	3 (.42%)
Heart Failures	3 (.42%)
Renal And Urinary Tract Investigati...	3 (.42%)
Spleen, Lymphatic And Reticulendoth...	3 (.42%)
Urinary Tract Signs	3 (.42%)
Appetite And General Nutritional	2 (.28%)
Bronchial Disorders	2 (.28%)
Gastrointestinal Inflammatory Condi...	2 (.28%)
Gastrointestinal Neoplasms Malignan...	2 (.28%)
Gastrointestinal Vascular Condition...	2 (.28%)
Hepatobiliary	2 (.28%)
Seizures	2 (.28%)
Vascular	2 (.28%)
Body Temperature Conditions	1 (.14%)
Bone, Calcium, Magnesium And Phosph...	1 (.14%)
Cardiac And Vascular Disorders Cong...	1 (.14%)
Cardiac Valve	1 (.14%)
Communication Disorders	1 (.14%)
Enzyme	1 (.14%)
Immunology And Allergy	1 (.14%)
Increased Intracranial Pressure And...	1 (.14%)
Metastases	1 (.14%)
Muscle	1 (.14%)
Neuromuscular	1 (.14%)
Peritoneal And Retroperitoneal Cond...	1 (.14%)
Respiratory Tract Therapeutic Proce...	1 (.14%)
Skin Appendage Conditions	1 (.14%)
Vision	1 (.14%)

Share/Embed Graph Export Data

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