KOGENATE FS

Kogenate Fs Adverse Events Reported to the FDA Over Time

How are Kogenate Fs adverse event reports trending over time?

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

Most Common Kogenate Fs Adverse Events Reported to the FDA

What are the most common Kogenate Fs adverse events reported to the FDA?

Anti Factor Viii Antibody Positive	55 (7.74%)
Factor Viii Inhibition	53 (7.45%)
Haematoma	32 (4.5%)
Haemorrhage	29 (4.08%)
Drug Ineffective	28 (3.94%)
Pyrexia	20 (2.81%)
Haemarthrosis	14 (1.97%)
Haematuria	12 (1.69%)
Hepatic Enzyme Increased	12 (1.69%)
Joint Injury	12 (1.69%)
Hepatitis C Antibody Positive	11 (1.55%)
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Alanine Aminotransferase Increased	10 (1.41%)
Blood Glucose Increased	10 (1.41%)
Fatigue	10 (1.41%)
Pain In Extremity	10 (1.41%)
Somnolence	10 (1.41%)
Splenomegaly	10 (1.41%)
Abdominal Pain	9 (1.27%)
Abdominal Pain Upper	8 (1.13%)
Aspartate Aminotransferase Increase...	8 (1.13%)
Biliary Dilatation	8 (1.13%)
Blood Alkaline Phosphatase Increase...	8 (1.13%)
Chest Pain	8 (1.13%)
Cholecystitis Acute	8 (1.13%)
Hallucination	8 (1.13%)
Hallucination, Visual	8 (1.13%)
Hepatic Steatosis	8 (1.13%)
Hepatomegaly	8 (1.13%)
Intermittent Claudication	8 (1.13%)
Nerve Compression	8 (1.13%)
Pain	8 (1.13%)
Pericardial Haemorrhage	8 (1.13%)
Therapeutic Response Decreased	8 (1.13%)
Arthralgia	7 (.98%)
Cholecystitis	6 (.84%)
Disease Recurrence	6 (.84%)
Joint Effusion	6 (.84%)
Medication Error	6 (.84%)
Melaena	6 (.84%)
No Adverse Event	6 (.84%)
Muscle Haemorrhage	5 (.7%)
Swelling Face	5 (.7%)
C-reactive Protein Increased	4 (.56%)
Drug Interaction	4 (.56%)
Eye Swelling	4 (.56%)
Hypersensitivity	4 (.56%)
Incorrect Dose Administered	4 (.56%)
Joint Swelling	4 (.56%)
Kidney Rupture	4 (.56%)
Pneumonia	4 (.56%)
Rash Generalised	4 (.56%)
Unevaluable Event	4 (.56%)
Viral Hepatitis Carrier	4 (.56%)
Weight Increased	4 (.56%)
White Blood Cell Count Increased	4 (.56%)
Wrong Technique In Drug Usage Proce...	4 (.56%)
Infusion Related Reaction	3 (.42%)
Mass	3 (.42%)
Nausea	3 (.42%)
Otitis Media	3 (.42%)
Paraesthesia	3 (.42%)
Unresponsive To Stimuli	3 (.42%)
Vomiting	3 (.42%)
Accident	2 (.28%)
Alopecia	2 (.28%)
Anaphylactic Reaction	2 (.28%)
Asthenia	2 (.28%)
Bile Duct Obstruction	2 (.28%)
Body Temperature Increased	2 (.28%)
Cerebral Haemorrhage	2 (.28%)
Chest Discomfort	2 (.28%)
Chills	2 (.28%)
Coagulation Factor Viii Level Decre...	2 (.28%)
Convulsion	2 (.28%)
Device Related Infection	2 (.28%)
Drug Administration Error	2 (.28%)
Dyspnoea	2 (.28%)
Epistaxis	2 (.28%)
Extravasation	2 (.28%)
Fall	2 (.28%)
Flatulence	2 (.28%)
Gingival Bleeding	2 (.28%)
Hypoaesthesia	2 (.28%)
Inflammation	2 (.28%)
Infusion Site Pruritus	2 (.28%)
Infusion Site Reaction	2 (.28%)
Joint Range Of Motion Decreased	2 (.28%)
Ligament Operation	2 (.28%)
Limb Injury	2 (.28%)
Malaise	2 (.28%)
Mental Disorder	2 (.28%)
Oedema Peripheral	2 (.28%)
Oxygen Saturation Decreased	2 (.28%)
Peripheral Coldness	2 (.28%)
Plasmin Inhibitor Increased	2 (.28%)
Postoperative Fever	2 (.28%)
Procedural Complication	2 (.28%)
Psychological Factor Affecting Medi...	2 (.28%)
Renal Injury	2 (.28%)
Seroconversion Test Positive	2 (.28%)
Soft Tissue Haemorrhage	2 (.28%)

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

What are the most common Kogenate Fs adverse events reported to the FDA?

Hematology Investigations	63 (8.86%)
Vascular Hemorrhagic	61 (8.58%)
Coagulopathies And Bleeding Diathes...	53 (7.45%)
Therapeutic And Nontherapeutic Effe...	42 (5.91%)
Joint	34 (4.78%)
Hepatobiliary	30 (4.22%)
Gastrointestinal Signs	25 (3.52%)
Neurological	21 (2.95%)
Body Temperature Conditions	20 (2.81%)
Disturbances In Thinking	16 (2.25%)
Epidermal And Dermal Conditions	16 (2.25%)
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Hepatic And Hepatobiliary	16 (2.25%)
Medication Errors	16 (2.25%)
Bone And Joint Injuries	14 (1.97%)
Gallbladder	14 (1.97%)
Injuries	13 (1.83%)
Microbiology And Serology	13 (1.83%)
Infections - Pathogen Unspecified	12 (1.69%)
Metabolic, Nutritional And Blood Ga...	12 (1.69%)
Musculoskeletal And Connective Tiss...	12 (1.69%)
Urinary Tract Signs	12 (1.69%)
Arteriosclerosis, Stenosis, Vascula...	10 (1.41%)
Bile Duct	10 (1.41%)
Spleen, Lymphatic And Reticulendoth...	10 (1.41%)
Enzyme	8 (1.13%)
Pericardial	8 (1.13%)
Peripheral Neuropathies	8 (1.13%)
Administration Site Reactions	7 (.98%)
Allergic Conditions	6 (.84%)
Gastrointestinal Hemorrhages	6 (.84%)
Physical Examination Topics	6 (.84%)
Eye	5 (.7%)
Muscle	5 (.7%)
Ancillary Infectious Topics	4 (.56%)
Bone And Joint Therapeutic Procedur...	4 (.56%)
Procedural And Device Related Injur...	4 (.56%)
Protein And Chemistry Analyses	4 (.56%)
Psychiatric	4 (.56%)
Dental And Gingival Conditions	3 (.42%)
Tissue	3 (.42%)
Central Nervous System Vascular	2 (.28%)
Respiratory	2 (.28%)
Seizures	2 (.28%)
Skin Appendage Conditions	2 (.28%)
Upper Respiratory Tract Disorders	2 (.28%)
Angiedema And Urticaria	1 (.14%)
Blood And Lymphatic System Disorder...	1 (.14%)
Bronchial Disorders	1 (.14%)
Electrolyte And Fluid Balance Condi...	1 (.14%)
Headaches	1 (.14%)
Immunology And Allergy	1 (.14%)
Maternal Complications Of Pregnancy	1 (.14%)
Mood Disorders	1 (.14%)
Obstetric And Gynecological Therape...	1 (.14%)
Oral Soft Tissue Conditions	1 (.14%)
Renal Disorders	1 (.14%)
Skin And Subcutaneous Tissue	1 (.14%)
Therapeutic Procedures And Supporti...	1 (.14%)

Share/Embed Graph Export Data

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