XIAFLEX

Xiaflex Adverse Events Reported to the FDA Over Time

How are Xiaflex adverse event reports trending over time?

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

Most Common Xiaflex Adverse Events Reported to the FDA

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

Laceration	77 (8.29%)
Oedema Peripheral	74 (7.97%)
Contusion	70 (7.53%)
Drug Ineffective	37 (3.98%)
Pain In Extremity	29 (3.12%)
Lymphadenopathy	24 (2.58%)
Injection Site Haematoma	20 (2.15%)
Swelling	20 (2.15%)
Injection Site Pain	17 (1.83%)
Skin Graft	17 (1.83%)
Blood Blister	14 (1.51%)
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Pain	14 (1.51%)
Tenderness	14 (1.51%)
Tendon Rupture	14 (1.51%)
Axillary Pain	13 (1.4%)
Injection Site Swelling	12 (1.29%)
Ecchymosis	11 (1.18%)
Skin Laceration	10 (1.08%)
Erythema	9 (.97%)
Lymph Node Pain	9 (.97%)
Hypersensitivity	8 (.86%)
Hypoaesthesia	7 (.75%)
Incorrect Dose Administered	7 (.75%)
Arthralgia	6 (.65%)
Condition Aggravated	6 (.65%)
Dizziness	6 (.65%)
Haematoma	6 (.65%)
Musculoskeletal Stiffness	6 (.65%)
Discomfort	5 (.54%)
Disease Progression	5 (.54%)
Disease Recurrence	5 (.54%)
Drug Administration Error	5 (.54%)
Dyspnoea	5 (.54%)
Inappropriate Schedule Of Drug Admi...	5 (.54%)
Lymphangitis	5 (.54%)
Pruritus	5 (.54%)
Skin Discolouration	5 (.54%)
Blister	4 (.43%)
Fatigue	4 (.43%)
Hepatitis C	4 (.43%)
Injection Site Vesicles	4 (.43%)
Joint Range Of Motion Decreased	4 (.43%)
Loss Of Consciousness	4 (.43%)
Lymphadenitis	4 (.43%)
Medication Error	4 (.43%)
Road Traffic Accident	4 (.43%)
Vomiting	4 (.43%)
Wrong Technique In Drug Usage Proce...	4 (.43%)
Aortic Dissection	3 (.32%)
Asthenia	3 (.32%)
Burning Sensation	3 (.32%)
Cardio-respiratory Arrest	3 (.32%)
Cerebrovascular Accident	3 (.32%)
Chest Pain	3 (.32%)
Gastrinoma	3 (.32%)
Haemorrhage	3 (.32%)
Hiatus Hernia	3 (.32%)
Hypertensive Crisis	3 (.32%)
Injection Site Reaction	3 (.32%)
Multiple Injuries	3 (.32%)
Myalgia	3 (.32%)
No Adverse Event	3 (.32%)
Oesophageal Carcinoma	3 (.32%)
Oesophageal Stenosis	3 (.32%)
Procedural Complication	3 (.32%)
Pyrexia	3 (.32%)
Skin Lesion	3 (.32%)
Urticaria	3 (.32%)
Weight Decreased	3 (.32%)
Accidental Death	2 (.22%)
Accidental Exposure	2 (.22%)
Alanine Aminotransferase Increased	2 (.22%)
Anxiety	2 (.22%)
Aortic Aneurysm Rupture	2 (.22%)
Arthropathy	2 (.22%)
Aspartate Aminotransferase Increase...	2 (.22%)
Atrial Fibrillation	2 (.22%)
Blood Glucose Increased	2 (.22%)
Blood Pressure Systolic Increased	2 (.22%)
Carpal Tunnel Syndrome	2 (.22%)
Cervical Spinal Stenosis	2 (.22%)
Complex Regional Pain Syndrome	2 (.22%)
Confusional State	2 (.22%)
Cough	2 (.22%)
Cubital Tunnel Syndrome	2 (.22%)
Dermal Cyst	2 (.22%)
Dyskinesia	2 (.22%)
Haemoglobin Decreased	2 (.22%)
Hand Fracture	2 (.22%)
Heart Rate Irregular	2 (.22%)
Impaired Healing	2 (.22%)
Infection	2 (.22%)
Injection Site Haemorrhage	2 (.22%)
Injection Site Oedema	2 (.22%)
Injection Site Pruritus	2 (.22%)
Injury	2 (.22%)
Localised Oedema	2 (.22%)
Myocardial Infarction	2 (.22%)
Nerve Injury	2 (.22%)
Oesophagitis Ulcerative	2 (.22%)
Presyncope	2 (.22%)

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

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

Injuries	191 (20.56%)
Administration Site Reactions	68 (7.32%)
Epidermal And Dermal Conditions	50 (5.38%)
Musculoskeletal And Connective Tiss...	40 (4.31%)
Spleen, Lymphatic And Reticulendoth...	38 (4.09%)
Therapeutic And Nontherapeutic Effe...	37 (3.98%)
Neurological	29 (3.12%)
Medication Errors	27 (2.91%)
Skin And Subcutaneous Tissue Therap...	17 (1.83%)
Joint	13 (1.4%)
Skin Vascular Abnormalities	13 (1.4%)
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Allergic Conditions	9 (.97%)
Infections - Pathogen Unspecified	9 (.97%)
Vascular Hemorrhagic	9 (.97%)
Cardiac Arrhythmias	8 (.86%)
Procedural And Device Related Injur...	8 (.86%)
Respiratory	8 (.86%)
Aneurysms And Artery Dissections	7 (.75%)
Cardiac And Vascular Investigations	7 (.75%)
Gastrointestinal Signs	7 (.75%)
Hematology Investigations	6 (.65%)
Peripheral Neuropathies	6 (.65%)
Physical Examination Topics	6 (.65%)
Vascular	6 (.65%)
Central Nervous System Vascular	5 (.54%)
Metabolic, Nutritional And Blood Ga...	5 (.54%)
Tissue	5 (.54%)
Embolism And Thrombosis	4 (.43%)
Hepatobiliary	4 (.43%)
Tendon, Ligament And Cartilage	4 (.43%)
Vascular Hypertensive	4 (.43%)
Viral Infectious	4 (.43%)
Abdominal Hernias And Other Abdomin...	3 (.32%)
Angiedema And Urticaria	3 (.32%)
Bacterial Infectious	3 (.32%)
Body Temperature Conditions	3 (.32%)
Bone And Joint Injuries	3 (.32%)
Cutaneous Neoplasms Benign	3 (.32%)
Endocrine Neoplasms Malignant And U...	3 (.32%)
Fatal Outcomes	3 (.32%)
Gastrointestinal Neoplasms Malignan...	3 (.32%)
Gastrointestinal Stenosis And Obstr...	3 (.32%)
Gastrointestinal Ulceration And Per...	3 (.32%)
Movement Disorders	3 (.32%)
Muscle	3 (.32%)
Musculoskeletal And Connective Tiss...	3 (.32%)
Anxiety Disorders	2 (.22%)
Bone And Joint Therapeutic Procedur...	2 (.22%)
Cardiac Disorder Signs	2 (.22%)
Coronary Artery	2 (.22%)
Deliria	2 (.22%)
Gastrointestinal Vascular Condition...	2 (.22%)
Inner Ear And Viiith Cranial Nerve	2 (.22%)
Myocardial	2 (.22%)
Pulmonary Vascular	2 (.22%)
Acid-base	1 (.11%)
Arteriosclerosis, Stenosis, Vascula...	1 (.11%)
Benign Neoplasms Gastrointestinal	1 (.11%)
Bone Disorders	1 (.11%)
Breast	1 (.11%)
Chemical Injury And Poisoning	1 (.11%)
Cranial Nerve Disorders	1 (.11%)
Decreased And Nonspecific Blood Pre...	1 (.11%)
Disturbances In Thinking	1 (.11%)
Diverticular	1 (.11%)
Electrolyte And Fluid Balance Condi...	1 (.11%)
Gallbladder	1 (.11%)
Gastrointestinal Conditions	1 (.11%)
Gastrointestinal Inflammatory Condi...	1 (.11%)
Glucose Metabolism Disorders	1 (.11%)
Hearing	1 (.11%)
Heart Failures	1 (.11%)
Hepatic And Hepatobiliary	1 (.11%)
Hepatobiliary Neoplasms Malignant A...	1 (.11%)
Immunology And Allergy	1 (.11%)
Injuries By Physical Agents	1 (.11%)
Lifestyle Issues	1 (.11%)
Lower Respiratory Tract Disorders	1 (.11%)
Male Reproductive Tract Infections ...	1 (.11%)
Ocular Neuromuscular	1 (.11%)
Oral Soft Tissue Conditions	1 (.11%)
Pericardial	1 (.11%)
Pigmentation	1 (.11%)
Pleural	1 (.11%)
Product Quality Issues	1 (.11%)
Renal Disorders	1 (.11%)
Skin And Subcutaneous Tissue	1 (.11%)
Skin And Subcutaneous Tissue Disord...	1 (.11%)
Skin Appendage Conditions	1 (.11%)
Sleep Disorders	1 (.11%)
Therapeutic Procedures And Supporti...	1 (.11%)
Urinary Tract Signs	1 (.11%)
Vascular Inflammations	1 (.11%)
Vascular Therapeutic Procedures	1 (.11%)
Water, Electrolyte And Mineral	1 (.11%)

Share/Embed Graph Export Data

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