This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Xiaflex and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (62)
Death (6)
Life Threatening Events (1)
Reports by Reaction Type
Tendon Rupture (8),
Laceration (8),
Contusion (7),
Skin Graft (7),
Oedema Peripheral (6),
Swelling (6),
Disease Recurrence (5),
Drug Ineffective (4),
Hepatitis C (4),
Injection Site Haematoma (4),
Disease Progression (4),
Loss of Consciousness (4)
Below are a few examples of reports where side effects / adverse reactions may be related to Xiaflex. For a complete list or a specific selection of reports, please use the links above.
Possible Xiaflex side effects in male
Reported by a physician from United States on 2012-08-01
Patient: male
Reactions: Skin Wound, Skin Graft, Skin Exfoliation
Drug(s) suspected as cause:
Xiaflex
Possible Xiaflex side effects in 61 year old female
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: 61 year old female, weighing 65.8 kg (144.7 pounds)
Reactions: Contusion, Pain in Extremity, Skin Graft, Drug Ineffective, Injection Site Pain, Blood Blister, Burning Sensation, Lymph Node Pain, Burns Third Degree, Oedema Peripheral, Scar
Drug(s) suspected as cause:
Xiaflex
Dosage: 1 in 1 d, intralesional; 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2010-01-01
End date: 2010-01-01
Xiaflex
Dosage: 1 in 1 d, intralesional; 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2010-06-30
End date: 2010-06-30
Anesthetics, Local (Anesthetics, Local)
Dosage: topical
Administration route: Topical
Start date: 2010-07-01
End date: 2010-08-01
Other drugs received by patient: Nexium; Mysoline; Vitamins (Vitamins Nos)
Possible Xiaflex side effects in 84 year old male
Reported by a physician from Finland on 2012-08-01
Patient: 84 year old male
Reactions: Lymphadenopathy, Haematoma
Drug(s) suspected as cause:
Xiaflex
Other drugs received by patient: Aspirin; Prasterone; Avodart
Possible Xiaflex side effects in 54 year old male
Reported by a physician from United States on 2012-07-23
Patient: 54 year old male
Reactions: Dermal Cyst, Laceration
Drug(s) suspected as cause:
Xiaflex
Dosage: 0.58 mg, 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2012-04-11
End date: 2012-04-11
Anesthetics, Local (Anesthetics, Local)
Dosage: 1 in 1 d, intralesional
Indication: Anaesthesia
Start date: 2012-04-11
End date: 2012-04-11
Possible Xiaflex side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-07-18
Patient: 59 year old male
Reactions: Fatigue, Hepatitis C, Disease Recurrence, Asthenia, Disease Progression
Drug(s) suspected as cause:
Xiaflex
Dosage: 0.58 mg, 1 in 1 d, intralesional,0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-08-18
End date: 2011-08-18
Xiaflex
Dosage: 0.58 mg, 1 in 1 d, intralesional,0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-07-14
End date: 2011-07-14
Xiaflex
Dosage: 0.58 mg, 1 in 1 d, intralesional,0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-09-21
End date: 2011-09-21
Xiaflex
Dosage: 0.58 mg, 1 in 1 d, intralesional,0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-10-25
End date: 2011-10-25
Possible Xiaflex side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-12
Patient: male, weighing 95.3 kg (209.6 pounds)
Reactions: Weight Increased, Neuropathy Peripheral, Disease Recurrence, Pain in Extremity, Dupuytren's Contracture
Drug(s) suspected as cause:
Xiaflex
Possible Xiaflex side effects in 81 year old female
Reported by a consumer/non-health professional from United States on 2012-07-12
Patient: 81 year old female, weighing 58.5 kg (128.7 pounds)
Reactions: Drug Ineffective, Atrial Fibrillation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xiaflex
Other drugs received by patient: Levoxyl
Possible Xiaflex side effects in 55 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-12
Patient: 55 year old male
Reactions: Weight Decreased, Hiatus Hernia, Vomiting, Oesophagitis Ulcerative, Oesophageal Carcinoma, Oesophageal Stenosis, Haemoglobin Decreased, Gastrinoma, Chemical Injury
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xiaflex
Other drugs received by patient: Imovane (Zopiclone); Havlane (Loprazolam Mesilate); Stablon (Tianeptine Sodium)
Possible Xiaflex side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-07-12
Patient: 59 year old male
Reactions: Fatigue, Hepatitis C, Asthenia, Disease Progression
Drug(s) suspected as cause:
Xiaflex
Dosage: see image, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-09-21
End date: 2011-09-21
Xiaflex
Dosage: see image, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-07-14
End date: 2011-07-14
Xiaflex
Dosage: see image, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-08-18
End date: 2011-08-18
Xiaflex
Dosage: see image, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-10-25
End date: 2011-10-25
Possible Xiaflex side effects in male
Reported by a physician from United States on 2012-07-12
Patient: male
Reactions: Localised Infection, Laceration, Dermal Cyst
Drug(s) suspected as cause:
Xiaflex
Possible Xiaflex side effects in 75 year old male
Reported by a consumer/non-health professional from United States on 2012-07-06
Patient: 75 year old male, weighing 79.4 kg (174.6 pounds)
Reactions: Vascular Graft, Drug Ineffective, Gangrene, TOE Amputation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xiaflex
Dosage: ;bid;top
Administration route: Topical
Indication: Wound
Start date: 2010-01-01
Xiaflex
Dosage: ;bid;top
Administration route: Topical
Indication: Wound
Start date: 2012-06-01
Other drugs received by patient: Furosemide; Novolog; Lantus; Silver Gel; Carvedilol; Coumadin; Enalapril Maleate; Lanoxin
Possible Xiaflex side effects in 55 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-03
Patient: 55 year old male
Reactions: Weight Decreased, Hiatus Hernia, Vomiting, Dysphagia, Oesophagitis Ulcerative, Oesophageal Carcinoma, Oesophageal Stenosis, Haemoglobin Decreased, Gastrinoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Stablon (Tianeptine Sodium)
Dosage: 3 in 1 d, oral
Administration route: Oral
Indication: Depression
Start date: 2006-01-01
Xiaflex
Dosage: 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-11-28
End date: 2011-11-28
Other drugs received by patient: Imovane (Zopiclone); Havlane (Loprazolam Mesilate)
Possible Xiaflex side effects in
Reported by a individual with unspecified qualification from Spain on 2012-07-03
Patient:
Reactions: Fatigue, Disease Recurrence, Hepatitis C, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Basophil Percentage Increased, Disease Progression
Drug(s) suspected as cause:
Xiaflex
Dosage: 0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-07-14
End date: 2011-07-14
Xiaflex
Dosage: 0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-09-21
End date: 2011-09-21
Possible Xiaflex side effects in 67 year old female
Reported by a physician from Austria on 2012-06-22
Patient: 67 year old female
Reactions: Swelling, Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xiaflex
Possible Xiaflex side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-13
Patient: female
Reactions: Pneumonia, Diabetes Mellitus, Drug Ineffective, Wound Complication, Erythema, Cardiomyopathy, Lung Disorder, Impaired Healing, Cardiac Failure Congestive
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Xiaflex
Possible Xiaflex side effects in
Reported by a physician from Finland on 2012-06-08
Patient:
Reactions: Skin Discolouration
Drug(s) suspected as cause:
Xiaflex
Possible Xiaflex side effects in 55 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-08
Patient: 55 year old male
Reactions: Weight Decreased, Vomiting, Lymphadenopathy, Hiatus Hernia, Oesophagitis, Gastrinoma, Oesophageal Carcinoma, Oesophageal Ulcer, Oesophageal Stenosis, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xiaflex
Dosage: 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-11-28
End date: 2011-11-28
Stablon (Tianeptine Sodium)
Dosage: 3 in 1 d, oral
Administration route: Oral
Indication: Depression
Start date: 2006-01-01
Other drugs received by patient: Imovane (Zopiclone); Havlane (Loprazolam Mesilate)
Possible Xiaflex side effects in 58 year old male
Reported by a physician from United States on 2012-06-05
Patient: 58 year old male
Reactions: Haemorrhagic Stroke
Adverse event resulted in: death
Drug(s) suspected as cause:
Xiaflex
Other drugs received by patient: Zolpidem; Numoisyn (Sorbitol); Pilocarpine; Metfformin Hydrochloride; Simvastatin; Endocet (Paracetamol); Quinapril HCL; Omeprazole; Amlodipine
Possible Xiaflex side effects in 66 year old male
Reported by a physician from United States on 2012-05-31
Patient: 66 year old male
Reactions: Skin Graft, Injection Site Haematoma, Laceration, Excessive Granulation Tissue
Drug(s) suspected as cause:
Xiaflex
Other drugs received by patient: Coumadin; Allopurinol; Simvastatin; Atrovent; Hydrochlorothiazide
Possible Xiaflex side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-05-25
Patient: 59 year old male
Reactions: Hepatitis C, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Clostridial Infection, Disease Progression
Drug(s) suspected as cause:
Xiaflex
Dosage: 0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-10-25
End date: 2011-10-25
Xiaflex
Dosage: 0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-07-14
End date: 2011-07-14
Xiaflex
Dosage: 0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional, 0.58 mg, 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-09-21
End date: 2011-09-21
Possible Xiaflex side effects in 79 year old female
Reported by a physician from United States on 2012-05-23
Patient: 79 year old female, weighing 80.7 kg (177.6 pounds)
Reactions: Soft Tissue Disorder, Swelling, Ecchymosis, Myocardial Infarction, Discomfort
Adverse event resulted in: death
Drug(s) suspected as cause:
Xiaflex
Other drugs received by patient: Diltiazem HCL; Preservision EYE Vitamin and Mineral (Tetryzoline Hydrochloride); Fish OIL Omega 3 (Eicosapentaenoic Acid); Sertraline HCL (Sertraline Hydrochloride); Lidocaine; Coumadin; Lutein (Xantofyl); Vitamin D; Levothyroid (Levothyroxine); Metropolol (Metoprolol); Marcaine; Digoxin; Multivitamin; Magnesium Oxide (Magnsium Oxide); Calcium 600+d (Ergocalciferol)
Possible Xiaflex side effects in 58 year old male
Reported by a physician from United States on 2012-05-23
Patient: 58 year old male
Reactions: Cerebrovascular Accident
Adverse event resulted in: death
Drug(s) suspected as cause:
Xiaflex
Other drugs received by patient: Omeprazole; Metformin HCL; Zolpidem; Quinapril HCL; Simvastatin; Endocet (Paracetamol); Amlodipine; Pilocarpine; Numoisyn (Sorbitol)
Possible Xiaflex side effects in 83 year old female
Reported by a physician from Germany on 2012-05-11
Patient: 83 year old female
Reactions: Colonic Polyp, Inguinal Mass, Diverticulum, Mass, Osteoporosis, Interstitial Lung Disease, Kyphosis, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xiaflex
Possible Xiaflex side effects in 70 year old male
Reported by a consumer/non-health professional from United States on 2012-05-07
Patient: 70 year old male
Reactions: Disease Recurrence, Hepatic Neoplasm Malignant, Muscle Contracture, Lentigo
Drug(s) suspected as cause:
Xiaflex
Possible Xiaflex side effects in male
Reported by a individual with unspecified qualification from United States on 2012-04-21
Patient: male
Reactions: Cerebrovascular Accident, Aneurysm
Drug(s) suspected as cause:
Xiaflex
Possible Xiaflex side effects in 53 year old male
Reported by a physician from United States on 2012-04-13
Patient: 53 year old male
Reactions: Skin Graft, Laceration, Procedural Complication
Drug(s) suspected as cause:
Xiaflex
Dosage: 0.58 mg, 1 in 1 d, intralesional; 1 in 1 d, intralesional; 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2012-03-21
End date: 2012-03-21
Xiaflex
Dosage: 0.58 mg, 1 in 1 d, intralesional; 1 in 1 d, intralesional; 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2011-01-01
End date: 2011-01-01
Xiaflex
Dosage: 0.58 mg, 1 in 1 d, intralesional; 1 in 1 d, intralesional; 1 in 1 d, intralesional
Indication: Dupuytren's Contracture
Start date: 2012-02-01
End date: 2012-02-01
Other drugs received by patient: Prilosec; Viarga (Sildenafil Citrate)
Possible Xiaflex side effects in 70 year old female
Reported by a physician from United States on 2012-04-13
Patient: 70 year old female, weighing 54.4 kg (119.7 pounds)
Reactions: Medical Device Complication, Contusion, Laceration, Condition Aggravated, Device Dislocation, Arthralgia, Oedema Peripheral, Tenderness, Cervical Spinal Stenosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xiaflex
Other drugs received by patient: Ultram (Tamadol Hydrochloride); Aspirin; Glucosamine (Glucosamine); Calcium Carbonate; Premarin (Estogrens Conjugated); Extra Strength Tylenol; Anesthetics, Local (Anesthetics, Local); Simvastatin
Possible Xiaflex side effects in 81 year old male
Reported by a physician from Sweden on 2012-03-27
Patient: 81 year old male
Reactions: Skin Graft, Skin Lesion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xiaflex
Possible Xiaflex side effects in 55 year old female
Reported by a physician from Germany on 2012-03-27
Patient: 55 year old female
Reactions: Osteoarthritis, Tendon Rupture, Joint Range of Motion Decreased
Drug(s) suspected as cause:
Xiaflex
Other drugs received by patient: Acetylsalicylic Acid SRT
Possible Xiaflex side effects in 70 year old female
Reported by a physician from United States on 2012-03-26
Patient: 70 year old female, weighing 54.4 kg (119.7 pounds)
Reactions: Contusion, Arthralgia, Pain in Extremity, Oedema Peripheral, Condition Aggravated, Laceration, Cervical Spinal Stenosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xiaflex
Other drugs received by patient: Anesthetics, Local (Anesthetics, Local); Ultram; Simvastatin; Premarin; Extra Strength Tylenol
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