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Xiaflex (Collagenase Clostridium Histolyticum) - Side Effect Reports to FDA

 
 



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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