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Xiaflex Side Effects

Generic Name: collagenase clostridium histolyticum

Note: This page contains side effects data for the generic drug collagenase clostridium histolyticum. It is possible that some of the dosage forms included below may not apply to the brand name Xiaflex.

It is possible that some side effects of Xiaflex may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to collagenase clostridium histolyticum: injection powder for solution

As well as its needed effects, collagenase clostridium histolyticum (the active ingredient contained in Xiaflex) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking collagenase clostridium histolyticum, check with your doctor or nurse immediately:

More common—Dupuytren's contracture
  • Bruising or bleeding at the injection site
  • swelling of the hands
  • tearing of the skin
More common—Peyronie's disease
  • Itching, pain, redness, swelling, or bruise of the penis
  • popping sound or sensation in an erect penis
Less common—Peyronie's disease
  • Decreased interest in sexual intercourse
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • painful sexual intercourse
Incidence not known—Dupuytren's contracture
  • Bone pain
  • lower back or side pain
  • painful, swollen joints

Some collagenase clostridium histolyticum side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common—Dupuytren's contracture
  • Blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, lumps, numbness, rash, scarring, stinging, tingling, or ulceration at the injection site
  • bruise
  • flushing, redness of the skin or unusually warm skin at the injection site
  • itching, pain, swelling, or tenderness at the injection site
  • swollen, painful, or tender lymph glands in the neck or armpit

For Healthcare Professionals

Applies to collagenase clostridium histolyticum: injectable powder for injection


Very common (10% or more): Pain in extremity (35%), arthralgia (11%)
Common (1% to 10%): Shoulder pain
Uncommon (0.1% to 1%): Axillary mass, chest wall pain, groin pain, joint crepitation, joint stiffness, limb discomfort, muscle spasms, muscular weakness, musculoskeletal stiffness, neck pain, tendon rupture[Ref]


Very common (10% or more): Injection site hemorrhage (38%), injection site reaction (erythema, inflammation, irritation, pain, warmth) (35%), injection site swelling and edema (24%), pruritus (15%), blood blister (13%)
Common (1% to 10%): Ecchymosis, hyperhidrosis, rash, skin laceration
Uncommon (0.1% to 1%): Eczema, swelling face, pain of skin, skin exfoliation, skin lesion, scab, skin discoloration, skin tightness[Ref]


Very common (10% or more): Peripheral edema (most cases were swelling of the injected hand) (73%)
Frequency not reported: Vasovagal syncope (after finger extension procedures)[Ref]


Very common (10% or more): Contusion (any body system) and ecchymosis (70%), tenderness (24%)
Common (1% to 10%): Axillary pain
Uncommon (0.1% to 1%): Breast tenderness, hypertrophy breast[Ref]


Common (1% to 10%): Lymphadenopathy, lymph node pain
Uncommon (0.1% to 1%): Thrombocytopenia[Ref]


Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Diarrhea, vomiting, abdominal pain upper[Ref]


Patients with Peyronie's disease:
Very common (10% or more): Penile hematoma (65.5%), penile swelling (55%), penile pain (45.4%), penile ecchymoses (14.5%), a popping noise or popping sensation in the penis, sometimes described as "snapping" or "cracking", and sometimes accompanied by detumescence, hematoma, and/or pain (13.2%)
Common (1% to 10%): blood blister (4.5%), penile blister (3.3%), genital pruritus (3.1%), painful erection (2.9%), erectile dysfunction (1.8%), procedural pain (1.6%), injection site vesicles (1.3%), localized edema (1.3%), dyspareunia (1.1%), injection site pruritus (1.1%), nodule (1.1%), suprapubic pain (1.1%)
Uncommon (0.1% to 1%): Corporal rupture (penile fracture) (0.5%)[Ref]


Very common (10% or more): Lymphadenopathy (13%)
Common (1% to 10%): Lymph node pain
Uncommon (0.1% to 1%): Thrombocytopenia[Ref]


Uncommon (0.1% to 1%): Hypersensitivity[Ref]


Uncommon (0.1% to 1%): Injection site cellulitis, lymphangitis[Ref]

Nervous system

Common (1% to 10%): Burning sensation, dizziness, headache, hypoesthesia, paresthesia
Uncommon (0.1% to 1%): Disorientation, agitation, insomnia, irritability,


Uncommon (0.1% to 1%): Eyelid edema[Ref]


Uncommon (0.1% to 1%): Dyspnea, hyperventilation[Ref]


1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL:" ([2006]):

2. "Product Information. Xiaflex (collagenase clostridium histolyticum)." Auxilium Pharmaceuticals Inc, Norristown, PA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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