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Collagenase clostridium histolyticum Side Effects

In Summary

Commonly reported side effects of collagenase clostridium histolyticum include: bleeding at injection site, pruritus, bruise, and ecchymoses. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to collagenase clostridium histolyticum: injection powder for solution

In addition to its needed effects, some unwanted effects may be caused by collagenase clostridium histolyticum. In the event that any of these side effects do occur, they may 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

Minor Side Effects

Some of the side effects that can occur with collagenase clostridium histolyticum may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Musculoskeletal

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]

Local

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]

Cardiovascular

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]

Other

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]

Dermatologic

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

Gastrointestinal

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

Genitourinary

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]

Hematologic

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

Hypersensitivity

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

Immunologic

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,
restlessness[Ref]

Ocular

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

Respiratory

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

References

1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

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

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

Not all side effects for collagenase clostridium histolyticum may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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