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Dornase alfa Side Effects

In Summary

Commonly reported side effects of dornase alfa include: transient skin rash and voice disorder. Other side effects include: laryngitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to dornase alfa: inhalation solution

Along with its needed effects, dornase alfa may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dornase alfa:

More common
  • Body aches or pain
  • chest pain
  • congestion
  • cough
  • dryness or soreness of the throat
  • fever
  • hoarseness
  • runny nose
  • tender, swollen glands in the neck
  • trouble breathing
  • trouble swallowing
  • voice changes

Some side effects of dornase alfa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • heartburn
  • indigestion
  • rash
  • sneezing
  • stomach discomfort, upset, or pain
  • stuffy nose
Less common
  • Burning, dry, or itching eyes
  • discharge or excessive tearing
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

For Healthcare Professionals

Applies to dornase alfa: inhalation solution

Dermatologic

Very common (10% or more): Rash (up to 12%)
Rare (less than 0.1%): Urticaria[Ref]

Musculoskeletal

Very common (10% or more): Chest pain (up to 25%)[Ref]

Other

Very common (10% or more): Fever (up to 32%), voice alteration (up to 18%)[Ref]

Respiratory

Very common (10% or more): Pharyngitis (up to 40%), rhinitis (up to 30%), dyspnea (up to 17%)
Common (1% to 10%): Laryngitis, Force Vita Capacity (FVC) decreased of 10% of predicted
Rare (less than 0.1%): Chest pain (pleuritic/non-cardiac), dysphonia, pulmonary function tests decreased[Ref]

Gastrointestinal

Common (1% to 10%): Dyspepsia[Ref]

Immunologic

Common (1% to 10%): Development of serum antibodies (2% to 4%)[Ref]

Ocular

Common (1% to 10%): Conjunctivitis[Ref]

References

1. "Product Information. Pulmozyme (dornase alfa)." Genentech, South San Francisco, CA.

2. Bryson HM, Sorkin EM "Dornase alfa. A review of its pharmacological properties and therapeutic potential in cystic fibrosis." Drugs 48 (1994): 894-906

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. Witt DM, Anderson L "Dornase alfa: a new option in the management of cystic fibrosis." Pharmacotherapy 16 (1996): 40-8

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

Some side effects of dornase alfa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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