Pulmozyme Side Effects
Generic name: dornase alfa
Note: This document contains side effect information about dornase alfa. Some of the dosage forms listed on this page may not apply to the brand name Pulmozyme.
Some side effects of Pulmozyme may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to dornase alfa: inhalation solution
Along with its needed effects, dornase alfa (the active ingredient contained in Pulmozyme) 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 as soon as possible if any of the following side effects occur while taking dornase alfa:Rare
- Hives or welts
- redness of skin
- skin rash
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
- Chest pain or discomfort
- sore throat
- Difficulty breathing
- redness, itching, pain, swelling, or other irritation of eyes
- runny or stuffy nose
- upset stomach
For Healthcare Professionals
Applies to dornase alfa: inhalation solution
Dornase alfa (the active ingredient contained in Pulmozyme) has been generally well tolerated. Dose ranging studies employing daily dosages as high as 40 mg revealed no significant adverse effects. The most common adverse reactions have been respiratory in nature and included pharyngitis (36% to 40% versus 33% with placebo, n=968), voice alteration or hoarseness (12% to 16% versus 7%), laryngitis (3% to 4% versus 1%), dyspnea and increase in cough. Rash has also occurred frequently (10% to 12% versus 7%).
Many of these adverse reactions have been difficult to distinguish from symptoms of the underlying disease. Hoarseness and pharyngitis have been shown to be dose-related in one study. The hoarseness was transient and regressed after a 3 week period. Withdrawal rates in clinical trials have been similar between active and placebo groups.
Cardiovascular side effects have included chest pain, which has been reported in 18% to 21% of patients receiving dornase alfa (the active ingredient contained in Pulmozyme) versus 16% with placebo.
Ocular side effects have included conjunctivitis which has been reported in 4% to 5% of patients receiving dornase alfa (the active ingredient contained in Pulmozyme) versus 2% with placebo.
Hypersensitivity side effects have included a small percentage of patients who developed serum antibodies to the drug, but no anaphylaxis or severe allergic reactions have been reported. The clinical relevance of the rhDNase antibodies is presently unknown. No immunoglobulin E antibodies have been detected. exposed to the drug during clinical trials
Special face masks are not needed for caregivers involved with the administration of dornase alfa (the active ingredient contained in Pulmozyme) Studies have shown that the passive airborne exposure is well below the clinical dose during administration and nondetectable 15 to 45 minutes after treatment.
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