Dornase Alfa: uses, dosing, side effects & brands
Dornase Alfa is a recombinant human deoxyribonuclease 1 sold in the U.S. under one brand, for bronchitis and cystic fibrosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Recombinant Human Deoxyribonuclease 1
- Treats
- Bronchitis and Cystic Fibrosis
- Available as
- Solution
- Sold as
- Pulmozyme
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
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How dornase alfa is dosed
From the FDA label for Pulmozyme (application BLA103532). Other dornase alfa products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dosage is 2.5 mg (one single-dose ampule) inhaled once daily using a recommended nebulizer. ( 2.1 ) Some patients may benefit from twice daily administration. ( 2.1 ) See full prescribing information for the recommended nebulizers for use with PULMOZYME. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage, in most cystic fibrosis patients, is 2.5 mg (one single-dose ampule) inhaled once daily using a recommended jet nebulizer connected to an air compressor system or via a vibrating mesh nebulizer [see Dosage and Administration (2.2) ] . Some patients may benefit from twice daily administration [see Clinical Studies (14) ] . 2.2 Administration Instructions Nebulizer Information Administer PULMOZYME via a jet nebulizer connected to an air compressor with an adequate air flow and equipped with a mouthpiece or suitable face mask, or via a vibrating mesh nebulizer. Refer to Table 1 for the recommended Jet Nebulizers or Vibrating Mesh Nebulizers for use with PULMOZYME. No data are currently available to support the administration of PULMOZYME with other nebulizer systems. The eRapid Nebulizer System should only be used by adults and pediatric patients who can use a mouthpiece, and not by younger patients who need a mask to inhale PULMOZYME. Use the selected nebulizer in accordance with the manufacturer's instruction manual. Refer to the manufacturer's instruction…
Dornase Alfa side effects
The most common adverse reactions (occurring in ≥3% of patients treated with PULMOZYME over placebo) seen in clinical trials in CF patients were: voice alteration, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, decrease in FVC of ≥10%, fever, and dyspnea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to PULMOZYME in 902 patients, with exposures ranging from 2 weeks of daily administration up to once or twice daily administration for six months. PULMOZYME was studied in both placebo-controlled (n=804) and uncontrolled trials (n=98). The population of patients in placebo-controlled trials was with FVC ≥ 40% of predicted (n=643) or with more advanced pulmonary disease, FVC < 40% of predicted (n=161). The population in the uncontrolled trial included 98 pediatric patients with CF ranging from 3 months to 10 years of age. More than half of the patients received PULMOZYME 2.5 mg by inhalation once a day (n=581), while the rest of patients…
Who shouldn’t take dornase alfa
PULMOZYME is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product. PULMOZYME is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product. ( 4 )
Dornase Alfa drug interactions
Available data indicate there are no clinically important drug-drug interactions with PULMOZYME.
Every dornase alfa product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Pulmozyme.
Dornase Alfa and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for dornase alfa: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of dornase alpha (hamster) during breastfeeding. Because it is given by inhalation and is a large protein molecule with a molecular weight of about 37,000 Da, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. A task force respiratory experts from Europe, Australia and New Zealand found that dornase alfa is compatible with breastfeeding.
National Institute of Child Health and Human Development, record revised October 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about dornase alfa
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 932 reports naming dornase alfa, and the FDA flagged 88% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- infective pulmonary exacerbation of cystic fibrosis131 reports
- dyspnoea64 reports
- pyrexia56 reports
- cough46 reports
- diarrhoea43 reports
- malaise42 reports
- vomiting42 reports
- weight decreased42 reports
Read these as a signal, not a rate. A report does not mean dornase alfa caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is dornase alfa?
Pulmozyme (Dornase Alfa) is a recombinant human deoxyribonuclease 1 used to treat Bronchitis, Cystic Fibrosis.
What kind of drug is dornase alfa?
The FDA classifies dornase alfa as a recombinant human deoxyribonuclease 1. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take dornase alfa with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run dornase alfa against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does dornase alfa come in?
Across the brands we track, dornase alfa is currently marketed as solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic dornase alfa?
We do not currently list a generic-labelled dornase alfa product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Dornase Alfa: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/dornase-alfa
- MLA
- “Dornase Alfa: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/dornase-alfa.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for dornase alfa on DailyMed (NIH) ↗.