Prescription medicine
Dornase alfa Brand names: Pulmozyme
Dornase alfa (Pulmozyme) is a prescription medicine with an FDA approval on record since 1993. No generic is listed; pharmacies paid $53.16 per mL (Pulmozyme 1 mg/mL ampul) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the dornase alfa FDA label on DailyMed (effective December 17, 2025, Genentech, Inc.); the BLA 103532 record on Drugs@FDA; every dornase alfa label on DailyMed.
Highlights of the record
FDA label of December 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePULMOZYME ® is indicated, in conjunction with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) to improve pulmonary function.
Forms and strengths
- 1 mg/ml
Solution.
On the market
- Earliest approval on file
- December 30, 1993 Pulmozyme, Genentech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $53.16 per mL Pulmozyme 1 mg/mL ampul
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 19,492 through July 30, 2026
What is dornase alfa used for?
From the label: indications and usagePULMOZYME ® is indicated, in conjunction with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) to improve pulmonary function. In CF patients with an FVC ≥ 40% of predicted, daily administration of PULMOZYME has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics. PULMOZYME is a recombinant DNase enzyme indicated in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.
FDA pharmacologic class: Recombinant Human Deoxyribonuclease 1.
Source: FDA drug label (Pulmozyme), Genentech, Inc., effective December 17, 2025 (SPL set d8c78a7e-ff99-48f3-8952-643ec2ea0f86), via openFDA; the full label on DailyMed
Is there a generic for dornase alfa (Pulmozyme)?
No generic dornase alfa is approved (Drugs@FDA, October 8, 2026).
- 1993 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dornase alfa (Pulmozyme)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $53.16 per mL (Pulmozyme 1 mg/mL ampul), up 3% from $51.57 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Pulmozyme 1 mg/mL ampul (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pulmozyme 1 mg/mL ampul | Brand | $53.16 per mL | n/a | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the dornase alfa label say about other medicines?
The dornase alfa label names no other medicine on this site. The labels of 2 other medicines name dornase alfa. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (Pulmozyme), Genentech, Inc., effective December 17, 2025 (SPL set d8c78a7e-ff99-48f3-8952-643ec2ea0f86), via openFDA; the full label on DailyMed
What do FAERS reports show for dornase alfa?
The FDA Adverse Event Reporting System holds 19,492 reports that list dornase alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 819 are coded as a death and 10,582 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2019 (3,972, against a median of 1,160 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Dornase alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other