What the label lists and what reports show
Dornase alfa side effects
Dornase alfa's FDA label: “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% …” FAERS holds 19,492 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is infective pulmonary exacerbation of cystic fibrosis (2,306 reports).
- No generic listed
Check it at the source: the dornase alfa FDA label on DailyMed (effective December 17, 2025, Genentech, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe 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.
Table 2. Adverse Reactions Increased 3% or More in PULMOZYME Treated Patients Over Placebo in CF Clinical Trials
| Reaction | Placebo n=325 | Pulmozyme QD n=322 | Pulmozyme BID n=321 | Placebo n=159 | Pulmozyme QD n=161 |
|---|---|---|---|---|---|
| Voice alteration | 7% | 12% | 16% | 6% | 18% |
| Pharyngitis | 33% | 36% | 40% | 28% | 32% |
| Rash | 7% | 10% | 12% | 1% | 3% |
| Laryngitis | 1% | 3% | 4% | 1% | 3% |
| Chest Pain | 16% | 18% | 21% | 23% | 25% |
| Conjunctivitis | 2% | 4% | 5% | 0% | 1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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. …
Source: FDA drug label, 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?
19,492 reports list dornase alfa among the medicines taken, 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. Of the 18 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Dornase alfa: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions