Drug · FAERS side-effect profile with label screen
Dornase Alfa side effects: what 19,485 FDA adverse event reports show
Drug class
Recombinant Human Deoxyribonuclease 1
FDA label (Established Pharmacologic Class)
Brand names
Pulmozyme
openFDA label
Who reports
19,485 reports · 69% serious · 819 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
PULMOZYME ® 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.
FDA label, Indications and Usage
What it is
Dornase alfa is a recombinant human deoxyribonuclease I (rhDNase) an enzyme which selectively cleaves DNA. The protein is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing DNA encoding for the native human protein, deoxyribonuclease I (DNase).
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 4Likely indication confounding 3Reporting / coding artifact 3Lab value / disease marker 3Not in label — unassessed 27
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 969 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Amniotic fluid index increased | 13 | 2,757.4 983.1–7,733.9ROR 2,759.3 · χ² 9,198 / p <1e-300 | 359.9 EB05 223.8 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Cystic fibrosis hepatic disease | 11 | 972.2 429.0–2,203.0ROR 972.7 · χ² 5,072 / p <1e-300 | 269.9 EB05 160.8 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Infective pulmonary exacerbation of cystic fibrosis | 2,306 | 787.1 747.2–829.2ROR 892.6 · χ² 1,039,035 / p <1e-300 | 450.5 EB05 435.3 · IC025 +8.6 3/3 methods agree | Labeled (related wording) related wording | serious n=1,982 | no trial data cached |
| Cystic fibrosis respiratory infection suppression | 310 | 568.8 495.8–652.5ROR 578.0 · χ² 114,005 / p <1e-300 | 362.3 EB05 329.7 · IC025 +7.7 3/3 methods agree | Labeled (related wording) related wording | serious n=309 | no trial data cached |
| Cystic fibrosis | 1,761 | 500.7 474.0–529.0ROR 550.3 · χ² 596,386 / p <1e-300 | 339.2 EB05 326.1 · IC025 +8.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=1,677 | no trial data cached |
| Cystic fibrosis lung | 36 | 410.5 279.5–603.0ROR 411.3 · χ² 10,310 / p <1e-300 | 256.0 EB05 193.2 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=36 | no trial data cached |
| Cystic fibrosis related diabetes | 32 | 305.7 206.4–452.9ROR 306.2 · χ² 7,310 / p <1e-300 | 208.2 EB05 154.4 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=28 | no trial data cached |
| Distal intestinal obstruction syndrome | 60 | 230.6 174.5–304.7ROR 231.3 · χ² 11,077 / p <1e-300 | 178.8 EB05 144.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=58 | no trial data cached |
| Bacterial disease carrier | 89 | 149.8 120.1–187.0ROR 150.5 · χ² 11,398 / p <1e-300 | 127.9 EB05 107.1 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious n=84 · ♀ 91% (drug 55%) | no trial data cached |
| Pulmonary function test decreased | 493 | 135.8 123.8–149.0ROR 139.3 · χ² 58,374 / p <1e-300 | 120.0 EB05 111.3 · IC025 +6.6 3/3 methods agree | Likely indication confounding term in indications | serious n=416 | no trial data cached |
| Infective exacerbation of bronchiectasis | 30 | 122.4 83.9–178.5ROR 122.6 · χ² 3,130 / p <1e-300 | 102.8 EB05 75.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=30 | no trial data cached |
| Spinal muscular atrophy | 25 | 110.0 72.9–166.0ROR 110.2 · χ² 2,349 / p <1e-300 | 92.9 EB05 66.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 0% (drug 55%) · 100% clinician | no trial data cached |
| Bronchial secretion retention | 112 | 104.6 86.2–126.9ROR 105.2 · χ² 10,363 / p <1e-300 | 93.8 EB05 80.1 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=105 · ♀ 84% (drug 55%) | no trial data cached |
| Lower respiratory tract infection bacterial | 35 | 78.5 55.7–110.6ROR 78.6 · χ² 2,421 / p <1e-300 | 70.4 EB05 52.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=34 | no trial data cached |
| Respiratory tract infection bacterial | 33 | 75.9 53.3–108.0ROR 76.0 · χ² 2,207 / p <1e-300 | 68.2 EB05 50.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 12% (drug 55%) | no trial data cached |
| Bronchoscopy | 14 | 67.5 39.3–115.8ROR 67.5 · χ² 801 / p 2e-176 | 58.7 EB05 37.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Sputum increased | 122 | 65.8 54.8–79.0ROR 66.2 · χ² 7,272 / p <1e-300 | 61.5 EB05 52.8 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=91 | no trial data cached |
| Pseudomonas test positive | 47 | 65.0 48.4–87.2ROR 65.1 · χ² 2,730 / p <1e-300 | 59.9 EB05 46.8 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=32 | no trial data cached |
| Stoma closure | 16 | 60.2 36.4–99.6ROR 60.2 · χ² 826 / p 6e-182 | 53.6 EB05 35.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Pancreatic insufficiency | 18 | 55.8 34.8–89.6ROR 55.9 · χ² 869 / p 2e-191 | 50.4 EB05 33.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Sinus operation | 117 | 55.7 46.2–67.0ROR 56.0 · χ² 5,917 / p <1e-300 | 52.5 EB05 45.0 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=113 | no trial data cached |
| Foetal macrosomia | 13 | 53.6 30.7–93.6ROR 53.7 · χ² 590 / p 1e-130 | 47.8 EB05 29.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Increased viscosity of bronchial secretion | 30 | 53.6 37.1–77.3ROR 53.6 · χ² 1,423 / p <1e-300 | 49.5 EB05 36.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Positive airway pressure therapy | 11 | 53.0 28.9–97.1ROR 53.1 · χ² 486 / p 4e-108 | 46.7 EB05 27.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Bronchopulmonary aspergillosis allergic | 43 | 52.9 39.0–71.8ROR 53.0 · χ² 2,037 / p <1e-300 | 49.4 EB05 38.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=41 | no trial data cached |
| Lung infection pseudomonal | 26 | 51.8 35.0–76.8ROR 51.9 · χ² 1,188 / p 1e-260 | 47.8 EB05 34.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Superinfection | 69 | 51.8 40.7–65.9ROR 52.0 · χ² 3,229 / p <1e-300 | 48.8 EB05 39.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=69 · ♀ 100% (drug 55%) · 94% clinician | no trial data cached |
| Left-to-right cardiac shunt | 13 | 49.2 28.2–85.9ROR 49.3 · χ² 542 / p 4e-120 | 44.3 EB05 27.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Pneumococcal sepsis | 28 | 48.3 33.1–70.5ROR 48.4 · χ² 1,195 / p 3e-262 | 44.9 EB05 32.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 0% (drug 55%) · 100% clinician | no trial data cached |
| Forced expiratory volume decreased | 114 | 45.0 37.3–54.3ROR 45.3 · χ² 4,665 / p <1e-300 | 42.9 EB05 36.7 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=100 | no trial data cached |
| Motor neurone disease | 19 | 43.2 27.3–68.4ROR 43.3 · χ² 713 / p 2e-157 | 40.1 EB05 27.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Pseudomonas infection | 325 | 42.9 38.5–47.9ROR 43.6 · χ² 12,757 / p <1e-300 | 41.2 EB05 37.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 30.0 | no trial data cached |
| Increased bronchial secretion | 92 | 40.0 32.5–49.2ROR 40.2 · χ² 3,332 / p <1e-300 | 38.3 EB05 32.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=74 | no trial data cached |
| Intercepted product storage error | 118 | 38.5 32.1–46.2ROR 38.7 · χ² 4,123 / p <1e-300 | 37.0 EB05 31.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Burkholderia cepacia complex infection | 10 | 38.4 20.4–72.2ROR 38.4 · χ² 317 / p 4e-71 | 34.9 EB05 20.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Lung transplant | 118 | 36.8 30.6–44.2ROR 37.0 · χ² 3,937 / p <1e-300 | 35.4 EB05 30.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=114 | no trial data cached |
| Increased viscosity of upper respiratory secretion | 23 | 33.8 22.3–51.2ROR 33.9 · χ² 679 / p 6e-150 | 32.0 EB05 22.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 0% (drug 55%) | no trial data cached |
| Nasal inflammation | 30 | 31.4 21.9–45.2ROR 31.5 · χ² 829 / p 1e-182 | 30.0 EB05 22.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Pneumonia pseudomonal | 41 | 29.8 21.9–40.6ROR 29.9 · χ² 1,082 / p 1e-237 | 28.7 EB05 22.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=35 | no trial data cached |
| Intercepted medication error | 125 | 29.5 24.7–35.2ROR 29.7 · χ² 3,323 / p <1e-300 | 28.6 EB05 24.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | 2,306 | 787.1 747.2–829.2ROR 892.6 · χ² 1,039,035 / p <1e-300 | 450.5 EB05 435.3 · IC025 +8.6 3/3 methods agree | Labeled (related wording) related wording | serious n=1,982 | no trial data cached |
| Cystic fibrosis | 1,761 | 500.7 474.0–529.0ROR 550.3 · χ² 596,386 / p <1e-300 | 339.2 EB05 326.1 · IC025 +8.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=1,677 | no trial data cached |
| Hospitalisation | 1,310 | 9.3 8.8–9.8ROR 9.9 · χ² 9,708 / p <1e-300 | 9.2 EB05 8.8 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.4 | no trial data cached |
| Pneumonia (lung infection) | 1,298 | 4.3 4.1–4.6ROR 4.6 · χ² 3,363 / p <1e-300 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Cough | 993 | 3.8 3.6–4.1ROR 4.0 · χ² 2,092 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Off label use (used outside approved label) | 966 | 1.2 1.1–1.3ROR 1.2 · χ² 33 / p 6e-9 | 1.2 EB05 1.1 · IC025 +0.2 | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Infection | 946 | 7.1 6.7–7.6ROR 7.4 · χ² 4,951 / p <1e-300 | 7.0 EB05 6.7 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.2 | no trial data cached |
| No adverse event | 938 | 5.7 5.4–6.1ROR 6.0 · χ² 3,655 / p <1e-300 | 5.7 EB05 5.4 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Dyspnoea (shortness of breath) | 916 | 1.7 1.6–1.9ROR 1.8 · χ² 297 / p 7e-67 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Condition aggravated | 614 | 2.2 2.0–2.4ROR 2.2 · χ² 401 / p 2e-89 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 | no trial data cached |
| Headache | 545 | 0.9 0.9–1.0ROR 0.9 · χ² 2 / p 0.062 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.5 | no trial data cached |
| Pulmonary function test decreased | 493 | 135.8 123.8–149.0ROR 139.3 · χ² 58,374 / p <1e-300 | 120.0 EB05 111.3 · IC025 +6.6 3/3 methods agree | Likely indication confounding term in indications | serious n=416 | no trial data cached |
| Death | 485 | 0.6 0.6–0.7ROR 0.6 · χ² 129 / p 3e-30 | 0.6 EB05 0.6 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.5 | no trial data cached |
| Malaise (feeling unwell) | 470 | 1.2 1.1–1.3ROR 1.2 · χ² 9 / p 0.001 | 1.2 EB05 1.1 · IC025 +0.0 | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Fatigue (tiredness) | 462 | 0.6 0.6–0.7ROR 0.6 · χ² 97 / p 3e-23 | 0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.6 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Distal intestinal obstruction syndrome — n=60, PRR 230.6
- Infective exacerbation of bronchiectasis — n=30, PRR 122.4
- Spinal muscular atrophy — n=25, PRR 110.0
- Bronchial secretion retention — n=112, PRR 104.6
- Lower respiratory tract infection bacterial — n=35, PRR 78.5
- Respiratory tract infection bacterial — n=33, PRR 75.9
- Sputum increased — n=122, PRR 65.8
- Increased viscosity of bronchial secretion — n=30, PRR 53.6
- Bronchopulmonary aspergillosis allergic — n=43, PRR 52.9
- Lung infection pseudomonal — n=26, PRR 51.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Erythropoiesis-stimulating agents (darbepoetin alfa) ↔ Mortality / cardiovascular risk.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Dornase Alfa?
In FDA FAERS, the most frequently co-reported reaction terms for Dornase Alfa are infective pulmonary exacerbation of cystic fibrosis, cystic fibrosis, pneumonia, cough, infection, dyspnoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Dornase Alfa have an FDA boxed warning?
No. The FDA label retrieved for Dornase Alfa has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dornase Alfa causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID d8c78a7e-ff99-48f3-8952-643ec2ea0f86, effective 20251217; matched on
openfda.generic_name.exact:"DORNASE ALFA") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,009 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.