Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dornase alfa
Drug ID BADD_D00711
Description Dornase alfa is a biosynthetic form of human deoxyribunuclease I (DNase I) enzyme. It is produced in genetically modified Chinese hamster ovary (CHO) cells using recombinant DNA technology. The 260-amino acid sequence of dornase alfa is identical to the endogenous human enzyme. Dornase alfa cleaves extracellular DNA to 5´-phosphodinucleotide and 5´-phosphooligonucleotide end products without affecting intracellular DNA. In individuals with cystic fibrosis, extracellular DNA, which is an extremely viscous anion, is released by degenerating leukocytes that accumulate during inflammatory responses to infections. Enzymatic breakdown of this extracellular DNA appears to reduce sputum viscosity and viscoelasticity.
Indications and Usage Used as adjunct therapy in the treatment of cystic fibrosis.
Marketing Status approved
ATC Code Not Available
DrugBank ID DB00003
KEGG ID D03896
MeSH ID C568813
PubChem ID Not Available
TTD Drug ID D0JE4D
NDC Product Code 50242-099; 50242-100; 69438-0012
UNII 953A26OA1Y
Synonyms dornase alfa | dornase alpha | rhDNase | recombinant human DNase | recombinant human deoxyribonuclease I | Pulmozyme
Chemical Information
Molecular Formula Not Available
CAS Registry Number 143831-71-4
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Pneumothorax22.05.02.003--
Pyrexia08.05.02.003--
Rash23.03.13.001---
Respiratory failure14.01.04.003; 22.02.06.002--
Rhinitis11.01.13.004; 22.07.03.006--
Sepsis11.01.11.003--
Sinusitis11.01.13.005; 22.07.03.007--
Sputum increased22.02.03.007---
Urticaria10.01.06.001; 23.04.02.001--
Vital capacity decreased13.19.01.002---
Weight decreased13.15.01.005--
Wheezing22.03.01.009--
Sputum abnormal13.19.03.001---
Pulmonary function test decreased13.19.01.001---
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