Does DORNASE ALFA Cause Off label use? 522 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 522 reports of Off label use have been filed in association with DORNASE ALFA (Pulmozyme). This represents 9.6% of all adverse event reports for DORNASE ALFA.
522
Reports of Off label use with DORNASE ALFA
9.6%
of all DORNASE ALFA reports
23
Deaths
94
Hospitalizations
How Dangerous Is Off label use From DORNASE ALFA?
Of the 522 reports, 23 (4.4%) resulted in death, 94 (18.0%) required hospitalization, and 9 (1.7%) were considered life-threatening.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for DORNASE ALFA. However, 522 reports have been filed with the FAERS database.
What Other Side Effects Does DORNASE ALFA Cause?
No adverse event (889)
Cystic fibrosis (565)
Hospitalisation (512)
Pneumonia (377)
Condition aggravated (304)
Dyspnoea (246)
Infective pulmonary exacerbation of cystic fibrosis (245)
Product storage error (242)
Death (225)
Cough (195)
What Other Drugs Cause Off label use?
RITUXIMAB (39,751)
INFLIXIMAB (34,801)
DENOSUMAB (34,612)
METHOTREXATE (24,020)
VEDOLIZUMAB (21,017)
ETANERCEPT (20,178)
TOCILIZUMAB (18,256)
PREDNISONE (17,867)
LENALIDOMIDE (17,017)
ADALIMUMAB (16,417)
Which DORNASE ALFA Alternatives Have Lower Off label use Risk?
DORNASE ALFA vs DORZOLAMIDE
DORNASE ALFA vs DORZOLAMIDE\TIMOLOL
DORNASE ALFA vs DOSTARLIMAB
DORNASE ALFA vs DOSTARLIMAB-GXLY
DORNASE ALFA vs DOTATATE GALLIUM GA-68