Does BENZETHONIUM\DEXTROMETHORPHAN HYDROBROMIDE\DYCLONINE\GUAIFENESIN\SALICYLIC ACID Cause Off label use? 5 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 5 reports of Off label use have been filed in association with BENZETHONIUM\DEXTROMETHORPHAN HYDROBROMIDE\DYCLONINE\GUAIFENESIN\SALICYLIC ACID. This represents 21.7% of all adverse event reports for BENZETHONIUM\DEXTROMETHORPHAN HYDROBROMIDE\DYCLONINE\GUAIFENESIN\SALICYLIC ACID.
How Dangerous Is Off label use From BENZETHONIUM\DEXTROMETHORPHAN HYDROBROMIDE\DYCLONINE\GUAIFENESIN\SALICYLIC ACID?
Of the 5 reports, 5 (100.0%) resulted in death, 5 (100.0%) required hospitalization, and 3 (60.0%) 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 BENZETHONIUM\DEXTROMETHORPHAN HYDROBROMIDE\DYCLONINE\GUAIFENESIN\SALICYLIC ACID. However, 5 reports have been filed with the FAERS database.