Does ACETAMINOPHEN\CHLORPHENIRAMINE\DEXTROMETHORPHAN\PSEUDOEPHEDRINE Cause Off label use? 10 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 10 reports of Off label use have been filed in association with ACETAMINOPHEN\CHLORPHENIRAMINE\DEXTROMETHORPHAN\PSEUDOEPHEDRINE. This represents 24.4% of all adverse event reports for ACETAMINOPHEN\CHLORPHENIRAMINE\DEXTROMETHORPHAN\PSEUDOEPHEDRINE.
How Dangerous Is Off label use From ACETAMINOPHEN\CHLORPHENIRAMINE\DEXTROMETHORPHAN\PSEUDOEPHEDRINE?
Of the 10 reports, 5 (50.0%) resulted in death, 7 (70.0%) required hospitalization, and 4 (40.0%) 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 ACETAMINOPHEN\CHLORPHENIRAMINE\DEXTROMETHORPHAN\PSEUDOEPHEDRINE. However, 10 reports have been filed with the FAERS database.