Does POLYETHYLENE GLYCOL 3350 Cause Off label use? 5,256 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 5,256 reports of Off label use have been filed in association with POLYETHYLENE GLYCOL 3350 (Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored). This represents 14.2% of all adverse event reports for POLYETHYLENE GLYCOL 3350.
How Dangerous Is Off label use From POLYETHYLENE GLYCOL 3350?
Of the 5,256 reports, 192 (3.7%) resulted in death, 233 (4.4%) required hospitalization, and 98 (1.9%) 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 POLYETHYLENE GLYCOL 3350. However, 5,256 reports have been filed with the FAERS database.