Does ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM Cause Off label use? 124 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 124 reports of Off label use have been filed in association with ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM. This represents 6.3% of all adverse event reports for ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM.
How Dangerous Is Off label use From ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM?
Of the 124 reports, 61 (49.2%) resulted in death, 85 (68.5%) required hospitalization, and 44 (35.5%) 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 ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM. However, 124 reports have been filed with the FAERS database.