Safety issues with ethanol as an excipient in drugs intended for pediatric use

Ethanol is commonly used as an excipient in the manufacture of medicines, including the ones intended for administration in children. However, ethanol cannot be considered an inert substance; on the contrary, its use in pharmaceutical preparations is associated with safety issues. Newborns, infants and children are not able to metabolize ethanol as efficiently as adults; as a consequence, they may be at higher risk of both acute and chronic alcohol-related toxicities.