In infants, especially preterm newborns, benzyl alcohol exposure can be risky due to their reduced metabolic capacity, potentially leading to “gasping syndrome”—a serious condition characterized by metabolic acidosis and respiratory distress. To avoid this risk, the European Medicines Agency (EMA) recommends that neonates under four weeks should not receive medications containing benzyl alcohol unless absolutely necessary and prescribed by a healthcare provider. For older infants, caution is also advised, particularly in cumulative daily doses.

Research suggests a daily exposure limit of benzyl alcohol at 5 mg/kg for young children, as their bodies metabolize it more slowly than adults. Toxic effects have been observed when doses reach around 90 mg/kg/day, especially in very young and preterm infants, leading to severe outcomes like neurological issues and respiratory distress.

https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-benzyl-alcohol-used-excipient-medicinal-products-human-use_en.pdf

https://www.ema.europa.eu/en/documents/report/benzyl-alcohol-and-benzoic-acid-group-used-excipients-report-published-support-questions-and-answers-benzyl-alcohol-used-excipient-medicinal-products-human-use-emachmp5081882013-and-t_en.pdf

https://www.pharmaexcipients.com/news/safe-excipient-exposure-in-neonates-and-small-children/