Safety of excipients in pediatric medications: Impact on child health.

In 30 seconds

This systematic review examined the safety of common excipients in medicines used for children, drawing on studies published between 2014 and 2025 and information from regulatory agencies. It identified 54 excipients with potential toxicity, grouped by function. Reported concerns included hepatic, renal and neurological toxicity, as well as hypersensitivity reactions. The review highlights that pediatric-specific safety data are limited and that children may be exposed to formulations adapted from adult medicines. It concludes that excipient risks warrant greater attention, particularly for younger children, and calls for age-specific formulations and improved safety information.

Key findings

• The review identified 54 excipients with potential toxicity in children, classified into four functional groups.
• Documented concerns included hepatic, renal and neurological toxicity, alongside hypersensitivity reactions.
• The authors identified a lack of specific safety data for the pediatric population as a significant limitation.

Why it matters

Excipients are often treated as inactive ingredients, yet this review describes potential toxicological risks in pediatric medicines and limited child-specific evidence. Awareness of formulation components may support more informed assessment of medication exposure, especially when adult formulations are adapted for children. The findings also point to the need for better pediatric safety data and clearer information for healthcare professionals.

What to keep in mind

The review reports a lack of specific safety data for children, limiting certainty about excipient risks in the pediatric population.