[Translated article] Safety of excipients in pediatric medications: impact on child health

OBJECTIVE: Excipients, the inactive components of medications, are essential in pharmaceutical formulations, but their safety in the pediatric population is not always guaranteed. Children, due to their physiological and metabolic immaturity, are more susceptible to the adverse effects of these additives. This study aimed to review the safety of the most common excipients in pediatric medicines, highlighting their risks and documented mechanisms of toxicity. METHOD: A systematic review was conducted following the guidelines for systematic reviews and meta-analyses, including studies published between 2014 and 2025. Searches were performed in PubMed, Web of Science, and ScienceDirect, along with regulations from key international and national regulatory agencies. RESULTS: Fifty-four excipients with potential toxicity in children were identified and classified into four functional groups. Notable adverse effects include hepatic, renal, and neurological toxicity, as well as hypersensitivity reactions. A significant limitation is the lack of specific data for the pediatric population. CONCLUSION: exposure to excipients in children is an underestimated clinical problem, exacerbated by the frequent use of formulations adapted from adults. The discussion addresses regulatory disparities, the critical need to develop medicines specifically designed for children, and the importance of collaborative initiatives to build pediatric safety databases. The pharmacist plays a key role in the informed selection of excipients. The findings indicate that a considerable proportion of excipients used in pediatric formulations carry documented toxicological risks, especially in younger age groups. This review underscores the urgent need for more rigorous safety evaluation, the development of age-specific formulations, and greater transparency in information for healthcare professionals.