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Published on: March 11, 2017

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

Leonel Silva-Chocoteco1, Monserratt Abud-González1, Cesar Ricardo Cortez-Álvarez1

  • 1Departamento de Farmacobiología, Universidad de Guadalajara, Guadalajara, Mexico.

Farmacia Hospitalaria : Organo Oficial De Expresion Cientifica De La Sociedad Espanola De Farmacia Hospitalaria
|June 24, 2026
PubMed

Insights

Pediatric excipient safety is a critical issue, as many inactive ingredients in medicines pose risks to children. More research and age-specific formulations are urgently needed to protect young patients.

Area of Science:

  • Pharmaceutical Science
  • Pediatric Pharmacology
  • Toxicology

Background:

  • Excipients are vital inactive components in medications.
  • Pediatric patients are more vulnerable to excipient adverse effects due to physiological immaturity.
  • Current safety data for excipients in children is often insufficient.

Purpose of the Study:

  • To review the safety of common excipients in pediatric medicines.
  • To identify risks and mechanisms of toxicity associated with pediatric drug additives.
  • To highlight the need for age-specific pharmaceutical formulations.

Main Methods:

  • Systematic review of studies published between 2014 and 2025.
  • Searches conducted in major scientific databases (PubMed, Web of Science, ScienceDirect).
  • Inclusion of regulatory guidelines from international and national agencies.

Main Results:

  • Fifty-four potentially toxic excipients identified and categorized.
  • Adverse effects include hepatic, renal, neurological toxicity, and hypersensitivity.
  • A significant limitation is the scarcity of pediatric-specific safety data.

Conclusions:

  • Excipient exposure in children is an underestimated problem, often due to adult-adapted formulations.
  • There is a critical need for pediatric-specific drug development and robust safety databases.
  • Pharmacists play a key role in informed excipient selection for pediatric patients.
Abstract

Keywords:
Drug compoundingDrug toxicityDrug-related side effects and adverse reactionsEfectos colaterales y reacciones adversas relacionados con medicamentosExcipientesExcipientsFormulación de medicamentosPediatricsPediatríaPharmaceutical preparationsPreparaciones farmacéuticasToxicidad de medicamentos

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