Work

Potentially harmful excipients in drugs: an analysis of labeling practices and adverse drug reactions

Year: 2026

Type: article

Abstract: Background Excipients play a crucial role in pharmaceutical formulations, however, their safety profile in pediatric populations remains inadequately characterized. Methods This retrospective multicenter study was conducted in two phases. Phase one reviewed package inserts of pediatric medications used at seven Fujian hospitals (July 2019–June 2024) to assess excipient labeling. Phase two analyzed associations between potentially harmful excipients (PHEs) exposure and adverse drug reactions using the reporting odds ratio (ROR) method at a single children's hospital. Results The rates of excipient labeling exhibited significant variation based on hospital type, drug source, and drug category. In total, 41.3% of pediatric cases and 43.2% of prescriptions included at least one PHE. Benzyl alcohol was associated with application site pain (ROR = 393.20, P < 0.05) and erythema (ROR = 85.84, P < 0.05); thimerosal was linked to application site irritation (ROR = 278.35, P < 0.05) and pruritus (ROR = 115.20, P < 0.05); and sodium citrate was associated with bradycardia (ROR = 157.59, P < 0.05). Conclusion The labeling of excipients in pediatric pharmaceutical products is insufficient in the institutions examined, potentially hindering the identification of excipient exposure in clinical practice. The safety signals identified in this study necessitate further systematic investigation and careful consideration within both regulatory and clinical contexts.

Source: Frontiers in Pharmacology

DOI: 10.3389/fphar.2026.1949057