Real-World Sodium Fluoride Safety Signals: Dual-Database Pharmacovigilance.

ABSTRACT:

Introduction and aims

Sodium fluoride is widely used in preventive dentistry, yet its global safety profile has not been comprehensively characterised using real-world data. This study aimed to characterise reporting patterns and safety signals associated with sodium fluoride through an integrated pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) and the World Health Organization (WHO) VigiBase.

Methods

Adverse event (AE) reports related to sodium fluoride were extracted from FAERS (2004-2024) and VigiBase (1971-2024). Reporting characteristics, including demographic distributions, reporter type, and event seriousness, were summarised descriptively. AEs were coded using the medical dictionary for regulatory activities (MedDRA) at the preferred term

SUBMITTER: Ning W 

PROVIDER: S-EPMC12905758 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature