Off-label use and pharmacovigilance among infants: analysis of the Thai Health Product Vigilance National Database

Background A lack of drug safety and efficacy studies in pediatric patients is a major problem contributing to inappropriate drug use among this population. The prevalence of ‘off-label’ drug use is high in pediatric patients, leading to an increased risk of adverse events (AEs). A pharmacovigilance database is useful for healthcare providers in monitoring AEs associated with off-label drug use.