Introduction: Oral adverse events (AEs) related to medication use are gaining increasing attention, yet the association between antiseizure medications (ASMs) and oral AEs remains insufficiently explored. This study aimed to identify and characterize oral AEs associated with ASMs using data from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), with the goal of improving awareness and guiding clinical decision-making.
Methods: We analyzed reports from the FAERS database (Q1 2004 to Q1 2024) related to 34 ASMs approved for the treatment of epilepsy or seizures. Four signal detection methods-reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS)-were employed to assess the strength of association between ASMs and specific oral AEs. A signal was considered significant only if it met all four criteria.
Results: 16 ASMs were found to be significantly associated with oral AEs. The most frequently reported oral AEs involved mucosal lesions, periodontal abnormalities, and dental hard tissue disorders. Notably, pregabalin was commonly associated with dry mouth, while lamotrigine showed significant signals for multiple mucosal conditions such as mouth ulceration and oral mucosa erosion. Phenytoin was prominently linked to gingival hypertrophy and other periodontal conditions, and valproic acid demonstrated high signal strength for tooth development disorders.
Conclusions: This large-scale pharmacovigilance analysis provides new insights into the oral safety profiles of ASMs. Clinicians should remain vigilant about potential oral AEs when prescribing ASMs, particularly in long-term treatment plans, and promote preventive dental care in these patients.
Keywords: Antiseizure medications; FAERS database; Oral adverse events; Oral mucosal lesions; Periodontal lesions.
Copyright © 2025 Elsevier Inc. All rights reserved.