Oral Adverse Effects of Antipsychotic Medications: A Case/Noncase Analysis of EudraVigilance Data.

OBJECTIVE

Neuropsychiatric disorders are associated with poor oral health, with antipsychotics as potential contributors. This study aimed to analyse the oral adverse effects of antipsychotics using the EudraVigilance database.

METHODS

A case/noncase analysis was conducted to calculate reporting odds ratios (ROR) and assess the disproportionality of oral adverse events.

RESULTS

A total of 5663 reports of oral adverse effects related to antipsychotics were identified. Atypical antipsychotics had a higher overall incidence (5663 vs. 787 for typical), but typical antipsychotics showed stronger associations with specific oral issues (ROR = 2.2 vs. 1.6 for atypical). The most commonly reported effects were disturbances in salivary flow, including xerostomia and hypersalivation. Olanzapine and quetiapine were linked to dry mouth (ROR = 1.8 and 3.0) and tooth loss (ROR = 1.7 and 1.8). Clozapine had the highest number of reports (1619) and ROR (33.1) for hypersalivation. Disproportionality analysis revealed significant associations with orofacial dyskinesia for all antipsychotics, except clozapine. Aripiprazole had the highest ROR (13.7) for orofacial dyskinesia and was linked to a swollen tongue in patients aged ≤ 17 years (12 cases, ROR = 3.6). No sex-based differences were identified.

CONCLUSIONS

Antipsychotics significantly affect oral health, highlighting the need for preventive dental care and interventions to reduce these effects and improve patient well-being.