A real-world pharmacovigilance study of esketamine nasal spray.
Medicine September 6, 2024 Yaqing Chen, Hangye Gu, Wenwei Li et al. 5 citations
Analysis of post-marketing safety data for esketamine nasal spray, using four statistical methods on 5,132 adverse event reports from the FDA Adverse Event Reporting System (Q1 2019 to Q2 2023), identified dissociation, sedation, and hypertension as the most frequently observed adverse drug events. New rare signals were detected, including interstitial cystitis, substance abuse, and drug diversion. These findings may help healthcare professionals assess patient symptoms and identify risks during clinical use.