{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T23:59:50Z","timestamp":1792799990134,"version":"4.5.0"},"reference-count":51,"publisher":"S. Karger AG","issue":"1","license":[{"start":{"date-parts":[[2020,8,27]],"date-time":"2020-08-27T00:00:00Z","timestamp":1598486400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"},{"start":{"date-parts":[[2020,8,27]],"date-time":"2020-08-27T00:00:00Z","timestamp":1598486400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Psychother Psychosom"],"published-print":{"date-parts":[[2021]]},"abstract":"<jats:p>&lt;b&gt;&lt;i&gt;Introduction:&lt;\/i&gt;&lt;\/b&gt; Esketamine nasal spray received approval for treatment-resistant depression in March 2019. &lt;b&gt;&lt;i&gt;Objective:&lt;\/i&gt;&lt;\/b&gt; Using the FDA Adverse Event Reporting System (FAERS) database (March 2019\u2013March 2020), we analysed esketamine-related adverse events (AEs) to detect and characterize relevant safety signals. &lt;b&gt;&lt;i&gt;Methods:&lt;\/i&gt;&lt;\/b&gt; We used the consolidated case\/non-case approach to estimate the reporting odds ratio (ROR) and information component (IC) with relevant confidence intervals (95% CI) for esketamine-related AEs with \u22654 counts. Comparisons between serious and non-serious AEs were performed using non-parametric tests. &lt;b&gt;&lt;i&gt;Results:&lt;\/i&gt;&lt;\/b&gt; The FAERS database contained 962 cases of esketamine-related AEs, with signals detected for several AEs, such as dissociation (ROR = 1,612.64, 95% CI = 1,354.63, 1,919.79; IC = 8.19, 95% CI = 7.96, 8.35), sedation (ROR = 238.46, 95% CI = 202.98, 280.15; IC = 7, 95% CI = 6.75, 7.18), feeling drunk (ROR = 96.17, 95% CI = 61.42, 150.57; IC = 4.84, 95% CI = 4.09, 5.36), suicidal ideation (ROR = 24.03, 95% CI = 18.72, 30.84; IC = 4.31, 95% CI = 3.9, 4.61), and completed suicide (ROR = 5.75, 95% CI = 3.18, 10.41; IC = 2.25, 95% CI = 1.23, 2.94). Signals for suicidal and self-injurious ideation, but not suicide attempt and completed suicide, remained when comparing esketamine to venlafaxine. Females and patients receiving antidepressant polypharmacy, co-medication with mood stabilizers, antipsychotics, benzodiazepines, or somatic medications were more likely to suffer from serious versus non-serious AEs (\u03c7&lt;sup&gt;2&lt;\/sup&gt; = 125.29, &lt;i&gt;p&lt;\/i&gt; &amp;#x3c; 0.001, \u03c7&lt;sup&gt;2&lt;\/sup&gt; = 9.08, &lt;i&gt;p&lt;\/i&gt; = 0.003, \u03c7&lt;sup&gt;2&lt;\/sup&gt; = 8.14, &lt;i&gt;p&lt;\/i&gt; = 0.004, \u03c7&lt;sup&gt;2&lt;\/sup&gt; = 19.48, &lt;i&gt;p&lt;\/i&gt; &amp;#x3c; 0.001, \u03c7&lt;sup&gt;2&lt;\/sup&gt; = 25.62, &lt;i&gt;p&lt;\/i&gt; &amp;#x3c; 0.001, and \u03c7&lt;sup&gt;2&lt;\/sup&gt; = 16.79, &lt;i&gt;p&lt;\/i&gt; &amp;#x3c; 0.001, respectively). &lt;b&gt;&lt;i&gt;Conclusions:&lt;\/i&gt;&lt;\/b&gt; Esketamine may carry a clear potential for serious AEs, which deserves urgent clarification by means of further prospective studies. 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