Safety Profile and Suicidality Associated with the Use of Esketamine in the Treatment of Major Depressive Disorder in European Countries: An EudraVigilance Database Analysis.
Pharmaceuticals (Basel, Switzerland) May 9, 2025 Ilaria Ammendolia, Carmen Mannucci, Emanuela Esposito et al. 2 citations
Increases in blood pressure (15.4%) and dissociation (15.0%) were the most frequently reported suspected adverse reactions to esketamine in European pharmacovigilance data. Women accounted for most reports, except for increased blood pressure and completed suicide, which were more common in men. Adults aged 18–64 and elders aged 65–85 had the largest number of reported adverse reactions. Compared with fluoxetine and venlafaxine, esketamine showed a potential increase in suicide risk among depressed patients. The authors recommend closer monitoring of patients with a history of suicide-related events or significant suicidal ideation before starting esketamine treatment.