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A real-world pharmacovigilance study of adverse events associated with esketamine: disproportionality analysis and detection of potential drug-drug interaction signals

Claudia Pisanu, Shungo Imai, Masami Tsuchiya, Mika Inoue, Keisuke Ikegami, Gianpaolo Zammarchi, Hayato Kizaki, Satoko Hori

European Journal of Clinical Pharmacology December 22, 2025 DOI: 10.1007/s00228-025-03954-z (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Observational study Peer reviewed
Intervention Esketamine
Topics Esketamine
Keywords Pharmacovigilance Adverse effect Intensive care medicine Pharmacology Drug interaction Risk assessment Medline
Citations 3
Key findings Esketamine is associated with potential adverse effects and drug-drug interaction signals in a real-world setting.

Abstract

Our results increase knowledge on potential risks related to esketamine AEs and potential drug-drug interaction signals in a real-world setting.

Comparable studies

Other observational and cohort studies on esketamine, most cited first.

Study Year Design Participants
Treating bipolar depression with esketamine: Safety and effectiveness data from a naturalistic multicentric study on esketamine in bipolar versus unipolar treatment‐resistant depression Patients with treatment-resistant bipolar depression (B-TRD) and unipolar... 2023 Observational cohort n = 70
Comparative Effectiveness of Intravenous Ketamine and Intranasal Esketamine in Clinical Practice Among Patients With Treatment-Refractory Depression: An Observational Study. Adults with treatment-resistant depression 2023 Observational study n = 62
Predicting outcome with Intranasal Esketamine treatment: A machine-learning, three-month study in Treatment-Resistant Depression (ESK-LEARNING) Treatment-resistant depression patients 2023 Retrospective, multicentric, real-world study n = 149
Esketamine in treatment-resistant depression patients comorbid with substance-use disorder: A viewpoint on its safety and effectiveness in a subsample of patients from the REAL-ESK study Patients with treatment-resistant depression and a substance use disorder 2023 Observational, retrospective, multicentre study n = 26
Rapid infusion of esketamine for unipolar and bipolar depression: a retrospective chart review Patients with treatment-resistant depression and bipolar depression meeting DSM-IV-TR... 2017 Retrospective observational study n = 27

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