ArticlePsychotherapy and psychosomatics2021
Post-Marketing Safety Concerns with Esketamine: A Disproportionality Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System.
Article in Psychotherapy and psychosomatics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 5 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
66 citing papers in PubMed, 5 syntheses or guidelines pooled it, 123 citations in OpenAlex.
- Dose-dependent adverse events of esketamine in treatment-resistant depression: a systematic review and meta-analysis of randomized controlled trials.Frontiers in pharmacology · 2026Pooled it
- Pooled it
- Efficacy of racemic ketamine or esketamine monotherapy for reducing suicidal ideation in uni- or bipolar depression: a systematic review and meta-analysis.European archives of psychiatry and clinical neuroscience · 2025Pooled it
- Comparative safety and tolerability of ketamine and esketamine for major depressive disorder: a systematic review and meta-analysis.Frontiers in pharmacology · 2025Pooled it
- Ventromedial prefrontal cortex/anterior cingulate cortex Glx, glutamate, and GABA levels in medication-free major depressive disorder.Translational psychiatry · 2021Pooled it
- The median effective dose of esketamine with different doses of oliceridine during hysteroscopic surgery.Frontiers in pharmacology · 2025Trial
- Effects of Remimazolam Tosilate Combined with Esketamine on Anesthetic Efficacy and Psychiatric Symptoms in Patients Undergoing Ambulatory Surgery: A Randomized Controlled Study.Drug design, development and therapy · 2025Trial
- Esketamine Combined with Dexmedetomidine to reduce Visceral Pain During elective Cesarean Section Under Combined Spinal-Epidural Anesthesia: A double-Blind Randomized Controlled Study.Drug design, development and therapy · 2024Trial
- Esketamine Use and Attempted Suicide or Intentional Self-Harm Among Individuals with Treatment-Resistant Depression: A Retrospective Cohort Study.Drug safety · 2026Article
- Adverse drug events and toxicological mechanisms of esketamine: a study based on US Food and Drug Administration Adverse Event Reporting System and network toxicology analysis.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Intranasal administration in modulating depressive-like behavior and reconstructing treatment paradigms through neuroinflammation and neurotrophic pathways.Journal of nanobiotechnology · 2026Review
- Post-marketing safety of lecanemab: a real-world study based on FAERS database, multicenter cohort and network pharmacology.Frontiers in psychiatry · 2026Article
- A real-world pharmacovigilance study of adverse events associated with esketamine: disproportionality analysis and detection of potential drug-drug interaction signals.European journal of clinical pharmacology · 2025Article
- Post-marketing safety profile and clinical prioritization of adverse events with avacopan in ANCA-associated vasculitis: a FAERS pharmacovigilance analysis.Renal failure · 2025Article
- The post-marketing safety of Esketamine among older adults(≥ 65): an real-world pharmacovigilance study.BMC pharmacology & toxicology · 2025Article
- The correlation of Esketamine with specific adverse events: a deep dive into the FAERS database.European archives of psychiatry and clinical neuroscience · 2025Article
- 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) · 2025Article
- Patient Experience with Intranasal Esketamine in Treatment-Resistant Depression: Insights from a Multicentric Italian Study (REAL-ESKperience).Journal of personalized medicine · 2025Article
- Long-term surveillance of the anti-amyloid monoclonal antibody lecanemab: rights and duties of pharmacovigilance.Alzheimer's research & therapy · 2025Article
- Reply: [Post-marketing safety concerns with Lecanemab: a disproportionality analysis using the FDA adverse event reporting system].Alzheimer's research & therapy · 2025Article
6 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEsketamine nasal spray received approval for treatment-resistant depression in March 2019.
objectiveUsing the FDA Adverse Event Reporting System (FAERS) database (March 2019-March 2020), we analysed esketamine-related adverse events (AEs) to detect and characterize relevant safety signals.
methodsWe 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 ≥4 counts. Comparisons between serious and non-serious AEs were performed using non-parametric tests.
resultsThe 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 (χ2 = 125.29, p < 0.001, χ2 = 9.08, p = 0.003, χ2 = 8.14, p = 0.004, χ2 = 19.48, p < 0.001, χ2 = 25.62, p < 0.001, and χ2 = 16.79, p < 0.001, respectively).
conclusionsEsketamine may carry a clear potential for serious AEs, which deserves urgent clarification by means of further prospective studies.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.