ArticleBMC pharmacology & toxicology2025
The post-marketing safety of Esketamine among older adults(≥ 65): an real-world pharmacovigilance study.
Article in BMC pharmacology & toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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
2 citing papers in PubMed.
- Pleiotropic modulation of the gut-brain-lung axis by ketamine and its enantiomers.Molecular psychiatry · 2026Review
- The effect of esketamine on perioperative neurocognitive dysfunction in elderly patients undergoing gastrointestinal tumor surgery: a randomized double-blind controlled study.Frontiers in medicine · 2025Article
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
aimsThis study aims to investigate the safety profile of Esketamine, with a particular focus on comparing adverse events (AEs) between adults (< 65 years) and older adults (≥ 65 years) using data from the FDA Adverse Event Reporting System (FAERS).
methodsWe conducted a comprehensive analysis of FAERS data from 2019 to 2024, identifying 6,452 Esketamine-related AE reports. After removing data without age information, these reports were categorized into two age groups: 536 from older adults and 3,566 from younger adults. Reporting odds ratios (RORs) were calculated to determine the relative risk of specific AEs in each age group.
resultsAt system Organ Class (SOC)level, the Esketamine-related AEs of both adults group and older adults group were seen in 17 organ systems. The analysis revealed significant differences in AE profiles of psychiatric disorders between the two age groups. Older adults had a higher incidence of dissociation, suicidal ideation, depression, and anxiety, compared to younger adults. Additionally, older adults reported more general and administration site conditions, suggesting a greater susceptibility to systemic and local reactions. Gastrointestinal and respiratory disorders were less frequent in older adults, but their potential impact remains critical.
conclusionsThe findings highlight a higher risk of severe psychiatric and general AEs in older adults treated with Esketamine, necessitating careful patient selection, monitoring, and tailored treatment protocols.
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