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The correlation of Esketamine with specific adverse events: a deep dive into the FAERS database

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European Archives of Psychiatry and Clinical Neuroscience Aims and scope Submit manuscript

Abstract

Analyzing the vast data from FAERS database to evaluate the association between Esketamine and specific adverse events to guide clinical practice and regulatory decisions. Data related to Esketamine adverse events from 2019 Q1 to 2023 Q1 were collected from FAERS database. After data standardization, various signal quantification technologies, such as ROR, PRR, BCPNN, and MGPS, were employed to identify and evaluate adverse reaction signals closely related to the use of Esketamine comprehensively. A total of 5061 reports with Esketamine as the primary suspected drug were obtained, identifying 117 adverse reaction terms (PT) involving 27 system organ class (SOC) categories. Apart from the adverse events already mentioned in the drug’s instructions, this study identified some new, clinically valuable potential AE signals, such as Flashback, Tachyphylaxis, and Autoscopy. In addition, high-ranking results included euphoric mood, feeling of relaxation, and feeling drunk. Notably, the occurrence frequencies of suicidal ideation and suicide attempt were relatively high, so clinicians should be particularly vigilant about these potential adverse reactions when using Esketamine. Moreover, since this drug is administered as a nasal spray, issues such as drug monitoring procedure incorrectly performed and nasal discomfort may arise. This study underscores the potential adverse reactions and risks of Esketamine in clinical applications, especially regarding long-term efficacy, addiction risks, and suicidal risks.

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Availability of data and materials

The dataset generated during and analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

This study was performed using the FAERS source that was provided by the FDA. The information, results, or interpretation of the current study do not represent any opinion of the FDA.

Funding

The work is supported by the National Natural Science Foundation of China (No. 82104244), Wuxi Municipal Science and Technology Bureau (K20231039 and K20231049), Top Talent Support Program for young and middle-aged people of Wuxi Health Committee (HB2023088), Scientific Research Program of Wuxi Health Commission (No. Q202101 and ZH202110), Wuxi Taihu Talent Project (No. WXTTP2021) and Medical Key Discipline Program of Wuxi Health Commission (No. FZXK2021012).

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Authors and Affiliations

  1. Mental Health Center of Jiangnan University, Wuxi Central Rehabilitation Hospital, Wuxi, 214151, Jiangsu, China

    Ying Jiang, Zhiqiang Du, Yuan Shen, Qin Zhou & Haohao Zhu

Authors
  1. Ying Jiang
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  2. Zhiqiang Du
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  3. Yuan Shen
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  4. Qin Zhou
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  5. Haohao Zhu
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Contributions

YJ, HZ: conceived the study; YJ, ZD, QZ and YS: collected the report; YJ, QZ and HZ: wrote the manuscript and edited the manuscript. All authors have approved publishment of the manuscript.

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Correspondence to Haohao Zhu.

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Jiang, Y., Du, Z., Shen, Y. et al. The correlation of Esketamine with specific adverse events: a deep dive into the FAERS database. Eur Arch Psychiatry Clin Neurosci (2023). https://doi.org/10.1007/s00406-023-01732-5

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  • DOI: https://doi.org/10.1007/s00406-023-01732-5

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