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

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Title: The correlation of Esketamine with specific adverse events: a deep dive into the FAERS database.
Authors: Jiang, Ying (AUTHOR), Du, Zhiqiang (AUTHOR), Shen, Yuan (AUTHOR), Zhou, Qin (AUTHOR), Zhu, Haohao (AUTHOR)
Source: European Archives of Psychiatry & Clinical Neuroscience. Aug2025, Vol. 275 Issue 5, p1373-1381. 9p.
Subjects: Suicidal ideation, Adverse health care events, Pharmacy databases, Regulatory compliance, Risk assessment, Drugs, Medical practice, Intranasal medication
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. [ABSTRACT FROM AUTHOR]
Copyright of European Archives of Psychiatry & Clinical Neuroscience is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: The correlation of Esketamine with specific adverse events: a deep dive into the FAERS database.
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  Data: <searchLink fieldCode="AR" term="%22Jiang%2C+Ying%22">Jiang, Ying</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Du%2C+Zhiqiang%22">Du, Zhiqiang</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Shen%2C+Yuan%22">Shen, Yuan</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zhou%2C+Qin%22">Zhou, Qin</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zhu%2C+Haohao%22">Zhu, Haohao</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22European+Archives+of+Psychiatry+%26+Clinical+Neuroscience%22">European Archives of Psychiatry & Clinical Neuroscience</searchLink>. Aug2025, Vol. 275 Issue 5, p1373-1381. 9p.
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  Data: <searchLink fieldCode="DE" term="%22Suicidal+ideation%22">Suicidal ideation</searchLink><br /><searchLink fieldCode="DE" term="%22Adverse+health+care+events%22">Adverse health care events</searchLink><br /><searchLink fieldCode="DE" term="%22Pharmacy+databases%22">Pharmacy databases</searchLink><br /><searchLink fieldCode="DE" term="%22Regulatory+compliance%22">Regulatory compliance</searchLink><br /><searchLink fieldCode="DE" term="%22Risk+assessment%22">Risk assessment</searchLink><br /><searchLink fieldCode="DE" term="%22Drugs%22">Drugs</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+practice%22">Medical practice</searchLink><br /><searchLink fieldCode="DE" term="%22Intranasal+medication%22">Intranasal medication</searchLink>
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  Data: 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. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of European Archives of Psychiatry & Clinical Neuroscience is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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              Text: Aug2025
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