Disproportionality analysis of serotonin syndrome associated with selective serotonin reuptake inhibitors: a pharmacovigilance analysis.
Purpose: The incidence and risk of serotonin syndrome associated with selective serotonin reuptake inhibitors (SSRIs) have increased. However, large-scale studies investigating this relationship remain limited. Therefore, this study aims to evaluate the signal detection between six SSRIs and seroton...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 81; no. 8; pp. 1167 - 1176 |
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| Autores principales: | , , , , , , , , , , |
| Formato: | equations & formulas research tables/charts Journal Article |
| Publicado: |
Springer Nature
Aug2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=186782426&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 186782426 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Aug2025 vid: 81 iid: 8 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 186782426 185721172 186782426 186782426 10.1007/s00228-025-03856-0 186782426 ppf: 1167 ppct: 9 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Disproportionality analysis of serotonin syndrome associated with selective serotonin reuptake inhibitors: a pharmacovigilance analysis. aug: au: Choi, Taelim Oh, Jeongseon Cho, Jaehyeong Park, Jaeyu Kim, Tae Hyeon Kang, Jiseung Hajek, André Kim, Jaewon Woo, Selin Hwang, Yerin Yon, Dong Keon affil: https://ror.org/01zqcg218 Center for Digital Health, Medical Science Research Institute, Kyung Hee University College of Medicine, Seoul, South Korea sug: subj: Serotonin Syndrome Risk Factors Serotonin Uptake Inhibitors Adverse Effects Pharmacovigilance Risk Assessment Adverse Drug Event Funding Source Human Male Female Descriptive Statistics Odds Ratio Confidence Intervals Hyperthermia Prevalence Nervous System Diseases Recovery Data Analysis Software Male Female ab: Purpose: The incidence and risk of serotonin syndrome associated with selective serotonin reuptake inhibitors (SSRIs) have increased. However, large-scale studies investigating this relationship remain limited. Therefore, this study aims to evaluate the signal detection between six SSRIs and serotonin syndrome, rank their relative risks, and propose practical preventive strategies. Methods: This study utilized the global pharmacovigilance database, which systematically compiles adverse drug reaction reports from over 140 countries. The analysis focused on individuals diagnosed with serotonin syndrome associated with SSRIs, classified under the Anatomical Therapeutic Chemical code 'N06AB' and categorized into six types. A disproportionality analysis was conducted using the information component (IC) with IC0.25 and the reporting odds ratio (ROR) with 95% confidence interval (CI) to assess the signal detection between serotonin syndrome and SSRIs. Results: Among 35 million reports, 24,674 reports of serotonin syndrome were identified from 1968 to 2024, including 4,035 associated with SSRIs. Sertraline (24.46%) was the most frequently implicated SSRI. All SSRIs indicated a significant signal detection with serotonin syndrome, with citalopram exhibited the highest signal (ROR: 77.29 [95% CI, 71.63–83.40]; IC: 6.13 [IC025, 6.01]). Hyperthermia and neurological manifestations were the most prevalent. The median time to onset was one day. Recovery rate was 62.21%, and mortality was 0.25%. Conclusion: The findings underscore the potential signal detection between SSRIs and serotonin syndrome. Results also highlight the need to strengthen prevention and management to mitigate associated risks, while long-term studies on serotonin syndrome are essential for improving patient safety and optimizing treatment. pubtype: Academic Journal doctype: equations & formulas research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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