Emerging adverse event signals of new analgesic suzetrigine: a disproportionality analysis of the FAERS database.

IF 1.7 Q4 CLINICAL NEUROLOGY

Pain management Pub Date : 2026-09-01 Epub Date: 2026-05-17 DOI:10.1080/17581869.2026.2675485

Slobodan M Janković, Snežana V Janković

{"title":"Emerging adverse event signals of new analgesic suzetrigine: a disproportionality analysis of the FAERS database.","authors":"Slobodan M Janković, Snežana V Janković","doi":"10.1080/17581869.2026.2675485","DOIUrl":null,"url":null,"abstract":"Background: Suzetrigine, new non-opioid analgesic, does not cause respiratory depression and dependence, the main limiting factors for the use of opioids; however, its complete safety profile is not yet established.Objective: The aim of this study is first to review the adverse effects of suzetrigine published so far, and then to analyze the spontaneous reports of adverse events for suzetrigine in the FAERS database to identify possible signals of hitherto unknown adverse effects.Methods: The study's outcomes were the four standard disproportionality indices calculated for each adverse event reported: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Yule's Q, and Information Component (IC).Results: There are four signals of possible adverse effects of suzetrigine: paresthesia (ROR 19.62 ± 5.69, PRR 1.38 ± 0.36, IC 4.18 ± 0.41, Yules Q 0.90 ± 0.03), burning sensations (ROR 15.75 ± 7.26, PRR 2.43 ± 1.08, IC 3.93 ± 0.64, Yules Q 0.88 ± 0.05), a swollen tongue (ROR 13.04 ± 10.66, PRR 4.95 ± 4.00, IC 3.68 ± 1.08, Yules Q 0.86 ± 0.10), and abnormal dreams (ROR 23.49 ± 17.81, PRR 13.97 ± 10.44, IC 4.53 ± 1.01, Yules Q0.92 ± 0.06).Conclusions: After the first year of widespread use of suzetrigine, there are only a few signals of possible side effects that were not observed in clinical studies, of which paresthesias have the highest probability of being a real side effect.","PeriodicalId":20000,"journal":{"name":"Pain management","volume":" ","pages":"1003-1007"},"PeriodicalIF":1.7000,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540228/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain management","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/17581869.2026.2675485","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/5/17 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Suzetrigine, new non-opioid analgesic, does not cause respiratory depression and dependence, the main limiting factors for the use of opioids; however, its complete safety profile is not yet established.

Objective: The aim of this study is first to review the adverse effects of suzetrigine published so far, and then to analyze the spontaneous reports of adverse events for suzetrigine in the FAERS database to identify possible signals of hitherto unknown adverse effects.

Methods: The study's outcomes were the four standard disproportionality indices calculated for each adverse event reported: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Yule's Q, and Information Component (IC).

Results: There are four signals of possible adverse effects of suzetrigine: paresthesia (ROR 19.62 ± 5.69, PRR 1.38 ± 0.36, IC 4.18 ± 0.41, Yules Q 0.90 ± 0.03), burning sensations (ROR 15.75 ± 7.26, PRR 2.43 ± 1.08, IC 3.93 ± 0.64, Yules Q 0.88 ± 0.05), a swollen tongue (ROR 13.04 ± 10.66, PRR 4.95 ± 4.00, IC 3.68 ± 1.08, Yules Q 0.86 ± 0.10), and abnormal dreams (ROR 23.49 ± 17.81, PRR 13.97 ± 10.44, IC 4.53 ± 1.01, Yules Q0.92 ± 0.06).

Conclusions: After the first year of widespread use of suzetrigine, there are only a few signals of possible side effects that were not observed in clinical studies, of which paresthesias have the highest probability of being a real side effect.

查看原文本刊更多论文

新型镇痛药苏三嗪的新出现的不良事件信号：FAERS数据库的歧化分析。

背景：舒三嗪是新型非阿片类镇痛药，不会引起呼吸抑制和依赖，是阿片类药物使用的主要限制因素；然而，其完整的安全性尚未建立。目的：本研究的目的是首先回顾到目前为止发表的关于suzetriine的不良反应，然后分析FAERS数据库中关于suzetriine不良事件的自发报告，以识别迄今未知的不良反应的可能信号。方法：研究结果为每个不良事件报告计算的四个标准歧化指数：报告优势比（ROR）、比例报告比（PRR）、Yule’s Q和信息成分（IC）。结果:有四个信号suzetrigine可能的副作用:感觉异常(ROR 19.62±5.69,1.38±0.36 PRR、IC 4.18±0.41,圣诞问0.90±0.03),燃烧的感觉(ROR 15.75±7.26,PRR 2.43±1.08,3.93±0.64 IC,圣诞问0.88±0.05),舌头肿胀(ROR 13.04±10.66,PRR 4.95±4.00,3.68±1.08 IC,圣诞问0.86±0.10),和异常的梦想(ROR 23.49±17.81,PRR 13.97±10.44,4.53±1.01 IC,圣诞Q0.92±0.06)。结论：在广泛使用舒三嗪一年后，只有少数可能的副作用信号未在临床研究中观察到，其中感觉异常作为真正副作用的概率最高。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Pain management CLINICAL NEUROLOGY-

CiteScore

2.90

自引率

5.90%

发文量