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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1488469

Mining and analysis of dizziness adverse event signals in postoperative analgesia patients based on the FDA adverse event reporting system database

Provisionally accepted
Fengqi Zhou Fengqi Zhou 1Haiou He Haiou He 2Zhen Zhang Zhen Zhang 1*Jing Gao Jing Gao 1
  • 1 Xiang Yang No.1 People’s Hospital, Xiangyang, China
  • 2 Suizhou Hospital, Hubei University of Medicine, Suizhou, China

The final, formatted version of the article will be published soon.

    Objective:This study aimed to explore the association between drugs used in postoperative anesthesia patients and postoperative dizziness using the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database, along with other risk factors for dizziness.Using the FAERS database, we retrospectively analyzed dizziness cases reported between 2004 and the third quarter of 2023. We analyzed the relationship between drugs during postoperative anesthesia and the risk of postoperative dizziness, and conducted subgroup analysis according to age, gendersex and other factors. Signal detection was further performed using the reported odds ratio (ROR) method to identify medications significantly associated with an increased risk of postoperative dizziness.A total of 166,292 dizziness case reports were obtained, with 128 cases specifically related to postoperative analgesia. A total of 166,292 case reports of dizziness were obtained, of which 67 cases reported adverse reactions of dizziness during postoperative analgesia. The number of dizziness reports has been increasing yearly, with a higher concentration of cases among individuals aged 18 to 85 years, predominantly in female patients. The analysis identified that amitriptyline, clonazepam, and ketamine were significantly associated with an increased risk of dizziness, with RORs of 34.91, 17.39, and 7.37, respectively. Subgroup analyses revealed variations in the relative risk of dizziness based on sex and age groups.Overall, the number of reported cases of dizziness was increasing yearly, concentrated among people aged 18 to 85 years, and mainly female patients. The analysis results showed that amitriptyline, clonazepam, ketamine, and hydrocodone were significantly associated with increased risk of dizziness, with RORs of 34.909, 17.386, 7.373, and 4.643 respectively. Subgroup analysis results showed that the relative risk of dizziness during postoperative analgesia differed between gender and age groups. Ketamine may be associated with higher risk of dizziness in the adult male subgroup.The results of this study suggest that specific medications used by patients with postoperative analgesia are associated with an increased risk of postoperative dizziness.Future studies should further validate this finding and explore other potential risk factors.

    Keywords: Dizziness, Postoperative analgesia, FAERS, drug safety, Signal detection

    Received: 30 Aug 2024; Accepted: 23 Jan 2025.

    Copyright: © 2025 Zhou, He, Zhang and Gao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Zhen Zhang, Xiang Yang No.1 People’s Hospital, Xiangyang, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.