ORIGINAL RESEARCH article
Front. Cell. Infect. Microbiol.
Sec. Intestinal Microbiome
Volume 15 - 2025 | doi: 10.3389/fcimb.2025.1455735
This article is part of the Research TopicInsights of Probiotics and Fermented Diet on Gut MicrobiomeView all 5 articles
A Pharmacovigilance Study on Probiotic Preparations Based on the FDA Adverse Event Reporting System (FAERS) from 2005 to 2023
Provisionally accepted
Yitong Wang1
Weifu Tan1
Xuyang Li1,2Guangli Yang1Yunxiao Wang1,2Jing Liao1Aner Lu1Guoqing Zhang1Kuidai Chen1
Liling Yang1Wei Li1*- 1Dongguan Binhaiwan Central Hospital, Dongguan, China
- 2Jinan University, Guangzhou, Guangdong Province, China
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Background: Probiotics are recognized as beneficial foods, but adverse reactions reported by individuals still exist. This study aims to analysis adverse events (AE) related to probiotics from the FAERS database from the first quarter (Q1) of 2005 to the fourth quarter (Q4) of 2023.The AE data related to probiotic from the 2005 Q1 to the 2023 Q4 were collected. R language was applied to analyze the standardized AE data and three algorithms including the reporting odds ratio (ROR), the proportional reporting ratio (PRR) and the empirical Bayes geometric mean (EBGM) were used to identify AE signals.In this study, 10,698,312 reports were collected from the FAERS database, of which 74 probiotic-related adverse events were reported. About one third of the reported cases were older than 60 years.36.36% of the reported cases required Hospitalization. A total of 285 preference terms (PTS) and 15 system organ classes (SOC) were identified. In the overall analysis, only 9 PTs and 2 SOCs met significant disproportionality for all three algorithms simultaneously. SOCs included
Keywords: probiotic, FAERS, Pharmacovigilance, adverse events, adverse drug reactions, gender, Age Pharmacovigilance Study on Probiotic Gastrointestinal disorders (N=97, ROR=5.3
Received: 27 Jun 2024; Accepted: 23 Apr 2025.
Copyright: © 2025 Wang, Tan, Li, Yang, Wang, Liao, Lu, Zhang, Chen, Yang and Li. 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: Wei Li, Dongguan Binhaiwan Central Hospital, Dongguan, China
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