Mining and Analysis of Adverse Event Signals Related to Probiotic Preparations Based on FAERS

OBJECTIVE  To mine the risk signals of adverse events associated with probiotics based on the Food and Drug Administration adverse event reporting system(FAERS) database.

METHODS  Data on adverse events related to probiotics reported in the FAERS database from the first quarter of 2004 to the fourth quarter of 2023 were collected. Records with probiotics as the primary suspect were selected for analysis. Data mining was conducted using the reporting odds ratio method and the medicines and health care products regulatory agency method within the disproportionality analysis.

RESULTS  A total of 63 reports with probiotics as the primary suspect were obtained, reporting 257 adverse events. Thirteen signals of adverse events related to probiotics were identified according to the disproportionality analysis, involving six system organ classes, primarily centered on gastrointestinal disorders. Some adverse events were not documented in the package inserts of probiotics approved in China, necessitating more evidence to establish causality between probiotics and these adverse events.

CONCLUSION  Although the number of reports of adverse events related to probiotics in FAERS is relatively low, some signals of adverse events are identified. This study provides important reference information for the management of adverse events of probiotics.