ArticleFrontiers in cellular and infection microbiology2025
A pharmacovigilance study on probiotic preparations based on the FDA Adverse Event Reporting System from 2005 to 2023.
Article in Frontiers in cellular and infection microbiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Clinical Guidance and Practical Recommendations for Probiotic Use in Patients With Irritable Bowel Syndrome, Functional Constipation, andJournal of neurogastroenterology and motility · 2026Review
- Clinical guidance and practical recommendations for probiotic use in patients with irritable bowel syndrome, functional constipation, and Clostridioides difficile infection considering sex-based differences: a Korean translation.Ewha medical journal · 2026Article
- Current Concepts in Probiotic Safety and Efficacy.Nutrients · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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. Methods: 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. Results: 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 Gastrointestinal disorders (N=97, ROR=5.3, PRR=3.84, EBGM=3.84) and Hepatobiliary disorders (N=9, ROR =3.39, PRR=3.32, EBGM=3.32). PTs included Gastrointestinal pain (ROR=77.76, PRR=76.69, EBGM=76.63), Hypophagia (ROR=24.13, PRR=23.88, EBGM=28.88), and Hepatobiliary disorders (N=97, ROR=5.3, PRR=3.84, EBGM=3.84) and Flatulence (ROR=23.75, PRR=23.28, EBGM=23.27) were the top four highest. Meanwhile, s found new unique adverse signals such as Agitation (ROR=12.48, PRR=12.32, EBGM=12.32) and Anxiety (ROR=4.10, PRR=4.04, EBGM=4.04). Additionally, subgroup analyses were performed to identify AE signals based on gender and age. Metabolism and nutrition disorders (N=6, ROR=3.21, PRR=3.04, EBGM=3.04) and Asthenia (N=3, ROR=5.9, PRR=5.71, EBGM=5.71) were unique AE signal for the male group. Conclusion: Although, the risk of adverse reactions arising from the application of probiotics cannot be ignored. However, However, the results of this FAERS-based study continue to support the overall safety of probiotic preparations. It is necessary to pay attention to the potential influence of factors such as gender and age on the effects and adverse reactions of probiotic application in basic research and clinical application.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.