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. 2025 Jul 8:16:1557691.
doi: 10.3389/fphar.2025.1557691. eCollection 2025.

Glucagon-like peptide-1 receptor agonist-induced cholecystitis and cholelithiasis: a real-world pharmacovigilance analysis using the FAERS database

Chao Tao #  1   2 , Yinhui Zhang #  1   2 , Tenggang Wan #  3 , Wenting Zhao  2 , Jing Chen  4 , Ke Wang  1   2 , Liuxuan Yang  1 , Guojun Wang  1 , Qian Ding  4 , Jinlu Shang  5 , Meiling Zhou  1
Affiliations

Glucagon-like peptide-1 receptor agonist-induced cholecystitis and cholelithiasis: a real-world pharmacovigilance analysis using the FAERS database

Chao Tao et al. Front Pharmacol. .

Abstract

Background: With the widespread use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in managing diabetes and obesity, the occurrence of GLP-1 RA-induced cholecystitis and cholelithiasis has raised increasing concern among healthcare professionals.

Methods: This study extracted adverse event reports of GLP-1 RA-induced cholecystitis and cholelithiasis from the FDA Adverse Event Reporting System database, covering Q1 2004 to Q2 2024. Disproportionality analysis methods, including the reporting odds ratio, proportional reporting ratio, and Bayesian confidence propagation neural network, were employed to identify associations between GLP-1 RAs and these AEs. The analysis focused on the five most commonly prescribed GLP-1 RAs, evaluated at both high-level term and preferred term levels.

Results: A total of 1,829 reports were identified in which GLP-1 RAs were listed as the primary suspect drug, involving 1,651 patients. All three signal detection methods indicated a positive signal between GLP-1 RAs and these conditions. The majority of cases occurred in patients aged 45 years and older, with a significantly higher prevalence in females. The median onset time of GLP-1 RA-induced cholecystitis and cholelithiasis was 182 days, with variations observed across different drugs, genders, and age groups.

Conclusion: This study provides a comprehensive pharmacovigilance analysis of GLP-1 RA-induced cholecystitis and cholelithiasis, offering valuable insights into the prevention and management of these AEs.

Keywords: FAERS; cholecystitis; cholelithiasis; disproportionality analysis; glucagon-like peptide-1 receptor agonists; pharmacovigilance.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
The flow chart of the study.
FIGURE 2
FIGURE 2
Overview of AE reports related to cholecystitis and cholelithiasis in the FAERS database. (a) Annual number of AE reports. (b) Gender distribution of patients. (c) Age distribution of patients. (d) Occupational distribution of reporters. (e) Top 10 countries by the number of reports. (f) Outcome distribution of AEs in patients.
FIGURE 3
FIGURE 3
(a) Median onset time of GLP-1 RA-induced cholecystitis and cholelithiasis. (b) Proportional distribution of GLP-1 RA-induced cholecystitis and cholelithiasis incidence across various time intervals. Red blocks indicate significant associations between cholecystitis and cholelithiasis and specific time periods, while grey blocks denote weak associations. (c) Median onset time of GLP-1 RA-induced cholecystitis and cholelithiasis across different genders and age groups. Red blocks indicate shorter median onset times, while grey blocks denote longer median onset times.
FIGURE 4
FIGURE 4
Reporting proportions at the HLT and PT levels. Red blocks indicate significant associations between cholecystitis and cholelithiasis and their corresponding PT, while grey blocks denote non-significant associations.
FIGURE 5
FIGURE 5
AE signal detection results for GLP-1 RAs associated with cholecystitis and cholelithiasis, based on (a) ROR, (b) PRR, and (c) BCPNN. (d) The number of positive drugs identified by the ROR, PRR, and BCPNN methods.
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