Objective  To analyze adverse drug event (ADE) signals associated with exenatide based on data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), and to provide insights for rational medication use in clinical settings.

Methods ADE reports of exenatide as the primary suspected drug were obtained by collecting the data of FAERS database from the first quarter 2014 to the second quarter 2024. ADE signals were analyzed by joint reporting odds ratio (ROR) method, proportional reporting odds ratio (PRR) method, Bayesian confidence interval progressive neural network (BCPNN) method and multi-item gamma Poisson shrinker (MGPS) method.

Results  After data cleaning, 118  745 reports of exenatide-related ADEs were collected. These ADEs spanned 14 system-organ classes and involved 185 preferred terms. Commonly reported ADEs included reactions at the injection site, hypoglycemia, reduced appetite, and cholelithiasis. Severe ADEs were primarily cases of acute pancreatitis, in consistent with the drug’s labeling. Moreover, the instructions did not record ADE signals of pancreatic cancer, thyroiditis, and reduced frustration tolerance.

Conclusion Prescription of the exenatide should be vigilant about the signals not listed on the product labeling, such as pancreatic cancer, thyroid cancer, and decreased frustration tolerance, to improve the safety of medication use in patients.

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