Mining and disproportionality analysis of adverse events signals for naltrexone based on real-world data from the FAERS database.

Background: This study aims to analyze adverse events (AEs) associated with naltrexone based on the FAERS database, providing a foundation for its safety monitoring.

Research design and methods: Disproportionality analysis methods, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) algorithms, were employed to quantify signals of naltrexone-related AEs.

Results: AEs related to naltrexone from the first quarter of 2013 to the fourth quarter of 2023 were extracted from the FAERS database for detailed analysis. Among a total of 41,757,311 reports 28,745 were directly associated with naltrexone, involving 27 organ systems. We identified 110 positive signals for AEs at the preferred term (PT) level using disproportionality analysis, which included known AEs such as agitation, depressed mood, sleep disorder, tremor, delirium, and decreased libido. Additionally, our findings suggested potential risks of restless legs syndrome, eosinophilic pneumonia, and otolithiasis, which were not mentioned in the drug's label, thereby supplementing the existing safety information.

Conclusions: The analysis of the FAERS database identified AEs associated with naltrexone, contributing to the awareness of clinical practitioners and pharmacists regarding the drug-related risk signals. This awareness facilitates timely preventive and therapeutic measures, ensuring patient safety.