Analysis of Duloxetine-Related Adverse Events Using the Food and Drug Administration Adverse Event Reporting System: Implications for Monitoring and Management.

Background: The objective of this study was to examine the characteristics of adverse drug reactions of duloxetine and investigate the potential precautions that may exist beyond the drug label.

Methods: This study used data from the Food and Drug Administration Adverse Event Reporting System database 2004-2023 and the linked information of duloxetine. Four algorithms used to evaluate the correlation between duloxetine and adverse events include reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker.

Results: Adverse reactions involving duloxetine were associated with 24 System Organ Classes. Among them, the three most frequent systems affected were psychiatric disorders (reporting odds ratio [ROR] 5.05), nervous system disorders (ROR 2.27), and general medical conditions and administration site conditions (ROR 0.83). Of particular note, the number of reported cases and the risk of occurrence of adverse events of drug withdrawal syndrome (n = 7498), nausea (n = 7942), and headache (n = 5732) were the highest, increasing each year and reached a peak submission in 2017. More importantly, the occurrence of reproductive system and breast disorders (chisq 317.85) was not mentioned in the drug leaflet.

Conclusions: Psychiatric and nervous system disorders are the most frequently reported adverse events associated with duloxetine, with drug withdrawal syndrome, nausea, and headache being especially common. The emergence of mood-related symptoms, such as agitation and irritability, underscores the need for vigilant monitoring of mental health. Additionally, potential risks affecting the reproductive system suggest areas for further attention. These findings highlight the importance of proactive monitoring to improve patient safety during duloxetine treatment.