Comprehensive analysis of adverse events associated with vortioxetine using the FDA adverse event reporting system

Our study identified potential new AE signals, offering a broader understanding of the safety profile of vortioxetine, and providing valuable references for its clinical monitoring and further research. It should be noted that nearly half of the reports originated from patients, highlighting the value of patient-reported data in pharmacovigilance, but also reminding us of the need for cautious interpretation due to potential self-reporting biases.