Disproportionality evaluation of adverse effects and suicide/self-injury risk factors associated with vortioxetine: a large-scale pharmacovigilance study

The detected risk signals indicate only the statistical correlation between the target drug and the target adverse reaction and do not indicate the inevitable causal link between the drug and adverse response. Likely confounders include vortioxetine's preferential prescription in complex patient populations (attributed to its broad-spectrum efficacy and safety profile) rather than intrinsic drug effects. Future studies should consider controlling for these confounders to provide a more definitive assessment.