Background: Irbesartan is widely used for hypertension management, but its relationship with erectile dysfunction (ED) is unclear. This study combines real-world data from the FAERS database with Mendelian randomization to explore this potential association. Methods: We conducted multiple pharmacovigilance analyses, including odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Gamma-Poisson Shrinker (GPS), to assess the association between irbesartan and ED. Additionally, Mendelian randomization was applied to investigate the causal relationship. Results: The pharmacovigilance analyses indicated a significant association between irbesartan and ED: ROR = 3.38 (95% CI: 2.36-4.84), PRR = 3.38 (95% CI: 2.36-4.83), IC = 1.75 (95% CI: 1.13-2.17), and EBGM = 3.37 (95% CI: 2.36-4.83). Mendelian randomization analysis also showed a significant correlation using the inverse variance weighting method (P = .01, β = 10.06, SE = 3.91), with other methods yielding consistent directional results. Conclusion: Our study reveals a significant association and potential causal link between irbesartan use and ED. These findings highlight the need to consider ED as a possible adverse effect when prescribing irbesartan. Further research and clinical monitoring are essential to understand the underlying mechanisms and develop strategies to mitigate this side effect.
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