
This study aims to determine the safety profile of oral PDE5is with a particular focus on priapism and malignant melanoma. A total of 94,713 ICSRs for PDE5is were extracted. 31,827 ICRS were identified relating to adult men taking oral sildenafil, tadalafil, vardenafil, or avanafil for sexual dysfunction. The most common ADRs included poor drug efficacy, headache, abnormal vision, flushing, and dyspepsia. PDE5is show significant signals correlating with priapism among a large international cohort.
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