{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T18:39:28Z","timestamp":1792003168468,"version":"4.4.0"},"reference-count":41,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2023,9,19]],"date-time":"2023-09-19T00:00:00Z","timestamp":1695081600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100003392","name":"Natural Science Foundation of Fujian Province","doi-asserted-by":"publisher","award":["2022J05298"],"award-info":[{"award-number":["2022J05298"]}],"id":[{"id":"10.13039\/501100003392","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Andrology"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Sildenafil, a selective inhibitor of phosphodiesterase type 5 (PDE5), is widely used for the treatment of erectile dysfunction (ED). However, the safety profile of sildenafil, including adverse event (AEs), requires comprehensive evaluation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This retrospective pharmacovigilance study aimed to evaluate AEs linked to sildenafil by analyzing data sourced from the FDA Adverse Event Reporting System (FAERS) database. A case\/non\u2010case design was utilized, and various algorithms including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multiitem gamma Poisson shrinker (MGPS) were employed to measure the signals indicating the presence of sildenafil\u2010related AEs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 339,230 reports, 33,692 specifically mentioned sildenafil use. Most of AEs occurred in males over 60 years old. The United States accounted for the highest proportion of reported AEs. Severe outcomes, including death, disability, and life\u2010threatening events, were reported. Significant system organ class (SOC) included \u201cReproductive system and breast disorders\u201d (SOC: 10038604), \u201cNeoplasms benign, malignant and unspecified\u201d (SOC: 10038738), \u201cVascular disorders\u201d (SOC: 10047065), and \u201cBlood and lymphatic system disorders\u201d (SOC: 10005329). Noteworthy preferred terms (PTs) associated with sildenafil included \u201cVision blurred,\u201d \u201cFlushing,\u201d \u201csudden hearing loss,\u201d \u201cPainful erection,\u201d and \u201cPriapism.\u201d Unexpected AEs, such as \u201cMalignant melanoma,\u201d \u201cPulmonary hypertension,\u201d \u201cMalignant melanoma in situ,\u201d \u201cPulmonary arterial hypertension,\u201d \u201cMetastatic malignant melanoma,\u201d \u201cMalignant melanoma stage III,\u201d \u201cMalignant melanoma stage II,\u201d \u201cAcquired hemophilia,\u201d \u201cAortic dissection rupture,\u201d and \u201cIntracranial artery dissection\u201d were also identified.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These findings emphasize the importance of monitoring and understanding the potential risks associated with sildenafil. Further investigation is warranted to validate these associations and address previously unrecognized safety concerns.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/andr.13533","type":"journal-article","created":{"date-parts":[[2023,9,19]],"date-time":"2023-09-19T07:14:50Z","timestamp":1695107690000},"page":"785-792","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":72,"title":["A real\u2010world pharmacovigilance study of FDA adverse event reporting system events for sildenafil"],"prefix":"10.1111","volume":"12","author":[{"given":"Yan","family":"Wang","sequence":"first","affiliation":[{"name":"Medical Reproductive Center People's Hospital of Jiuquan City  Jiuquan Gansu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin","family":"Zhao","sequence":"additional","affiliation":[{"name":"Xiamen Health and Medical Big Data Center  Xiamen China"},{"name":"Xiamen Medicine Research Institute  Xiamen 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