{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:03:25Z","timestamp":1789949005942,"version":"4.0.1"},"reference-count":32,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T00:00:00Z","timestamp":1788739200000},"content-version":"vor","delay-in-days":6,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Doxorubicin (DOX), an effective anticancer agent, is associated with dose\u2010dependent cardiovascular toxicity. Understanding its mechanisms and risk factors will facilitate novel interventions to minimize DOX\u2010induced cardiovascular toxicity. Thus, this study performed data mining of the FDA Adverse Event Reporting System (FAERS) to detect and analyze DOX\u2010induced cardiac\u2010related adverse events (AEs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data from 2004 to 2025, where DOX was the primary suspect, were extracted from FAERS via OpenVigil. Using the Medical Dictionary for Regulatory Activities, AEs were categorized into preferred terms (PTs) and system organ classes (SOCs). This study used descriptive analysis and signal detection algorithms including Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Multi\u2010item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 2421 reports of DOX\u2010associated AEs were extracted in FAERS. Reports primarily involved female cancer patients (55.02%) between 18and 65\u2009years (48.12%) from the United States. Most signals were of moderate to strong signal intensity, with cardiotoxicity, cardiac failure, and cardiomyopathy being the most reported. Interestingly, while cardiac disorders were mainly found to be strongly linked to DOX, novel vascular AEs like endothelial dysfunction were also among the top signals strongly associated with DOX. Out of the six serious AEs associated with DOX\u2010induced cardiotoxicities, \u201cDeath\u201d and \u201cInitial\/prolonged hospitalization\u201d were the most commonly reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study provides valuable insights into DOX\u2010induced cardiovascular toxicity using real\u2010world data from FAERS. Vascular events like endothelial dysfunction were shown to be significant novel AEs experienced by cancer patients undergoing treatment with DOX. Thus, careful monitoring of potential DOX\u2010AEs associations will help improve the risk\u2013benefit ratio of DOX\u2010treated patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70474","type":"journal-article","created":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T23:16:01Z","timestamp":1788822961000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Endothelial and Vascular Toxicity Signals Associated With Doxorubicin: A Pharmacovigilance Analysis of the\n                    <scp>FDA<\/scp>\n                    Adverse Event Reporting System (\n                    <scp>FAERS<\/scp>\n                    ) Database"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9352-027X","authenticated-orcid":false,"given":"Emelith Florendo","family":"Cerbito","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences College of Pharmacy, QU Health, Qatar University  Doha Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7859-8490","authenticated-orcid":false,"given":"Lana","family":"Kattan","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences College of Pharmacy, QU Health, Qatar University  Doha Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1234-2273","authenticated-orcid":false,"given":"Hevna","family":"Dhulkifle","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences College of Pharmacy, QU Health, Qatar University  Doha Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5745-9643","authenticated-orcid":false,"given":"Hesham M.","family":"Korashy","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences College of Pharmacy, QU Health, Qatar University  Doha Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0276-9916","authenticated-orcid":false,"given":"Zaid H.","family":"Maayah","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences College of Pharmacy, QU Health, Qatar University  Doha Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,7]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.016704"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yjmcc.2019.11.150"},{"issue":"5","key":"e_1_2_10_4_1","first-page":"827","article-title":"Adriamycin Cardiotoxicity: A Survey of 1273 Patients","volume":"63","author":"Praga C.","year":"1979","journal-title":"Cancer Treatment 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