{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T22:44:43Z","timestamp":1777934683131,"version":"3.51.4"},"reference-count":36,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T00:00:00Z","timestamp":1751500800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Oncol Pharm Pract"],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Antineoplastic agents can cause oral toxicity, including \u201cantineoplastic agents-associated stomatitis\u201d (AAS) and \u201cantineoplastic agents-associated oral Candidiasis\u201d (AAOC), in children, adults, and older cancer patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To identify the risk of AAS and AAOC associated with using antineoplastic agents.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The FDA FAERS database for spontaneously reported adverse effects of \u201cantineoplastic agents\u201d was searched and analysed for the occurrence of the MedDRA preferred term \u201cstomatitis\u201d and \u201coral Candidiasis\u201d using \u201cquantitative safety signal analysis\u201d, which contains spontaneous safety reports collected from 1976 to the end of 2021.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The results of stomatitis in 27477 and oral candidiasis in 3136 case reports from the FDA database, which received antineoplastic agents during the treatment process. Among all three age groups studied, 4 and 7 antineoplastic agents were strongly associated with the occurrence of AAOC and AAS, respectively (reported odds ratio [ROR]\u2009&gt;\u2009100), and the lowest association with AAOC and AAS was reported in 19 and 33 antineoplastic agents, respectively (ROR &lt; 1).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>There are several limitations to providing information on the side effects of new antineoplastic agents in drug databases. Signal detection in pharmacovigilance is a process in which safety issues, including possible drug-related side effects, are investigated. Our study highlights the gap in the database regarding the potential risk of AAOC and AAS, as reported by the FDA for new drugs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10781552251354840","type":"journal-article","created":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T04:02:34Z","timestamp":1751515354000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Exploring the potential relationship between antineoplastic agents and their association with stomatitis and oral candidiasis in cancer patients"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9173-2853","authenticated-orcid":false,"given":"Ali","family":"Amanati","sequence":"first","affiliation":[{"name":"Clinical Research Development Center, Amir Oncology Teaching Hospital, Shiraz University of Medical Sciences, Shiraz, Iran"},{"name":"Professor Alborzi Clinical Microbiology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robbert Van","family":"Manen","sequence":"additional","affiliation":[{"name":"Signalman Safety Consulting, Kattendijke, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laleh","family":"Mahmoudi","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran"},{"name":"Health Policy Research Center, Institute of Health, Shiraz University of Medical Sciences, Shiraz, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hafez","family":"Shojaadini","sequence":"additional","affiliation":[{"name":"Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seyed Reza","family":"Abdipour Mehrian","sequence":"additional","affiliation":[{"name":"Clinical Research Development Center, Amir Oncology Teaching Hospital, Shiraz University of Medical Sciences, Shiraz, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohadese","family":"Boroughani","sequence":"additional","affiliation":[{"name":"Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,7,3]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1155\/2014\/581795"},{"key":"e_1_3_4_3_2","article-title":"Oral complications of chemotherapy: a review","volume":"3","author":"Venkatesh C","year":"2015","unstructured":"Venkatesh C, Jani M, Shah A. 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