{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T00:01:01Z","timestamp":1760140861046,"version":"build-2065373602"},"reference-count":18,"publisher":"Wiley","license":[{"start":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T00:00:00Z","timestamp":1759968000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>This real\u2010world pharmacovigilance study utilizes FDA Adverse Event Reporting System (FAERS) data (2004\u20132024) to characterize age\u2010related disparities in hydroxychloroquine (HCQ)\u2010associated adverse events (AEs), addressing gaps in age\u2010stratified risk assessment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Disproportionality analysis (reporting odds ratios, RORs) and parametric Weibull modelling were applied to compare AE signals and time\u2010to\u2010onset profiles between paediatric (\u226418\u2009years; <jats:italic>n<\/jats:italic>\u2009=\u20091744) and geriatric (\u226560\u2009years; <jats:italic>n<\/jats:italic>\u2009=\u200914\u2009115) populations from 22\u2009249\u2009476 HCQ\u2010related reports.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Paediatric AEs exhibited significantly earlier onset (median 9.5\u00a0days <jats:italic>vs<\/jats:italic>. 19\u2009days). Ten novel paediatric\u2010specific signals were identified, including COVID\u201019\u2010related cardiotoxicity (ROR\u2009=\u20093.26, 95% confidence interval [CI] 1.87\u20136.94) and hypokalaemia complications (ROR\u2009=\u200925.77, 95% CI 18.7\u201335.52), with distinct reporting patterns compared to geriatric cohorts. Weibull shape parameters revealed divergent risk trajectories: constant hazard profiles in children (\u03b1\u2009=\u20090.52, \u03b2\u2009=\u200946.68) contrasted with escalating risks in older adults (\u03b1\u2009=\u20090.40, \u03b2\u2009=\u200993.66), suggesting mechanistic differences in toxicity progression.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Significant age\u2010related variations in HCQ\u2010associated AE profiles, temporal dynamics and risk evolution underscore the necessity for age\u2010stratified pharmacovigilance frameworks. Paediatric\u2010specific cardiotoxic and metabolic risks, coupled with geriatric\u2010specific cumulative toxicity patterns, mandate tailored therapeutic monitoring strategies to optimize safety across age extremes.<\/jats:p><\/jats:sec>","DOI":"10.1002\/bcp.70293","type":"journal-article","created":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T23:19:59Z","timestamp":1760051999000},"source":"Crossref","is-referenced-by-count":0,"title":["Age\u2010related differences in hydroxychloroquine\u2010associated adverse events: A pharmacovigilance study based on the FDA Adverse Event Reporting System"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0809-2291","authenticated-orcid":false,"given":"Guanghan","family":"Sun","sequence":"first","affiliation":[{"name":"The Affiliated Hospital of Shandong University of Traditional Chinese Medicine  Jinan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jingrong","family":"Yang","sequence":"additional","affiliation":[{"name":"The Affiliated Hospital of Shandong University of Traditional Chinese Medicine  Jinan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lei","family":"Wan","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Anhui University of Chinese Medicine  Hefei China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xia","family":"Xu","sequence":"additional","affiliation":[{"name":"School of Traditional Chinese Medicine Anhui University of Chinese Medicine  Hefei China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jing","family":"Wang","sequence":"additional","affiliation":[{"name":"School of Traditional Chinese Medicine Anhui University of Chinese Medicine  Hefei China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,10,9]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41584\u2010020\u20100372\u2010x"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598\u2010023\u201042816\u20105"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/bib\/bbaa209"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12911\u2010020\u20101053\u2010z"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.2169\/internalmedicine.4317\u201019"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.5694\/mja2.51299"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.7326\/M22\u20102453"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(24)02190\u20101"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(21)02177\u20102"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.JAA.0000805852.13262.54"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2022.04.039"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jiph.2024.102623"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1080\/15563650.2020.1817479"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/bcr\u20102017\u2010223639"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.2169\/internalmedicine.0961\u201022"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2020.04.024"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.41121"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.3760\/cma.j.cn112140\u201020200622\u201000656"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bcp.70293","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T23:20:00Z","timestamp":1760052000000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/bcp.70293"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,9]]},"references-count":18,"alternative-id":["10.1002\/bcp.70293"],"URL":"https:\/\/doi.org\/10.1002\/bcp.70293","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"value":"0306-5251","type":"print"},{"value":"1365-2125","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,9]]},"article-number":"bcp.70293"}}