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We evaluated the risk of adverse events (AEs) associated with both labelled and off\u2010label use of modafinil. A systematic search of PubMed, Embase, and Cochrane identified 54 studies that met the inclusion criteria. In labelled uses, narcolepsy patients had significantly elevated risks of diarrhoea (risk ratio [RR]: 2.16, 95% confidence interval [CI]: 1.06\u20134.41) and nausea compared to those with placebo (RR: 2.44, 95% CI: 1.05\u20135.72). OSA\/hypopnea syndrome patients had higher risks of insomnia (RR: 5.82), anxiety\/nervousness (RR: 3.26), and headache (RR: 1.92). SWSD patients had elevated risks of insomnia (RR: 4.09), anxiety\/nervousness (RR: 3.85), and nausea (RR: 2.93). Among off\u2010label users, patients with attention deficit hyperactivity disorder had higher risks of insomnia (RR: 4.97) and decreased appetite (RR: 4.21). Patients with major depressive disorder showed higher risks of anxiety\/nervousness (RR: 1.95). While modafinil users share common AEs, specific risks vary across patient groups. Our findings on condition\u2010specific AE profiles would support cautious prescribing of modafinil and careful consideration of alternative treatments.<\/jats:p>","DOI":"10.1111\/bcpt.70147","type":"journal-article","created":{"date-parts":[[2025,12,10]],"date-time":"2025-12-10T06:46:18Z","timestamp":1765349178000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Assessing Condition\u2010Specific Adverse Event Profiles of Modafinil for Labelled and Off\u2010Label Uses: A Systematic Review and Meta\u2010Analysis"],"prefix":"10.1111","volume":"138","author":[{"given":"Jaehee","family":"Jung","sequence":"first","affiliation":[{"name":"College of Pharmacy, Yonsei Institute of Pharmaceutical Sciences Yonsei University  Incheon South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaeyoon","family":"Youm","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Medicine &amp; Regulatory Sciences, College of Medicine and College of Pharmacy Yonsei University  Incheon South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-0054-6991","authenticated-orcid":false,"given":"Jihyun","family":"Kang","sequence":"additional","affiliation":[{"name":"Graduate Program of Industrial Pharmaceutical Science, Yonsei Institute of Pharmaceutical Sciences Yonsei University  Incheon South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7264-7602","authenticated-orcid":false,"given":"Ah\u2010Young","family":"Kim","sequence":"additional","affiliation":[{"name":"College of Pharmacy Ewha Womans University  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jae\u00a0Kyung","family":"Suh","sequence":"additional","affiliation":[{"name":"National Evidence\u2010based Healthcare Collaborating Agency (NECA)  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hye\u2010Young","family":"Kang","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Yonsei Institute of Pharmaceutical Sciences Yonsei University  Incheon South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,12,9]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v67n0406"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/gkad944"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.chi.0000205709.63571.c9"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/da.20801"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drugalcdep.2009.11.023"},{"issue":"9","key":"e_1_2_9_7_1","first-page":"777","article-title":"Modafinil's Effects on Simulator Performance and Mood in Pilots During 37 h Without Sleep","volume":"75","author":"Caldwell J. 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