{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T10:14:51Z","timestamp":1788257691581,"version":"build-2803163510"},"reference-count":37,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T00:00:00Z","timestamp":1754524800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"},{"start":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T00:00:00Z","timestamp":1754524800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Sci Rep"],"DOI":"10.1038\/s41598-025-13786-7","type":"journal-article","created":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T08:56:51Z","timestamp":1754557011000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A pharmacovigilance study of vortioxetine based on data from the FDA adverse event reporting system"],"prefix":"10.1038","volume":"15","author":[{"given":"Miao","family":"Liu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yang","family":"Xia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenwen","family":"Long","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaowen","family":"Han","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Xiong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,8,7]]},"reference":[{"key":"13786_CR1","doi-asserted-by":"publisher","first-page":"493","DOI":"10.1038\/clpt.2013.39","volume":"93","author":"EL Theunissen","year":"2013","unstructured":"Theunissen, E. L. et al. A randomized trial on the acute and steady-state effects of a new antidepressant, Vortioxetine (Lu AA21004), on actual driving and cognition. Clin. Pharmacol. Ther. 93, 493\u2013501 (2013).","journal-title":"Clin. Pharmacol. Ther."},{"key":"13786_CR2","doi-asserted-by":"publisher","first-page":"693","DOI":"10.1017\/S1092852923002249","volume":"28","author":"MC Christensen","year":"2023","unstructured":"Christensen, M. C. et al. Clinical benefits of Vortioxetine 20\u00a0mg\/day in patients with major depressive disorder. CNS Spectr. 28, 693\u2013701 (2023).","journal-title":"CNS Spectr."},{"key":"13786_CR3","doi-asserted-by":"publisher","DOI":"10.1007\/s10072-025-07987-1","author":"G Verrienti","year":"2025","unstructured":"Verrienti, G., Colonna, I. & Raccagni, C. Use of Vortioxetine in different neurological fields: a systematic review and future perspectives. Neurol. Sci. https:\/\/doi.org\/10.1007\/s10072-025-07987-1 (2025).","journal-title":"Neurol. Sci."},{"key":"13786_CR4","doi-asserted-by":"publisher","first-page":"17","DOI":"10.1017\/S1092852915000826","volume":"20","author":"RS McIntyre","year":"2015","unstructured":"McIntyre, R. S., Lee, Y. & Mansur, R. B. Treating to target in major depressive disorder: response to remission to functional recovery. CNS Spectr. 20, 17\u201331 (2015).","journal-title":"CNS Spectr."},{"key":"13786_CR5","doi-asserted-by":"publisher","first-page":"53","DOI":"10.1016\/j.bbi.2025.01.029","volume":"126","author":"L Xue","year":"2025","unstructured":"Xue, L., Lewis, E., Bocharova, M., Young, A. H. & Aarsland, D. Decreased neutrophil-to-lymphocyte ratio predicted cognitive improvement in late-life depression treated with vortioxetine: findings from an eight-week randomized controlled trial. Brain Behav. Immun. 126, 53\u201358 (2025).","journal-title":"Brain Behav. Immun."},{"key":"13786_CR6","doi-asserted-by":"publisher","first-page":"621","DOI":"10.1007\/s40122-024-00597-3","volume":"13","author":"JF Ib\u00e1\u00f1ez","year":"2024","unstructured":"Ib\u00e1\u00f1ez, J. F. Effectiveness of Vortioxetine in patients with major depressive disorder associated with chronic pain: an observational study in a Spanish population. Pain Therapy. 13, 621\u2013635 (2024).","journal-title":"Pain Therapy"},{"key":"13786_CR7","doi-asserted-by":"publisher","first-page":"2346","DOI":"10.1038\/s41598-025-86976-y","volume":"15","author":"K He","year":"2025","unstructured":"He, K. et al. A real-world pharmacovigilance study of brodalumab based on the FDA adverse event reporting system. Sci. Rep. 15, 2346 (2025).","journal-title":"Sci. Rep."},{"key":"13786_CR8","doi-asserted-by":"publisher","first-page":"102827","DOI":"10.1016\/j.ctrv.2024.102827","volume":"130","author":"M Hua","year":"2024","unstructured":"Hua, M. et al. Abemaciclib increases the risk of venous thromboembolism in breast cancer: integrate meta-analysis, pharmacovigilance database analysis, and in vitro validation. Cancer Treat. Rev. 130, 102827 (2024).","journal-title":"Cancer Treat. Rev."},{"key":"13786_CR9","doi-asserted-by":"publisher","first-page":"1458438","DOI":"10.3389\/fphar.2024.1458438","volume":"15","author":"K Zhao","year":"2024","unstructured":"Zhao, K., Zhao, Y., Xiao, S. & Tu, C. Assessing the real-world safety of tralokinumab for atopic dermatitis: insights from a comprehensive analysis of FAERS data. Front. Pharmacol. 15, 1458438 (2024).","journal-title":"Front. Pharmacol."},{"key":"13786_CR10","doi-asserted-by":"publisher","DOI":"10.1007\/s11096-025-01869-4","author":"Q Gong","year":"2025","unstructured":"Gong, Q. et al. Real-world safety of maribavir: a retrospective study based on signal detection in the FDA adverse event reporting system. Int. J. Clin. Pharm. https:\/\/doi.org\/10.1007\/s11096-025-01869-4 (2025).","journal-title":"Int. J. Clin. Pharm."},{"key":"13786_CR11","doi-asserted-by":"publisher","first-page":"53","DOI":"10.1186\/s12991-023-00486-7","volume":"22","author":"S Li","year":"2023","unstructured":"Li, S. et al. Sex difference in incidence of major depressive disorder: an analysis from the global burden of disease study 2019. Ann. Gen. Psychiatry. 22, 53 (2023).","journal-title":"Ann. Gen. Psychiatry"},{"key":"13786_CR12","doi-asserted-by":"publisher","first-page":"100188","DOI":"10.1016\/j.eclinm.2019.10.001","volume":"17","author":"S Watson","year":"2019","unstructured":"Watson, S., Caster, O., Rochon, P. A. & den Ruijter, H. Reported adverse drug reactions in women and men: aggregated evidence from globally collected individual case reports during half a century. EClinicalMedicine 17, 100188 (2019).","journal-title":"EClinicalMedicine"},{"key":"13786_CR13","doi-asserted-by":"publisher","first-page":"345","DOI":"10.1016\/j.jad.2023.01.074","volume":"328","author":"M Adair","year":"2023","unstructured":"Adair, M., Christensen, M. C., Florea, I., Loft, H. & Fagiolini, A. Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: an updated analysis of efficacy and tolerability. J. Affect. Disord. 328, 345\u2013354 (2023).","journal-title":"J. Affect. Disord"},{"key":"13786_CR14","doi-asserted-by":"publisher","first-page":"421","DOI":"10.1016\/j.jad.2017.12.056","volume":"229","author":"BT Baune","year":"2018","unstructured":"Baune, B. T., Sluth, L. B. & Olsen, C. K. The effects of Vortioxetine on cognitive performance in working patients with major depressive disorder: A short-term, randomized, double-blind, exploratory study. J. Affect. Disord. 229, 421\u2013428 (2018).","journal-title":"J. Affect. Disord"},{"key":"13786_CR15","doi-asserted-by":"publisher","first-page":"146","DOI":"10.1016\/j.pharmthera.2010.07.001","volume":"128","author":"J Walstab","year":"2010","unstructured":"Walstab, J., Rappold, G. & Niesler, B. 5-HT3 receptors: role in disease and target of drugs. Pharmacol. Ther. 128, 146\u2013169 (2010).","journal-title":"Pharmacol. Ther."},{"key":"13786_CR16","doi-asserted-by":"publisher","first-page":"63","DOI":"10.1007\/s11920-017-0816-4","volume":"19","author":"A Wichniak","year":"2017","unstructured":"Wichniak, A., Wierzbicka, A., Wal\u0119cka, M. & Jernajczyk, W. Effects of antidepressants on sleep. Curr. Psychiatry Rep. 19, 63 (2017).","journal-title":"Curr. Psychiatry Rep."},{"key":"13786_CR17","doi-asserted-by":"publisher","first-page":"627","DOI":"10.3390\/clockssleep5040042","volume":"5","author":"Z Mlyncekova","year":"2023","unstructured":"Mlyncekova, Z. et al. Effects of Vortioxetine on sleep architecture of adolescents with major depressive disorder. Clocks Sleep. 5, 627\u2013638 (2023).","journal-title":"Clocks Sleep."},{"key":"13786_CR18","doi-asserted-by":"publisher","first-page":"e8748","DOI":"10.7717\/peerj.8748","volume":"8","author":"AR Eugene","year":"2020","unstructured":"Eugene, A. R. Association of sleep among 30 antidepressants: a population-wide adverse drug reaction study, 2004\u20132019. PeerJ 8, e8748 (2020).","journal-title":"PeerJ"},{"key":"13786_CR19","doi-asserted-by":"publisher","first-page":"1092","DOI":"10.1177\/0269881115592347","volume":"29","author":"SC Leiser","year":"2015","unstructured":"Leiser, S. C., Iglesias-Bregna, D., Westrich, L., Pehrson, A. L. & Sanchez, C. Differentiated effects of the multimodal antidepressant Vortioxetine on sleep architecture: part 2, Pharmacological interactions in rodents suggest a role of serotonin-3 receptor antagonism. J. Psychopharmacol. 29, 1092\u20131105 (2015).","journal-title":"J. Psychopharmacol."},{"key":"13786_CR20","doi-asserted-by":"publisher","first-page":"102106","DOI":"10.1016\/j.pneurobio.2021.102106","volume":"204","author":"YQ Wang","year":"2021","unstructured":"Wang, Y. Q., Liu, W. Y., Li, L., Qu, W. M. & Huang, Z. L. Neural circuitry underlying REM sleep: A review of the literature and current concepts. Prog Neurobiol. 204, 102106 (2021).","journal-title":"Prog Neurobiol."},{"key":"13786_CR21","doi-asserted-by":"publisher","first-page":"382","DOI":"10.1016\/j.neuropharm.2014.10.015","volume":"89","author":"L Westrich","year":"2015","unstructured":"Westrich, L., Haddjeri, N., Dkhissi-Benyahya, O. & S\u00e1nchez, C. Involvement of 5-HT\u2087 receptors in vortioxetine\u2019s modulation of circadian rhythms and episodic memory in rodents. Neuropharmacology 89, 382\u2013390 (2015).","journal-title":"Neuropharmacology"},{"key":"13786_CR22","doi-asserted-by":"publisher","first-page":"429","DOI":"10.1515\/revneuro-2014-0016","volume":"25","author":"JM Monti","year":"2014","unstructured":"Monti, J. M. & Jantos, H. The role of serotonin 5-HT7 receptor in regulating sleep and wakefulness. Rev. Neurosci. 25, 429\u2013437 (2014).","journal-title":"Rev. Neurosci."},{"key":"13786_CR23","doi-asserted-by":"publisher","unstructured":"Wu, M. Y., Chang, J. R., Lee, Y. K., Lin, P. C. & Tsai, T. Y. The effect and safety of rapid and gradual urinary decompression in urine retention: A systematic review and Meta-Analysis. Medicina (Kaunas) 58(10), 1441 https:\/\/doi.org\/10.3390\/medicina58101441 (2022).","DOI":"10.3390\/medicina58101441"},{"key":"13786_CR24","doi-asserted-by":"publisher","first-page":"691","DOI":"10.1007\/s40801-024-00465-8","volume":"11","author":"S Uekusa","year":"2024","unstructured":"Uekusa, S. et al. A pharmacovigilance study on psychotropic Agent-Induced urinary retention using the Japanese adverse drug event report database. Drugs Real. World Outcomes. 11, 691\u2013700 (2024).","journal-title":"Drugs Real. World Outcomes"},{"key":"13786_CR25","doi-asserted-by":"publisher","first-page":"331","DOI":"10.1017\/S1092852915000334","volume":"20","author":"SM Stahl","year":"2015","unstructured":"Stahl, S. M. Modes and nodes explain the mechanism of action of vortioxetine, a multimodal agent (MMA): modifying serotonin\u2019s downstream effects on glutamate and GABA (gamma amino Butyric acid) release. CNS Spectr. 20, 331\u2013336 (2015).","journal-title":"CNS Spectr."},{"key":"13786_CR26","doi-asserted-by":"publisher","first-page":"373","DOI":"10.1016\/j.mcna.2017.10.013","volume":"102","author":"AS Manjunath","year":"2018","unstructured":"Manjunath, A. S. & Hofer, M. D. Urologic emergencies. Med. Clin. North. Am. 102, 373\u2013385 (2018).","journal-title":"Med. Clin. North. Am."},{"key":"13786_CR27","doi-asserted-by":"publisher","first-page":"727","DOI":"10.5114\/aoms.2019.86928","volume":"16","author":"WS Aronow","year":"2020","unstructured":"Aronow, W. S. & Shamliyan, T. A. Effects of antidepressants on QT interval in people with mental disorders. Arch. Med. Sci. 16, 727\u2013741 (2020).","journal-title":"Arch. Med. Sci."},{"key":"13786_CR28","doi-asserted-by":"publisher","first-page":"264","DOI":"10.1016\/j.bcp.2018.03.016","volume":"152","author":"K Villatoro-G\u00f3mez","year":"2018","unstructured":"Villatoro-G\u00f3mez, K. et al. Molecular determinants of Kv7.1\/KCNE1 channel Inhibition by amitriptyline. Biochem. Pharmacol. 152, 264\u2013271 (2018).","journal-title":"Biochem. Pharmacol."},{"key":"13786_CR29","doi-asserted-by":"publisher","first-page":"270","DOI":"10.1159\/000447034","volume":"85","author":"AF Carvalho","year":"2016","unstructured":"Carvalho, A. F., Sharma, M. S., Brunoni, A. R., Vieta, E. & Fava, G. A. The safety, tolerability and risks associated with the use of newer generation antidepressant drugs: A critical review of the literature. Psychother. Psychosom. 85, 270\u2013288 (2016).","journal-title":"Psychother. Psychosom."},{"key":"13786_CR30","doi-asserted-by":"publisher","first-page":"399","DOI":"10.1016\/j.jad.2023.11.084","volume":"347","author":"Z Chen","year":"2024","unstructured":"Chen, Z. et al. Escitalopram-induced QTc prolongation and its relationship with KCNQ1, KCNE1, and KCNH2 gene polymorphisms. J. Affect. Disord. 347, 399\u2013405 (2024).","journal-title":"J. Affect. Disord"},{"key":"13786_CR31","doi-asserted-by":"publisher","first-page":"114891","DOI":"10.1016\/j.psychres.2022.114891","volume":"317","author":"T Toba-Oluboka","year":"2022","unstructured":"Toba-Oluboka, T., Tibbo, P. G., Dempster, K. & Alda, M. Genetic factors contribute to medication-induced QT prolongation: A review. Psychiatry Res. 317, 114891 (2022).","journal-title":"Psychiatry Res."},{"key":"13786_CR32","doi-asserted-by":"publisher","first-page":"1164028","DOI":"10.3389\/fcvm.2023.1164028","volume":"10","author":"N D\u00edez-Escut\u00e9","year":"2023","unstructured":"D\u00edez-Escut\u00e9, N. et al. Sex differences in long QT syndrome. Front. Cardiovasc. Med. 10, 1164028 (2023).","journal-title":"Front. Cardiovasc. Med."},{"key":"13786_CR33","doi-asserted-by":"publisher","first-page":"1639","DOI":"10.1016\/j.jacc.2015.12.063","volume":"67","author":"PJ Schwartz","year":"2016","unstructured":"Schwartz, P. J. & Woosley, R. L. Predicting the unpredictable: Drug-Induced QT prolongation and Torsades de pointes. J. Am. Coll. Cardiol. 67, 1639\u20131650 (2016).","journal-title":"J. Am. Coll. Cardiol."},{"key":"13786_CR34","doi-asserted-by":"crossref","unstructured":"Kallergis, E. M., Goudis, C. A., Simantirakis, E. N., Kochiadakis, G. E. & Vardas, P. E. Mechanisms, risk factors, and management of acquired long QT syndrome: a comprehensive review. ScientificWorldJournal 212178 (2012). (2012).","DOI":"10.1100\/2012\/212178"},{"key":"13786_CR35","doi-asserted-by":"publisher","DOI":"10.1007\/s00787-024-02560-1","author":"MP DelBello","year":"2024","unstructured":"DelBello, M. P. et al. Vortioxetine in children and adolescents with major depressive disorder: 6-month and 18-month open-label, flexible-dose, long-term extension studies. Eur. Child. Adolesc. Psychiatry. https:\/\/doi.org\/10.1007\/s00787-024-02560-1 (2024).","journal-title":"Eur. Child. Adolesc. Psychiatry"},{"key":"13786_CR36","first-page":"CD013674","volume":"5","author":"SE Hetrick","year":"2021","unstructured":"Hetrick, S. E. et al. New generation antidepressants for depression in children and adolescents: a network meta-analysis. Cochrane Database Syst. Rev. 5, CD013674 (2021).","journal-title":"Cochrane Database Syst. Rev."},{"key":"13786_CR37","doi-asserted-by":"publisher","first-page":"796","DOI":"10.7150\/ijms.6048","volume":"10","author":"T Sakaeda","year":"2013","unstructured":"Sakaeda, T., Tamon, A., Kadoyama, K. & Okuno, Y. Data mining of the public version of the FDA adverse event reporting system. Int. J. Med. Sci. 10, 796\u2013803 (2013).","journal-title":"Int. J. Med. Sci."}],"container-title":["Scientific Reports"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41598-025-13786-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41598-025-13786-7","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41598-025-13786-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T14:59:25Z","timestamp":1757343565000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41598-025-13786-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,7]]},"references-count":37,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["13786"],"URL":"https:\/\/doi.org\/10.1038\/s41598-025-13786-7","relation":{},"ISSN":["2045-2322"],"issn-type":[{"value":"2045-2322","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,7]]},"assertion":[{"value":"6 April 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 July 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 August 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"28886"}}