{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T19:30:00Z","timestamp":1786649400420,"version":"build-2736575974"},"reference-count":20,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"5","license":[{"start":{"date-parts":[[2025,8,22]],"date-time":"2025-08-22T00:00:00Z","timestamp":1755820800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-sa\/4.0"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:p>\n                    Dexmedetomidine (DEX), as a widely used medication for sedation, its usage has increased significantly. The concerns about its side effects remain, making a thorough safety evaluation necessary. Data on adverse drug events related to DEX from the first quarter of 2004 to the fourth quarter of 2023 were collected from the US Food and Drug Administration. Signal quantification techniques were used for the analysis, including reporting odds ratios (RORs), proportional reporting ratios, Bayesian confidence propagation neural network and empirical Bayes geometric mean. An analysis of 20,629,811 adverse event (AE) reports identified 1977 cases of DEX-related AEs, covering 24 system organ classes and 344 preferred terms (PTs). The most common PTs were bradycardia (\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    = 263), cardiac arrest (\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    = 150), and hypotension (\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    = 141). Based on the ROR algorithm, the top three were: transcranial electrical motor evoked potential monitoring abnorma, acute motor axonal neuropathy, and trigemino-cardiac reflex. In addition, this study identified the adverse effects such as diabetes insipidus, coronary arteriospasm, and intestinal pseudo-obstruction, which were not previously mentioned in the instructions. It is essential to monitor, identify, and address these adverse reactions effectively.\n                  <\/jats:p>","DOI":"10.4103\/ijp.ijp_688_24","type":"journal-article","created":{"date-parts":[[2025,8,22]],"date-time":"2025-08-22T12:00:39Z","timestamp":1755864039000},"page":"344-349","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":0,"title":["Safety assessment of dexmedetomidine: Real-world adverse event analysis from the Food and Drug Administration Adverse Events Reporting System public dashboard"],"prefix":"10.4103","volume":"57","author":[{"given":"Yi","family":"Yin","sequence":"first","affiliation":[{"name":"Department of Pediatric Intensive Care Unit, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Pediatric Intensive Care Unit, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Youpeng","family":"Jin","sequence":"additional","affiliation":[{"name":"Department of Pediatric Intensive Care Unit, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2025,8,22]]},"reference":[{"key":"R1-20260421","doi-asserted-by":"crossref","first-page":"1119","DOI":"10.1007\/s40265-015-0419-5","article-title":"Dexmedetomidine: A review of its use for sedation in the intensive care setting","volume":"75","author":"Keating","year":"2015","journal-title":"Drugs"},{"key":"R2-20260421","doi-asserted-by":"crossref","first-page":"110960","DOI":"10.1016\/j.jclinane.2022.110960","article-title":"Association between dexmedetomidine administration and 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a patient with negative findings of an acetylcholine provocation test","volume":"39","author":"Sasaki","year":"2023","journal-title":"J Arrhythm"},{"key":"R9-20260421","doi-asserted-by":"crossref","first-page":"689","DOI":"10.1161\/01.CIR.101.6.689","article-title":"Alpha-adrenergic coronary vasoconstriction and myocardial ischemia in humans","volume":"101","author":"Heusch","year":"2000","journal-title":"Circulation"},{"key":"R10-20260421","doi-asserted-by":"crossref","first-page":"20","DOI":"10.2344\/anpr-69-01-02","article-title":"Coronary spasm during postoperative sedation with dexmedetomidine","volume":"69","author":"Sato","year":"2022","journal-title":"Anesth Prog"},{"key":"R11-20260421","doi-asserted-by":"crossref","first-page":"1364","DOI":"10.1097\/ALN.0b013e3181d74f55","article-title":"Susceptibility of transcranial electric motor-evoked potentials to varying targeted blood levels of dexmedetomidine during spine surgery","volume":"112","author":"Mahmoud","year":"2010","journal-title":"Anesthesiology"},{"key":"R12-20260421","doi-asserted-by":"crossref","first-page":"919032","DOI":"10.3389\/fphar.2022.919032","article-title":"Dex modulates the balance of water-electrolyte metabolism by depressing the expression of AVP in PVN","volume":"13","author":"Yang","year":"2022","journal-title":"Front Pharmacol"},{"key":"R13-20260421","doi-asserted-by":"crossref","first-page":"685","DOI":"10.1177\/08971900211053261","article-title":"Probable dexmedetomidine induced diabetes insipidus: A case review","volume":"36","author":"Vani","year":"2023","journal-title":"J Pharm Pract"},{"key":"R14-20260421","doi-asserted-by":"crossref","first-page":"237","DOI":"10.5114\/ait.2023.130859","article-title":"Dexmedetomidine-induced diabetes insipidus during coronary artery bypass graft surgery","volume":"55","author":"Tang","year":"2023","journal-title":"Anaesthesiol Intensive Ther"},{"key":"R15-20260421","doi-asserted-by":"crossref","first-page":"e247292","DOI":"10.1136\/bcr-2021-247292","article-title":"Atypical trigeminocardiac reflex during intranasal dexmedetomidine sedation of a 6-month-old premature baby","volume":"15","author":"Bayard","year":"2022","journal-title":"BMJ Case Rep"},{"key":"R16-20260421","doi-asserted-by":"crossref","first-page":"2562","DOI":"10.1177\/0300060519847368","article-title":"Dose-dependent neurotoxicity caused by the addition of perineural dexmedetomidine to ropivacaine for continuous femoral nerve block in rabbits","volume":"47","author":"Wang","year":"2019","journal-title":"J Int Med Res"},{"key":"R17-20260421","doi-asserted-by":"crossref","first-page":"278","DOI":"10.12659\/AJCR.913645","article-title":"Acute colonic pseudo-obstruction caused by dexmedetomidine: A case report and literature review","volume":"20","author":"P\u00e9rez-Lara","year":"2019","journal-title":"Am J Case 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