{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T11:11:32Z","timestamp":1793531492199,"version":"4.5.0"},"reference-count":32,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,1,15]],"date-time":"2025-01-15T00:00:00Z","timestamp":1736899200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Sodium-glucose co-transporter two inhibitors (SGLT2is) are widely used in clinical practice due to their proven cardiovascular and renal benefits. However, various adverse drug reactions (ADRs) have been reported. This study aims to systematically update the ADRs associated with SGLT2is and identify the differences among various SGLT2is acovigilance of various SGLT-2 inhibitors.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Data from the FAERS database covering Q1 2013 to Q2 2024 were selected for disproportionality analysis. ADRs were defined using the System Organ Classes (SOC) and Preferred Terms (PT) from the MedDRA 27.0 dictionary. Four signal detection metrics\u2014reporting odds ratio (ROR), proportional reporting ratios (PRRs), Bayesian Confidence Propagation Neural Network (BCPNN), and empirical Bayesian geometric mean (EBGM)\u2014were utilized to infer ADRs and assess differences among specific SGLT2i drugs through intersection analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Except for canagliflozin, both dapagliflozin and empagliflozin showed a general increase in ADRs. Specifically, canagliflozin had 93 ADRs, dapagliflozin had 173, and empagliflozin had 214. Most of these were related to Infections and Infestations, Investigations, and Reproductive System and Breast Disorders, notably manifesting as inflammatory conditions of the urinary and reproductive systems, such as orchitis and testicular abscess, consistent with FDA labeling. Additionally, overlooked ADRs were identified, including bladder cancer, cholangiocarcinoma, and thrombotic strokes, none of which were reported for canagliflozin.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>While shared ADRs for SGLT2is are noted in FDA labeling, monitoring for high-risk populations, such as those with cancers or strokes, remains crucial to prevent deterioration. Medication regimens may need adjustment, including selecting canagliflozin or non-SGLT2i alternatives when necessary.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fmed.2024.1515847","type":"journal-article","created":{"date-parts":[[2025,1,15]],"date-time":"2025-01-15T06:15:47Z","timestamp":1736921747000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":8,"title":["A study on the pharmacovigilance of various SGLT-2 inhibitors"],"prefix":"10.3389","volume":"11","author":[{"given":"Yanwen","family":"Dong","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yangyang","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaomei","family":"Lan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huiyan","family":"Zeng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,1,15]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"14790","DOI":"10.1038\/s41598-020-71908-9","article-title":"Global, regional, and national burden and trend of diabetes in 195 countries and territories: an analysis from 1990 to 2025","volume":"10","author":"Lin","year":"2020","journal-title":"Sci Rep"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"S35","DOI":"10.1016\/j.jegh.2015.05.003","article-title":"Prevalence of self-reported sleep duration and sleep habits in type 2 diabetes patients in South Trinidad","volume":"5","author":"Ramtahal","year":"2015","journal-title":"J Epidemiol Glob Health"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"841","DOI":"10.1093\/ajh\/hpae092","article-title":"State-of-the-art-review: mechanisms of action of sglt2 inhibitors and clinical implications","volume":"37","author":"Vallon","year":"2024","journal-title":"Am J Hypertens"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"900","DOI":"10.1007\/s00125-019-4861-x","article-title":"Canagliflozin should be prescribed with caution to individuals with type 2 diabetes and high risk of amputation","volume":"62","author":"Monteiro-Soares","year":"2019","journal-title":"Diabetologia"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"645634618","DOI":"10.1177\/03000605241271750","article-title":"Dapagliflozin-induced abnormal uterine bleeding in a patient with dilated cardiomyopathy and chronic heart failure: a case report","volume":"52","author":"Gong","year":"2024","journal-title":"J Int Med Res"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"1959","DOI":"10.1007\/s00228-024-03759-6","article-title":"Sodium-glucose cotransporter 2 inhibitors and renal cancer in the us fda adverse event reporting system","volume":"80","author":"Xu","year":"2024","journal-title":"Eur J Clin Pharmacol"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"E81","DOI":"10.24546\/0100490464","article-title":"Comparison over time of adverse drug reactions in diabetes patients treated with sodium-glucose cotransporter 2 inhibitors","volume":"70","author":"Ueda","year":"2024","journal-title":"Kobe J Med Sci"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"1400","DOI":"10.1111\/jdi.13481","article-title":"Do sodium-glucose cotransporter 2 inhibitors lead to fracture risk? 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