{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T18:21:07Z","timestamp":1785349267525,"version":"3.55.0"},"reference-count":35,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2025,6,16]],"date-time":"2025-06-16T00:00:00Z","timestamp":1750032000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"\u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, Cluj-Napoca, Romania"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Background\/Objectives: Patients\u2019 perspectives on adverse drug reactions (ADRs) may be used to update the safety profile of a drug. We aimed to prospectively follow-up on type 2 diabetes (T2D) patients who were new users of sodium-glucose co-transporter 2 inhibitors (SGLT2i) and to characterize the patient-reported ADRs within routine practice in Romania. Methods: T2D patients from ambulatory settings were interviewed over the phone based on standardized forms, at four time-points across 12 months. We captured the patients\u2019 history and auto-medication, as well as any ADR that implied causality to SGLT2i, based on the patient\u2019s perspective. Results: In total, 64 patients, with genders being equally represented and with a median age of 59 years (Q1, Q3: 51, 64) were followed-up with. We identified 73 ADRs to SGLT2i that were suspected to be associated with the drug, with an average of 2.35 ADRs per patient (range 0\u20137 ADRs\/patient). The most reported ADR was pollakiuria (7; 9.58%), followed by vulvovaginal candidiasis (6; 8.21%), dysuria (4; 5.47%), and hypoglycemia (4; 5.47%). SGLT2i treatment was interrupted for eight patients. Three (4.10%) ADRs were considered serious as important medical events (hypertensive crisis, angina pectoris, and dyspnea). A positive dechallenge was recorded for 14 ADRs, of which 9 ADRs had a positive rechallenge as well. A probable causality was assessed for 13 of the 73 patient-reported ADRs. Conclusions: Most of the identified ADRs were in line with the known safety profile of SGLT2i. Only three ADRs were serious and unexpected relative to the safety profile, but these had confounding factors that could explain the reactions. Therefore, no new safety concerns related to SGLT2i were determined in this observational study.<\/jats:p>","DOI":"10.3390\/ph18060904","type":"journal-article","created":{"date-parts":[[2025,6,17]],"date-time":"2025-06-17T03:37:07Z","timestamp":1750131427000},"page":"904","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Adverse Drug Reactions to SGLT2i Reported by Type 2 Diabetes New Users: An Active Surveillance Study"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9068-7293","authenticated-orcid":false,"given":"Camelia","family":"Buc\u0219a","sequence":"first","affiliation":[{"name":"Pharmacovigilance Research Center, Faculty of Pharmacy, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ioana","family":"Fren\u021b","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Research Center, Faculty of Pharmacy, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramona","family":"Stefan","sequence":"additional","affiliation":[{"name":"Marymed Medical Center, 420120 Bistri\u021ba, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1124-6984","authenticated-orcid":false,"given":"Adriana","family":"Fodor","sequence":"additional","affiliation":[{"name":"Department of Diabetes and Nutrition Diseases, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400006 Cluj-Napoca, Romania"},{"name":"Department of Diabetes, Emergency Clinical County Hospital Cluj, 400006 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1624-6916","authenticated-orcid":false,"given":"Georgeta","family":"Inceu","sequence":"additional","affiliation":[{"name":"Department of Diabetes and Nutrition Diseases, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400006 Cluj-Napoca, Romania"},{"name":"Department of Diabetes, Emergency Clinical County Hospital Cluj, 400006 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2109-8409","authenticated-orcid":false,"given":"Andreea","family":"Farca\u0219","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Research Center, Faculty of Pharmacy, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0977-8874","authenticated-orcid":false,"given":"Adriana","family":"Rusu","sequence":"additional","affiliation":[{"name":"Department of Diabetes and Nutrition Diseases, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400006 Cluj-Napoca, Romania"},{"name":"Department of Diabetes, Emergency Clinical County Hospital Cluj, 400006 Cluj-Napoca, Romania"},{"name":"Department 2, Faculty of Nursing and Health Sciences, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400337 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Negovan","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Research Center, Faculty of Pharmacy, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"},{"name":"Directorate of Drug and Medical Device Policy, Ministry of Health, 011478 Bucharest, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6854-2194","authenticated-orcid":false,"given":"Cristina","family":"Mogo\u0219an","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Physiology and Pathophysiology, \u201cIuliu Ha\u021bieganu\u201d University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,6,16]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Mascolo, A., Di Napoli, R., Balzano, N., Cappetta, D., Urbanek, K., De Angelis, A., Scisciola, L., Di Meo, I., Sullo, M.G., and Rafaniello, C. 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