{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T14:35:42Z","timestamp":1790778942321,"version":"4.1.0"},"reference-count":43,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2021,5,7]],"date-time":"2021-05-07T00:00:00Z","timestamp":1620345600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"\u201cIuliu Ha\u021bieganu\u201d University of Medicine and Pharmacy, Cluj-Napoca","award":["PCD 1529\/64\/18\/01\/2019"],"award-info":[{"award-number":["PCD 1529\/64\/18\/01\/2019"]}]},{"name":"This paper was published under the frame of European Social Found, Human Capital Operational Programme 2014-2020","award":["POCU\/380\/6\/13\/125171"],"award-info":[{"award-number":["POCU\/380\/6\/13\/125171"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Background: The objective of this study was to characterize individual case safety reports (ICSRs) and adverse drug reactions (ADRs) related to second-generation cephalosporins and resulting in hepatobiliary disorders, in VigiBase, WHO global database. Methods: All second-generation cephalosporins hepatobiliary ADRs reported up to July 2019 were included. Characteristic of cephalosporins and ADRs, aside from disproportionality data were evaluated. Results: A total of 1343 ICSRs containing 1585 ADRs were analyzed. Cefuroxime was suspected to have caused hepatobiliary disorders in most cases\u2014in 38% of adults and in 35% of elderly. Abnormal hepatic function was the most frequent ADR, followed by jaundice and hepatitis. For 49% of the ADRs reported in the elderly and 51% in the adult population, the outcome was favorable, with fatal outcome for 2% of the adults and 10% of the elderly. Higher proportional reporting ration (PRR) values were reported in the elderly for cefotetan-associated jaundice, cefuroxime-associated acute hepatitis and hepatitis cholestatic as well as for cefotiam and cefmetazole-associated liver disorder. Conclusion: Hepatobiliary ADRs were reported for 2nd generation cephalosporins, with over 50% of cases in adults, without gender differences. Cholestatic hepatitis was predominately reported in the elderly and this category was more prone to specific hepatic reactions.<\/jats:p>","DOI":"10.3390\/ph14050441","type":"journal-article","created":{"date-parts":[[2021,5,7]],"date-time":"2021-05-07T22:36:24Z","timestamp":1620426984000},"page":"441","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8427-4142","authenticated-orcid":false,"given":"Mariana","family":"Sipos","sequence":"first","affiliation":[{"name":"Department of Pharmacology, Physiology and Physiopathology, Faculty of Pharmacy, \u201cIuliu Ha\u0163ieganu\u201d University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2109-8409","authenticated-orcid":false,"given":"Andreea","family":"Farcas","sequence":"additional","affiliation":[{"name":"Drug Information Research Center, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4218-8622","authenticated-orcid":false,"given":"Daniel Corneliu","family":"Leucuta","sequence":"additional","affiliation":[{"name":"Department of Medical Informatics and Biostatistics, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9068-7293","authenticated-orcid":false,"given":"Camelia","family":"Bucsa","sequence":"additional","affiliation":[{"name":"Drug Information Research Center, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madalina","family":"Huruba","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Physiology and Physiopathology, Faculty of Pharmacy, \u201cIuliu Ha\u0163ieganu\u201d University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6854-2194","authenticated-orcid":false,"given":"Cristina","family":"Mogosan","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Physiology and Physiopathology, Faculty of Pharmacy, \u201cIuliu Ha\u0163ieganu\u201d University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"},{"name":"Drug Information Research Center, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,5,7]]},"reference":[{"key":"ref_1","first-page":"1","article-title":"Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: A systematic review of the world literature","volume":"14","author":"Onakpoya","year":"2016","journal-title":"BMC Med."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1431","DOI":"10.1093\/jac\/dkr159","article-title":"Hepatic safety of antibiotics used in primary care","volume":"66","author":"Andrade","year":"2011","journal-title":"J. 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