{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T05:53:49Z","timestamp":1784181229662,"version":"3.55.0"},"reference-count":27,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,2,10]],"date-time":"2023-02-10T00:00:00Z","timestamp":1675987200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100001700","name":"Ministry of Education, Culture, Sports, Science and Technology","doi-asserted-by":"publisher","award":["20K08326"],"award-info":[{"award-number":["20K08326"]}],"id":[{"id":"10.13039\/501100001700","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hepatology Research"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>This study aimed to analyze the current trends of drug\u2010induced liver\u2010related adverse events in the Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) databases.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The characteristics of implicated drugs were investigated by analyzing big data on drug\u2010induced liver\u2010related adverse events over the past 20\u00a0years in FAERS, comparing drug rankings between the JADER and FAERS databases, and calculating rankings of drugs inducing liver\u2010related adverse events using the Medical Dictionary for Regulatory Activities Terminology.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the 452\u00a0272 cases registered in FAERS from 1997 to 2019, warfarin, paracetamol, and adalimumab were the drugs most related to drug\u2010induced liver injury (DILI). In the 38\u00a0919 cases registered in JADER from 2004 to 2019, sorafenib, nivolumab, and herbal extracts were the drugs most related to DILI. No associations were found between the top 30 drugs in either of the two databases. Notably, the number of drug\u2010induced liver\u2010related adverse event reports and total adverse events has sharply increased in recent years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Although liver\u2010related adverse events are largely caused by host immunity and other constitutional factors, differences in primary diseases, countries, and historical backgrounds lead to differences in the number of reports. Securing an appropriate database and a mechanism to collect real\u2010time information on the frequency of adverse drug reactions is warranted.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hepr.13883","type":"journal-article","created":{"date-parts":[[2023,1,21]],"date-time":"2023-01-21T06:48:30Z","timestamp":1674283710000},"page":"556-568","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Analysis of drug\u2010induced liver\u2010related adverse event trend reporting between 1997 and 2019"],"prefix":"10.1111","volume":"53","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9135-3092","authenticated-orcid":false,"given":"Hiroteru","family":"Kamimura","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology Niigata University Graduate School of Medical and Dental Sciences  Niigata Japan"},{"name":"Department of Network Medicine for Digestive Diseases Niigata University School of Medicine  Niigata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toru","family":"Setsu","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Niigata University Graduate School of Medical and Dental Sciences  Niigata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6683-1219","authenticated-orcid":false,"given":"Naruhiro","family":"Kimura","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Niigata University Graduate School of Medical and Dental Sciences  Niigata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makoto","family":"Miyazawa","sequence":"additional","affiliation":[{"name":"Division of Pharmacy Niigata University Medical &amp; Dental Hospital  Niigata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shota","family":"Kaneko","sequence":"additional","affiliation":[{"name":"Division of Pharmacy Niigata University Medical &amp; Dental Hospital  Niigata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenya","family":"Kamimura","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Niigata University Graduate School of Medical and Dental Sciences  Niigata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsunori","family":"Tsuchiya","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Niigata University Graduate School of Medical and Dental Sciences  Niigata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihiro","family":"Uesawa","sequence":"additional","affiliation":[{"name":"Department of Medical Molecular Informatics Meiji Pharmaceutical University  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuji","family":"Terai","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Niigata University Graduate School of Medical and Dental Sciences  Niigata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,2,10]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.21095"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.02.006"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001259"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12877\u2010017\u20100621\u20102"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2020.600255"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018\u2010200326030\u201000002"},{"key":"e_1_2_9_8_1","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).Introductory guide: MedDRA version 24.1;2021.https:\/\/admin.meddra.org\/sites\/default\/files\/guidance\/file\/000594_intguide_%2024_1.pdf. 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