{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T22:08:33Z","timestamp":1785276513802,"version":"3.55.0"},"reference-count":22,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Drug Safety"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:p>Nearly all medications carry the risk of drug-induced liver injury (DILI). Idiosyncratic reactions are rare and poorly predictable, and the mechanisms are not always well understood. Pirfenidone is an oral antifibrotic drug used to treat idiopathic pulmonary fibrosis. While elevation of liver enzymes is a common adverse reaction during therapy, it rarely leads to discontinuation or reduction of the drug. Although isolated cases of liver damage or liver failure have been reported, they are infrequent. This report presents the case of a 70-year-old woman with known idiopathic pulmonary fibrosis, depression, hypothyroidism, and hypercholesterolemia who presented at our emergency department with jaundice, anorexia, and asthenia. The patient\u2019s medication regimen included lamotrigine, simvastatin, levothyroxine, and pirfenidone, which had been introduced 6\u2009months prior. Laboratory testing revealed elevated liver enzyme levels consistent with acute hepatocellular hepatitis. Following a medical workup, which included anamnesis, laboratory testing, iconographic investigations, and liver biopsy, we concluded that the patient had suffered from pirfenidone-induced liver injury. Pirfenidone was withdrawn, and liver tests gradually improved. The purpose of this clinical case report is to highlight this rare adverse reaction and to make clinicians aware of its assessment and management. In 2018, only one other case of severe liver failure leading to the death of the patient was reported. Early detection of potential DILI during the workup is crucial to discontinue the suspected medication promptly. Any drug-induced hepatitis must be reported for registration.<\/jats:p>","DOI":"10.1177\/20420986241270866","type":"journal-article","created":{"date-parts":[[2024,9,14]],"date-time":"2024-09-14T08:54:26Z","timestamp":1726304066000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Pirfenidone-induced liver injury, a case report of a rare idiosyncratic reaction"],"prefix":"10.1177","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-9963-5317","authenticated-orcid":false,"given":"Florent","family":"Fortunati","sequence":"first","affiliation":[{"name":"Service d\u2019H\u00e9pato-gastroent\u00e9rologie, Cliniques universitaires Saint-Luc, UCLouvain, Avenue Hippocrate 10, Brussels 1200, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoine","family":"Froidure","sequence":"additional","affiliation":[{"name":"Service de pneumologie, Cliniques universitaires Saint-Luc, UCLouvain, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Baldin","sequence":"additional","affiliation":[{"name":"Service d\u2019anatomopathologie, Cliniques universitaires Saint-Luc, UCLouvain, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yves","family":"Horsmans","sequence":"additional","affiliation":[{"name":"Service d\u2019H\u00e9pato-gastroent\u00e9rologie, Cliniques universitaires Saint-Luc, UCLouvain, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Lanthier","sequence":"additional","affiliation":[{"name":"Service d\u2019H\u00e9pato-gastroent\u00e9rologie, Cliniques universitaires Saint-Luc, UCLouvain, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G\u00e9raldine","family":"Dahlqvist","sequence":"additional","affiliation":[{"name":"Service d\u2019H\u00e9pato-gastroent\u00e9rologie, Cliniques universitaires Saint-Luc, UCLouvain, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6431-3618","authenticated-orcid":false,"given":"B\u00e9n\u00e9dicte","family":"Delire","sequence":"additional","affiliation":[{"name":"Service d\u2019H\u00e9pato-gastroent\u00e9rologie, Cliniques universitaires Saint-Luc, UCLouvain, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,9,14]]},"reference":[{"key":"bibr1-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1186\/1755-1536-3-16"},{"key":"bibr2-20420986241270866","unstructured":"National Institute of Diabetes and Digestive and Kidney Diseases. LiverTox: Clinical and research information on drug-induced liver injury\u2014Pirfenidone [Internet]. Bethesda, MD: National Institute of Diabetes and Digestive and Kidney Diseases, https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK548769\/ (2012, accessed 24 June 2020)."},{"key":"bibr3-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-pharmtox-030220-015007"},{"key":"bibr4-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1136\/bcr-2013-201554"},{"key":"bibr5-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2016.05.003"},{"key":"bibr6-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1016\/S1089-3261(05)70097-0"},{"key":"bibr7-20420986241270866","unstructured":"National Institute of Diabetes and Digestive and Kidney Diseases. LiverTox: Clinical and research information on drug-induced liver injury [Internet]. Bethesda, MD: National Institute of Diabetes and Digestive and Kidney Diseases, https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK547852\/ (2012, accessed 4 January 2024)."},{"key":"bibr8-20420986241270866","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001259"},{"key":"bibr9-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2008.09.011"},{"key":"bibr10-20420986241270866","volume":"16","author":"Katarey D","year":"2016","journal-title":"Clin Med (Lond)"},{"key":"bibr11-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2016-313369"},{"key":"bibr12-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1016\/j.lfs.2022.121048"},{"key":"bibr13-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1002\/hep4.1133"},{"key":"bibr14-20420986241270866","unstructured":"EMA : Direct Healthcare Professional Communication. Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI) [Internet], https:\/\/www.ema.europa.eu\/en\/documents\/dhpc\/direct-healthcare-professional-communication-dhpc-esbriet-pirfenidone-important-safety-update-new_en.pdf (2020, accessed 29 October 2020)."},{"key":"bibr15-20420986241270866","doi-asserted-by":"publisher","DOI":"10.3390\/ph15050645"},{"key":"bibr16-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2015.03.006"},{"key":"bibr17-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-019-05591-w"},{"key":"bibr18-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2011.58"},{"key":"bibr19-20420986241270866","doi-asserted-by":"publisher","DOI":"10.3390\/ijms17010014"},{"key":"bibr20-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1016\/0895-4356(93)90101-6"},{"key":"bibr21-20420986241270866","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001836"},{"key":"bibr22-20420986241270866","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(22)00165-0"}],"container-title":["Therapeutic Advances in Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20420986241270866","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/20420986241270866","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20420986241270866","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T23:40:30Z","timestamp":1777592430000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/20420986241270866"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1]]},"references-count":22,"alternative-id":["10.1177\/20420986241270866"],"URL":"https:\/\/doi.org\/10.1177\/20420986241270866","relation":{},"ISSN":["2042-0986","2042-0994"],"issn-type":[{"value":"2042-0986","type":"print"},{"value":"2042-0994","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1]]},"article-number":"20420986241270866"}}