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However, its administration is associated with rare but serious idiosyncratic liver injury, which has warranted a black box warning on the drug labels and frequent monitoring of liver blood tests in the clinic. This review outlines mechanistic investigations that have been conducted to date and constructs a working narrative as an explanation for the idiosyncratic drug-induced liver injury (IDILI) events that have occurred thus far. Potential risk factors which may contribute to individual susceptibility to DILI reactions are addressed, and key areas for future investigative\/clinical development are highlighted.<\/jats:p>","DOI":"10.1093\/toxsci\/kfae142","type":"journal-article","created":{"date-parts":[[2024,11,4]],"date-time":"2024-11-04T15:06:46Z","timestamp":1730732806000},"page":"11-27","source":"Crossref","is-referenced-by-count":4,"title":["Tolvaptan safety in autosomal-dominant polycystic kidney disease; a focus on idiosyncratic drug-induced liver injury liabilities"],"prefix":"10.1093","volume":"203","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3352-3866","authenticated-orcid":false,"given":"Sean","family":"Hammond","sequence":"first","affiliation":[{"name":"Department of Pharmacology and Therapeutics, Centre for Drug Safety Science, University of Liverpool , Liverpool, L69 3GE,","place":["United Kingdom"]},{"name":"ApconiX , Alderley Edge, SK10 4TG,","place":["United 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