biostudies-literatureAtallah EInnovative Medicines InitiativeTranslational Safety Biomarker PipelineNational Institute for Health Research (NIHR)1327-1343https://www.ebi.ac.uk/biostudies/studies/S-EPMC7617394biostudies-literatureUnknown17(11)<h4>Introduction</h4>Idiosyncratic drug-induced liver injury (DILI) is an unpredictable event, and there are no specific biomarkers that can distinguish DILI from alternative explanations or predict its clinical outcomes.<h4>Areas covered</h4>This systematic review summarizes the available evidence for all biomarkers proposed to have a role in the diagnosis or prognosis of DILI. Following a comprehensive search, we included all types of studies in humans. We included DILI cases based on any threshold criteria but excluded intrinsic DILI, commonly caused by paracetamol overdose. We classified studies into diagnostic and prognostic categories and assessed their methodological quality. After reviewing the literature, 14 studies were eligible.<h4>Expert opinion</h4>Diagnostic studies were heteExpert opinion on drug metabolism & toxicologyBiomarkers of idiosyncratic drug-induced liver injury (DILI) - a systematic review.PMC7617394IS-BRU-0211-20106ACF-2018-12-007NIHR-INF-1215Atallah EKullak-Ublick GAAlvarez-Alvarez IGerbes ALCubero FJFreixo CAithal GPfalseBiomarkers of idiosyncratic drug-induced liver injury (DILI) - a systematic review.<h4>Introduction</h4>Idiosyncratic drug-induced liver injury (DILI) is an unpredictable event, and there are no specific biomarkers that can distinguish DILI from alternative explanations or predict its clinical outcomes.<h4>Areas covered</h4>This systematic review summarizes the available evidence for all biomarkers proposed to have a role in the diagnosis or prognosis of DILI. Following a comprehensive search, we included all types of studies in humans. We included DILI cases based on any threshold criteria but excluded intrinsic DILI, commonly caused by paracetamol overdose. We classified studies into diagnostic and prognostic categories and assessed their methodological quality. After reviewing the literature, 14 studies were eligible.<h4>Expert opinion</h4>Diagnostic studies were hete2021-01-01T00:00:00Z2021 Nov2026-06-01T18:11:04.336Z2025-04-04T00:26:29.596ZS-EPMC76173943472779710.1080/17425255.2021.1999410