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ACG Clinical Guideline: Diagnosis and Management of Idiosyncratic Drug-Induced Liver Injury
Abstract
Idiosyncratic drug-induced liver injury (DILI) is common in gastroenterology and hepatology practices, and it can have multiple presentations, ranging from asymptomatic elevations in liver biochemistries to hepatocellular or cholestatic jaundice, liver failure, or chronic hepatitis. Antimicrobials, herbal and dietary supplements, and anticancer therapeutics (e.g., tyrosine kinase inhibitors or immune-checkpoint inhibitors) are the most common classes of agents to cause DILI in the Western world. DILI is a diagnosis of exclusion, and thus, careful assessment for other etiologies of liver disease should be undertaken before establishing a diagnosis of DILI. Model for end-stage liver disease score and comorbidity burden are important determinants of mortality in patients presenting with suspected DILI. DILI carries a mortality rate up to 10% when hepatocellular jaundice is present. Patients with DILI who develop progressive jaundice with or without coagulopathy should be referred to a tertiary care center for specialized care, including consideration for potential liver transplantation. The role of systemic corticosteroids is controversial, but they may be administered when a liver injury event cannot be distinguished between autoimmune hepatitis or DILI or when a DILI event presents with prominent autoimmune hepatitis features.
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RUCAM is the most widely used and accepted DILI diagnostic tool.
“It is the most widely used and accepted DILI diagnostic tool.2, 3”
From A revised electronic version of RUCAM for the diagnosis of DILI (2022) · cites this paper as [2]
The lack of a reliable diagnostic biomarker and evidence-based treatment paradigm has resulted in limited guidance on how to manage DI-ALH.
“The lack of a reliable diagnostic biomarker and evidence-based treatment paradigm has resulted in limited guidance on how to manage this aspect of DILI.”
From Nomenclature, diagnosis and management of drug-induced autoimmune-like hepatitis (DI-ALH): An expert opinion meeting report (2023) · cites this paper as [26]
The lack of reliable diagnostic biomarkers and an evidence-based treatment paradigm has resulted in limited guidance on how to manage this aspect of DILI.
“The lack of reliable diagnostic biomarkers and an evidence-based treatment paradigm has resulted in limited guidance on how to manage this aspect of DILI.2,25–27”
From Nomenclature, diagnosis and management of drug-induced autoimmune-like hepatitis (DI-ALH): An expert opinion meeting report (2023) · cites this paper as [26]
There are reports of corticosteroids having beneficial effects in patients with moderate or severe DILI.
“Data on corticosteroid use in DILI is scarce with no randomized controlled studies to evaluate their efficacy and safety; however, there are reports of corticosteroids having beneficial effects in patients with moderate or severe DILI.[18,23]”
From Drug-induced liver injury: Diagnosis, management and the role of liver transplantation (2025) · cites this paper as [18]
Data on corticosteroid use in DILI is scarce with no randomized controlled studies to evaluate their efficacy and safety.
“Data on corticosteroid use in DILI is scarce with no randomized controlled studies to evaluate their efficacy and safety; however, there are reports of corticosteroids having beneficial effects in patients with moderate or severe DILI.[18,23]”
From Drug-induced liver injury: Diagnosis, management and the role of liver transplantation (2025) · cites this paper as [18]
RUCAM can provide systematic and framed guidance for the assessment of patients with suspected DILI.
“Although there are some ambiguities regarding how to score certain sections as well as suboptimal reliability, RUCAM can provide systematic and framed guidance for the assessment of patients with suspected DILI and is the most widely used tool [26,27,51,59].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [27]
RUCAM is the most widely used tool for causality assessment in DILI.
“Although there are some ambiguities regarding how to score certain sections as well as suboptimal reliability, RUCAM can provide systematic and framed guidance for the assessment of patients with suspected DILI and is the most widely used tool [26,27,51,59].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [27]
There is insufficient evidence suggesting that currently reported drug- and host-related risk factors can increase all-cause susceptibility to iDILI.
“There is insufficient evidence suggesting that currently reported drug-and host-related risk factors can increase all-cause susceptibility to iDILI [1,27].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [27]
The RUCAM score, combined with expert opinion, may be the best current practical causality assessment method for establishing a diagnosis of HDS-DILI or HILI.
“The RUCAM score, combined with expert opinion, may be the best current practical causality assessment method for establishing a diagnosis of HDS-DILI or HILI [27,59].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [27]
The RUCAM score may show reduced reliability in the causality assessment of suspected HDS-DILI or HILI.
“Therefore, the RUCAM score may show reduced reliability in the causality assessment of suspected HDS-DILI or HILI [27].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [27]
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Drug-induced liver injury in COVID-19 treatment: Incidence, mechanisms and clinical management
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Metadata
- Authors
- Chalasani, N. P., Maddur, H., Russo, M. W., Wong, R. J., Reddy, K. R., & on behalf of the Practice Parameters Committee of the American College of Gastroenterology
- Affiliations
- Indiana University Indianapolis (US)
- Northwestern University (US)
- Carolinas Medical Center (US)
- VA Palo Alto Health Care System (US)
- University of Pennsylvania (US)
- Corresponding author
- Chalasani, Naga P.
- Venue
- American Journal of Gastroenterology
- Published
- 2021-05
- Volume
- 116
- Issue
- 5
- Pages
- 878-898
- ISSN
- 0002-9270 (ISSN-L)
- 1572-0241
- OpenAlex
- W4205136705
- Semantic Scholar
- 2c1e0585092198394e24121ea3fbf9704f76ae03
- Cited by
- 430
- References
- 165
- Citations by year
- 2026: 103 · 2025: 94 · 2024: 85 · 2023: 65 · 2022: 65 · 2021: 18
- FWCI
- 34.38
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The American Journal of Gastroenterology (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- idiosyncratic drug-induced liver injury, drug-induced liver injury, diagnosis of exclusion, hepatocellular jaundice, cholestatic jaundice, liver failure, chronic hepatitis, antimicrobial agents, herbal and dietary supplements, tyrosine kinase inhibitors, immune checkpoint inhibitors, Model for End-Stage Liver Disease, comorbidity burden, mortality, liver transplantation, corticosteroids
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