Drug-induced liver injury

Andrade, Raul J.; Chalasani, Naga; Björnsson, Einar S.; Suzuki, Ayako; Kullak-Ublick, Gerd A.; Watkins, Paul B.; Devarbhavi, Harshad; Merz, Michael; Lucena, M. Isabel; Kaplowitz, Neil; Aithal, Guruprasad P.

doi:10.1038/s41572-019-0105-0

Cited by 924Drug-Induced Hepatotoxicity and ProtectionPharmacovigilance and Adverse Drug ReactionsDrug-Induced Adverse Reactions

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Drug-induced liver injury

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Andrade, Raul J., Chalasani, Naga, Björnsson, Einar S., Suzuki, Ayako, Kullak-Ublick, Gerd A., Watkins, Paul B., Devarbhavi, Harshad, Merz, Michael, Lucena, M. Isabel, Kaplowitz, Neil, Aithal, Guruprasad P.·2019·Nature Reviews Disease Primers

DOI 10.1038/s41572-019-0105-0

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Abstract

Drug-induced liver injury (DILI) is an adverse reaction to drugs or other xenobiotics that occurs either as a predictable event when an individual is exposed to toxic doses of some compounds or as an unpredictable event with many drugs in common use. Drugs can be harmful to the liver in susceptible individuals owing to genetic and environmental risk factors. These risk factors modify hepatic metabolism and excretion of the DILI-causative agent leading to cellular stress, cell death, activation of an adaptive immune response and a failure to adapt, with progression to overt liver injury. Idiosyncratic DILI is a relative rare hepatic disorder but can be severe and, in some cases, fatal, presenting with a variety of phenotypes, which mimic other hepatic diseases. The diagnosis of DILI relies on the exclusion of other aetiologies of liver disease as specific biomarkers are still lacking. Clinical scales such as CIOMS/RUCAM can support the diagnostic process but need refinement. A number of clinical variables, validated in prospective cohorts, can be used to predict a more severe DILI outcome. Although no pharmacological therapy has been adequately tested in randomized clinical trials, corticosteroids can be useful, particularly in the emergent form of DILI related to immune-checkpoint inhibitors in patients with cancer.

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The vast majority of DILI cases occur at therapeutic doses in a small proportion of individuals exposed to the drug, representing an idiosyncratic reaction, and are unpredictable based on the drug's mechanism of action and related to the uniqueness of the individual.
“The vast majority of cases of DILI occur at therapeutic doses in a small proportion of individuals exposed to the drug, representing an idiosyncratic reaction, and therefore unpredictable based on the drug's mechanism of action and related to the uniqueness of the individual [1,2].”
From DILI Differences and Similarities between the US and Europe (2026) · cites this paper as [1]
Drug-induced liver injury (DILI) is an uncommon adverse reaction to drugs and other chemicals, including herbal and dietary supplements (HDS).
“Drug-induced liver injury (DILI) is an uncommon adverse reaction to drugs, and other chemicals, including herbal and dietary supplements (HDS).”
From DILI Differences and Similarities between the US and Europe (2026) · cites this paper as [1]

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Cites a retracted work: 10.1016/j.jhep.2018.04.024
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Cited work 10.1016/j.jhep.2018.04.024 · retracted 2018-05-03 · notice 10.1016/j.jhep.2018.04.024 · this paper published 2019-08-22
Cites a retracted work: 10.1128/aac.04976-14
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The cited work was retracted on 2015-12-28 (notice 10.1128/aac.04976-14), before this paper was published (2019-08-22). Its authors could have known.
Cited work 10.1128/aac.04976-14 · retracted 2015-12-28 · notice 10.1128/aac.04976-14 · this paper published 2019-08-22

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Drug induced liver injury: an update
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Drug-induced liver injury: An overview and update
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Drug-induced liver injury: Pathogenesis, epidemiology, clinical features, and practical management
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Authors: Andrade, R. J., Chalasani, N., Björnsson, E. S., Suzuki, A., Kullak-Ublick, G. A., Watkins, P. B., Devarbhavi, H., Merz, M., Lucena, M. I., Kaplowitz, N., & Aithal, G. P.
Affiliations: Indiana University School of Medicine (US)
Duke University (US)
Novartis (Switzerland) (CH)
University of North Carolina at Chapel Hill (US)
St.John's Medical College Hospital (IN)
University of Zurich (CH)
Spanish Clinical Research Network (ES)
Nottingham University Hospitals NHS Trust (GB)
Corresponding author: Lucena, M. Isabel
ORCID: Chalasani, Naga
Suzuki, Ayako
Kullak-Ublick, Gerd A.
Watkins, Paul B.
Devarbhavi, Harshad
Merz, Michael
Lucena, M. Isabel
Kaplowitz, Neil
Aithal, Guruprasad P.
Venue: Nature Reviews Disease Primers
Publisher: Springer Science and Business Media LLC
Published: 2019-08-22
Volume: 5
Issue: 1
Pages: 58-58
ISSN: 2056-676X (ISSN-L)
DOI: 10.1038/s41572-019-0105-0
OpenAlex: W1565605888
Cited by: 924
References: 982
Citations by year: 2026: 152 · 2025: 197 · 2024: 161 · 2023: 127 · 2022: 145 · 2021: 97 · 2020: 38
FWCI: 9.11
Type: journal article
Language: en
Open access: green
www.zora.uzh.ch
Licence: other-oa
www.springernature.com/gp/researchers/text-and-data-mining (tdm)
www.springernature.com/gp/researchers/text-and-data-mining (vor)
Locations: Nature Reviews Disease Primers (publishedVersion)
PubMed (publishedVersion)
Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
RISalud Institutional Health Repository of Andalucía (submittedVersion, cc-by-nc-nd)
Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
Zurich Open Repository and Archive (University of Zurich)
Topics: Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Health Sciences › Medicine › Pharmacology (medical) › Drug-Induced Adverse Reactions
Keywords: drug-induced liver injury, idiosyncratic drug reactions, xenobiotic toxicity, genetic susceptibility, hepatic metabolism, immune response, corticosteroids, immune checkpoint inhibitors, hepatotoxicity
MeSH terms: Biopsy, Humans, Risk Factors, Biomarkers, Chemical and Drug Induced Liver Injury

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