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Updated: Nov 16, 2025

Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
Published on: January 31, 2022
Liver Injury Associated with Metamizole Exposure: Features of an Underestimated Adverse Event
Sabine Weber1, Andreas Benesic2,3,4, Jens Neumann5
1Department of Medicine II, Liver Centre Munich, University Hospital, LMU Munich, Marchioninistr. 15, 81377, Munich, Bavaria, Germany. sabine.weber@med.uni-muenchen.de.
Introduction And Objective:
The potential of metamizole to cause drug-induced liver injury (DILI) has received increasing attention. We investigated the distinguishing features of a case series comprising 32 patients with suspected metamizole-induced DILI.
Methods:
For the current analysis, 32 of 238 patients with DILI included in our prospective study on drugs potentially causing DILI were included. Diagnosis of DILI was based on expert opinion and RUCAM (Roussel Uclaf Causality Assessment Method) score and supported by an in vitro test using monocyte-derived hepatocyte-like cells.
Results:
Suspected metamizole-DILI was characterised by a female predominance, hepatocellular pattern of injury, high proportion of antinuclear antibody positivity, and predominance of eosinophilic cell infiltration and necrosis in the histopathological analysis. With 22%, a high proportion of these metamizole-associated liver injury cases developed acute liver failure, which was characterised by a longer latency of metamizole use and more pronounced liver biochemistry abnormalities at onset and peak levels. Furthermore, jaundice was a common finding in the metamizole-associated liver injury cases with 66% presenting with peak bilirubin levels of 3 mg/dL or higher, which was associated with a worse outcome and a higher frequency of acute liver failure.
Conclusions:
Our analysis of a well-characterised DILI cohort further supports the potential of metamizole causing DILI and provides important features for the establishment of a signature pattern of liver injury observed in patients treated with metamizole.
Clinical Trial Registration:
ClinicalTrials.gov: NCT02353455.
Insights
Metamizole can cause drug-induced liver injury (DILI), often presenting with female predominance and hepatocellular damage. A significant percentage develop acute liver failure, highlighting the need for vigilance.
Area of Science:
- Hepatology
- Pharmacovigilance
- Drug-induced liver injury (DILI)
Background:
- Metamizole's potential to cause drug-induced liver injury (DILI) is gaining attention.
- Understanding the specific characteristics of metamizole-induced DILI is crucial for early detection and management.
Purpose of the Study:
- To investigate the distinguishing clinical and histopathological features of metamizole-induced DILI.
- To identify patterns associated with severe outcomes like acute liver failure.
Main Methods:
- Analysis of a case series of 32 patients with suspected metamizole-DILI from a larger prospective study.
- Diagnosis confirmed by expert opinion, Roussel Uclaf Causality Assessment Method (RUCAM) score, and in vitro testing.
Main Results:
- Metamizole-DILI cases showed female predominance, hepatocellular injury, and eosinophilic infiltration.
- 22% of cases progressed to acute liver failure, linked to longer latency and severe biochemical abnormalities.
- Jaundice (peak bilirubin ≥ 3 mg/dL) was common (66%) and associated with worse outcomes.
Conclusions:
- This study supports metamizole as a cause of DILI.
- Identified key features may help establish a signature pattern for metamizole-associated liver injury.
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