Evidence map›Paper›PMID 39912769›Full record

Observational studyLiver international : official journal of the International Association for the Study of the Liver2025

Drug-Induced Liver Injury Caused by Metamizole: Identification of a Characteristic Injury Pattern.

Sabine Weber, Franziska Erhardt, Julian Allgeier, Didem Saka, Nirali Donga, Jens Neumann, Christian M Lange, Alexander L Gerbes

Registry-linked trialAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Liver international : official journal of the International Association for the Study of the Liver, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02353455 (Cells of Monocytic Origin as Surrogate Markers for Individual Drug Effects and Hepatotoxicity), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02353455 unknown statusnot on this map

Cells of Monocytic Origin as Surrogate Markers for Individual Drug Effects and Hepatotoxicity

TypeobservationalSponsorAndreas Benesic, MDRan2013 to 2022Enrolled300ConditionsDrug-induced Disorder of Liver, Adverse Reaction to DrugArmsBlood sampling
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Sabine WeberDepartment of Medicine II, LMU Klinikum, Munich, Germany.ORCID 0000-0001-7077-8078
Franziska ErhardtDepartment of Medicine II, LMU Klinikum, Munich, Germany.
Julian AllgeierDepartment of Medicine II, LMU Klinikum, Munich, Germany.
Didem SakaDepartment of Medicine II, LMU Klinikum, Munich, Germany.
Nirali DongaDepartment of Medicine II, LMU Klinikum, Munich, Germany.
Jens NeumannInstitute of Pathology, Medical Faculty, LMU, Munich, Germany.
Christian M LangeDepartment of Medicine II, LMU Klinikum, Munich, Germany.ORCID 0000-0001-9983-5136
Alexander L GerbesDepartment of Medicine II, LMU Klinikum, Munich, Germany.

Funding

EFPIAEuropean Union's Horizon 2020 Research and Innovation ProgrammeInnovative Medicines Initiative 2 Joint Undertaking 821283
6 · The paper itself

Abstract

BACKGROUND AND

aimsDrug-induced liver injury (DILI) due to metamizole has gained increasing attention. Causality assessment remains a challenge, especially in patients with co-medications. We therefore aimed to further characterise metamizole DILI cases.

methodsThe data of patients with metamizole intake from our prospective study on acute liver injury with potential drug-related causes were analysed. Diagnosis and causality assessment were based on a thorough work-up and long-term follow-up.

resultsDILI was associated with metamizole in 61 of 324 DILI patients (prevalence 18.8%). A highly characteristic clinical pattern was observed in 43 of the 61 patients, characterised by marked elevation of transaminases peaking at the time of DILI recognition and a more pronounced increase of bilirubin within the first 3 days of clinical presentation. Patients fitting this picture had higher rates of jaundice, coagulopathy, and acute liver failure, however outcomes did not differ significantly when compared to non-metamizole DILI and autoimmune hepatitis (AIH) patients. Overall, fatal adverse outcomes defined by death or liver transplantation were observed in 13.1% of metamizole DILI patients. On multivariate analysis, only aspartate aminotransferase (AST) and INR were independently associated with a fatal adverse outcome. INR, in particular, performed better than Hy's law, bilirubin, transaminases, and the model for end-stage liver disease (MELD), with a c-statistic of 0.85 (95% CI: 0.70-1.0). At a cut-off of ≥ 2.1, sensitivity and specificity for a fatal adverse outcome were 75% and 96%, respectively.

conclusionsMetamizole DILI can present with a characteristic pattern that can help clinicians to identify metamizole as the causative agent. Outcome, however, is not associated with this clinical picture and should rather be predicted by INR at onset.

trial registrationClinicalTrials.gov identifier: NCT02353455.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalChemical and Drug Induced Liver InjuryDipyroneAdultAgedAspartate AminotransferasesBilirubinFemaleHumansMaleMiddle AgedMultivariate AnalysisProspective StudiesAnti-Inflammatory Agents, Non-SteroidalAspartate AminotransferasesBilirubinDipyronedrug adverse reactionsdrug toxicityhepatotoxicityliver injury

Identifiers

PMID39912769
PMCPMC11801327

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.