Ornidazole-Induced Liver Injury: The Clinical Characterization of a Rare Adverse Reaction and Its Implications from a Multicenter Study

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dc.contributor.authorCaliskan, Ali Riza
dc.contributor.authorTuran, Ilker
dc.contributor.authorVatansever, Sezgin
dc.contributor.authorWeninger, Jasmin
dc.contributor.authorSamdanci, Emine Turkmen
dc.contributor.authorAkatli, Ayse Nur
dc.contributor.authorIsik, Elvan
dc.date.accessioned2026-04-04T13:31:12Z
dc.date.available2026-04-04T13:31:12Z
dc.date.issued2025
dc.departmentİnönü Üniversitesi
dc.description.abstractBackground and Aims: Ornidazole, a nitroimidazole antibiotic, is widely used for protozoal and anaerobic infections and is generally considered safe. However, ornidazole-induced liver injury (OILI) is an underrecognized yet potentially severe adverse reaction. This multicenter study aims to characterize the clinical features, histopathology, and outcomes of OILI to improve the awareness and management of this rare entity worldwide. Methods: We conducted a retrospective analysis of 101 patients with OILI from eight tertiary centers between 2006 and 2023. Cases were included based on liver enzyme elevations temporally linked to ornidazole and the exclusion of other causes. Causality was assessed using the Roussel Uclaf Causality Assessment Method (RUCAM) score. Clinical data, laboratory parameters, autoantibody profiles, histology, treatments, and outcomes were evaluated. Results: OILI was classified as highly probable in 42.6% of cases (n = 43), probable in 51.5% of cases (n = 52), and possible in 5.9% (n = 6) of cases. The predominant pattern was acute hepatocellular injury (83.2%) (n = 84). Autoimmune-like hepatitis occurred in 5% of cases (n = 5), with ANA positivity in 16.8% of cases (n = 17). Corticosteroids were used in 24.8% of cases (n = 25) and were associated with higher ANA positivity and a 20% (n = 5) relapse rate post-discontinuation. Recovery was achieved in 87.7% of cases (n = 88), while 7.9% of cases (n = 8) required liver transplantation and 4% (n = 4) died. Conclusions: Ornidazole can cause serious idiosyncratic liver injury, including autoimmune phenotypes, and should be considered in the differential diagnosis of acute hepatitis. Given the notable risk of liver failure and death, early recognition, drug discontinuation, and close monitoring are essential. In select cases, corticosteroids and plasmapheresis may be beneficial, though the evidence remains limited.
dc.identifier.doi10.3390/biomedicines13071695
dc.identifier.issn2227-9059
dc.identifier.issue7
dc.identifier.orcid0000-0001-8840-5472
dc.identifier.orcid0000-0003-1465-5406
dc.identifier.orcid0000-0002-4783-7620
dc.identifier.orcid0000-0003-0779-992X
dc.identifier.orcid0000-0003-3660-7237
dc.identifier.orcid0000-0002-9415-147X
dc.identifier.orcid0009-0008-7116-8931
dc.identifier.pmid40722768
dc.identifier.scopus2-s2.0-105011657994
dc.identifier.scopusqualityQ1
dc.identifier.urihttps://doi.org/10.3390/biomedicines13071695
dc.identifier.urihttps://hdl.handle.net/11616/108645
dc.identifier.volume13
dc.identifier.wosWOS:001535748300001
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.language.isoen
dc.publisherMdpi
dc.relation.ispartofBiomedicines
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.snmzKA_WOS_20250329
dc.subjectdrug-induced liver injury
dc.subjectornidazole-induced liver injury
dc.subjecthepatitis
dc.subjectliver transplantation
dc.subjectcorticosteroid therapy
dc.titleOrnidazole-Induced Liver Injury: The Clinical Characterization of a Rare Adverse Reaction and Its Implications from a Multicenter Study
dc.typeArticle

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