The Fibrosis-4 Index Predicts Ceftriaxone-Associated Gallstone Formation: Risk Stratification Using the Fibrosis-4 Index in a Clinical Cohort.

Authors

Hideo Kato, Mao Hagihara, Hiroshige Mikamo, Takuya Iwamoto

Published in

JGH open : an open access journal of gastroenterology and hepatology. Volume 10. Issue 10. Pages e70468. Epub Sep 26, 2026.

Abstract

Ceftriaxone is widely used because of its broad antimicrobial spectrum and convenient dosing; however, high biliary excretion can lead to calcium-ceftriaxone precipitation and gallstone-like formations. Although exposure-related risk factors have been described, the effect of hepatic fibrosis on ceftriaxone-associated gallstone formations remains unclear.
To clarify the role of hepatic fibrosis in ceftriaxone-related gallstone formation.
We conducted a retrospective study on adult patients who received intravenous ceftriaxone and underwent abdominal computed tomography at a tertiary hospital between October 2021 and July 2025. The primary outcome was newly detected gallstone formations during or after ceftriaxone therapy. Clinical variables, including treatment duration, cumulative dose, and fibrosis-4 index, were analyzed. Decision tree, Kaplan-Meier, Cox proportional hazards, and receiver operating characteristic analyses were performed.
Among the 320 eligible patients, 98 (30.6%) developed newly detected gallstones. Patients with gallstones had longer treatment duration (10 vs. 6 days, p < 0.001), higher cumulative dose (22 vs. 10 g, p < 0.001), and higher fibrosis-4 scores (2.86 vs. 1.68, p < 0.001). Decision tree analysis identified fibrosis-4 (cutoff: 2.56) as the primary stratifying variable modifying exposure-related thresholds. Kaplan-Meier analysis showed earlier gallstone development in patients with fibrosis-4 ≥ 2.56. In multivariable Cox analysis, fibrosis-4 ≥ 2.56 was independently associated with gallstone formation. The incorporation of fibrosis-4 improved model discrimination.
Elevated FIB-4 levels were independently associated with CRO-related gallstone formation. The FIB-4 index may facilitate risk stratification during CRO therapy, although the observed association should not be interpreted as direct evidence of hepatic fibrosis.

PMID:
42801096
Bibliographic data and abstract were imported from PubMed on 27 Sep 2026.

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