Amoxicillin–Clavulanate-Induced Liver Injury

Andrew S. DeLemos, Marwan Ghabril, Don C. Rockey, Jiezhun Gu, Huiman X. Barnhart, Robert J. Fontana, David E. Kleiner, Herbert L. Bonkovsky, Liver Injury Network (Dilin) Drug-Induced Liver Injury Network (Dilin)

Research output: Contribution to journalArticle

23 Scopus citations


Background and Aims: Amoxicillin–clavulanate (AC) is the most frequent cause of idiosyncratic drug-induced injury (DILI) in the US DILI Network (DILIN) registry. Here, we examined a large cohort of AC-DILI cases and compared features of AC-DILI to those of other drugs. Methods: Subjects with suspected DILI were enrolled prospectively, and cases were adjudicated as previously described. Clinical variables and outcomes of patients with AC-DILI were compared to the overall DILIN cohort and to DILI caused by other antimicrobials. Results: One hundred and seventeen subjects with AC-DILI were identified from the cohort (n = 1038) representing 11 % of all cases and 24 % of those due to antimicrobial agents (n = 479). Those with AC-DILI were older (60 vs. 48 years, P <0.001). AC-DILI was more frequent in men than women (62 vs. 39 %) compared to the overall cohort (40 vs. 60 %, P <0.001). The mean time to symptom onset was 31 days. The Tb, ALT, and ALP were 7 mg/dL, 478, and 325 U/L at onset. Nearly all liver biopsies showed prominent cholestatic features. Resolution of AC-DILI, defined by return of Tb to

Original languageEnglish (US)
Pages (from-to)1-11
Number of pages11
JournalDigestive Diseases and Sciences
StateAccepted/In press - Mar 22 2016



  • Allergy
  • Amoxicillin
  • Augmentin
  • Clavulanic acid
  • Drug-induced liver injury
  • Liver toxicity

ASJC Scopus subject areas

  • Gastroenterology
  • Physiology

Cite this

DeLemos, A. S., Ghabril, M., Rockey, D. C., Gu, J., Barnhart, H. X., Fontana, R. J., Kleiner, D. E., Bonkovsky, H. L., & Drug-Induced Liver Injury Network (Dilin), L. I. N. D. (Accepted/In press). Amoxicillin–Clavulanate-Induced Liver Injury. Digestive Diseases and Sciences, 1-11.