Identification and Characterization of Fenofibrate-Induced Liver Injury

Jawad Ahmad, Joseph A. Odin, Paul H. Hayashi, Naga Chalasani, Robert J. Fontana, Huiman Barnhart, Elizabeth T. Cirulli, David E. Kleiner, Jay H. Hoofnagle

Research output: Contribution to journalArticle

14 Scopus citations


Background: Fenofibrate is a commonly used hypolipidemic associated with rare instances of hepatotoxicity, and routine liver biochemistry monitoring is recommended. Aims: The aim of this study is to describe the presenting clinical features, liver histopathology, and outcomes of 7 cases of acute liver injury associated with fenofibrate. Methods: All cases of definite, very likely, and probable drug-induced liver injury (DILI) attributed to fenofibrate enrolled in the DILI Network study between 2004 and 2015 were reviewed. Results: Among 1229 patients with confirmed DILI, 7 cases (0.6%) were attributed to fenofibrate. The median age was 43 (range 37–61) years, and latency to onset was short (5–8 weeks) in 4 patients but more prolonged (18–56 weeks) in the rest. Laboratory results at presentation showed hepatocellular, mixed, and cholestatic injury, but 6 cases presented with jaundice. No patient had undergone routine monitoring. Four patients required hospitalization and 2 in whom drug discontinuation was delayed had a severe outcome, 1 undergoing liver transplantation, and 1 developing chronic injury and death. Liver biopsy was available in 4 patients and showed diverse injury patterns. Genetic studies showed the presence of the rare HLA-A*33:01 in 3 patients (43 vs. 1% in control populations). The causality scores were highly likely in 5 and probable in 2. Conclusions: Liver injury after fenofibrate exposure occurs with variable latency, enzyme elevation, and histology. Although most cases are self-limited, severe injury and mortality can occur, particularly if drug withdrawal is delayed. Jaundice or abnormal laboratory tests during fenofibrate therapy should trigger prompt discontinuation.

Original languageEnglish (US)
Pages (from-to)3596-3604
Number of pages9
JournalDigestive diseases and sciences
Issue number12
StatePublished - Dec 1 2017
Externally publishedYes


  • Fenofibrate
  • Hepatotoxicity
  • Liver injury tests

ASJC Scopus subject areas

  • Physiology
  • Gastroenterology

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    Ahmad, J., Odin, J. A., Hayashi, P. H., Chalasani, N., Fontana, R. J., Barnhart, H., Cirulli, E. T., Kleiner, D. E., & Hoofnagle, J. H. (2017). Identification and Characterization of Fenofibrate-Induced Liver Injury. Digestive diseases and sciences, 62(12), 3596-3604.