The hepatic safety profile of duloxetine: a review

Expert Opin Drug Metab Toxicol. 2008 Mar;4(3):281-5. doi: 10.1517/17425255.4.3.281.


Background: Hepatotoxicity related to the use of duloxetine resulted in rewording of the US product insert.

Objective: To characterize the hepatic safety profile of duloxetine.

Methods: We conducted a PubMed search of all English-language articles published between January 1990 and December 2007 and contacted the manufacturer (Eli Lilly, Inc.).

Results: Elevations of alanine aminotransferase to three times the upper limit of normal occurs in 0.9-1.7% of duloxetine-treated patients versus 0.0-0.3% of placebo-treated patients. Hepatocellular, cholestatic and mixed hepatocellular-cholestatic forms of hepatic injury have been described.

Conclusion: Duloxetine does not appear to pose a greater hazard for hepatic toxicity when compared to other conventional antidepressants. Systematic monitoring of liver aminotransferases does not appear to be warranted with routine duloxetine use.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Alanine Transaminase / blood
  • Antidepressive Agents / adverse effects*
  • Aspartate Aminotransferases / blood
  • Duloxetine Hydrochloride
  • Humans
  • Liver / drug effects*
  • Thiophenes / adverse effects*


  • Antidepressive Agents
  • Thiophenes
  • Duloxetine Hydrochloride
  • Aspartate Aminotransferases
  • Alanine Transaminase