Liver injury associated with dimethyl fumarate in multiple sclerosis patients

Mult Scler. 2017 Dec;23(14):1947-1949. doi: 10.1177/1352458516688351. Epub 2017 Jan 13.


Background: In pre-approval trials, there was an increased incidence of mild, transient elevations of liver aminotransferases in study subjects treated with dimethyl fumarate (DMF).

Objective/methods: To evaluate post-marketing cases of drug-induced liver injury associated with DMF.

Results: We identified 14 post-marketing cases of clinically significant liver injury. Findings included newly elevated serum liver aminotransferase and bilirubin levels that developed as early as a few days after the first dose of DMF. The pattern of liver injury was primarily hepatocellular. No cases resulted in liver failure.

Conclusion: Health professionals should be alerted to possible serious liver injury in patients receiving DMF.

Keywords: Dimethyl fumarate; drug hypersensitivity; drug-induced liver injury; multiple sclerosis.

MeSH terms

  • Adult
  • Bilirubin / blood*
  • Chemical and Drug Induced Liver Injury / enzymology*
  • Chemical and Drug Induced Liver Injury / etiology*
  • Dimethyl Fumarate / adverse effects*
  • Female
  • Humans
  • Immunosuppressive Agents / adverse effects*
  • Male
  • Middle Aged
  • Multiple Sclerosis / drug therapy*
  • Severity of Illness Index
  • Transaminases / blood*


  • Immunosuppressive Agents
  • Transaminases
  • Dimethyl Fumarate
  • Bilirubin