Mixed hepatocellular-cholestatic liver injury after pioglitazone therapy

Ann Intern Med. 2002 Mar 19;136(6):449-52. doi: 10.7326/0003-4819-136-6-200203190-00008.


Background: Pioglitazone is an oral hypoglycemic agent in the thiazolidinedione class. Only one case of hepatotoxicity related to this agent has previously been reported.

Objective: To report the clinical course of a patient with hepatitis after therapy with pioglitazone.

Design: Case report.

Setting: A community hospital.

Patient: A 49-year-old diabetic man taking pioglitazone, 30 mg/d.

Intervention: Discontinuation of pioglitazone therapy.

Measurements: Serum aminotransferase and bilirubin levels, standard blood tests for causes of hepatitis and cirrhosis other than drug toxicity, and liver biopsy.

Results: After 6 months of pioglitazone therapy, significant hepatic dysfunction developed. Blood tests excluded viral, metabolic, and autoimmune disorders. Liver biopsy showed mixed hepatocellular-cholestatic injury compatible with drug toxicity. After treatment with pioglitazone was discontinued, liver enzyme values returned to normal.

Conclusion: Patients receiving pioglitazone may develop serious liver injury and should be observed for evidence of hepatitis.

Publication types

  • Case Reports

MeSH terms

  • Bilirubin / blood
  • Chemical and Drug Induced Liver Injury / diagnosis
  • Chemical and Drug Induced Liver Injury / enzymology
  • Chemical and Drug Induced Liver Injury / etiology*
  • Cholestasis, Intrahepatic / chemically induced*
  • Cholestasis, Intrahepatic / diagnosis
  • Cholestasis, Intrahepatic / enzymology
  • Diabetes Mellitus, Type 2 / drug therapy
  • Female
  • Humans
  • Hypoglycemic Agents / adverse effects*
  • Liver / enzymology
  • Middle Aged
  • Pioglitazone
  • Thiazoles / adverse effects*
  • Thiazolidinediones*
  • Transaminases / blood


  • Hypoglycemic Agents
  • Thiazoles
  • Thiazolidinediones
  • Transaminases
  • Bilirubin
  • Pioglitazone