• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Urso and Urso Forte (ursodiol) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Abnormal Liver Function Tests
  • Liver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter. This monitoring will allow the early detection of a possible deterioration of the hepatic function. Treatment discontinuation should be considered if the above parameters increase to a level considered clinically significant in patients with stable historical liver function test levels.
  • Caution has to be exercised to maintain the bile flow of the patients taking ursodiol.
 

ADVERSE REACTIONS

Postmarketing Experience
  • Hepatobiliary disorders: jaundice (or aggravation of preexisting jaundice).
  • Abnormal Laboratory Tests: ALT increased, AST increased, blood alkaline phosphatase increased, blood bilirubin increased, γ-GT increased, hepatic enzyme increased, liver function test abnormal, transaminases increased.
 

PATIENT COUNSELING INFORMATION

  • Caution has to be exercised to maintain the bile flow of the patients taking ursodiol