Ursodiol 93 5360 00093 5360 01 Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Ursodiol tablets, 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (PBC).
What should I know before taking it?
Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation.
What important warnings are listed?
Abnormal Liver Function Tests: Liver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin level should be monitored. Treatment discontinuation should be considered if parameters increase to a level considered clinically significant in patients with stable historical liver function test levels. Caution should be exercised to maintain patients’ bile flow. (5.1) Enteroliths in Patients with Risk for Intestinal Stenosis or Stasis: Monitor for obstructive gastrointestinal symptoms; if symptoms occur, hold ursodiol until a clinical evaluation has been conducted. (5.2)
How is this medication usually taken?
•Ursodiol Tablets, USP 250 mg: 250 mg tablet •Ursodiol Tablets, USP 500 mg: 500 mg scored tablet
What side effects are listed?
Most common adverse reactions reported with the use of ursodiol during worldwide postmarketing and clinical experience (≥1%) are, in alphabetical order: abdominal discomfort, abdominal pain, alopecia, diarrhea, nausea, pruritus, and rash. (6) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
What interactions are listed?
Bile Acid Sequestering Agents: May interfere with the action of ursodiol tablets, 250 mg and 500 mg by reducing its absorption. (7.1) Aluminum-based Antacids: May interfere with the action of ursodiol tablets, 250 mg and 500 mg by reducing its absorption. (7.2) Drugs that alter the metabolism of lipids or induce cholestasis may interfere with the action of ursodiol tablets, 250 mg and 500 mg. (7.3)
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb79b62a-b450-4d7a-be28-5ee4d174fd58
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.