ursodiol

Action and Spectrum

Drug Interaction

Adverse Reaction

Adverse drug reactions  

 Frequency defined 

>10%  

Dizziness  

Nausea  

Headache  

Back pain  

Upper respiratory tract infection  

Vomiting  

Diarrhea  

Dyspepsia  

1-10%  

Hyperglycemia  

Flatulence  

Cholecystitis  

Leukopenia  

Alopecia  

Rash  

Peptic ulcer  

Thrombocytopenia  

Urinary tract infection  

>1%  

Angioedema  

Abdominal pain  

Peripheral edema  

Fatigue  

Pruritus  

Thrombocytopenia  

Black Box Warning

Contraindication / Caution

Pregnancy / Lactation

Pregnancy warnings:     

AU TGA pregnancy category: B3 

US FDA pregnancy category: Not assigned. 

Lactation: 

Excreted into human milk is unknown 

Pregnancy Categories:       

Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first or later trimester.       

Category B: No evidence shown of risk to the fetus found in animal reproduction studies, and there are not enough studies on pregnant women       

Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for a result in humans must take care of potential risks in pregnant women       

Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.       

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.       

Category N: There is no data available for the drug under this category 

Pharmacology

Adminstartion

Patient Information Leaflet

Patient Information Leaflet  

Generic Name: ursodiol  

Why do we use ursodiol? 

ursodiol is an Gallstone solubilizing agents used treat a type of liver disease called primary biliary cirrhosis and gall bladder disease.