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Brand Name :
Reltone, Actigall, Urso, Urso DS, Urso Forte,
Synonyms :
Ursodiol, Ursodeoxycholic Acid
Class :
Gallstone solubilizing agents
Dosage Forms & Strengths
Capsules
300mg
tablets
250mg
500mg
Dosage Forms & Strengths
capsules
300mg
tablets
250mg
500mg
may decrease the serum concentration of ursodiol
may diminish the therapeutic effect of ursodiol
bazedoxifene/conjugated estrogens
may diminish the therapeutic effect of ursodiol
may diminish the therapeutic effect of ursodiol
may diminish the therapeutic effect of ursodiol
may diminish the therapeutic effect of ursodiol
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
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
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.