Ursodiol: uses, dosing, side effects & brands
Ursodiol is a bile acid sold in the U.S. under 3 brand and generic names, for cholelithiasis and biliary liver cirrhosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Bile Acid
- Treats (across its forms)
- Cholelithiasis and Biliary Liver Cirrhosis
- Available as
- Tablet · Capsule
- Sold as
- 3 products — Urso 250, Urso Forte and Ursodiol
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $14 for a 30-count supply — not your price
How Urso 250 is dosed
From the FDA label for Urso 250 (application NDA020675). Other ursodiol products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended adult dosage : 13-15 mg/kg/day administered in two to four divided doses with food. ( 2.1 ) Scored URSO Forte tablet : scored tablet can be broken in halves to provide recommended dosage. ( 2.3 , 16 ) 2.1 General Dosing Information The recommended adult dosage for URSO 250 and URSO Forte in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient’s need at the discretion of the physician. 2.2 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 [see Warnings and Precautions ( 5.1 ) ]. 2.3 Scoring the URSO Forte Tablet The URSO Forte scored tablet can be broken in halves to provide recommended dosage. To break URSO Forte scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets. [see How…
Everything below is the FDA label for Urso 250 (tablet). Ursodiol is also sold as capsule, and those are different medicines to take — follow the label for the one you were prescribed.
Urso 250 side effects
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 Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The following table summarizes the adverse reactions observed in two placebo-controlled clinical trials. ADVERSE REACTIONS VISIT AT 12 MONTHS VISIT AT 24 MONTHS UDCA n (%) Placebo n (%) UDCA n (%) Placebo n (%) Diarrhea --- --- 1 (1.32) --- Elevated creatinine --- --- 1 (1.32) --- Elevated blood glucose 1 (1.18) --- 1 (1.32) --- Leukopenia --- --- 2 (2.63) --- Peptic ulcer --- --- 1 (1.32) --- Skin rash --- --- 2 (2.63) --- Thrombocytopenia --- --- 1 (1.32) --- Note: Those adverse reactions occurring at the same or higher incidence in the placebo as in the UDCA group have been deleted from this table (this includes diarrhea and thrombocytopenia at 12 months, nausea/vomiting, fever and other toxicity). UDCA =…
Who shouldn’t take Urso 250
Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. ( 4 )
Urso 250 drug interactions
Bile Acid Sequestering Agents : May interfere with the action of URSO 250 and URSO Forte by reducing its absorption. ( 7.1 ) Aluminum-based Antacids : May interfere with the action of URSO 250 and URSO Forte by reducing its absorption. ( 7.2 ) Drugs that alter the metabolism of lipids or induce cholestasis may interfere with the action of URSO 250 and URSO Forte. ( 7.3 ) 7.1 Bile Acid Sequestering Agents Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of URSO 250 and URSO Forte by reducing its absorption. 7.2 Aluminum-based Antacids Aluminum-based antacids have been shown to adsorb bile acids in vitro and may be expected to interfere with URSO 250 and URSO Forte in the same manner as the bile acid sequestering agents. 7.3 Drugs Affecting Lipid Metabolism Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the effectiveness of URSO 250 and URSO Forte.
Every ursodiol product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | Generic | $14 | View → | |
| 2 | 72/100 | Prescription | Tablet | Generic | $14 | View → | |
| 3 | 68/100 | Prescription | Capsule | Generic | $14 | View → |
What ursodiol pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
How long ursodiol keeps
No ursodiol label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does ursodiol expire? The in-use limits and storage rules from its labelsUrsodiol and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for ursodiol: levels in milk, effects in breastfed infants, and the drugs it would consider insteadUrsodiol (ursodeoxycholic acid) is naturally present in human milk. Because of the low levels of ursodiol in breastmilk after exogenous administration, amounts ingested by the infant are small and are not expected to cause any adverse effects in breastfed infants. Ursodiol has been given safely directly to newborns treat neonatal jaundice. No special precautions are required.
National Institute of Child Health and Human Development, record revised February 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about ursodiol
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 19,698 reports naming ursodiol, and the FDA flagged 78% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- pruritus1,283 reports
- diarrhoea1,116 reports
- fatigue1,076 reports
- nausea998 reports
- pyrexia841 reports
- pneumonia709 reports
- vomiting660 reports
- headache606 reports
Read these as a signal, not a rate. A report does not mean ursodiol caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 26, 2026.
Related calculators
Frequently asked questions
What is Urso 250?
URSO 250 (ursodiol, 250 mg) is available as a film-coated tablet for oral administration. URSO Forte (ursodiol, 500 mg) is available as a scored film-coated tablet for oral administration. Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. It is a bitter-tasting white powder consisting of crystalline particles freely soluble in ethanol and glacial acetic acid, slightly soluble in chloroform, sparingly soluble in ether, and practically insoluble in water.
What kind of drug is ursodiol?
The FDA classifies ursodiol as a bile acid. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take ursodiol with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ursodiol against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is ursodiol sold under?
We track 3 ursodiol-containing products in the U.S.: Urso 250, Urso Forte and Ursodiol. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does ursodiol come in?
Across the brands we track, ursodiol is currently marketed as tablet and capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic ursodiol?
Yes. Our catalog lists 1 generic ursodiol product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Ursodiol: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ursodiol
- MLA
- “Ursodiol: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ursodiol.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for ursodiol on DailyMed (NIH) ↗.