Ursodiol
Ursodiol is a bile acid medicine used to dissolve certain gallstones, prevent gallstones during rapid weight loss, and treat primary biliary cholangitis (PBC), depending on the product.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 40 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Ursodiol is a long-standing bile acid medicine, available generically, that dissolves certain cholesterol gallstones, prevents them during rapid weight loss, and treats primary biliary cholangitis (PBC, a chronic liver disease), where it is the usual first choice; it lowers the cholesterol the liver makes and releases and cuts its absorption from the gut, so bile keeps cholesterol dissolved. Most people tolerate it well, and what they notice is usually mild diarrhea or belly discomfort. Report severe belly pain or signs of a bowel blockage promptly, because hardened masses in the gut (enteroliths) have rarely formed, mostly in people with Crohn’s disease or past bowel surgery.
Clinical pearls
- Capsules are labeled for gallstones and tablets for PBC, so make sure a refill is the same form you started on.
- Cholestyramine, colestipol and aluminum-based antacids bind ursodiol in the gut, so do not take them at the same time.
- Estrogens, birth control and clofibrate raise cholesterol in bile and can work against ursodiol when it is dissolving gallstones.
- For PBC, take the tablets with food and expect liver tests and bilirubin monthly for three months, then every six months.
Patient information guide A plain-language walkthrough of Ursodiol, written from its FDA label.
What Ursodiol is used for
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Ursodiol is used for gallstone conditions and for a liver disease, depending on the product.
- Ursolign, Reltone, and ursodiol capsules: dissolving radiolucent (x-ray-transparent), noncalcified gallbladder stones smaller than 20 mm in people who would otherwise have gallbladder removal but have higher surgical risk or refuse surgery.
- Ursolign, Reltone, and ursodiol capsules: preventing gallstones in obese patients losing weight rapidly.
- Urso 250, Urso Forte, and ursodiol tablets: treating primary biliary cholangitis (PBC).
How Ursodiol works
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Ursodiol is a bile acid that acts in the liver, bile, and gut. It reduces cholesterol made and released by the liver and blocks some cholesterol absorption in the intestine.
This turns bile from cholesterol-precipitating (forming crystals) into cholesterol-dissolving. That makes it suitable for dissolving cholesterol gallstones.
Ursodiol dosage
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Ursodiol is taken by mouth, and the schedule depends on the product and condition.
- Capsules for gallstone dissolution are generally taken in 2 or 3 divided doses daily, with gallbladder ultrasounds about every 6 months in the first year.
- Capsules for gallstone prevention during weight loss are taken as a set daily amount.
- Urso 250, Urso Forte, and ursodiol tablets for PBC are generally taken in two to four divided doses with food.
Follow your prescriber and pharmacy label.
Dosing details from the FDA-approved label
From the Ursodiol prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Gallstone Dissolution (radiolucent gallbladder stones)
- 8-10 mg/kg/day given in 2 or 3 divided doses
- Ultrasound images of the gallbladder at 6-month intervals for the first year; if stones appear dissolved, continue therapy and confirm on repeat ultrasound within 1 to 3 months
- Gallstone Prevention in patients undergoing rapid weight loss
- 600 mg/day (300 mg b.i.d. per Ursolign label)
- Primary biliary cholangitis (PBC), adults (tablets)
- 13-15 mg/kg/day administered in two to four divided doses with food
- Dosing regimen adjusted according to each patient's need at the discretion of the physician; liver function tests and bilirubin monitored every month for three months, then every six months
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Gallstone Dissolution The recommended dose for Reltone™ treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses. Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of Reltone™ therapy to monitor gallstone response. If gallstones appear to have dissolved, Reltone™ therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of Reltone™ therapy, the likelihood of success is greatly reduced. Gallstone Prevention The recommended dosage of Reltone™ for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day.
Gallstone Dissolution The recommended dose for Reltone™ treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses. Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of Reltone™ therapy to monitor gallstone response. If gallstones appear to have dissolved, Reltone™ therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of Reltone™ therapy, the likelihood of success is greatly reduced.
Gallstone Prevention The recommended dosage of Reltone™ for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day.
Read the full Dosage and Administration section on DailyMed →
Ursodiol side effects
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Many people have no trouble, but these effects were reported:
Common side effects
- Abdominal pain
- Diarrhea
- Constipation
- Nausea or vomiting
- Indigestion (dyspepsia)
- Headache
- Dizziness
- Back pain
When to get medical help
- Call your doctor if you develop signs of a bowel blockage, such as obstructive stomach or intestinal symptoms. Rare cases of hardened masses in the gut (enteroliths) needed surgery.
- Get medical help for severe or worsening abdominal pain, since gallbladder problems can occur with gallstones.
- Seek help for allergic symptoms, as ursodiol should not be used by people allergic to bile acids.
Ursodiol warnings and precautions
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Rare cases of enteroliths (hardened masses in the gut) causing blockage and needing surgery have been reported. Risk is higher with conditions that narrow or slow the intestines, such as Crohn’s disease or certain surgeries.
For capsules, safety beyond 24 months for stone dissolution is not established. If partial dissolution isn’t seen by 12 months, success becomes much less likely.
Ursodiol interactions
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Some medicines can reduce how well ursodiol works.
- Cholestyramine and colestipol: may reduce absorption.
- Aluminum-based antacids: may bind bile acids.
- Estrogens, oral contraceptives, clofibrate: raise cholesterol in bile and may counteract it.
Interactions listed in the FDA-approved label
From the Ursodiol prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Bile acid sequestering agents such as cholestyramine and colestipol: May interfere with the action of ursodiol capsules by reducing its absorption.
- Aluminum-based antacids: Have been shown to adsorb bile acids in vitro and may be expected to interfere with ursodiol capsules in the same manner as the bile acid sequestering agents.
- 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 ursodiol capsules.
Read the label’s full interactions text
Drug Interactions Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of ursodiol capsules by reducing its absorption. Aluminum-based antacids have been shown to adsorb bile acids in vitro and may be expected to interfere with ursodiol capsules in the same manner as the bile acid sequestering agents. 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 ursodiol capsules.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Ursodiol
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- Don’t use if you’re allergic to bile acids.
- Capsules won’t work on calcified, radiopaque, or bile pigment stones.
- Capsules aren’t for people with compelling reasons for gallbladder surgery, such as acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula.
- Tell your doctor about Crohn’s disease or bowel surgery.
Ursodiol overdose
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No accidental or intentional overdose has been reported with ursodiol capsules. The most likely sign of a severe overdose would be diarrhea, which is treated by managing symptoms.
What Ursodiol does in the body
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Ursodiol lowers cholesterol made and released by the liver and reduces cholesterol absorption in the gut. It shifts bile so it can hold more cholesterol dissolved. Bile levels reach steady state in about 3 weeks and fall to about 5% to 10% within about a week after stopping.
How your body processes Ursodiol
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About 90% of ursodiol capsules is absorbed in the small bowel. The liver pulls most of it out of the blood, so only small amounts reach general circulation. It is attached to glycine or taurine in the liver, released into bile, and stored in the gallbladder. Very little leaves in the urine, and some is broken down by gut bacteria and lost in stool.
How to store Ursodiol
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Store at 20° - 25°C (68° - 77°F) . Keep out of reach of children.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Ursodiol
17 supplements and herbal products have documented interactions with Ursodiol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Ursodiol: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Ursodiol — the kind of thing our pharmacy team would talk through with you at the counter.
What is ursodiol for?
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How should I take it?
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What side effects should I expect?
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Can other medicines affect it?
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How will we know it’s working?
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Is Ursodiol available over the counter?
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When was Ursodiol first available?
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Who makes Ursodiol?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Ursodiol on HelloPharmacist
Ursodiol forms and strengths (how it comes)
Ursodiol is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Ursodiol inactive ingredients by manufacturer.
Capsule
How this form is used
- Ursolign is used for certain noncalcified gallbladder stones smaller than 20 mm when surgery is not an option.
- Reltone is used to dissolve certain gallstones and to prevent gallstones in obese patients losing weight rapidly.
- Ursodiol capsules are used for gallstone dissolution and gallstone prevention during rapid weight loss.
- Ursolign for stone dissolution is given in 2 or 3 divided doses a day, with gallbladder ultrasounds every 6 months in the first year.
- Reltone for stone dissolution is given in 2 or 3 divided doses a day, with ultrasound monitoring.
- Ursodiol capsules for gallstone prevention during rapid weight loss are taken as a set daily amount, per the label.
Tablet
How this form is used
- Urso 250 and Urso Forte tablets are used to treat primary biliary cholangitis (PBC).
- Ursodiol tablets are used to treat primary biliary cholangitis (PBC).
- Urso 250 and Urso Forte are taken in two to four divided doses a day with food.
- Urso Forte is a scored tablet that can be snapped in half, and the halves should be swallowed unchewed with water because of the bitter taste.
- Liver tests are monitored monthly for three months, then every six months.
Oral suspension
Ursodiol on the U.S. market: products, makers and brands
How Ursodiol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
27 companies list 49 Ursodiol product records with the FDA, mostly as capsule, tablet, oral suspension; the earliest marketing or approval year on record is 1987. Brand names on the directory include Actigall, Urso 250, Urso Forte and 3 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (16) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Ursodiol is used (Medicaid data)
A general measure of how commonly Ursodiol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ursodiol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ursodiol prescribed? Of the 1,601 medications we measure, Ursodiol ranks #426 by Medicaid prescriptions — more than 73% of them.
Utilization by Ursodiol product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
Other Ursodiol products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 22 of 114 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ursodiol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 22 of 114 listed Ursodiol NDCs with Medicaid activity.
Compare Ursodiol products
A representative set of FDA-listed product records for Ursodiol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 300 mg | Oral | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 300 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 300 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 300 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 300 mg | Oral | AvKARE | NDA AUTHORIZED GENERIC | View NDC → |
| 300 mg | Oral | AvPAK × 2 listings | ANDA | View NDC → |
| 300 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 300 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 300 mg | Oral | Epic Pharma, LLC | ANDA | View NDC → |
| 200 mg | Oral | FH2 Pharma LLC | ANDA | View NDC → |
| 400 mg | Oral | FH2 Pharma LLC | ANDA | View NDC → |
| 300 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Intra-Sana Laboratories | ANDA | View NDC → |
| 400 mg | Oral | Intra-Sana Laboratories | ANDA | View NDC → |
| 300 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 300 mg | Oral | Laurus Labs Limited | ANDA | View NDC → |
| 300 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 300 mg | Oral | NorthStar Rx LLC | ANDA | View NDC → |
| 150 mg | Oral | Pangea Pharmaceuticals, LLC | ANDA | View NDC → |
| 300 mg | Oral | PuraCap Laboratories, LLC × 2 listings | ANDA | View NDC → |
| 300 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 300 mg | Oral | VGYAAN Pharmaceuticals LLC | ANDA | View NDC → |
| 300 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 300 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| 250 mg | Oral | Allergan, Inc. | NDA | View NDC → |
| 500 mg | Oral | Allergan, Inc. | NDA | View NDC → |
| 250 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 500 mg | Oral | AvKARE | ANDA | View NDC → |
| 250 mg | Oral | BluePoint Laboratories | ANDA | View NDC → |
| 500 mg | Oral | BluePoint Laboratories | ANDA | View NDC → |
| 250 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 500 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 250 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 250 mg | Oral | Endo USA, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Endo USA, Inc. | ANDA | View NDC → |
| 250 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 500 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 250 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 250 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 500 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 250 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 500 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 250 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 500 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
Showing 49 of 49 products — FDA National Drug Code Directory. See every product, package size and price: browse all 49 Ursodiol NDCs →
Ursodiol side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ursodiol — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Ursodiol are pruritus, diarrhoea, fatigue; about 80% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ursodiol in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Ursodiol FDA approval history
How Ursodiol went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Ursodiol was first approved by the FDA in 1987 (Brand: ACTIGALL · Teva Branded Pharm); the first generic version was approved in 2000. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Ursodiol recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Ursodiol recalls since July 2021.
✅No Ursodiol recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
Ursodiol supply and shortage status
Whether Ursodiol is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Ursodiol is not in shortage right now; the FDA has 1 past shortage record for it.
✅No current shortage of Ursodiol on recordRead the full Ursodiol shortage page — affected NDCs, other makers, and what to do →
Source: openFDA, from the FDA Drug Shortages database.
💵 What Ursodiol costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule · Oral | 300 mg | $0.429 per capsule | NDC details & price history |
| Tablet · Oral | 250 mg | $0.450 per tablet | NDC details & price history |
| Tablet · Oral | 500 mg | $0.647 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 250 mg | $0.450 per tablet | NDC details & price history |
| Capsule | 300 mg | $0.429 per capsule | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Ursodiol brand names
Ursodiol is sold under 6 brand names in the FDA directory — Actigall, Urso 250, Urso Forte, Reltone 200 mg and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Ursodiol: manufacturers and labelers
27 companies list Ursodiol products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Strides Pharma Science Limited, Zydus Lifesciences Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 3 more on the FDA NDC directory.
Ursodiol drug class (RxNorm)
Ursodiol belongs to the Bile Acid class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Ursodiol page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Actavis Pharma, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →