Generic Urso ( Ursodiol )

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Urso (Ursodiol 150 mg, 300 mg): Comprehensive Patient Information for Canada

Basic Product Information

Mechanism of Action

In simple terms: Ursodiol is a naturally occurring bile acid that helps improve the flow of bile in the liver and reduces the amount of cholesterol in bile. It works by replacing toxic bile acids that can damage liver tissue with a more hydrophilic (water-friendly) bile acid. This helps protect liver cells from damage caused by cholestasis (reduced bile flow) and can help dissolve certain types of cholesterol gallstones over time.

For specialists: Ursodiol is a hydrophilic dihydroxy bile acid that exerts multiple hepatoprotective effects. It stabilizes plasma membranes against cytolysis by tensioactive bile acids accumulated in cholestasis. It halts apoptosis by preventing the formation of mitochondrial pores, membrane recruitment of death receptors, and endoplasmic-reticulum stress. Ursodiol induces changes in the expression of metabolizing enzymes and transporters that reduce bile acid cytotoxicity and improve renal excretion. It also has immunomodulatory properties that limit the exacerbated immunological response occurring in autoimmune cholestatic diseases by counteracting the overexpression of MHC antigens and limiting cytokine production by immunocompetent cells. Ursodiol increases hepatic bile excretion, competes with endogenous bile acids for reabsorption in the ileum, and shifts the bile acid composition from hydrophobic to hydrophilic bile acids.

Pharmacokinetics

• Absorption: Following oral administration, the majority of ursodiol is absorbed by passive diffusion, and its absorption is incomplete. Approximately 90% of an oral dose is absorbed. Once absorbed, ursodiol undergoes hepatic extraction to the extent of about 50% in the absence of liver disease. Food does not significantly affect the extent of absorption, but administration with food is recommended for consistency.
• Metabolism: Ursodiol undergoes extensive enterohepatic recycling. Following hepatic conjugation with glycine or taurine, it is secreted into bile and then hydrolyzed to active ursodiol in the intestine. A small proportion undergoes bacterial degradation with each cycle, yielding 7-keto-lithocholic acid or lithocholic acid.
• Elimination: Ursodiol is excreted primarily in the feces, with less than 1% excreted in urine. The biological half-life of ursodiol is approximately 3.5 to 5.8 days after a single dose. After discontinuation of treatment, ursodiol concentrations in bile decrease within one week to 5–10% of steady-state concentrations.
• Onset of Action: For cholestatic liver diseases, improvement in liver function tests may be observed within weeks to months. For gallstone dissolution, complete dissolution requires months of therapy.
• Duration of Action: Steady-state concentrations of ursodiol in bile are achieved after approximately 3 weeks of repeated dosing. The therapeutic effect is maintained with continued daily dosing.

Uses in Daily Life and Best Practice Advice

Ursodiol is prescribed in Canada for the management of cholestatic liver diseases and certain gallstone conditions. Your physician will determine the appropriate use and dose based on your specific medical situation.

• Typical Uses: Management of cholestatic liver diseases, such as primary biliary cirrhosis (primary biliary cholangitis, PBC); dissolution of radiolucent, noncalcified gallbladder stones less than 20 mm in greatest diameter in patients who cannot undergo surgery; and prevention of gallstone formation in obese patients experiencing rapid weight loss.
• Administration: Take with food. Swallow tablets whole with water. Urso Forte tablets can be split into halves for appropriate dosage; do not chew. For 250 mg tablets, the usual dose is 13–15 mg/kg/day in 2–4 divided doses with food for PBC. For gallstone dissolution, the dose is 8–10 mg/kg/day in 2–3 divided doses.
• Monitoring: Liver transaminases should be monitored every 4 weeks for the first 3 months of treatment, then every 3 months. For gallstone dissolution, ultrasound monitoring should be performed 6–10 months after treatment initiation.
• Do Not Stop Without Medical Advice: Treatment duration for gallstone dissolution is typically 6–24 months. If stone size has not decreased within 12 months, treatment should be discontinued. Do not stop taking ursodiol without consulting your physician.

Morning vs. Evening Dosing

Ursodiol is typically taken 2 to 4 times daily with food. There is no specific clinical recommendation for morning versus evening dosing, but dividing the dose with meals helps with absorption and consistency. Always follow the schedule recommended by your physician.

• Divided Dosing: The daily dose is usually divided into 2 to 4 doses taken with meals.
• Consistency: Take ursodiol at the same times each day to ensure steady levels and maximum effectiveness.
• Missed Dose: If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
• Professional Guidance: Your healthcare provider may adjust the timing and frequency based on your condition and other medications.

Administration With or Without Food

Ursodiol should be taken with food. Taking it with meals improves absorption and helps reduce the risk of gastrointestinal upset. Do not administer with aluminum-based antacids or bile acid sequestrants, as these substances bind ursodiol in the intestine and prevent its absorption.

• Take ursodiol with meals or snacks.
• Swallow the tablet whole with water. Urso Forte tablets may be split in half if needed; do not chew.
• If aluminum-based antacids are needed, take them at least 2 hours after ursodiol.
• If bile acid sequestrants such as cholestyramine or colestipol are needed, take them 5 hours or more after ursodiol.
• Avoid taking ursodiol at the same time as these interacting medications.

Interaction Warnings

Indications for Ursodiol

"Off-label" means use outside the official approved indication, usually based on current medical guidelines and scientific evidence.

Dosing According to Clinical Indication

Doses should always be adjusted according to the advice of your physician and depending on your health condition. Do not exceed the recommended dose unless advised by a physician.

Side Effects and Safety Profile

Guidelines for Correct Use

• Take ursodiol exactly as prescribed by your physician. Do not change your dose without medical advice.
• Take the medication with food, at the same times each day.
• Swallow tablets whole with water. Urso Forte tablets may be split in half if needed; do not chew.
• Do not take ursodiol at the same time as cholestyramine, colestipol, or aluminum-based antacids.
• Keep all medical appointments for monitoring of liver function, especially during the first 3 months of treatment.
• For gallstone dissolution, follow-up ultrasound examinations are important to assess treatment response.
• Inform every healthcare provider (including dentists, surgeons, and pharmacists) that you are taking ursodiol.
• If you are pregnant, planning to become pregnant, or breastfeeding, consult your physician. Effective contraception is recommended for women of childbearing potential during treatment.
• If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Do not double the dose.
• Store at room temperature in a dry place. Keep out of reach of children.

Alternative Treatment Options

• Obeticholic Acid (Ocaliva): A second-line therapy for primary biliary cholangitis for patients who do not respond adequately to ursodiol. Available by prescription in Canada.
• Fenofibrate: Off-label second-line therapy for PBC in patients with inadequate response to ursodiol.
• Laparoscopic Cholecystectomy: Surgical removal of the gallbladder is the definitive treatment for symptomatic gallstones and is preferred for most patients who are surgical candidates.
• Extracorporeal Shock Wave Lithotripsy (ESWL): A non-invasive procedure that uses shock waves to break up gallstones. Sometimes combined with ursodiol therapy.

Comparison: Ursodiol remains the first-line treatment for primary biliary cholangitis and is the only approved oral medication for gallstone dissolution. It is generally well tolerated with a favorable safety profile. Surgical cholecystectomy remains the definitive treatment for symptomatic gallstones. For PBC patients who do not respond adequately to ursodiol, second-line therapies such as obeticholic acid may be added. Your physician will determine the best option for your specific condition.

Legal Status, Registration, and Coverage in Canada

• Registration: Ursodiol is authorized for sale in Canada by Health Canada as a prescription drug. Urso and Urso DS (Aptalis Pharma Canada ULC) are no longer being manufactured for sale in Canada. Generic ursodiol products are available in 250 mg and 500 mg tablets from multiple manufacturers, including Jamp Pharma, Pharmascience, and Nora Pharma.
• Prescription Status: Prescription only in Canada.
• Coverage: Coverage varies by province and territory. In Ontario, ursodiol is listed as a Limited Use product under the Ontario Drug Benefit (ODB) formulary for the treatment of primary biliary cirrhosis (LU Code 273) and primary sclerosing cholangitis (LU Code 534). In Quebec, ursodiol is covered under the RAMQ formulary. Generic formulations are generally more affordable than brand-name products.
• Pharmacovigilance: Adverse reactions should be reported to Health Canada's MedEffect Canada program at 1-866-234-2345.

Recent Research and Clinical Guidelines (2022–2026)

• The 2026 review on primary biliary cholangitis confirms that ursodiol remains the first-line treatment option for PBC. The recommended dose is 13–15 mg/kg/day. Second-line therapies such as elafibranor and seladelpar are FDA-approved for patients with inadequate response to ursodiol, and evolving algorithms should consider earlier addition of second-line therapies at 6 months, especially in younger patients with increased liver stiffness.
• German clinical practice guidelines (2026) recommend ursodiol at a dose of 13–15 mg/kg/day as lifelong standard therapy for primary biliary cholangitis.
• Danish clinical guidelines (2026) recommend 10–12 mg/kg/day divided into 2 doses for gallstone dissolution, with treatment duration typically 6–24 months. If gallstone size does not decrease within 12 months, treatment should be discontinued.
• Nora Pharma launched a generic ursodiol product for the Canadian market in 250 mg and 500 mg tablets in November 2024.
• Health Canada has issued a safety communication regarding an increased risk of serious liver adverse effects with high-dose ursodiol (twice the recommended dose) in patients with primary sclerosing cholangitis.

Availability and Supply in Canada

Prices and availability may vary by province, territory, and pharmacy. Generic ursodiol is widely available in Canada and is generally more affordable than brand-name products. The 150 mg and 300 mg capsule strengths are not standard Canadian products; if a 150 mg dose is prescribed, it may require splitting a 300 mg capsule or using a compounded formulation. Check with your local pharmacy for current pricing and availability.

Frequently Asked Questions (FAQ)

1. Is Urso (ursodiol) available in Canada?
   Urso and Urso DS are no longer being manufactured for sale in Canada. However, generic ursodiol tablets are available by prescription in 250 mg and 500 mg strengths from manufacturers including Jamp Pharma, Pharmascience, and Nora Pharma.
2. What is the difference between the 150 mg and 300 mg doses of ursodiol?
   The 150 mg and 300 mg capsule strengths are not standard commercially available products in Canada. Canadian products are primarily 250 mg and 500 mg tablets. A 150 mg dose would typically be achieved by splitting a 300 mg capsule or a 500 mg tablet, or by using a compounded formulation. Your physician will determine the appropriate strength and dosing regimen for your condition.
3. What is ursodiol used for?
   Ursodiol is used to treat cholestatic liver diseases, such as primary biliary cirrhosis (PBC), and to dissolve certain types of gallstones (radiolucent, noncalcified stones less than 20 mm) in patients who cannot undergo surgery. It is also used to prevent gallstone formation in obese patients experiencing rapid weight loss.
4. How long does it take for ursodiol to dissolve gallstones?
   Gallstone dissolution requires months of therapy, typically 6 to 24 months. Complete dissolution does not occur in all patients, and recurrence within 5 years has been observed in up to 50% of patients who do dissolve their stones. If stone size has not decreased within 12 months, treatment should be discontinued.
5. Can I take ursodiol with other medications?
   Ursodiol can interact with cholestyramine, colestipol, aluminum-based antacids, cyclosporine, ciprofloxacin, nitrendipine, and estrogenic hormones. Always inform your physician and pharmacist about all medications and supplements you are taking before starting ursodiol.
6. What should I do if I miss a dose of ursodiol?
   If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
7. Can I stop taking ursodiol if I feel better?
   No. Do not stop taking ursodiol without consulting your physician. For gallstone dissolution, stopping treatment prematurely may allow stones to recur. For PBC, ursodiol is lifelong therapy that helps slow disease progression.
8. Is ursodiol safe during pregnancy?
   Ursodiol should not be used during pregnancy unless clearly necessary. Animal studies have shown reproductive toxicity during early gestation. Women of childbearing potential should use effective contraception during treatment. Consult your physician if you are pregnant, planning to become pregnant, or breastfeeding.
9. What are the signs of serious side effects I should watch for?
   Seek immediate medical attention if you experience severe right upper abdominal pain, signs of liver decompensation (confusion, yellowing of skin or eyes, abdominal swelling), or severe allergic reactions (rash, hives, difficulty breathing, swelling of the face or throat).
10. Is ursodiol covered by Canadian health insurance?
    Coverage varies by province and territory. In Ontario, ursodiol is covered under the ODB formulary as a Limited Use product for primary biliary cirrhosis and primary sclerosing cholangitis. In Quebec, it is covered under the RAMQ formulary. Check with your provincial or territorial drug plan and private insurance provider for coverage details.

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