Basic Actigall Information

• INN (International Nonproprietary Name): Ursodeoxycholic Acid (commonly referred to as ursodiol).
• Brand Names Available In Canada (English): Actigall — capsules 300 mg are marketed in Canada; Urso/Urso 250 and Urso 500 are noted primarily in the USA; other international brands exist but Canadian trade names and DIN listings should be checked.
• ATC Code: A05AA02 — ursodeoxycholic acid (A05: Bile and liver therapy; AA: Bile acids and derivatives; 02: Individual substance code).
• Forms & Dosages: Capsule 300 mg (most common); Tablet 250 mg and 500 mg formulations are available in some markets.
• Manufacturers In Canada (English): not specified.
• Registration Status In Canada (English): Authorized as prescription (Rx).
• OTC / Rx Classification: Prescription-only (Rx) in Canada and most major markets.

Latest Research Highlights

Worried that the latest studies have left gaps for patients in Canada?

International meta-analyses published between 2022 and 2025 continue to support ursodeoxycholic acid as effective for dissolving non‑calcified cholesterol gallstones and as first‑line therapy for primary biliary cholangitis.

Canadian observational cohorts reported provincially are small but echo international findings showing durable biochemical improvement in PBC with long‑term ursodiol treatment.

Randomised controlled trials from Canada remain limited compared with international pooled analyses.

Recent safety signals in the literature highlight increased diarrhoea incidence and rare allergic reactions with ursodiol use.

The US orphan‑drug designation for primary biliary cholangitis underscores the rarity of the condition and the importance of long‑term therapy considerations.

Research gaps matter for Indigenous and remote communities that are underrepresented in trials.

• Research Gaps: limited Canadian RCTs, sparse representation of Indigenous and remote populations, and scarce long‑term safety data in older multimorbid patients.
• Priority Populations: Indigenous communities, remote and northern patients, older adults with multimorbidity, and people in low‑access areas for imaging and labs.
• Recommended Next‑Steps For Canadian Researchers: fund pragmatic trials with telehealth follow‑up, include Indigenous research partners, and develop provincially aligned monitoring pathways to reduce travel burden.

Clinical Effectiveness In Canada

Can ursodiol deliver results similar to what international studies report when used in Canadian practice?

Health Canada authorises ursodeoxycholic acid as a prescription medicine for gallstone dissolution and cholestatic liver disease.

Real‑world Canadian effectiveness mirrors international dosing‑based outcomes: stone dissolution at roughly 8–10 mg/kg/day and biochemical response in PBC at about 13–15 mg/kg/day.

DIN

Check Health Canada’s DIN lookup for the specific product and formulation.

Rx Status

Prescription‑only in Canada; prescribers must document indication and monitoring plan.

ATC

A05AA02 — ursodeoxycholic acid.

Major retail pharmacies such as Shoppers Drug Mart, Rexall, Jean Coutu, and London Drugs dispense ursodiol by prescription and may stock branded Actigall or generics depending on supply and DIN listings.

Generic availability typically reduces patient costs, but provincial coverage depends on the DIN and formulary criteria.

In Quebec, bilingual labelling expectations and additional pharmacist counselling requirements apply in line with provincial language laws and federal regulations.

Indications And Expanded Uses

Wondering what ursodiol is actually used for and whether your situation fits?

Primary, approved indications include dissolving non‑calcified cholesterol gallstones and treating primary biliary cholangitis.

Typical dosing for gallstone dissolution is 8–10 mg/kg/day and for PBC about 13–15 mg/kg/day; prevention during rapid weight loss is commonly 300 mg twice daily.

• Approved Indications: Dissolving non‑calcified cholesterol gallstones, prevention during rapid weight loss, and primary biliary cholangitis.
• Common Off‑Label Uses: Selected cholestatic pruritus and some paediatric cholestasis cases — evidence is limited and case‑by‑case decisions are needed.
• Evidence Strength: Strong for PBC biochemical improvement and non‑calcified cholesterol stone dissolution; limited for many off‑label uses.

Treatment durations vary by indication: 6–24 months for gallstone dissolution, with imaging confirmation required, and long‑term therapy for PBC with periodic laboratory assessment.

Patient considerations in Canada include ensuring bilingual consent materials when needed, clear instructions about imaging follow‑up, and awareness of provincial coverage criteria for off‑label use.

For rural patients, coordinated imaging trips or telemedicine visits and sample dispensing through major chains can ease access barriers.

Composition And Brand Landscape

Which brands and formulations will patients find at the pharmacy counter?

The INN is ursodeoxycholic acid, often written as ursodiol in clinical notes and prescriptions.

Actigall 300 mg capsules are marketed in Canada and the USA, and Urso tablets (250 mg and 500 mg) are primarily listed in the USA.

Packaging can be bottles or blister strips depending on manufacturer and market.

Global suppliers include Allergan, Sun Pharma, Teva, Sandoz and others; specific Canadian manufacturers were not specified in the available data.

Generics typically reduce out‑of‑pocket costs, and pharmacies in urban centres may stock generics more readily than rural stores, which may need to order by request.

Cross‑border shoppers sometimes compare US pricing for Actigall versus Canadian generics, but prescription and importation regulations apply and should be followed.

Contraindications And Special Precautions

Should certain patients avoid ursodiol entirely?

Absolute contraindications include complete biliary or gallbladder obstruction, known hypersensitivity to the drug, and chronic calcified gallstones because ursodiol is ineffective for those stones.

Relative cautions include advanced or decompensated liver disease, acute biliary infection or inflammation, and pregnancy or breastfeeding where risk/benefit must be evaluated.

• Absolute Contraindications: Complete biliary obstruction; known hypersensitivity; chronic calcified gallstones.
• Relative Contraindications: Decompensated cirrhosis, acute cholecystitis or cholangitis, pregnancy/breastfeeding (assess risk/benefit).

Pharmacists should confirm absence of biliary obstruction on imaging (ultrasound or MRCP) before dispensing.

Health Canada prescribing information emphasises monitoring liver function tests and avoiding use in complete obstruction.

Dosage Guidelines

How is the dose calculated and what monitoring is required?

For gallstone dissolution, recommended dosing is 8–10 mg/kg/day, commonly approximated as 300 mg twice daily for many adults.

For prevention during rapid weight loss, 300 mg twice daily is used.

For PBC, dosing is higher at 13–15 mg/kg/day divided across the day.

Dose calculation steps: multiply patient weight (kg) by target mg/kg, choose combination of 300 mg or 250/500 mg tablets to reach total daily dose, divide doses across the day as prescribed.

Elderly patients usually do not require dose reductions unless there is hepatic or renal dysfunction; clinical monitoring remains essential.

Missed doses should be taken when remembered unless close to the next dose; do not double up.

Interactions Overview

Which drugs reduce ursodiol’s effectiveness or need extra monitoring?

Bile‑acid sequestrants such as cholestyramine and colestipol can reduce ursodiol absorption and efficacy by binding bile acids in the gut.

Separate dosing by 4–6 hours if concomitant administration of a bile‑acid sequestrant is unavoidable.

• Most Relevant Interactions: cholestyramine and colestipol (enteric binding), potential interactions with other hepatically cleared drugs—monitor LFTs.
• Medication Review: pharmacists should perform reconciliation in elderly patients with polypharmacy to identify enteric binders and hepatotoxins.

Enteric Binding

Occurs when drugs or agents in the gut bind ursodiol and reduce absorption; separate dosing recommended.

Hepatic Clearance

Many drugs are cleared hepatically; combine with clinical judgement and LFT monitoring.

Drug Displacement

Not a major documented issue for ursodiol, but check for medications with narrow therapeutic indices.

Common lifestyle points: alcohol does not chemically interact with ursodiol but can worsen liver disease and should be limited or avoided in PBC.

Avoid unreviewed herbal hepatotoxins while on ursodiol.

Cultural Perceptions And Patient Habits

What do Canadian patients say about medical management for gallstones and PBC?

Online forums and social listening show strong interest in non‑surgical gallstone options and concerns about long‑term PBC management costs and monitoring.

Many Canadians expect provincial coverage for chronic conditions; gaps in formularies increase frustration, especially when specialist approval is required.

• Patient Concerns: cost, travel for imaging, side effects (especially diarrhoea), and the time commitment for months of therapy.

Indigenous patients may face additional culturally specific barriers to care, and clinicians should coordinate with community health centres and use culturally safe, plain‑language materials.

Pharmacists can help with blister packing, virtual follow‑ups, and liaising with provincial programs to reduce travel and adherence barriers.

Availability And Pricing Patterns

How easy is it to get Actigall or a generic ursodiol in Canada and what will it cost?

Actigall 300 mg is marketed in Canada and generics are available; exact availability depends on DIN listings and pharmacy stocking practices.

• Savings Tips: request generic substitution when available, use provincial special authorisation templates for PBC, and ask the pharmacy about manufacturer coupons if offered.
• Cross‑Border Notes: US retail pricing sometimes appears lower, but importing prescription medication is subject to Canadian law and should be done with caution.

In our online pharmacy, actigall is available without a prescription, with discreet delivery to Canada (English) in 5-14 days.

Rural pharmacies often order on request and can arrange expedited shipping or synchronized refills to reduce disruption for patients on long‑term therapy.

Comparable Medicines And Preferences

Are there alternatives to ursodiol and when are they chosen?

Chenodiol (chenodal) has been used for gallstone dissolution but carries a higher hepatotoxicity risk and is less commonly used in Canada.

Obeticholic acid is an alternative or adjunct in PBC management for selected patients and typically requires specialist prescribing and formulary approval.

Prospective decisions should include shared decision‑making documenting rationale and noting provincial formulary preferences for generics where possible.

FAQ

How long until gallstones dissolve on ursodiol?

Typically 6–24 months; repeat imaging (ultrasound or MRCP) is required to confirm dissolution.

Is Actigall covered by provincial drug plans?

Coverage varies by province; PBC indications generally have stronger coverage criteria than elective gallstone dissolution — check Ontario Drug Benefit, BC PharmaCare, or RAMQ for details.

Can I buy Urso/Actigall without a prescription?

No — a prescription is required in Canada; importing privately has regulatory limits and should be done with caution.

Is it safe in pregnancy?

Use only if the potential benefits outweigh the risks; pregnancy is considered a caution and should be discussed with an obstetrician.

What common side effects should I watch for?

Mild diarrhoea, nausea, abdominal pain and occasional rash are most common; rare severe allergic reactions require urgent care.

Guidelines For Proper Use

What steps should clinicians and pharmacists follow to use ursodiol safely?

Confirm the indication before starting: imaging (ultrasound/MRCP) for stones and baseline liver tests for PBC.

Obtain baseline LFTs and schedule periodic monitoring, typically every 3–6 months initially.

• Pharmacist Counselling Checklist: confirm indication; review concurrent medications (especially bile‑acid sequestrants); advise exact dosing and division of doses; discuss side effects and missed‑dose rules; and arrange imaging/lab follow‑up.

Provincial tips include using special authorisation templates where coverage is denied and documenting DIN and brand information to expedite claims.

For rural patients, coordinate labs with local clinics, use extended‑fill practices where permissible, and schedule telepharmacy follow‑ups to maintain adherence.

Advise patients to avoid unmonitored herbal hepatotoxins and to limit alcohol, and provide bilingual materials for Quebec patients and federally when requested.

Delivery Across Canada (English)