Trusted, medically reviewed health information • Not a substitute for medical advice
Medically Verified MonographPrescription OnlyClass: Gallstone Dissolution Agents

Ursodiol

Generic Name: Ursodiol

Common Brand Names: Actigall, Urso 250, Urso Forte
Dosage Form:Capsule, Tablet
Route:Oral
Pregnancy Category:B
Last Reviewed:9/21/2026

Seek Urgent Medical Attention If:

You experience severe allergic reaction symptoms (swelling of the face, lips, tongue, or throat causing difficulty breathing), severe rash with skin peeling, sudden intense chest pain, or symptoms of overdose. Call emergency medical services immediately.

Uses & Medical Indications

Dissolution of radiolucent gallstones; prevention of gallstones; treatment of primary biliary cholangitis (PBC)

Medical Conditions Treated:

Gallstones, Primary Biliary Cholangitis

Dosage & Administration Guidelines

Adult Dosage

Gallstones: 8-10 mg/kg/day in 2-3 divided doses. PBC: 13-15 mg/kg/day in 2-4 divided doses.

Pediatric Dosage

PBC: 13-15 mg/kg/day

Elderly / Geriatric Considerations

No specific adjustments

Maximum Dose Limit

Based on weight

Renal Impairment:

No adjustment required

Hepatic Impairment:

Contraindicated in complications of liver disease requiring surgery

Side Effects & Safety Warnings

Common Side Effects

Diarrhea, headache, dizziness, dyspepsia

Serious Adverse Reactions

Worsening of liver function in some patients, cholecystitis

Contraindications:

Calcified cholesterol stones, radio-opaque stones, acute cholecystitis

Important Warnings & Precautions:

Monitor for abnormal liver tests. Not for treatment of acute cholecystitis.

Interactions (Drugs, Food & Alcohol)

Drug-Drug Interactions:

Bile acid sequestrants, aluminum-based antacids, oral contraceptives

Food & Dietary Interactions:

N/A

Alcohol Interaction Warning:

N/A

Pregnancy & Breastfeeding Safety

Pregnancy Safety

Generally considered safe if needed

Breastfeeding / Lactation

Present in human milk in small amounts, likely safe

Patient Counseling & Practical Advice

How to Take:

Take with food. Do not chew tablets. May take months for gallstones to dissolve.

What to Do if You Miss a Dose:

Take as soon as remembered. Skip if close to next dose.

Recommended Monitoring & Lab Tests:

Liver function tests (AST, ALT, GGT, Alk Phos, Bilirubin), ultrasound of gallbladder

Trustworthy Sources & Medical Review

Content for Ursodiol was synthesized and fact-checked against standardized regulatory monographs, official pharmacopoeias, and national health authorities:

  • Central Drugs Standard Control Organization (CDSCO) — National List of Essential Medicines
  • World Health Organization (WHO) — Model List of Essential Medicines 23rd List
  • Indian Pharmacopoeia Commission (IPC) — Indian Pharmacopoeia Drug Monographs
  • National Health Service (NHS) — Medicines A to Z Clinical Guidelines
Reviewer Credentials: PharmD, Clinical PharmacologistLast Reviewed Date: 9/21/2026

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