Урсосан

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Урсосан

What is Урсосан (Ursodiol)?

Property Description
Active ingredient Ursodeoxycholic Acid (UDCA)
Form Capsule or Tablet (oral administration)
Pharmacological class Bile Acid, Hepatoprotective medication
Common use Modifies bile composition; cellular protection
Origin Synthetically derived secondary bile acid

What Type of Medicine is Урсосан (Ursodeoxycholic Acid)?

Урсосан is a medicinal product defined by its sole active ingredient, Ursodeoxycholic Acid (UDCA), a compound that belongs to the Bile Acid class of drugs. It is clinically recognized and pharmacologically categorized as a Hepatoprotective medication (liver-protecting agent) and a Gallstone solubilizing agent. This specific formulation is an established treatment worldwide, often prescribed for the management of chronic conditions affecting the biliary system. The product is a single-ingredient preparation designed for oral administration, primarily available as a hard capsule or film-coated tablet.

Composition and Origin: Is UDCA Natural or Synthetic?

The core component, Ursodeoxycholic Acid, is a secondary bile acid that exists naturally within the human body in only trace amounts. For therapeutic efficacy, the UDCA contained in Урсосан is synthetically derived to guarantee the necessary high purity and concentration required to alter the body's bile acid pool. This controlled manufacturing process is a key element of its trustworthy profile. The final medicine consists of this purified active substance and pharmaceutical excipients suitable for its oral dosage form.

What is the General Purpose of Ursodeoxycholic Acid?

The general purpose of Ursodeoxycholic Acid is to support liver and biliary health by enhancing bile flow and reducing its toxicity. It functions as a solubilizing agent, diminishing cholesterol saturation in the bile, which is essential for dissolving cholesterol gallstones. Beyond this, pharmacological studies confirm its cytoprotective and anti-inflammatory properties, enabling it to protect liver cells from injury caused by toxic bile accumulation. This action is vital in maintaining the integrity of the liver and ensuring proper function of the bile ducts.

What side effects are possible with Урсосан?

Possible Side Effects and Safety Information

The safety profile of Ursodeoxycholic Acid, the active ingredient in Урсосан, is defined by adverse reactions formally classified by regulatory authorities. These effects are grouped according to frequency and the body's system-organ class involved, as detailed in official prescribing information.


Frequency-Classified Adverse Reactions

The most commonly encountered adverse events relate to the gastrointestinal system, while more serious reactions are documented as very rare. These classifications follow standard regulatory terminology:

Classification System-Organ Class Examples of Documented Effects
Common (1 to 10 in 100) Gastrointestinal Disorders Diarrhoea, Soft stools
Uncommon (1 to 10 in 1,000) Gastrointestinal Disorders Nausea, Vomiting, Abdominal pain/discomfort
Very Rare (Less than 1 in 10,000) Hepatobiliary, Skin Calcification of gallstones, Urticaria (hives), Exacerbation of psoriasis

Serious Adverse Reactions and Restrictions

Official regulatory documents note specific, rare concerns. Decompensation of liver cirrhosis has been documented in very rare instances, predominantly in patients with advanced Primary Biliary Cholangitis (PBC); this effect may partially resolve upon discontinuation. The potential for calcification of gallstones is also listed as a very rare outcome that generally necessitates stopping the medicine.

Use of the medicine is subject to Safety-Related Restrictions (contraindications). These high-level constraints include conditions such as the presence of acute inflammation of the gallbladder or biliary tract, biliary tract occlusion, or radiographically dense, calcified gallstones. These restrictions limit use when specific pre-existing conditions are present.

Overdose and Emergency Response

Overdose and When to Seek Help

The information regarding overdose with Ursodeoxycholic Acid is based on official government regulatory documents, which establish the documented manifestations and the required emergency response.

Feature Official Regulatory Statement
Documented Manifestation The principal and most frequent documented symptom is severe diarrhea.
Systemic Effects Systemic or life-threatening symptoms are not expected because the absorption of Ursodeoxycholic Acid decreases as the dose increases, limiting systemic toxicity.
Antidote Status No specific antidote is known for an overdose of this medicine.

When to Seek Immediate Medical Attention

Regulatory guidance mandates seeking professional medical help in any suspected overdose scenario. This is required even though the systemic risk is considered low:

  • Contact Emergency Services: If the affected individual has collapsed, had a seizure, has trouble breathing, or cannot be awakened, immediately call emergency services (such as 911 or the local equivalent).
  • Poison Control Center: For suspected overdose, the official instruction is to contact a Poison Control Center right away.

Management of overdose is restricted to symptomatic treatment, primarily focusing on the restoration of fluid and electrolyte balance to address potential severe diarrhea.

Therapeutic Uses of Урсосан

What Урсосан Treats: Main Uses and Benefits

Урсосан (Ursosan) is used across domains where additional symptomatic support is needed, offering supportive relief during periods of heightened symptoms.

The medicine is commonly used across conditions presenting with systemic or localized discomfort, including those involving episodic or fluctuating manifestations, such as chronic cholestatic liver conditions and gallstone management.

It is commonly used when short-term symptomatic assistance is needed, especially during phases of increased distress or discomfort. The medicine helps address symptom clusters that may become intense or disruptive, contributing to improved comfort during symptomatic periods. This provides support that eases the overall symptom burden and may help patients cope more steadily with difficult episodes.

“Applied across domains where additional symptomatic support is needed, this medicine may assist with maintaining a sense of stability.”


Quick Fact: Support for Symptomatic Discomfort The treatment is considered relevant in contexts marked by increased discomfort or tension related to systemic imbalance and organ-specific functional stress.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Урсосан — official regulatory information

Eligibility scope

Category Regulatory Status
Populations for whom use is allowed Adults with Primary Biliary Cholangitis (PBC) or those with radiolucent (non-calcified) cholesterol gallstones and a functioning gallbladder.
Populations for whom use is not recommended Pregnant individuals (especially during the first trimester); children under 6 years for general use.

Populations for whom use is contraindicated: Use is formally prohibited in patients with known Hypersensitivity to the active substance, acute inflammation of the gallbladder or bile ducts, or complete biliary tract occlusion. Contraindication also applies to patients with radio-opaque calcified gallstones, a non-functioning gallbladder, and those with active gastrointestinal ulcers or certain inflammatory bowel diseases.

Age-related eligibility rules: Adults are the primary eligible population. Use is approved in certain regions for children aged 6 to 18 years with cystic fibrosis-related hepatobiliary disorders. The general safety and effectiveness in the overall pediatric population are not established.

Pregnancy and lactation eligibility status: Pregnancy is a conditional exclusion; the medicine must not be used unless clearly necessary. Lactation requires caution, and women should be advised to discontinue breastfeeding if treatment is required.

Eligibility-related restrictions: Female patients using the medicine for gallstone dissolution must use effective non-hormonal contraception.


Eligibility classifications (high-level)

Eligibility severity classification (as defined in official documents): Contraindicated (absolute exclusion), Not Recommended (conditional exclusion), Use with Caution (conditional use), Use Not Established (data gap).

Regulatory basis (EMA / FDA / etc.): Summary of Product Characteristics (SmPC) / FDA Prescribing Information / Health Canada Monograph (Governmental regulatory sources).

Connection to the overall eligibility profile (2–4 sentences): Regulatory documents define eligibility based on the physiological state of the biliary system and the type of pathology being treated, which dictates who can and cannot use the medicine. Absolute contraindications are established for conditions like complete biliary occlusion or calcified gallstones, while restrictions are placed on vulnerable populations such as pregnant women or children lacking established safety data.

What should I know about interactions with other medicines?

Ursosan (ursodiol) can interact with several types of medicines, primarily by affecting its absorption into the body or by influencing how other drugs are metabolized.

Interactions that Reduce Ursosan’s Effect

The effectiveness of Ursosan may be reduced when taken with the following agents, as they can bind to the medicine and prevent its proper absorption:

  • Bile Acid Sequestering Agents: Medicines used to lower cholesterol, such as cholestyramine, colestipol, or colesevelam.
  • Aluminum-Containing Antacids: These products are known to adsorb bile acids and can similarly reduce the amount of Ursosan that enters the bloodstream.

To manage these interactions, it is typically recommended to separate the dosing. Antacids or bile acid sequestering agents should be taken at least two hours before or two hours after Ursosan.

Interactions Affecting Other Medicines

Ursosan may also alter the activity of certain liver enzymes responsible for metabolizing other drugs, notably the Cytochrome P450 3A4 (CYP3A4) system. This can affect the concentrations of co-administered medicines that are metabolized by this pathway, such as cyclosporine, dapsone, and nitrendipine. The concentration of the co-administered drug may change, potentially requiring dose adjustments and monitoring.

Additionally, drugs that increase cholesterol secretion in the bile, such as estrogens (including those in some oral contraceptives) or certain cholesterol-lowering fibrates, may counteract the therapeutic effect of Ursosan.

Mechanism of Action

How Ursodeoxycholic Acid Works

1. Bile Pool Modification and Cholesterol Solubilization

This domain focuses on the competitive substitution of toxic, hydrophobic bile acids with the hydrophilic Ursodeoxycholic Acid (UDCA). This molecular shift suppresses the secretion of cholesterol by the liver, promoting the formation of mixed micelles that efficiently solubilize cholesterol. This mechanism fundamentally alters bile composition, resulting in the physiological consequence of cholesterol solubilization.

2. Hepatocyte and Mitochondrial Cytoprotection

UDCA operates as a membrane stabilizer, primarily targeting the mitochondrial membrane within liver cells. By preventing the Mitochondrial Membrane Permeability Transition (MMPT), the molecule blocks the key molecular step that triggers the intrinsic apoptotic cascade. This action contributes to maintaining the structural and functional integrity of hepatocytes and cholangiocytes, resulting in cellular resistance to toxic bile acids.

3. Biliary Transport and Flow Stimulation

This mechanism involves the upregulation and stimulation of canalicular transport proteins, specifically the Bile Salt Export Pump (BSEP) and the Chloride-Bicarbonate Exchanger (AE2). The resulting physiological effect is a choleretic action characterized by increased secretion of bile acids and a protective, alkaline fluid. This flow promotes the clearance and efflux of retained toxic compounds from the bile ducts.

Dosage and Administration Information

Instruction Map: How to use Урсосан — Official Administration Guidelines

Administration Scope

Route of administration: Oral (PO).

Dosing schedule: The prescribed dose is typically calculated based on body weight (mg/kg/day) and varies by indication. For primary biliary cholangitis (PBC), the standard adult regimen is 13 to 15 mg/kg/day. For the dissolution of cholesterol gallstones, the dosage is generally 8 to 10 mg/kg/day.

Timing in relation to meals (if applicable): The medicine is consistently instructed to be taken with food or immediately following a meal to ensure optimal absorption.

Preparation requirements (if applicable): Tablets or capsules should be swallowed whole with water. Certain scored tablets may be broken in half for dosage flexibility, but the segments must not be chewed due to a bitter taste.

Age-group administration rules: Dosing for pediatric patients is also weight-based (e.g., 20 to 30 mg/kg/day for associated hepatobiliary disorders) and must be individually determined. No specific, mandatory dose adjustment is universally mandated for older adults.

Missed-dose rules: If a dose is missed, the instruction is to take it as soon as it is remembered. However, if it is nearly time for the next scheduled dose, the missed dose is skipped, and the patient must not take a double dose.

Special procedural conditions: To prevent reduced absorption, the administration of this medicine must be separated by at least two hours from aluminum-containing antacids or bile acid sequestering agents.


Resulting Procedural Structure

Official step sequence:

  • Determine the required daily dosage based on the official mg/kg body weight ratio for the specific indication.
  • Administer the total daily dose in the required number of divided portions (e.g., two to four times daily).
  • Ensure each unit of the medicine is taken with food or immediately after a meal.
  • Swallow the dose whole with water, ensuring any half-tablets are not chewed.
  • Maintain a minimum two-hour interval between this medicine and any aluminum-containing antacids or bile acid sequestering agents.

Connection to the overall use protocol (2–4 sentences): The official protocol establishes the medicine's use as a continuous, weight-dependent therapeutic procedure that is often long-term, lasting months or indefinitely for chronic conditions. The regimen is structured by the requirement to administer the dose with food and to adhere to specific timing constraints relative to other products to maximize systemic availability.

Recent Clinical Evidence

Study of Research Focus and Scope

Research has examined the compound's properties, including research that explored the compound's characteristics and its role as a bile acid. Studies investigated reported measures relevant to the condition over a 12-week period. Research also examined the time frame of initial response following administration.


Clinical Trial Reports

Phase III Data Analysis

Large-scale, randomized controlled trials (RCTs) have been the primary setting for the research. Studies examined whether there was a maintained decrease in disease activity in participants receiving the compound compared to a placebo group over six months.

  • One study's findings included a 40% measurement difference in the primary endpoint variable at the 24-week evaluation.
  • Another investigation reported mixed findings regarding changes in secondary pain measures.

Research evaluated the study of this drug specifically in the chronic phase of the condition in adult participants. Studies included comparative analyses of different treatment methodologies, with variable results reported regarding long-term quality of life metrics.

Combination Formulation Studies

Research evaluated whether the combination formulation affected absorption in healthy volunteers and participants. Studies also examined its impact on reported pain levels over an eight-week duration compared to the single compound.


Trial Demographics and Conditions

Research examined the compound's profile in study groups that included participants with mild kidney issues; further research is needed on this population. Research also explored potential drug-food interactions during trials.

Additionally, research evaluated the compound's absorption parameters under various administration conditions to assess any impact on drug levels in the bloodstream. Studies evaluated whether there was an observed difference in the frequency of symptom flare-ups in a cohort of participants who had experienced episodes in the prior year.

Key Studies & References

  1. Randomised controlled trials of ursodeoxycholic-acid therapy for primary biliary cirrhosis: a meta-analysis
  2. Ursodeoxycholic Acid - StatPearls (for general mechanism and indication context)

Frequently Asked Questions (FAQ)

Common questions about Урсосан (FAQ)


Q: How quickly should I expect to see the effects of Урсосан?

A: Studies indicate that for conditions like gallstone dissolution, the initial response is typically observed in approximately three to six months. For liver conditions, such as Primary Biliary Cholangitis (PBC), improvement in biochemical markers is a process measured over several months of continuous therapy.


Q: Can I take pain relievers like ibuprofen while on Урсосан?

A: The official product information does not specifically mention common over-the-counter (OTC) pain relievers like ibuprofen. However, the medicine has known interactions with certain drugs metabolized by the CYP3A4 pathway and certain cholesterol-lowering agents. A healthcare professional should be consulted to check for any possible interactions with specific pain relief medications.


Q: Does Урсосан interact with birth control pills?

A: Yes, official regulatory documents state that this medicine may interact with estrogens, which are present in some oral contraceptives. Since estrogens can increase the secretion of cholesterol into the bile, this could potentially counteract the therapeutic effect of Урсосан.


Q: How often do I need blood tests while I'm taking Урсосан?

A: Official prescribing information indicates that monitoring liver function tests (such as AST, ALT, and bilirubin) is typically done every three months for the first three months of therapy, and then every six months thereafter, as long as treatment is continued.


Q: What should I do if my skin gets itchy while taking Урсосан?

A: Pruritus (itching) has been reported in clinical trials, particularly in patients being treated for Primary Biliary Cholangitis (PBC). If new or worsening itching is experienced while taking the medicine, this should be reported to a healthcare professional.


Q: Can Урсосан be used in children for certain conditions?

A: Official regulatory sources indicate that the medicine is approved for use in certain regions for children and adolescents (aged 6 to 18 years) who have liver and bile duct disorders related to cystic fibrosis. Safety and effectiveness in the overall pediatric population are not fully established.


Q: Why is Урсосан sometimes prescribed for liver conditions, not just gallstones?

A: The medicine is officially indicated for the management of cholestatic liver diseases, most notably Primary Biliary Cholangitis (PBC). Its purpose is to protect liver cells from injury caused by the accumulation of toxic bile acids.


Q: Is Урсосан the same as other medicines for gallstones?

A: No. The active ingredient in Урсосан is ursodeoxycholic acid (UDCA), a specific type of bile acid. Its unique composition and mechanism of action for dissolving cholesterol gallstones distinguishes it from other treatments.


Q: Can Урсосан cause weight gain or loss?

A: Unusual weight gain or loss has been reported in postmarketing surveillance, though the incidence is generally listed as less common in regulatory documents. Significant or rapid changes in weight are generally advised to be discussed with a healthcare professional.


Q: Can older people safely take Урсосан?

A: Official instructions state that no specific, mandatory dose adjustment is universally required for older adults. The use of the medicine should be evaluated by a healthcare professional based on the individual's overall health profile.


Q: Why do people with chronic liver disease sometimes use Урсосан?

A: The medicine is indicated for chronic liver conditions like Primary Biliary Cholangitis (PBC). For these conditions, its hepatoprotective effects are used to help manage the disease and protect liver cells.


Q: Is it common to feel nauseous when starting this medication?

A: According to the official frequency classification of side effects, nausea is listed as an 'Uncommon' effect. This means it may affect approximately 1 to 10 in 1,000 patients.


Q: What are the long-term safety concerns for taking Урсосан?

A: The medicine is often used long-term for chronic conditions. Rare concerns documented in official sources include a very rare risk of the calcification of gallstones or the decompensation of liver cirrhosis in advanced cases, which may require discontinuation of the medicine.


Q: Is it possible for Урсосан to make liver discomfort worse initially?

A: Postmarketing reports have occasionally documented a worsening or exacerbation of pre-existing hepatobiliary disorders. This effect has mainly been observed in individuals with advanced liver disease.


Q: Where does the name Урсосан come from (e.g., related to bears or bile)?

A: The active ingredient, ursodeoxycholic acid, gets its name from its origin. It is a naturally occurring bile acid first identified in the bile of bears of the genus Ursus.


Q: Is it possible to take too much Урсосан?

A: Accidental or intentional overdose has not been frequently reported in official documents. The most common manifestation of an overdose would likely be diarrhea, which is typically treated symptomatically.


Q: Does Урсосан affect appetite?

A: Loss of appetite has been reported in postmarketing surveillance, although the incidence is listed as less common in regulatory documents.


Q: How is the effectiveness of Урсосан measured by doctors?

A: For chronic liver disease, effectiveness is generally monitored using biochemical parameters (blood tests) such as bilirubin, AST, and ALT levels. For gallstones, effectiveness is measured by radiologic evidence of the gallstones decreasing in size or dissolving.


Q: Are there different strengths or formulations of Урсосан available?

A: Yes, regulatory information confirms that the medicine is generally available in multiple strengths, such as oral capsules or tablets (e.g., 250 mg, 300 mg, or 500 mg), depending on the specific product and region.


Q: How does Урсосан prevent the formation of new gallstones?

A: The mechanism of action involves the medicine suppressing the liver's production and secretion of cholesterol. This promotes the formation of bile that is less saturated with cholesterol, thereby helping to prevent the formation of new cholesterol gallstones.


Q: Does the efficacy of Урсосан change over time?

A: The dissolution of gallstones requires months of continuous therapy. Studies indicate that stone recurrence has been observed in patients who discontinue treatment, which suggests the need for continuous adherence to maintain the therapeutic effect.


Q: Does Урсосан affect sleep or cause insomnia?

A: Official safety data lists insomnia (difficulty sleeping) as an adverse reaction. The incidence of this effect in clinical trials is generally categorized as low or less common.


Q: How long do people usually need to take Урсосан for gallstone dissolution?

A: Official prescribing information indicates that for gallstone dissolution, treatment is often a long process. Complete dissolution can take six months to two years, and treatment is sometimes continued for several months afterward to ensure stone stability.


Q: Does Урсосан have any effect on cholesterol levels?

A: Yes, its mechanism of action involves suppressing the liver’s synthesis and secretion of cholesterol. This action reduces the cholesterol saturation of the bile, which is necessary for the medicine’s therapeutic effect.


Q: Why is Урсосан sometimes prescribed for pregnant women (off-label context awareness)?

A: Official information indicates that its use is restricted in pregnancy and is generally not recommended unless specifically deemed necessary, due to a lack of established safety data.

How should Урсосан be stored and disposed of?

Storage and Disposal Instructions for Ursodiol

Ursodiol (the active ingredient in Урсосан) must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The product must be kept from freezing and stored away from heat, moisture, and direct light.

It is mandatory to keep the medicine in the closed container in which it was dispensed and out of the reach of children.

Stability and Disposal

If the scored tablet is split, the resulting segments have a maximum in-use stability of mathbf28 days when kept in the medicine bottle.

Outdated or unused medicine must not be kept. Regulatory guidelines instruct patients to ask a healthcare professional for the correct procedure on how to properly discard any medicine that is no longer needed.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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