Ursofalk

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Medically reviewed

Marina Burgos

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 Ursofalk

Property Description
Active ingredient Ursodeoxycholic Acid (UDCA)
Form Capsules, Tablets, Oral Suspension
Pharmacological class Bile Acid Preparation, Cholagogue and Choleretic
Common use Normalization of bile composition and flow
Origin Naturally occurring secondary bile acid

What Type of Medicine is Ursofalk? (Identity and Classification)

Ursofalk is a specialized prescription pharmaceutical preparation whose single active ingredient is Ursodeoxycholic Acid (UDCA), also known as Ursodiol. This compound is chemically defined as a naturally occurring secondary bile acid, a substance found in small amounts within the human body. The preparation is manufactured and widely recognized in Europe, distinguishing it within global markets where generic UDCA versions exist under different trade names.

In pharmacotherapeutic classification, UDCA belongs to the therapeutic group of Cholagogues and Choleretics. This classification indicates its primary function is to influence bile flow and composition. UDCA is recognized for increasing bile secretion and providing cytoprotection to hepatocytes, serving as a management tool for conditions where bile flow is impaired.

Composition, Forms, and General Purpose (Structure and Benefit)

Ursofalk is a single-ingredient product available for oral administration in various dosage forms, including hard gelatin capsules, tablets, and an oral suspension. The availability of the oral suspension formulation makes it particularly suitable for paediatric patients and others who may have difficulty swallowing solid forms.

The general purpose of this medication is to manage and normalize the functions of the liver and biliary tract where bile flow or chemistry is compromised. It achieves this by altering the composition of bile, specifically by reducing its saturation of substances like cholesterol, and offering a potent cytoprotective effect that shields the cells lining the bile ducts and liver. This action is crucial for supporting the overall health of the hepatobiliary system.

What side effects are possible with Ursofalk?

Possible Side Effects and Safety Information

Ursofalk (ursodeoxycholic acid) is generally well-tolerated, but like all medications, it can cause adverse reactions. The safety profile is primarily characterized by effects on the gastrointestinal and hepatobiliary systems.

Common and Less Common Side Effects

Gastrointestinal effects are the most frequently reported adverse reactions, with soft stools or diarrhoea being classified as common (may affect up to 1 in 10 people). These effects are typically dose-dependent and may resolve upon temporary dose reduction.

Serious Adverse Reactions

Serious reactions are very rare (may affect up to 1 in 10,000 people). These primarily involve the liver and bile ducts. In patients being treated for primary biliary cholangitis (PBC), decompensation of hepatic cirrhosis has been reported, which partially regressed after treatment discontinuation. Very rarely, treatment of PBC has been associated with severe right upper abdominal pain.

Contraindications and Monitoring

Ursofalk is contraindicated in individuals with acute inflammation of the gallbladder or biliary tract, occlusion of the biliary tract, frequent episodes of biliary colic, radio-opaque calcified gallstones, or impaired contractility of the gallbladder. Hypersensitivity to bile acids is also a contraindication.

Safety Monitoring: Regular assessment of liver function tests (LFTs) is mandated throughout treatment. For example, LFTs should be monitored every four weeks for the first three months, and then every three months thereafter. If used for gallstone dissolution, gallbladder imaging should be performed periodically.

Overdose and Emergency Response

The official regulatory documentation for Ursodeoxycholic Acid (Ursofalk) primarily describes overdose as an event with low systemic toxicity.

Overdose Scope

Domain Official Regulatory Statement
Documented Overdose Presentations The most likely clinical manifestation of an acute overdose is diarrhea or the presentation of soft stools.
Physiological Systems Affected The gastrointestinal system is affected, which may necessitate management of fluid and electrolyte imbalances if severe or persistent diarrhea occurs.
Emergency-Response Statements Treatment for overdose must be symptomatic and supportive. No specific antidote is known for Ursodeoxycholic Acid overdose.
When Immediate Medical Help is Required Immediate medical attention should be sought for a suspected overdose, particularly if persistent diarrhea is experienced. Therapy must be discontinued if diarrhea is severe or persistent.

Overdose Classifications (High-Level)

Classification Aspect Regulatory Description
Severity classification Regulatory bodies generally view the risk of severe or life-threatening systemic outcomes as low based on available data.
Overdose-context constraints Dosage reduction is the mandated action if diarrhea is experienced, highlighting the dose-dependent nature of the gastrointestinal effect.

Resulting Overdose Structure

Official statements mandate that if diarrhea is present, fluid and electrolyte imbalances must be corrected. The necessary actions—seeking immediate medical attention, discontinuing therapy, and providing symptomatic care—are all focused on managing the primary, documented adverse effect. This approach is required because no specific antidote is known.

Therapeutic Uses of Ursofalk

Ursofalk's therapeutic utility is focused on three primary areas where normalization of bile composition and flow provides significant patient benefit. It is commonly used in clinical settings marked by underlying liver disease and specific issues with the biliary system.

Primary Biliary Cholangitis (PBC) Management

This medication is generally used for the long-term, chronic management of Primary Biliary Cholangitis, a condition characterized by impaired bile flow and elevated markers of liver stress. Ursodeoxycholic Acid may be part of symptomatic management in this condition. The key therapeutic benefit supports the patient during difficult episodes by easing distress and is considered relevant for easing symptoms that create noticeable physiological strain.

Dissolution of Specific Gallstones

Ursofalk is relevant in situations where patients require non-surgical treatment for cholesterol-based gallstones that are small, non-calcified, and form in a functioning gallbladder. This application offers the practical benefit of dissolving the stones, which may assist with easing symptoms related to the presence of gallstones and assists with maintaining functional stability when the symptoms are more noticeable.

Supportive Care for Cholestatic Conditions

The medication also provides essential supportive therapeutic benefit in specific situations, such as managing bile flow impairment (cholestasis) in pediatric patients with systemic diseases like Cystic Fibrosis. It is applied in addressing symptoms related to systemic imbalance in this patient group, offering support which helps maintain a sense of stability when symptoms are more noticeable.


Final Therapeutic Summary

Ursofalk is primarily applied in therapeutic areas that require supportive management of conditions affecting the liver and biliary system, notably Primary Biliary Cholangitis (PBC), the dissolution of specific cholesterol gallstones, and hepatobiliary disorders associated with Cystic Fibrosis.

The use of this medication contributes to easing the overall symptom load related to conditions marked by systemic imbalance and functional stress.

“It is commonly used to help with symptoms related to bile flow issues, helping patients cope more steadily with symptom fluctuations.”

Quick Fact: Relief for Cholestatic Pruritus

This medication supports the patient by addressing symptoms that interfere with daily comfort, such as intense itching, and is relevant when supportive symptom management is appropriate in conditions involving inflammatory or irritative processes.

Regulatory References

  1. According to the NIH LiverTox overview

Eligibility and Restrictions for Use

Ursofalk eligibility is strictly governed by the patient's underlying clinical status and age, as defined by regulatory labeling.

Populations for Whom Use is Contraindicated

Use of Ursofalk is absolutely prohibited (contraindicated) in patients with:

  • Acute inflammation of the gallbladder or biliary tract.
  • Complete obstruction of the biliary tract (e.g., the common bile duct or cystic duct).
  • Radio-opaque calcified gallstones, impaired contractility of the gallbladder, or frequent episodes of biliary colic.
  • Decompensated hepatic cirrhosis (in advanced Primary Biliary Cholangitis).
  • Known hypersensitivity to ursodeoxycholic acid or other bile acids.

Age and Physiological Status Rules

Population Group Eligibility Status (Regulatory)
Adults / Older Adults Generally permitted for approved uses; no evidence suggests an alteration in the standard adult dose is needed for older adults.
Children (6–18 years) Permitted only for hepatobiliary disorders associated with Cystic Fibrosis. Safety is not established for other indications (e.g., gallstones).
Pregnancy Contraindicated during the first three months of pregnancy. Use during pregnancy is generally not permitted unless clearly necessary.
Women of Childbearing Potential Must use reliable contraception (non-hormonal or low-estrogen). Non-hormonal methods are required if the medication is used for gallstone dissolution.

Regulatory documentation requires that the possibility of pregnancy be excluded before initiating treatment.

What should I know about interactions with other medicines?

The official regulatory documents detail specific pharmacokinetic and pharmacodynamic interactions for Ursodeoxycholic Acid (UDCA). Bile acid sequestering agents, such as cholestyramine and colestipol, as well as aluminum-based antacids (e.g., aluminum hydroxide), significantly reduce the absorption of Ursofalk in the intestine. To manage this pharmacokinetic interaction, these products must be administered at least two hours before or two hours after Ursofalk.

A major pharmacodynamic interaction is documented with estrogens, hormonal contraceptives, and lipid-lowering drugs like clofibrate. These substances increase hepatic cholesterol secretion, which directly counteracts the therapeutic effectiveness of Ursofalk when used for dissolving cholesterol gallstones. For this reason, co-administration is officially restricted for that specific indication, and female patients must use effective non-hormonal contraception.

UDCA may also alter the exposure of other co-administered medicines. Regulatory labels report that UDCA can influence the activity of the CYP3A4 enzyme system and intestinal transporters, leading to changes in plasma levels. This effect may increase the absorption of cyclosporine, or reduce the exposure of compounds like nitrendipine and dapsone. Monitoring the levels of these co-administered drugs is a constraint defined in the official prescribing information.

Mechanism of Action

How Ursofalk Works

The mechanism of Ursofalk (Ursodeoxycholic Acid, UDCA) involves multi-pronged action to modify bile composition and exert cellular stabilization within the hepatobiliary system. Its action proceeds via three distinct, simultaneous physiological processes.

Redefining Bile Chemistry and Solubilization

This domain centers on UDCA's role as a highly water-soluble bile acid that enters the bile acid pool and performs a competitive substitution, physically displacing the body's more toxic, fat-soluble bile acids. This primary action fundamentally shifts the composition of the bile, which modifies its chemical injury potential and results in decreased cholesterol saturation.

Cellular Stabilization and Apoptosis Interruption

UDCA establishes cellular stabilization by incorporating into the plasma and mitochondrial membranes of hepatocytes and cholangiocytes. By blocking the opening of the Mitochondrial Permeability Transition Pore (MPTP), this mechanism actively interrupts the apoptotic cascade, which sustains cellular viability against chemically induced stress.

Modulating Biliary Transport and Flow Dynamics

The drug modulates key transport mechanics by upregulating secretory proteins like the Bile Salt Export Pump (BSEP) and simultaneously stimulating the secretion of water and bicarbonate ( HCO3^-) by bile duct cells. This results in choleresis (increased bile flow), which increases the volume and alkalinity of bile, establishing a high-volume transport environment.

Dosage and Administration Information

Administration and Dosing Protocol

Ursofalk (Ursodeoxycholic Acid) is administered orally and is available in hard capsules, film-coated tablets, and an oral suspension. The prescribed amount is weight-based, calculated in milligrams per kilogram of body weight (mg/kg/day).

Official Dosing Regimens

Indication Standard Adult Daily Dose Frequency and Timing
Primary Biliary Cholangitis (PBC) 12-16 mg/kg/day Initially, the dose is divided for administration two to four times daily. Once therapeutic parameters improve, the full daily dose may be taken once daily in the evening.
Gallstone Dissolution Approximately 10 mg/kg/day Administered once daily specifically in the evening, usually at bedtime.

Instructions for Use

Solid forms (capsules and tablets) must be swallowed whole with an accompanying liquid and must not be crushed or chewed. For specific uses such as PBC, the medication is generally directed to be taken with food. The oral suspension form should be shaken well before the required dose is measured and administered.

For pediatric use in Cystic Fibrosis-associated hepatobiliary disorders, the standard regimen is 20 mg/kg/day administered in divided doses. If a scheduled dose is missed, the protocol is to not take a double dose; instead, the dose should be taken as soon as remembered, or simply skipped if it is near the time for the next dose.

Recent Clinical Evidence

Research evidence / Overview of studies for Ursofalk

Evidence for use in Primary Biliary Cholangitis (PBC)

The research available for Primary Biliary Cholangitis (PBC) includes large, long-term observational studies and formal reviews of randomized controlled trials (RCTs). Researchers have explored studies in patient populations with confirmed PBC, measuring hard endpoints, including overall patient survival and the need for liver transplantation, over extended periods. They also measured changes in surrogate markers, such as serum levels of liver enzymes. Studies reported associations between use of the medicine and long-term outcomes, including liver transplant-free status, over many years of follow-up. It is not yet clear whether the findings are consistent for patient-reported outcomes describing perceived discomfort, such as fatigue or itching.

Evidence for use in Dissolution of Cholesterol Gallstones

Research has examined this medicine in clinical trials primarily focused on gallstones, tracking outcomes over several months or years. The main outcomes studied were the rate at which complete gallstone dissolution or a reduction in size was observed, as measured by imaging. Studies reported various dissolution rates; findings describe that different measured rates were observed for smaller stones compared to larger ones. The research describes that the required study administration periods were long, often lasting from six months up to two years. What remains uncertain is the durability of the findings, as follow-up studies reported that gallstones can recur in some observed patients after dissolution was achieved.

Evidence in Special Populations, including Pediatric Patients

Research has explored studies of this medicine in special populations, particularly children and adolescents who have cholestatic liver disorders associated with conditions like Cystic Fibrosis. These studies involved randomized controlled designs and long-term clinical reports, focusing on young populations. Research described changes measured in liver enzyme markers in these pediatric populations. However, the evidence quality varies across studies, with many controlled trials being short-term. The data for certain long-term outcomes, such as preventing severe liver disease progression, rely more heavily on observational settings, meaning certainty remains low regarding the full range of long-term effects.

Key Studies & References

  1. Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended URSODEOXYCHOLIC ACID (EMA Review)

Frequently Asked Questions (FAQ)

Common questions about Ursofalk (FAQ)


Q: How quickly should I expect to see an improvement after starting Ursofalk?

Clinical monitoring is required throughout treatment. According to official product information, monitoring of liver function tests (LFTs) is required periodically, often with a higher frequency during the initial months of treatment. For dissolving gallstones, your progress is checked using imaging (like ultrasound or X-ray) typically every six months to see if the stones are reducing in size.


Q: Does Ursofalk help dissolve all types of gallstones?

No. Official regulatory documents indicate that Ursofalk is specifically used for the dissolution of small, non-calcified, radiolucent cholesterol gallstones that are less than 15 mm in diameter. It is not used for gallstones that are already hardened or calcified. Use of the medicine requires a functioning gallbladder, which is assessed by a healthcare professional.


Q: Can Ursofalk affect my appetite?

Changes in appetite have been reported, although they are not listed among the most common effects. Loss of appetite (anorexia) has been noted as a reported adverse reaction.


Q: Is it normal to have mild stomach discomfort when first starting Ursofalk?

Gastrointestinal issues are the most common type of adverse reaction. While diarrhea or soft stools are most frequent, general abdominal pain or stomach discomfort has also been reported in clinical experience. If any discomfort becomes persistent or severe, it is important to consult a healthcare professional.


Q: How long does a course of treatment with Ursofalk usually last?

The required duration of treatment varies significantly by the condition being treated. For dissolving gallstones, the duration of treatment is often extended, typically involving several months up to two years. For Primary Biliary Cholangitis (PBC), treatment is typically intended for long-term management.


Q: What are the signs that Ursofalk might not be working for my condition?

For gallstone dissolution, effectiveness is monitored using imaging. If the gallstones show no reduction in size after 12 months of continuous treatment, the professional guidance recommends reassessment of the therapy. For liver conditions, your physician monitors regular liver function test results to assess response.


Q: Will Ursofalk treatment prevent future gallstones from forming?

Ursofalk is primarily used to treat existing gallstones. Regulatory documents sometimes cite its potential use for preventing gallstone formation in certain high-risk situations, such as in obese patients undergoing rapid weight loss. However, it is also noted that gallstones can recur after a course of dissolution treatment is completed.


Q: Is there a generic version of Ursofalk available?

Ursofalk is a brand name for the active ingredient Ursodeoxycholic Acid (UDCA), also known as Ursodiol. According to regulatory reviews, generic versions containing the same active ingredient are available on the market under different trade names in various countries.


Q: Can Ursofalk cause changes in sleep patterns?

Official reports on adverse reactions have included instances of insomnia (difficulty falling or staying asleep) and general sleep disturbance. If you notice a persistent change in your sleep patterns, you should consult a healthcare professional.


Q: Is it possible to develop a rash as a side effect of Ursofalk?

Yes, skin rash has been reported as a common side effect. More severe skin reactions like urticaria (hives) have been reported rarely.


Q: Can Ursofalk cause or worsen heartburn?

Official regulatory reports include heartburn or acid/sour stomach as a documented side effect of Ursodeoxycholic Acid. This is generally listed as a less common effect.


Q: What should I do if the side effects of Ursofalk are bothersome?

Regulatory guidance addresses the most common side effect, stating that if diarrhoea occurs, the prescribed dose may need to be reduced. If diarrhoea becomes persistent, professional guidance states that the treatment may need to be discontinued. For any persistent or bothersome side effects, it is advisable to seek consultation with the prescribing physician.


Q: Does Ursofalk have any effect on kidney function?

While the medicine primarily affects the liver and bile ducts, some reports from clinical trials have noted adverse events related to the urinary system. These have included reports of elevated creatinine (a marker of kidney function) and urinary tract infections.


Q: What clinical trials have been done on Ursofalk's long-term safety?

Official regulatory documents cite long-term clinical experience with the active ingredient. For paediatric patients with Cystic Fibrosis-related disorders, long-term experience of 10 years or more has been collected. For Primary Biliary Cholangitis, treatment is often ongoing and is continuously monitored by regular liver function tests.


Q: Is it safe to drive while taking Ursofalk?

Based on the regulatory product information, Ursodeoxycholic Acid has no or negligible influence on the ability to drive and use machines. Therefore, it is generally considered safe to perform these tasks while on this medication.


Q: Can I take Ursofalk if I have a history of peptic ulcers?

While a history of peptic ulcers is not listed as a formal contraindication, the occurrence of a peptic ulcer has been reported as an adverse event in some clinical reports. A history of ulcers is an important factor to discuss with the prescriber before starting treatment.


Q: Is Ursofalk used for any conditions other than gallstones and liver diseases?

The official regulatory uses for Ursofalk are specific. The approved indications are limited to Primary Biliary Cholangitis (PBC), the dissolution of certain cholesterol gallstones, and certain hepatobiliary disorders associated with Cystic Fibrosis in children and adolescents.


Q: Why is Ursofalk sometimes prescribed for pregnant women with cholestasis?

Ursofalk is officially contraindicated during the first three months of pregnancy. Its use during pregnancy is generally not permitted, except in specific situations where a healthcare professional determines it is clearly necessary. The regulatory text does not name Intrahepatic Cholestasis of Pregnancy as an official indication, but notes this exception.


Q: Does Ursofalk affect cholesterol levels in the blood?

The primary mechanism of action involves the bile. Ursofalk is effective at decreasing the cholesterol saturation of the bile, which is necessary for gallstone dissolution. Official documents primarily focus on this action, and do not make explicit claims about the effect on total systemic cholesterol levels in the bloodstream.

How should Ursofalk be stored and disposed of?

Storage Conditions

Ursofalk must be stored out of the sight and reach of children.

Required storage for the capsules and tablets is generally below 25^circC (77°F). All forms must be protected from light and moisture, and the product must be kept from freezing [1.5, 2.1].

  • Container Rules: The medication must be kept in the original package to maintain its stability [1.4, 4.4].
  • Post-Opening Stability: The oral suspension must be used within 4 months of opening the bottle; unused portions should be discarded after this period [1.1].

Disposal Instructions

Expired or unused Ursofalk must not be thrown away via wastewater or household waste [4.5].

Official regulatory documents instruct the patient to ask the pharmacist how to throw away medicines no longer used [4.5]. These specific disposal measures are required to help protect the environment [4.5].

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

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