Ursomax

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Medically reviewed

Rosario Oropesa

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 Ursomax

Property Description
Active ingredient Ursodeoxycholic Acid (UDCA) / Ursodiol
Form Capsule or Tablet (Oral Preparation)
Pharmacological class Cholelitholytic Agent, Hepatoprotective Agent
General purpose Bile composition modulation and liver cell protection
Origin Derived Bile Acid (synthetic therapeutic derivative)

What Type of Medicine is Ursodeoxycholic Acid (Ursodiol)?

Ursomax is the trade name for a prescription medicine whose sole active ingredient is Ursodeoxycholic Acid (UDCA), commonly referred to as Ursodiol. It is officially classified as both a Cholelitholytic Agent and a Hepatoprotective Agent within its therapeutic category. This classification is clinically recognized for its utility in managing conditions of the biliary system.

The substance itself is a specific type of Bile Acid that naturally occurs in small quantities in humans, making it an endogenous compound. However, for pharmaceutical use, the therapeutic agent is produced as a precise synthetic derivative. Other popular brands containing this same active ingredient include Actigall, Urso, and Ursofalk, indicating that UDCA is a well-established substance.

What is the Composition and Form of Ursomax?

Ursomax is formulated as a single-ingredient product, containing only Ursodeoxycholic Acid alongside necessary inert pharmaceutical excipients. This medication is designed as an Oral Preparation and is available in solid forms, specifically as a Capsule or a Tablet. The oral route of administration ensures that the active compound is efficiently absorbed and delivered to the liver, where it exerts its primary effects.

The primary action of UDCA involves modulating the concentration of bile acids within the body, which stabilizes bile flow. This quality ensures the formulation provides a consistent and reliable therapeutic effect focused on improving bile flow dynamics.

What is the General Purpose of Ursodiol?

The general purpose of Ursodiol therapy is to manage conditions related to bile composition and impaired bile flow. Its primary action involves modulating bile composition by reducing the cholesterol saturation of bile.

This unique physiological action facilitates a general therapeutic benefit by chemically supporting the integrity of the bile ducts and liver cells through cytoprotection, where it replaces more toxic bile acids. This results in the potential for the gradual dissolution of small, non-calcified cholesterol gallstones, a typical use scenario, and provides essential support for the liver and biliary system when bile flow is compromised.

Regulatory References

  1. Ursodiol (MedlinePlus)

What side effects are possible with Ursomax?

Possible Side Effects and Safety Information

The safety profile of Ursodeoxycholic Acid (Ursomax) is formally structured in regulatory documents, outlining adverse reactions based on their frequency and the physiological system affected.

Officially Documented Adverse Reactions

Side effects are categorized by the body system affected, with the majority falling under Gastrointestinal Disorders.

Classification Adverse Reaction Body System (SOC)
Common (1 to 10 in 100 users) Diarrhea, Past-like stools Gastrointestinal
Uncommon (1 to 10 in 1,000 users) Nausea, Vomiting, Elevated liver enzyme levels Gastrointestinal, Hepatobiliary
Very Rare (less than 1 in 10,000 users) Calcification of gallstones, Urticaria Hepatobiliary, Skin

Serious Safety Considerations

The regulatory profile documents very rare but clinically significant adverse reactions. For patients with advanced Primary Biliary Cholangitis (PBC), the potential for hepatic decompensation (worsening of liver function) has been noted. This effect is more likely at the start of treatment or during dose increases and may partially reverse upon discontinuation of the medicine.

Safety Restrictions (Contraindications)

Ursodeoxycholic Acid should not be used in individuals with specific pre-existing conditions as defined in the official labeling. These contraindications include acute inflammation of the gallbladder or biliary tract, complete occlusion of the biliary tract (e.g., common bile duct obstruction), and the presence of calcified radiopaque gallstones.

Overdose and Emergency Response

Overdose and when to seek help

The information below summarizes the officially documented descriptions of Ursodeoxycholic Acid (Ursodiol) overdose and the regulator-mandated emergency actions.


Documented Manifestations and Risk Classification

Official regulatory documents state that the primary manifestation of severe overdose is diarrhea. This is attributed to the mechanism that absorption of Ursodiol decreases as the dose increases, which limits the potential for other symptoms. Due to this factor, the regulatory basis for this medicine classifies the occurrence of serious adverse effects as unlikely following overdosage.

No specific antidote is documented for Ursodeoxycholic Acid overdose; treatment is therefore required to be symptomatic and supportive.


Required Emergency Actions

Immediate medical attention is mandated for any suspected overdose. Regulatory guidance requires individuals to contact a healthcare professional, hospital emergency department, or regional poison control centre immediately.

If the individual has developed severe, life-threatening symptoms, such as having collapsed, had a seizure, has trouble breathing, or cannot be awakened, immediate contact with emergency services is required.

Management procedures described in official labeling include the use of ion-exchange resins to bind bile acids in the intestine, and mandate that liver function should be monitored using blood tests during observation.

Therapeutic Uses of Ursomax

Ursomax is applied across domains where additional symptomatic support may be needed for symptoms that interfere with daily functioning. The active ingredient is relevant in contexts involving heightened systemic burden, such as specific chronic and acute conditions including primary biliary cholangitis and the dissolution of gallstones. This medicine is commonly used across conditions presenting with episodic or fluctuating manifestations, or those marked by increased physiological stress. It helps address symptom clusters that may become intense or disruptive, and may assist with maintaining functional stability during periods of heightened symptoms.

The medicine is considered relevant within clinical settings that involve acute or unstable symptom patterns. Ursomax is relevant when symptoms become temporarily overwhelming, and may provide supportive relief when symptoms interfere with routine activities.

Quick Fact: Relevant for Managing Symptom Clusters

Eligibility and Restrictions for Use

Who Can and Cannot Use Ursomax?

The official eligibility profile for Ursomax (Ursodeoxycholic Acid/Ursodiol) is strictly defined by regulatory authorities and centers on the patient's underlying disease, liver function, and biliary tract status.


Populations for whom use is allowed (As Stated in Label)

Classification Eligibility Rule
Adults Approved for those with Primary Biliary Cholangitis (PBC) and for the dissolution of small, radiolucent, non-calcified cholesterol gallstones.
Pediatric Approved for children aged 6 to 18 years only for cystic fibrosis–associated hepatobiliary disorders.

Populations for whom use is Contraindicated (Absolute Non-Eligibility)

Use of Ursomax is prohibited in patients with:

  • Known hypersensitivity to bile acids or any ingredient in the formulation.
  • Complete occlusion of the biliary tract or acute inflammation of the gallbladder.
  • Radio-opaque calcified gallstones or severely impaired gallbladder contractility.
  • Active peptic ulcers or inflammatory diseases of the small intestine or colon.

Restricted and Conditional Use

Use is not recommended in patients with decompensated cirrhosis (advanced PBC with symptoms like ascites or variceal bleeding). Furthermore, the medicine must not be used during pregnancy, and women of childbearing potential are required to use reliable contraception throughout therapy.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Ursodeoxycholic Acid (Ursomax) defines interactions based on two primary categories: those that interfere with its efficacy and those that alter the systemic exposure of co-administered medicines.


Interactions Affecting Ursomax Efficacy

Co-administration is formally restricted with certain substances when Ursomax is used for gallstone dissolution. This restriction applies to Oestrogenic Hormones, including hormonal oral contraceptives, and lipid-lowering drugs such as Clofibrate (a fibrate). These substances are officially noted to increase hepatic cholesterol secretion, which directly counteracts the anti-cholesterol effect of Ursomax.


Interactions Requiring Timing Separation

Certain medicinal products interfere with the absorption of Ursomax, which reduces its overall efficacy. This includes Bile Acid Sequestering Agents (e.g., Cholestyramine and Colestipol) and Aluminum-based Antacids. To prevent this reduction in absorption, regulatory guidance states these agents must be taken at least 2 hours before or 2 hours after Ursomax.


Exposure Changes to Co-administered Drugs

Ursomax alters the absorption and systemic levels of specific other medicines. It is documented to increase the intestinal absorption and subsequent plasma concentrations of Ciclosporin (Cyclosporine), which necessitates therapeutic monitoring. Conversely, Ursomax has been shown to reduce the plasma peak concentration and overall exposure (AUC) of medicines such as the calcium antagonist Nitrendipine. A reduction in therapeutic effect has also been reported with Ciprofloxacin and Dapsone.

Mechanism of Action

Ursomax, which is ursodeoxycholic acid (UDCA), is a hydrophilic bile acid that is absorbed in the small intestine and selectively accumulates in the hepatic circulation, becoming a major fraction of the total bile acid pool.

Its mechanism involves several targets. UDCA acts as a competitive displacement agent, increasing the ratio of hydrophilic to hydrophobic bile acids in the bile acid pool, thus modulating the physicochemical properties of bile. This shift reduces the cellular toxicity of endogenous hydrophobic bile acids on the hepatocyte and cholangiocyte membranes.

Intracellularly, UDCA exhibits an anti-apoptotic effect by stabilizing mitochondrial membranes, which inhibits the mitochondrial pathway of apoptosis and prevents the release of cytochrome C. UDCA also modulates membrane transport proteins, such as upregulating the expression of the Cl^-/ HCO3^- anion exchanger (AE2) on the cholangiocyte canalicular membrane. This action leads to a stimulation of bicarbonate and bile secretion (choleretic effect) into the bile ducts. At a system level, it also suppresses the hepatic synthesis and secretion of cholesterol and acts as an inhibitor of intestinal cholesterol absorption.

Dosage and Administration Information

Administration Guidelines for Ursomax (Ursodiol)

The administration of Ursodeoxycholic Acid (Ursodiol) is governed by its labeling, detailing the required route, dosing patterns, and specific timing for proper use. The medicine is exclusively for oral administration and is available in forms such as capsules, tablets (which may be scored for flexibility), and prepared oral suspensions.

Dosing Regimens and Frequency

Dosage is typically weight-based, ranging from 8 to 15 mg/kg of body weight per day, which varies depending on the specific condition being managed. The daily amount is generally administered in divided doses (e.g., two to four times daily), ensuring consistent delivery of the active ingredient. For gallstone prevention in specific contexts, a non-weight-based dose of 600 mg daily is administered as 300 mg twice daily.

Administration Conditions and Duration

Ursodiol should be taken with food or a small snack to facilitate proper administration. If a tablet is scored to be broken in half for precise dosing, the fragments must be swallowed whole and not chewed.

The treatment duration is determined by the condition: for Primary Biliary Cholangitis, usage is typically long-term and chronic. For gallstone dissolution, a course can last from 6 to 24 months, with continuation required for at least three months after stones are confirmed to be dissolved. If a dose is missed, it should be taken when remembered, unless it is nearly time for the next dose; in this case, the missed dose must be skipped to avoid taking a double amount.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Ursomax (Ursodiol)


Evidence for Use in Primary Biliary Cholangitis (PBC)

The research base for Ursomax in Primary Biliary Cholangitis (PBC) is built upon several types of studies, including short-term Randomized Controlled Trials (RCTs) and multi-year observational studies. These research efforts primarily examined adult patients with a diagnosis of PBC. Researchers tracked key hard clinical endpoints of disease progression, such as liver transplantation or liver-related death. Studies also monitored changes in blood tests, specifically liver enzymes like Alkaline Phosphatase (ALP) and Total Bilirubin.

Research reported observations of lower levels of certain liver enzymes and patterns related to changes in liver function test results. Furthermore, some trials explored patterns related to the histological features of fibrosis and cirrhosis in the observed populations. Studies indicate that a significant proportion of the patient population was observed to have an inadequate biochemical response in research settings.


Evidence for Use in Dissolving Cholesterol Gallstones

The evidence for this use includes Randomized Controlled Trials (RCTs) and controlled clinical trials. These studies examined adult patients whose gallstones met specific criteria: small (typically under 15 mm) and radiolucent. The outcomes measured in these trials included the achievement of complete gallstone dissolution, assessed radiologically. Secondary measurements monitored the partial reduction in stone size and reported changes in the frequency of biliary pain.

Reported dissolution rates varied depending on stone and patient characteristics, and this outcome was typically observed only after extended periods of study. Recurrence was associated with the cessation of treatment in some studies.


The Study Landscape for Primary Sclerosing Cholangitis (PSC)

Ursomax was evaluated in research settings for Primary Sclerosing Cholangitis (PSC) in Randomized Controlled Trials (RCTs). Studies monitored changes in liver biochemistry and tracked major clinical endpoints of disease progression. Findings were mixed, with inconsistent or inconclusive observations across major trials related to long-term clinical outcomes. Furthermore, some studies reported that trials involving high-dose regimens were stopped early due to reported observations. The evidence in this area is limited and findings are still uncertain regarding long-term clinical outcomes.

Frequently Asked Questions (FAQ)

Common questions about Ursomax (FAQ)


Q: How long does it usually take for Ursomax to start working for gallstones?

While the full course of treatment for gallstones can take several months, studies indicate the medicine may begin to work within a few days. Patients typically do not feel an immediate difference.

Changes to gallstones or improvements in blood tests are generally observed only after several months of continued therapy.


Q: How long might a person need to take Ursomax for treatment?

The required treatment length depends on the specific condition being managed. For the chronic condition primary biliary cholangitis (PBC), official guidelines indicate that use is often long-term.

For dissolving cholesterol gallstones, the course typically lasts from 6 to 24 months, as described in regulatory documents.


Q: Can Ursomax interact with common over-the-counter pain relievers?

Official documents emphasize the importance of discussing all co-administered medicines with a healthcare provider.

However, specific non-prescription pain relievers like ibuprofen or paracetamol are generally noted as permissible in some regulatory patient information.


Q: What types of prescription medicines are known to interact with Ursomax?

Interactions are described in the official drug profile across several categories. These include medicines where Ursomax's efficacy may be reduced (such as Oestrogenic hormones) and other drugs where the plasma concentration of the co-administered medicine may change (such as Ciclosporin).

Bile Acid Sequestering Agents and Aluminum-based antacids are also known to interfere with Ursomax's absorption.


Q: Does Ursomax interact with cholesterol-lowering drugs like statins?

The regulatory profile restricts the use of certain older lipid-lowering drugs, specifically naming agents like Clofibrate (a fibrate).

These restrictions apply to medicines that increase the liver’s cholesterol secretion, as they can counteract the intended cholesterol-modulating effects of Ursomax.


Q: What happens if a person misses taking a dose of Ursomax?

According to official administration guidelines, a missed dose should be taken when remembered, unless it is nearly time for the next scheduled dose.

If it is almost time for the next dose, the missed one should be skipped entirely to avoid taking a double amount.


Q: Is it possible to take Ursomax for many years?

Yes, studies and official information indicate that for the management of chronic conditions such as Primary Biliary Cholangitis (PBC), the use of Ursomax is often described as long-term and chronic.


Q: Is Ursomax a naturally occurring substance?

Ursodeoxycholic acid naturally occurs in the human body in small quantities, meaning it is an endogenous compound.

However, the medicine used for pharmaceutical therapy is a precisely manufactured synthetic derivative of this substance.


Q: How is Ursomax different from the bile acid my body makes naturally?

Ursomax is a hydrophilic bile acid, which means it is more water-soluble than the bile acids the body produces naturally.

Its function is to change the overall composition of the total bile acid pool, thereby reducing the concentration of the body's more potentially toxic hydrophobic bile acids.


Q: Is Ursomax an anti-inflammatory medicine?

Official regulatory documents primarily classify Ursomax as a Cholelitholytic Agent (gallstone dissolving) and a Hepatoprotective Agent (liver protecting).

This classification reflects its main actions, which involve modulating bile composition and protecting liver cells.


Q: Does Ursomax affect liver enzyme levels?

Yes, official safety documentation indicates that elevated liver enzyme levels have been documented as an uncommon adverse reaction.

For this reason, monitoring of these levels is often required during the course of therapy.


Q: What is the general relationship between Ursomax and cholesterol?

Ursomax acts to reduce the cholesterol saturation of bile, which is one of its primary therapeutic functions.

It achieves this by suppressing the synthesis and secretion of cholesterol from the liver while also reducing its absorption in the intestine.


Q: Can Ursomax cause stomach discomfort or nausea?

Nausea is officially documented as an uncommon side effect in the regulatory profile. Other gastrointestinal issues are also frequently reported in patient safety data.

These can include general upset stomach or stomach pain.


Q: Is it normal to experience a headache while taking Ursomax?

Headache is a reaction that has been frequently reported in patient safety data during the use of Ursodiol. It is described as a common adverse reaction in official safety documents.


Q: Why might a person feel dizzy after starting Ursomax?

Dizziness is a reaction that has been reported in the post-marketing or clinical trial safety data for Ursodiol.

It is listed as a possible nervous system reaction in the drug's safety profile.


Q: Has hair loss been reported as a side effect of taking Ursomax?

Yes, hair loss (alopecia) is documented as a dermatologic reaction that has been reported in patient safety data.

All reported adverse reactions are detailed in the official safety profile.


Q: Is back pain a possible reported side effect of Ursomax?

Back pain is a musculoskeletal reaction that has been frequently reported in patient safety data during the use of Ursodiol.

This is included in the full list of documented adverse reactions from clinical trials.


Q: What signs might indicate an allergic reaction to Ursomax?

Signs of a severe allergic reaction that have been reported include swelling of the face, lips, mouth, or throat, and difficulty breathing or wheezing.

A generalized rash or hives (urticaria) is also listed as a very rare reaction in the official safety profile.


Q: Does taking Ursomax affect sleep patterns?

Trouble sleeping, or insomnia, is documented as a psychiatric reaction that has been reported in patient safety data.

This is included in the official drug safety profile.


Q: Are there any specific vitamins or supplements that should not be taken with Ursomax?

Patients are generally advised to inform their healthcare provider about all vitamins, herbal products, and other supplements they use.

Ursomax can potentially interact with certain agents, which may affect their absorption or overall efficacy.


Q: Can Ursomax be used by people who have existing inflammatory bowel conditions, like Crohn's disease?

Ursomax is prohibited (contraindicated) for use in patients with active peptic ulcers or inflammatory diseases of the small intestine or colon.

This non-eligibility rule includes conditions like Crohn's disease, as noted in the official prescribing information.


Q: Are there special considerations for using Ursomax in older adults?

While studies have not found specific geriatric-related problems that limit its use, elderly patients have been observed to be more sensitive to the effects of the medicine compared to younger adults.

This observation is noted in the official regulatory profile.


Q: Why is the dosage of Ursomax sometimes based on a person's body weight?

The required dose for many conditions is often weight-based (e.g., measured in mg per kg of body weight).

This calculation is used to ensure the active ingredient achieves the intended concentration to effectively treat the specific condition.


Q: Does Ursomax affect blood sugar levels?

An increased blood sugar level (hyperglycemia) has been reported as a serious adverse reaction in the safety data for Ursodiol.

This is monitored as part of the medicine’s overall safety profile.


Q: Can Ursomax cause fluid retention or swelling?

Swelling of the ankles or feet, known as peripheral edema, has been reported as a cardiovascular adverse reaction in patient safety data.

This is detailed in the official safety profile of the medicine.


Q: What happens if a person suddenly stops taking Ursomax?

Abruptly discontinuing the medicine, particularly for gallstone dissolution, is associated with a risk of compromising the intended outcome, according to official information.

In patients with advanced Primary Biliary Cholangitis (PBC), a temporary worsening of liver function (hepatic decompensation) has been noted if the medicine is discontinued.

How should Ursomax be stored and disposed of?

How to Store and Dispose of Ursomax (Ursodeoxycholic Acid)

Official regulatory information defines specific conditions necessary to maintain the quality and stability of Ursomax. The medicine must be stored at controlled room temperature, typically between 20 C and 25 C (68 F and 77 F), and must be kept from freezing.

Storage and Handling Requirements

  • Protection: The product requires protection from excessive heat and moisture and must be kept in a tightly closed container.
  • Stability: If scored tablets are broken, the resulting half-tablets must be used within 28 days.
  • Child Safety: Ursomax must be stored out of the reach and sight of children.

Disposal Instructions

Unused or expired medicine should be handled according to official guidance. The preferred method is using a community drug take-back program. If one is unavailable, the medicine should be mixed with an undesirable substance (like dirt or coffee grounds), sealed in a container, and discarded in the household trash. Identifying information on the prescription label must be scratched out before disposal.

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

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