Chenofalk

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Chenofalk

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Chenofalk

Quick Facts

Property Description
Active ingredient Chenodeoxycholic Acid (CDCA)
Form Film-coated tablets
Pharmacological class Cholelitholytic Agent
Common use Dissolution of cholesterol gallstones
Origin Derived (synthetic preparation of a natural substance)

What Type of Medicine is Chenofalk?

Chenofalk is a specialized, prescription-only medicine whose primary function classifies it as a cholelitholytic agent, which is a drug used to facilitate the breakdown of certain solid formations in the biliary system. Its generic name, or International Nonproprietary Name (INN), is Chenodeoxycholic Acid (CDCA), also known as Chenodiol, and it belongs to the pharmacological class of bile acid derivatives. This specific medication is primarily positioned for use in adult patients presenting with cholesterol-rich gallstones.

Chenodeoxycholic Acid: Composition and Pharmaceutical Form

The composition of the medicine is centered on its single active ingredient, Chenodeoxycholic Acid. Although CDCA is a primary bile acid naturally synthesized in the body, the final pharmaceutical product is a standardized, synthetic preparation. Chenofalk is manufactured for oral administration and is presented as film-coated tablets. The tablet format is a key differentiating factor, designed for systemic action via the digestive tract, ensuring controlled delivery of the active substance.

General Purpose and Benefit

The general purpose of administering Chenofalk is to manage the presence of cholesterol concretions by achieving their gradual dissolution. This cholelitholytic action is clinically recognized for its role in modifying the chemical environment of the bile, promoting a reduction of cholesterol saturation. By achieving this chemical alteration, the medicine facilitates the necessary solubilization that helps break down and clear existing cholesterol deposits, providing a medical pathway for managing specific biliary formations.

Regulatory References

  1. MedlinePlus: Chenodiol
  2. DailyMed: Chenodiol Oral Tablets

What side effects are possible with Chenofalk?

Possible Side Effects and Safety Information

The safety profile of Chenofalk (Chenodeoxycholic Acid) is characterized by a high prevalence of gastrointestinal effects and the potential for hepatobiliary adverse reactions, as documented in official regulatory labeling.

Adverse Reaction Classification

Side effects are officially classified by frequency based on clinical data:

  • Very Common (Affects more than 1 in 10 people): The most frequently documented reactions are Diarrhea or loose stools and Elevated liver transaminases (ALT/AST), which are increases in liver enzyme levels.
  • Common (Affects 1 to 10 in 100 people): This category includes abdominal pain and constipation.

The most significant and serious adverse reaction documented is Hepatotoxicity (Liver Injury). Due to this potential, regulatory documents mandate the periodic monitoring of liver transaminases and total bilirubin throughout the course of treatment. These enzyme increases are typically dose-related and reversible upon dose adjustment.

Safety Constraints and Special Populations

Official regulatory information defines conditions under which Chenofalk should not be used, including acute cholecystitis, cholangitis, and complete biliary obstruction. The medicine is also ineffective and restricted from use in patients with calcified or pigment gallstones.

Regarding special populations, use is not recommended during pregnancy or in women of childbearing potential who are not using effective contraception. Furthermore, patients with pre-existing hepatic impairment are at higher risk and require extreme caution or are typically restricted from use.

Overdose and Emergency Response

This section outlines the officially documented profile for overdose concerning Chenofalk (Chenodeoxycholic Acid), based strictly on government regulatory labeling and authoritative prescribing information.

Documented Overdose Profile

According to official regulatory prescribing information, accidental or intentional overdoses involving chenodeoxycholic acid have not been formally reported. Consequently, government labels do not describe specific symptom clusters, clinical signs, or laboratory abnormalities resulting from overdose.

One high-dose exposure observation is documented in regulatory sources where a patient was recorded to have tolerated 4 grams per day (or 58 mg/kg/day) for a period of six months without incident. This observation serves as the primary data point regarding high-level human exposure recorded in the official overdose section.

Overdose Status Regulatory Documentation
Reported Cases None reported in official prescribing information.
Antidote Availability No specific antidote is known or documented in the regulatory label.

When to Seek Help

Due to the lack of reported cases, the official Overdosage section does not explicitly mandate specific emergency actions or provide immediate, regulator-defined help-seeking instructions. The regulatory information does not contain specific required procedures, such as gastric lavage, or define monitoring requirements for overdose situations. Management principles are expected to align with general supportive treatment, although specific measures are not detailed in the official overdose profile.

Therapeutic Uses of Chenofalk

What Chenofalk Treats: Main Uses and Benefits

Chenofalk, which contains the active substance chenodeoxycholic acid (CDCA), is used across conditions where functional stability becomes affected. The medicine is commonly used across conditions associated with acute or disruptive episodes, such as cerebrotendinous xanthomatosis (CTX).

This medicine is commonly used to help with providing support that helps ease the overall symptom burden. The medicine is relevant in contexts involving heightened systemic burden, such as cerebrotendinous xanthomatosis (CTX) and conditions linked to organ-specific functional stress. It may assist with managing symptoms related to inflammatory or irritative states, including symptom clusters that may become intense or disruptive, relevant for easing systemic or localized discomfort. The medicine is applied in addressing conditions where functional stability becomes affected.

“The medicine is applied in scenarios where additional management of discomfort is required.”

Quick Fact: Supports patients during episodes of heightened discomfort.

Regulatory References

  1. EMA therapeutic overview for Chenodeoxycholic acid

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Chenofalk — Official Regulatory Information

Eligibility Scope

Category Regulatory Statement
Populations for whom use is allowed Adults are approved for gallstone dissolution, while adults and children from one month of age are approved for Cerebrotendinous Xanthomatosis (CTX).
Populations for whom use is contraindicated The medicine is contraindicated in pregnancy and for patients with known hepatocyte dysfunction, bile ductal abnormalities, Inflammatory Bowel Disease, or complications related to gallstones.
Age-related eligibility rules Pediatric use for gallstone dissolution is categorized as not established for safety and effectiveness. Use in adults and children geq one month is established for CTX.
Pregnancy and lactation eligibility Pregnancy is contraindicated (Category X); women of childbearing potential are required to use effective contraception. Use in nursing mothers requires caution as excretion into human milk is not known.
Eligibility-related restrictions Use is limited to patients with radiolucent cholesterol gallstones; use with radiopaque stones is prohibited. Close monitoring of liver enzymes (ALT/AST) is required for all patients.

Eligibility Classifications (High-Level)

Classification Basis in Official Documents
Eligibility severity classification Defined as Contraindicated (absolute prohibition) or Not Established (where safety data is lacking).
Eligibility-context constraints Eligibility is constrained by Organ Function (pre-existing liver/biliary conditions) and Pathology Type (gallstone composition and visualization).

Resulting Eligibility Structure

Official eligibility statements:

  • Use is contraindicated in patients with known hepatocyte dysfunction, bile ductal abnormalities, or Inflammatory Bowel Disease.
  • The medicine is contraindicated for women who are pregnant, requiring women of childbearing potential to use effective contraception.
  • It is approved for adults for gallstone use and for children from one month of age for the CTX indication.

Connection to the overall eligibility profile (2–4 sentences): Official regulatory documents define who can and cannot use the medicine by establishing absolute prohibitions based on liver and biliary function, reproductive status, and the specific nature of the condition being treated. Furthermore, eligibility is structured by age, where use is established in children for CTX but not established for the gallstone dissolution indication.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define specific substance classes and products that interact with Chenodeoxycholic Acid (Chenofalk), primarily through reduced absorption or counteracting its therapeutic effect.

Formal Interaction Restrictions

Substance Category Interaction Pattern Regulatory Instruction
Bile Acid Sequestering Agents (e.g., Cholestyramine) Decreased intestinal absorption of Chenodeoxycholic Acid. Avoid concomitant use (prohibited).
Aluminum-based Antacids (e.g., Aluminum Hydroxide) Adsorption of bile acids, reducing Chenodeoxycholic Acid absorption. Avoid concomitant use (prohibited).

Documented Pharmacodynamic Interactions

Coumarin derivatives (e.g., Warfarin) interact with Chenodeoxycholic Acid, which may officially prolong the prothrombin time and increase the risk of hemorrhage. If co-administration is unavoidable, professional monitoring of prothrombin time is required.

Medications that increase hepatic cholesterol secretion, such as Estrogens, Oral Contraceptives, and Clofibrate, are documented to counteract the intended cholelitholytic effectiveness of Chenofalk.

Pharmacokinetic Considerations

Chenodeoxycholic Acid is not expected to inhibit major CYP enzymes (e.g., CYP3A4, 2D6). However, the drug is a high-affinity Bile Salt Export Pump (BSEP) substrate and may inhibit OATP1B1 and OATP1B3 transporters, though the clinical significance of this inhibition is officially unknown.

Mechanism of Action

Regulation of Hepatic Cholesterol Metabolism

Chenodeoxycholic Acid (CDCA) strategically acts on the liver to regulate the output of cholesterol. The drug engages mechanisms that suppress the synthesis and subsequent secretion of cholesterol into the bile . This initial step directly controls the precursor molecule whose concentration influences precipitation.

FXR-Mediated Bile Acid Pool Modulation

The core mechanism involves CDCA acting as an agonist for the Farnesoid X Receptor (FXR), a master regulator of bile acid and lipid homeostasis. FXR activation initiates a feedback cascade that limits the body's natural production of other bile acids, allowing the administered CDCA to become the dominant component of the bile acid pool.

Enhancing Biliary Solubilizing Capacity

The combined effect of reducing cholesterol secretion and increasing the concentration of bile acids fundamentally changes the physicochemical properties of bile. This mechanism enhances the bile’s micellar capacity, shifting the fluid from a supersaturated state to one that is unsaturated with cholesterol, thereby facilitating the slow, continuous solubilization of existing cholesterol deposits.

Dosage and Administration Information

How to Use Chenofalk

Chenofalk (Chenodeoxycholic Acid, CDCA) is administered following specific clinical protocols. It is formulated as film-coated tablets or capsules for oral administration.


Official Dosing Principles

Administration is typically structured around divided doses taken multiple times per day to maintain consistent levels. The precise dosage regimen varies based on the condition being addressed, necessitating careful adherence to the prescribed plan.

Indication Standard Adult Regimen Key Instruction
Gallstone Dissolution 13 to 16 mg/kg/day in divided doses, with gradual weekly dose increases. Treatment duration may last up to 24 months and is discontinued if no response is observed after 18 months.
Cerebrotendinous Xanthomatosis (CTX) 750 mg to 1,000 mg daily, typically in three divided doses. Use is considered a long-term or chronic therapeutic regimen.

Administration Conditions and Handling

Administration instructions define how the medicine is taken to ensure proper delivery of the active substance. The medicine may be taken with or without food. If a dose is missed, standard protocol indicates to omit the missed dose and resume the schedule at the next designated time; a double dose must not be taken to compensate.

For patients who cannot swallow the capsules, the contents may be mixed with a sodium bicarbonate solution (8.4%) prior to oral intake. Treatment initiation and supervision should be overseen by a physician with experience in treating the specific condition.

Recent Clinical Evidence

Research evidence / Overview of studies for Chenofalk

Evidence for use in Cerebrotendinous Xanthomatosis (CTX)

The research base for this rare genetic condition has utilized long-term observational cohort studies and recent randomized withdrawal trials. Research examined changes in key biomarkers like serum cholestanol and related bile alcohols. Studies reported measurements showing a decrease in these biomarkers during the studied treatment period. Patterns of stabilization or change were also observed in measured outcomes related to neurological disability and daily functioning in many cohorts.

Research so far indicates that while the measurements on key biomarkers were similar, long-term follow-up from prospective randomized trials is limited. The response regarding specific complex symptoms, such as psychosis or certain movement disorders, was described as variable in the research.

Evidence for Gallstone Dissolution

The use of this compound for dissolving gallstones was studied extensively in the past through large, controlled clinical trials. These studies focused on patients with radiolucent (non-calcified) cholesterol gallstones. Researchers monitored the measured rates of gallstone dissolution, confirmed via radiographic imaging, and changes in the cholesterol saturation of bile. Findings describe patterns observed in the studies where dissolution was reported across studied groups over treatment periods lasting up to two years.

It is important to understand that research is limited concerning use in patients who possess stones that are already calcified (hardened). Studies documented a pattern of high recurrence rates of gallstones after the medicine was stopped.

Research in Different Age Groups and Subgroups

Research has explored the compound in pediatric patients with CTX, with studies including children from the age of one month. In contrast, gallstone trials were evaluated strictly in adults who had a functioning gallbladder and non-calcified gallstones.

Areas of Research Uncertainty and Gaps

Due to the rarity of CTX, some research efforts relied on modest sample sizes. For gallstone dissolution, certainty remains low regarding sustained outcomes after treatment is concluded. Furthermore, evidence comparing this compound to other agents is limited, as much of the core evidence is historical.

Key Studies & References

  1. Label: CHENODAL - chenodiol tablet, film coated (DailyMed/NIH)
  2. Chenodiol (Chenodeoxycholic Acid) for Dissolution of Gallstones: The National Cooperative Gallstone Study

Frequently Asked Questions (FAQ)

Common questions about Chenofalk (FAQ)

Q: Is Chenofalk the same as [common competitor name]?

A: Chenofalk's active ingredient is chenodeoxycholic acid, which belongs to the class of bile acid derivatives. Regulatory documents define its specific composition and purpose. Information comparing this medicine directly to other treatments is not typically included in official regulatory documentation.

Q: Is Chenofalk safe for long-term use?

A: Official regulatory documents define the time period for use. For gallstone dissolution, treatment may last up to 24 months. For the condition cerebrotendinous xanthomatosis (CTX), it is defined as a long-term or chronic therapeutic regimen. Due to the potential for hepatotoxicity (liver injury), regulatory documents mandate the periodic monitoring of liver function throughout the course of treatment.

Q: Are there any specific foods I should avoid while on Chenofalk?

A: Official product information prohibits taking the medicine with certain aluminum-based antacids and bile acid sequestering agents, as these can reduce the amount of Chenofalk your body absorbs. Generally, the medicine may be taken with or without food.

Q: If I forget to take Chenofalk at the same time each day, what is the protocol?

A: Regulatory documents emphasize the importance of following the prescribed schedule to maintain consistent drug levels. If a dose is missed, patients are generally instructed to skip the missed dose entirely and simply take the next scheduled dose at the designated time. Regulatory guidance explicitly states that a double dose must not be taken to compensate for a missed dose.

Q: Why do some people say Chenofalk didn't work for them?

A: Clinical research documents several reasons why non-response may occur. For gallstone dissolution, studies indicate that treatment is typically discontinued if no dissolution is observed after 18 months, and there are high rates of gallstone recurrence after treatment is stopped. For CTX, the response to complex neurological symptoms was reported as variable in research.

Q: Are there any studies looking at Chenofalk's effect on quality of life?

A: Studies examining the use of Chenofalk in patients with CTX have reported measured outcomes related to changes in neurological disability and daily functioning in patient cohorts. These measures reflect aspects that can impact quality of life.

Q: Is Chenofalk often prescribed by general practitioners?

A: Official documents state that the initiation and supervision of treatment should be overseen by a physician with experience in treating the specific condition, suggesting specialized oversight is typically required.

Q: Is the research evidence for Chenofalk considered strong?

A: Research supporting the medicine includes large controlled clinical trials for gallstone dissolution and long-term observational cohort studies for CTX. Official documents do note that evidence comparing Chenofalk to other specific agents is limited, and some CTX studies used modest sample sizes due to the rarity of the condition.

Q: Can Chenofalk be crushed or split if it's a tablet?

A: Chenofalk is supplied as film-coated tablets or capsules. Official regulatory guidance for capsules allows the contents to be mixed with a solution for patients who have trouble swallowing. There is no specific instruction provided in regulatory documents regarding the crushing or splitting of the tablets.

Q: Is Chenofalk a new drug, or has it been around for a while?

A: Official documents note that much of the core research evidence supporting the use of this compound for gallstone dissolution is historical, indicating that the active ingredient, chenodeoxycholic acid, has been used clinically for a long period.

Q: How does Chenofalk compare to a placebo in clinical trials?

A: The clinical use of Chenofalk for gallstone dissolution was supported in the past through controlled clinical trials. These studies focused on comparing the measured rates of gallstone dissolution in treated groups versus control groups.

Q: What kinds of doctors usually prescribe Chenofalk?

A: Treatment must be supervised by a physician who has experience in treating the specific condition. Based on the approved uses, this oversight is typically provided by specialists such as gastroenterologists (for gallstones) or neurologists (for CTX).

Q: Does the time of day matter when taking Chenofalk?

A: The medicine is structured around divided doses taken multiple times per day to achieve and maintain consistent drug levels in the body. Therefore, the importance is placed on consistent dosing intervals rather than the specific time of day.

Q: Can young adults or teenagers use Chenofalk?

A: The medicine is approved for adults for gallstone dissolution and for children from one month of age for the CTX indication. Official regulatory documents indicate that the safety and effectiveness for pediatric use for the gallstone dissolution indication is not established.

Q: Can Chenofalk cause stomach upset or nausea?

A: The most frequently reported adverse reactions include gastrointestinal effects such as diarrhea and abdominal pain. Nausea is also listed in the adverse event profiles documented in clinical data.

Q: Is it normal to feel a bit tired when starting Chenofalk?

A: Clinical trial documentation lists general feelings of tiredness and muscular weakness as adverse reactions reported by patients using the medicine.

Q: Does Chenofalk have a black box warning?

A: The current FDA prescribing information for the active ingredient, chenodeoxycholic acid, does not contain a Black Box Warning.

Q: Does Chenofalk need to be stored in the refrigerator?

A: No. Official instructions state that the medicine must be stored at Controlled Room Temperature (between 20 C and 25 C), which is not refrigeration.

Q: Are headaches a common side effect of Chenofalk?

A: Headache is listed as one of the most common adverse reactions reported in clinical data. This side effect was reported with an incidence rate greater than 14 percent.

Q: Are there different strengths of Chenofalk available?

A: The official product information lists that the medicine is available as 250 mg film-coated tablets.

Q: What should I do if Chenofalk causes an allergic reaction?

A: Official regulatory documents define the medicine's contraindications and serious side effects, such as the potential for liver injury. The official documents emphasize the importance of monitoring for signs of worsening symptoms or serious adverse reactions. Conditions related to severe liver issues are listed as contraindications.

Q: Does Chenofalk interact with alcohol?

A: Regulatory-sourced information notes that conditions such as chronic alcoholism predispose to the formation of pigment gallstones, which are prohibited for treatment with this medicine. No specific direct drug interaction with ethanol is listed in the official product information.

Q: Does Chenofalk affect blood pressure?

A: Hypertension (high blood pressure) is listed as one of the most common adverse reactions reported in clinical data. This effect was reported with an incidence rate greater than 14 percent.

How should Chenofalk be stored and disposed of?

The storage and disposal of Chenofalk (chenodeoxycholic acid) tablets must adhere strictly to the conditions specified in official regulatory labeling.


Storage Requirements

Chenofalk must be stored at Controlled Room Temperature (CRT), defined as 20 C to 25 C (68 F to 77 F), with permitted short excursions between 15 C and 30 C. The tablets must be kept in the original container to maintain stability.

  • Child Safety: Store this and all medicines out of the sight and reach of children.

Disposal Instructions

Unused or expired Chenofalk should be disposed of through a medicine take-back program if one is available in the area. If a take-back option is not accessible, the medicine may be mixed with an undesirable substance (such as dirt or used coffee grounds) and placed into a sealed container before being thrown in the household trash. It is officially stated not to flush the tablets down the toilet or pour them into a drain.

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

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