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Ursodeoxycholic acid (ursodiol): Pediatric drug information

Ursodeoxycholic acid (ursodiol): Pediatric drug information
(For additional information see "Ursodeoxycholic acid (ursodiol): Drug information" and see "Ursodeoxycholic acid (ursodiol): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Actigall [DSC];
  • Reltone;
  • Urso 250;
  • Urso Forte
Brand Names: Canada
  • AG-Ursodiol;
  • GLN-Ursodiol;
  • JAMP-Ursodiol;
  • PMS-Ursodiol;
  • PMS-Ursodiol C;
  • Urso DS [DSC];
  • Urso [DSC]
Therapeutic Category
  • Gallstone Dissolution Agent
Dosing: Neonatal

Note: Extemporaneously compounded oral suspensions are available in multiple concentrations (eg, 20 mg/mL, 25 mg/mL, 50 mg/mL, 60 mg/mL); precautions should be taken to verify and avoid confusion between the different concentrations; dose should be clearly presented as mg of ursodiol (ie, not in mL or number of tablets).

Biliary atresia, status post-Kasai procedure

Biliary atresia, status post-Kasai procedure: Limited data available: Term neonates: Usual dose: Oral: 10 to 20 mg/kg/day in 2 to 3 divided doses. Dosing based on small prospective and retrospective trials of neonates and very young infants that included ursodiol as part of a multidrug regimen designed to reduce the risk of cholangitis (Ref). Some centers have reported higher doses (Ref); a range of 20 to 36 mg/kg/day (mean: 25 mg/kg/day) in divided doses was reported in neonates and infants (n=16) following Kasai procedures at a median age of 54 days (range: 14 to 89 days) (Ref).

Parenteral nutrition-induced cholestasis

Parenteral nutrition-induced cholestasis: Limited data available:

Treatment: Efficacy results variable: Preterm and term neonates: Reported range: Oral: 10 to 30 mg/kg/day in 3 divided doses; dosing based on reported retrospective studies that included preterm and term neonates (Ref).

Neonates who were treated with ursodiol had a significantly shortened duration of cholestasis (62.8 ± 10.7 days vs 92.4 ± 8.8 days) and decreased peak direct bilirubin (5.3 ± 0.6 mg/dL vs 8.7 ± 1.1 mg/dL) compared to no treatment (Ref); improvement of bilirubin was seen after 2 weeks and 50% of patients saw a decrease in transaminases (Ref). However, in another large retrospective trial (n=64), neonates receiving ursodiol (mean dose: 24.9 mg/kg/day) had a significantly prolonged resolution of cholestasis compared to controls (median: 79 vs 50 days); authors attribute this to smaller, more premature patients in the treatment group and possibly due to a delay in treatment with ursodiol (time from onset of cholestasis to treatment: median: 24 days) (Ref).

Prevention: Reported regimens variable: Preterm neonates: Oral: 20 to 25 mg/kg/day in 2 to 4 divided doses (Ref). In a randomized, placebo-controlled trial of 102 preterm neonates (n=42 treatment group), ursodiol doses of 20 to 25 mg/kg/day in 2 divided daily doses were shown to significantly prevent neonatal cholestasis (0% vs 11.7%) with significantly lower peak direct and total bilirubin levels (Ref). In a smaller prospective, randomized, controlled study of neonates who received parenteral nutrition for at least 12 days and were receiving <75 mL/kg/day of enteral feeds by day of life 14, 24 neonates received ursodiol at 20 mg/kg/day in 4 divided doses starting at day of life 14; results showed ursodiol was more effective at preventing cholestasis compared to erythromycin or placebo (Ref). Dose titration was reported in a double-blind, placebo-controlled study of 15 premature neonates requiring parenteral nutrition during the first few days of life; ursodiol was initiated at 5 mg/kg/day in 4 divided doses beginning on day of life 3 with initiation of parenteral nutrition; increase dose to 10 mg/kg/day in 4 divided doses with initiation of enteral feeding; increase dose to 20 mg/kg/day in 4 divided doses when full enteral feedings reached (Ref).

Dosing: Pediatric

Note: Extemporaneously compounded oral suspensions are available in multiple concentrations (eg, 20 mg/mL, 25 mg/mL, 50 mg/mL, 60 mg/mL); precautions should be taken to verify and avoid confusion between the different concentrations; dose should be clearly presented as mg of ursodiol (ie, not in mL or number of tablets).

Biliary atresia, status post-Kasai procedure

Biliary atresia, status post-Kasai procedure: Limited data available: Infants and Children: Oral: 10 to 20 mg/kg/day in 2 to 3 divided doses. Dosing based on small prospective and retrospective trials that included ursodiol as part of a multidrug regimen designed to reduce the risk of cholangitis (Ref). Some patients may require higher doses (Ref); a range of 20 to 36 mg/kg/day (mean: 25 mg/kg/day) in divided doses was reported in neonates and infants (n=16) following Kasai procedures at a median age of 54 days (range: 14 to 89 days) (Ref).

Cystic fibrosis-related liver disease

Cystic fibrosis-related liver disease: Limited data available: Infants, Children, and Adolescents: Oral: Initial: 20 mg/kg/day in 2 divided doses; reported range: 10 to 30 mg/kg/day in divided doses; individualize dose based on patient response (Ref).

Parenteral nutrition-induced cholestasis, treatment

Parenteral nutrition-induced cholestasis, treatment: Limited data available (Ref): Infants and Children: Oral: 30 mg/kg/day in 3 divided doses (Ref).

Pruritus secondary to cholestasis

Pruritus secondary to cholestasis: Limited data available: Infants, Children, and Adolescents: Oral: 15 to 20 mg/kg/day once daily or in divided doses twice daily; doses up to 30 mg/kg/day may be necessary in some patients (Ref). Dosing based on long-term (2.5 years), open-label, crossover trial of 13 patients (ages 2 to 27 years) with intrahepatic cholestasis; six of the 13 patients had symptomatic improvement in pruritus (Ref). In another study of 24 pediatric patients (1.5 to 15 years) treated with ursodiol, all patients experienced improvement in pruritus and 16.7% had complete resolution of pruritus (Ref).

Veno-occlusive disease following hematopoietic stem cell transplantation, prevention

Veno-occlusive disease (sinusoidal obstruction syndrome) following hematopoietic stem cell transplantation, prevention: Limited data available (Ref); efficacy results variable (Ref); reported dosing regimens variable; initiate during conditioning phase; refer to specific protocols:

Infants, Children, and Adolescents: Oral: Usual reported range: 10 to 15 mg/kg/day in 2 divided doses; some centers have used doses up to 30 mg/kg/day; if a solid dosage form appropriate for the patient, doses may be rounded to next available dosage form (eg, 150 mg tablet); maximum dose: 300 mg/dose (Ref).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Adult

(For additional information see "Ursodeoxycholic acid (ursodiol): Drug information")

Gallstone dissolution

Gallstone dissolution (capsules): Oral: 8 to 10 mg/kg/day in 2 to 3 divided doses; use beyond 24 months is not established.

Gallstone prevention

Gallstone prevention (capsules): Oral: 600 mg/day in 1 or 2 divided doses.

Gallstone prevention post–bariatric surgery

Gallstone prevention post–bariatric surgery (off-label use): Oral: 500 to 600 mg once daily or in 2 divided doses for 6 months. Note: Doses up to 1,200 mg/day were effective but were associated with a higher incidence of nonadherence (Ref).

Hepatic sinusoidal obstruction syndrome associated with stem cell transplant, prevention

Hepatic sinusoidal obstruction syndrome associated with stem cell transplant, prevention (off-label use): Oral: 12 mg/kg/day in 2 divided doses beginning 1 day before the conditioning regimen and continuing for 90 days after transplantation (Ref). Refer to institutional protocols for further information.

Intrahepatic cholestasis of pregnancy

Intrahepatic cholestasis of pregnancy (off-label use): Oral: 10 to 15 mg/kg/day in 2 to 3 divided doses (Ref) or 500 mg twice daily, gradually increase in increments of 500 mg/day (range: 500 mg to 2,000 mg/day in divided doses) (Ref); continue until delivery.

Primary biliary cholangitis

Primary biliary cholangitis (tablets): Oral: 13 to 15 mg/kg/day in 2 to 4 divided doses (with food). Note: May be given once daily (at bedtime) to improve compliance (Ref).

Primary sclerosing cholangitis

Primary sclerosing cholangitis (off-label use): Note: May be considered in patients who are not interested in clinical trial enrollment with persistently elevated alkaline phosphatase for at least 6 months prior to initiating therapy (Ref).

Oral: 13 to 23 mg/kg/day in 2 to 4 divided doses; continue as tolerated if there is a reduction or normalization in alkaline phosphatase and/or improvement in symptoms with 12 months of treatment (Ref).

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: No dosage adjustment necessary for any degree of kidney dysfunction (<1% excreted in urine (Ref)) (Ref).

Hemodialysis, intermittent (thrice weekly): Unlikely to be significantly dialyzed (mainly distributed in bile and small intestine (Ref)): No supplemental dose or dosage adjustment necessary (Ref).

Peritoneal dialysis: Unlikely to be significantly dialyzed (mainly distributed in bile and small intestine (Ref)): No dosage adjustment necessary (Ref).

CRRT: No dosage adjustment necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions (Significant): Considerations
Enteroliths

Ursodeoxycholic acid (UDCA) will precipitate from water at a pH of 8 to 8.1, and its glycine conjugated form will precipitate from water at a pH of 6.5 to 7.4 and 37ºC (98ºF), which may lead to crystalline formation within bile ducts (pH 6.5 to 8) or within the small intestine lumen (pH 6 to 8) (Ref). UDCA crystals are postulated to provide a base for enterolith/stone formation, and recurrent exposure allows additional precipitation and formation of the UDCA based enteroliths/stones (Ref). UDCA based enteroliths/stones can lead to obstruction, localized inflammation and infection and may recur with continued use of UDCA (Ref).

Mechanism: Unknown; likely related to the use of UDCA in the setting of conditions in which UDCA and its conjugated metabolites are exposed to an acidic environment, following liver first pass metabolism, for a prolonged period leading to precipitation of the conjugated metabolites or parent drug (Ref).

Onset: Delayed (ie, occurs after 30 days of drug therapy); case reports suggest may occur as early as 1 to 2 months after drug initiation or may take several months to years (Ref).

Risk factors:

• Recurrent biliary infection (eg, recurrent cholangitis) (Ref)

• History of gastrointestinal surgery with surgical anastomosis that allows for free communication between the gastrointestinal and biliary tracts (eg, choledochoduodenostomy, Roux-en-Y hepaticojejunostomy) (Ref)

• Impaired intestinal flow (bowel stasis) due to a blind loop or adhesions resulting as a complication of gastrointestinal surgery, especially in patients who undergo reoperation (Ref)

• Concomitant use of gastric acid suppression (eg, proton pump inhibitor) (Ref)

• Presence of intestinal stenosis (eg, proximal small intestine) associated with inflammatory bowel disease (Ref)

• Concomitant immunosuppression which may enhance bacterial overgrowth in the small intestine (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Gastrointestinal: Constipation (10% to 26%), diarrhea (1% to 27%), dyspepsia (3% to 17%), nausea (5% to 17%)

Nervous system: Dizziness (17%), headache (25%)

Neuromuscular & skeletal: Back pain (12%)

Respiratory: Upper respiratory tract infection (12% to 16%)

1% to 10%:

Dermatologic: Alopecia (5%), skin rash (3%)

Endocrine & metabolic: Increased serum glucose (1%)

Gastrointestinal: Cholecystitis (5%), peptic ulcer (1%), vomiting (10%)

Genitourinary: Urinary tract infection (7%)

Hematologic & oncologic: Leukopenia (3%), thrombocytopenia (1%)

Hypersensitivity: Hypersensitivity reaction (5%)

Neuromuscular & skeletal: Arthritis (6%), musculoskeletal pain (6%)

Renal: Increased serum creatinine (1%)

Respiratory: Bronchitis (7%), cough (7%), flu-like symptoms (7%), pharyngitis (8%)

<1%:

Gastrointestinal: Abdominal pain, anorexia, esophagitis

Nervous System: Asthenia

Postmarketing:

Cardiovascular: Peripheral edema

Dermatologic: Pruritus

Gastrointestinal: Abdominal distress, bezoar formation

Hepatic: Increased gamma-glutamyl transferase, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, increased serum bilirubin, jaundice

Hypersensitivity: Angioedema

Nervous system: Malaise

Neuromuscular and skeletal: Myalgia

Miscellaneous: Fever

Contraindications

Hypersensitivity to ursodiol or any component of the formulation (tablet); not to be used with calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones; patients with unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula; allergy to bile acids

Canadian labeling: Additional contraindications (not in US labeling): Complete biliary obstruction of extrahepatic origin; widespread intrahepatic obstruction

Warnings/Precautions

Concerns related to adverse effects:

• Biliary obstruction: Maintain bile flow during therapy to prevent biliary obstruction.

Disease-related concerns:

• Hepatic effects: Use with caution in patients with chronic liver disease. Monitor LFTs; consider discontinuing therapy in patients with significant elevations in LFTs.

Other warnings/precautions:

• Appropriate use: Gallbladder stone dissolution may take several months of therapy; complete dissolution may not occur and recurrence of stones within 5 years has been observed in up to 50% of patients. Patients should be cautiously selected for therapy, consider alternative treatments. Specific treatments should be initiated in patients with ascites, hepatic encephalopathy, variceal bleeding, or if an urgent liver transplant is necessary.

• Nonvisualizing gallbladder: Use with caution in patients with a nonvisualizing gallbladder; therapy should be discontinued if gallbladder nonvisualization occurs during treatment.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Actigall: 300 mg [DSC] [contains corn starch]

Reltone: 200 mg [contains corn starch]

Reltone: 400 mg [contains corn starch, fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]

Generic: 200 mg, 300 mg, 400 mg

Tablet, Oral:

Urso 250: 250 mg

Urso Forte: 500 mg [scored]

Generic: 250 mg, 500 mg

Generic Equivalent Available: US

Yes

Pricing: US

Capsules (Reltone Oral)

200 mg (per each): $23.94

400 mg (per each): $35.28

Capsules (Ursodiol Oral)

200 mg (per each): $50.00

300 mg (per each): $1.50 - $13.94

400 mg (per each): $70.00

Tablets (Urso 250 Oral)

250 mg (per each): $6.61

Tablets (Urso Forte Oral)

500 mg (per each): $11.71

Tablets (Ursodiol Oral)

250 mg (per each): $2.68

500 mg (per each): $4.75

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Urso: 250 mg [DSC]

Urso DS: 500 mg [DSC]

Generic: 250 mg, 500 mg

Extemporaneous Preparations

60 mg/mL Oral Suspension (ASHP Standard Concentration) (ASHP 2017)

A 60 mg/mL ursodiol oral suspension may be made with capsules. Empty the contents of twelve 300 mg capsules into a mortar. Add small portions of glycerin and mix to a uniform paste; mix while adding simple syrup in incremental proportions to almost 60 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 60 mL. Label "shake well" and "refrigerate". Stable for 35 days refrigerated (Johnson 1995).

Johnson CE, Nesbitt J. Stability of ursodiol in an extemporaneously compounded oral liquid. Am J Health Syst Pharm. 1995;52(16):1798-1800.8528836

20 mg/mL Oral Suspension

A 20 mg/mL ursodiol oral suspension may be made with capsules and either a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of methylcellulose 1% and syrup NF. Empty the contents of seventeen 300 mg capsules into a mortar. Add small portions of the chosen vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 255 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 255 mL. Label "shake well" and "refrigerate". Stable for 91 days refrigerated (Nahata 1999).

Nahata MC, Morosco RS, Hipple TF. Stability of ursodiol in two extemporaneously prepared oral suspensions. J Appl Ther Res. 1999;2:221-224.

25 mg/mL Oral Suspension

A 25 mg/mL ursodiol oral suspension may be made with capsules. Empty the contents of ten 300 mg capsules into a mortar; add 10 mL Glycerin, USP and mix until smooth. Mix while adding 60 mL Ora-Plus; transfer mixture to a light-resistant bottle, rinse mortar with a small amount of Orange Syrup, NF, and add quantity of syrup sufficient to make 120 mL. Label "shake well". Stable for 60 days at room temperature or refrigerated (Mallett 1997).

Mallett MS, Hagan RL, Peters DA. Stability of ursodiol 25 mg/mL in an extemporaneously prepared oral liquid. Am J Health Syst Pharm. 1997;54(12):1401-1404.9194984

50 mg/mL Oral Suspension

A 50 mg/mL ursodiol oral suspension may be made with tablets and 60 mL of either a 1:1 mixture of Ora-Plus and strawberry syrup or a 1:1 mixture of Ora-Plus and Ora-Sweet SF. Crush twelve 250 mg tablets in a mortar and reduce to a fine powder. Add small portions of the chosen vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 60 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 60 mL. Label "shake well" and "refrigerate". Stable for 90 days refrigerated (Johnson 2002).

Johnson CE, Streetman DD. Stability of oral suspensions of ursodiol made from tablets. Am J Health Syst Pharm. 2002;59(4):361-363.11885400
Administration: Pediatric

Oral: Do not administer with aluminum-based antacids or bile acid sequestrants. If aluminum-based antacids are needed, administer 2 hours after ursodiol; administer ursodiol 5 hours or more after bile acid sequestrants (Ref).

Tablets: Urso Forte can be split into halves for appropriate dosage; do not chew. Urso and Urso Forte should be administered with food.

Administration: Adult

Oral: Do not administer with aluminum-based antacids or bile acid sequestrants. If aluminum-based antacids are needed, administer 2 hours after ursodiol; some experts recommend administering ursodiol 1 hour prior to or 4 to 5 hours after bile acid sequestrants (Ref). Urso Forte can be split into halves for appropriate dosage; do not chew. Tablets should be taken with food.

Storage/Stability

Capsules: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Tablets:

Urso: Store at 20°C to 25°C (68°F to 77°F).

Urso Forte: Store at 20°C to 25°C (68°F to 77°F). When broken in half, scored Urso Forte 500 mg tablets maintain quality for up to 28 days when kept in current packaging and stored at 20°C to 25°C (68°F to 77°F). Split tablets should be stored separately from whole tablets due to bitter taste.

Use

Capsules: Gallbladder stone dissolution for patients with radiolucent, noncalcified gallbladder stones <20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk caused by systemic disease, advanced age, or idiosyncratic reaction to general anesthesia, or for patients who refuse surgery; prevention of gallstone formation in obese patients experiencing rapid weight loss (All indications: FDA approved in adults).

Tablets: Treatment of primary biliary cirrhosis (FDA approved in adults).

Has also been used to facilitate bile excretion in infants with biliary atresia, treat cholestasis secondary to parenteral nutrition (PN), aid fat absorption in cystic fibrosis-related liver disease, and prevent veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) following hematopoietic stem cell transplantation.

Medication Safety Issues
Sound-alike/look-alike issues:

Ursodiol may be confused with ulipristal

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aluminum Hydroxide: May decrease the serum concentration of Ursodiol. Management: Separate administration of ursodiol and aluminum-containing antacid products to prevent adsorption in the gastrointestinal tract. Risk D: Consider therapy modification

Bile Acid Sequestrants: May decrease the serum concentration of Ursodiol. Management: Administer ursodiol 1 hour before or at least 4 to 5 hours after bile acid sequestrants to minimize the potential for any significant interaction. Monitor for decreased therapeutic effects of ursodiol in patients receiving bile acid sequestrants. Risk D: Consider therapy modification

Estrogen Derivatives: May diminish the therapeutic effect of Ursodiol. Risk C: Monitor therapy

Nitrendipine: Ursodiol may decrease the absorption of Nitrendipine. Risk C: Monitor therapy

Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification

Dietary Considerations

Urso and Urso Forte should be taken with food.

Pregnancy Considerations

Ursodiol has been evaluated for treating intrahepatic cholestasis of pregnancy (ICP). Maternal symptoms (eg, itching, increased bile acid concentrations) generally occur during the second and third trimester. Fetal distress, preterm birth, and intrauterine death are also associated with ICP. Although some studies have shown a decrease in maternal symptoms (primarily itching) with ursodiol treatment, data is inconclusive regarding improvement of fetal/neonatal outcomes (ACG [Tran 2016]; Chappell 2019; Kong 2016; Ovadia 2021; Parízek 2016; Sepúlveda Marín 2016; Shen 2019; SMFM [Lee 2021]; Walker 2020; Zhang 2016).

The American College of Gastroenterology guideline for liver disease in pregnancy and the Society for Maternal-Fetal Medicine intrahepatic cholestasis of pregnancy consult series consider ursodiol a first-line therapy for the treatment of ICP during the second and third trimesters of pregnancy (ACG [Tran 2016]; SMFM [Lee 2021]).

Monitoring Parameters

Hepatic disease: Monitor liver function tests (GGT, AST, ALT, bilirubin, and alkaline phosphatase) monthly for the first 3 months and every 6 months thereafter or as clinically necessary.

Gallbladder disease: ALT, AST, sonogram.

Mechanism of Action

Ursodiol decreases the cholesterol content of bile and bile stones by reducing the secretion of cholesterol from the liver and the fractional reabsorption of cholesterol by the intestines. Mechanism of action in primary biliary cholangitis is not clearly defined. Ursodiol reduces hydrophobic bile acids; hydrophobic bile acids may be toxic to hepatic parenchymal cells in patients receiving hematopoietic stem cell transplantation (BCSH/BSBMT [Dignan 2013]; Ruutu 2002).

Pharmacokinetics (Adult Data Unless Noted)

Absorption: 90%

Protein binding: ~70%

Metabolism: Undergoes extensive enterohepatic recycling; following hepatic conjugation and biliary secretion, the drug is hydrolyzed to active ursodiol, where it is recycled or transformed to lithocholic acid by colonic microbial flora; during chronic administration, ursodiol becomes a major biliary and plasma bile acid constituting 30% to 50% of biliary and plasma bile acids

Excretion: Feces; urine (<1%)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Ursobil | Ursofalk | Ursosan;
  • (AR) Argentina: Dexo | Solutrat | Udca | Urdecole | Urigesic | Ursidesox | Ursodiol | Ursofalk | Ursomax | Ursotop | Urzac | Urzac Forte | Utral;
  • (AT) Austria: Ursofalk | Ursogrix;
  • (AU) Australia: Ursodeoxycholic acid apotex | Ursodox gh | Ursofalk | Ursosan;
  • (BD) Bangladesh: Antigall | Liconor | Liveric | Oxycol | Stener | Stonex | Udca | Udihep | Urso | Ursocol | Ursodex | Ursodil | Ursolic | Ursoren;
  • (BE) Belgium: Dozurso | Ursochol | Ursofalk;
  • (BG) Bulgaria: Choludexan | Ursofalk;
  • (BR) Brazil: Acido ursodesoxicolico | Duxio | Gulshen | Ursacol;
  • (CH) Switzerland: De-ursil | De-ursil rr | Ursochol | Ursodiol rr zentiva | Ursodiol zentiva | Ursofalk;
  • (CI) Côte d'Ivoire: Cholurso | Urlyx;
  • (CL) Chile: Solvobil | Ursofalk;
  • (CN) China: Ursodeoxycholic ac | Ursofalk;
  • (CO) Colombia: Litomen | Ursacol | Ursofalk | Ursox;
  • (CZ) Czech Republic: Ursofalk | Ursogrix | Ursonorm | Ursosan | Ursosan forte;
  • (DE) Germany: Cholacid | Cholofalk | Udc | Urso | Urso 1a pharma | Urso heumann | Ursochol | Ursofalk | Ursonorm;
  • (DO) Dominican Republic: UDCA Ferring | Ursacol | Ursofalk;
  • (EC) Ecuador: Ursocel | Ursofalk;
  • (EE) Estonia: Ursogrix;
  • (EG) Egypt: Biliver | Egyurso | Exosirylic | Galldepedra | Livagoal | Udexpan | Ursochol | Ursocholic | Ursodiol | Ursodol | Ursofalk | Ursogall | Ursosernox | Ursotwin;
  • (ES) Spain: Adisocol | Bilifalk | Ursobilane | Ursochol | Ursolite;
  • (ET) Ethiopia: Ursoliv;
  • (FI) Finland: Adursal | Ursochol;
  • (FR) France: Acide ursodesoxycholique arrow | Acide ursodesoxycholique biogaran | Acide ursodesoxycholique mylan | Acide ursodesoxycholique teva | Arsacol | Cholurso | Delursan | Dozurso | Tillhepo | Ursolvan;
  • (GB) United Kingdom: Cholurso | Destolit | Urdox | Ursodeoxychol | Ursodeoxychol acid | Ursofalk | Ursogal;
  • (GR) Greece: Ursofalk;
  • (HK) Hong Kong: Pms-ursodiol C | Uldeso | Ursodex | Ursofalk | Ursolvan | Ursosan;
  • (HR) Croatia: Ursofalk;
  • (HU) Hungary: Ursofalk;
  • (ID) Indonesia: Estazor | Lofibra | Pramur | Urdafalk | Urdahex | Urdex | Ursochol | Ursolic;
  • (IE) Ireland: Destolit | Ursodeoxycholic acid strides | Ursofalk;
  • (IL) Israel: Ursolit;
  • (IN) India: Actibile | Aliveon | Analiv Ud | Bilefix | Cholidol | Estuchol | Fortibile | Gb liv | Gemiuro | Golbi | Hepakind | Hepexa | Levalon | Livanza | Livokind | Livolysin | Livopill ud | Movebile | Open up | Otraliv | Sedogest | Shinoliv | Solubid | Sorbidiol | U.d.c.a. | Uclick | Uda | Udc | Udchamp | Udcoliv | Udcros | Udebile | Udgrace | Udichol | Udigold | Udigrand | Udihep | Udilink | Udiliv | Udimorr | Udiron | Udivor | Udoxyl | Udxic | Ulyses | Urdiogem | Urdohep | Uricure | Urijon | Urosec | Urs | Ursetor | Ursobiac | Ursocol | Ursodil | Ursodin | Ursodox | Ursodox sr | Ursofalk gr | Ursoford | Ursokem | Ursol | Ursolic | Ursolid | Ursomax | Ursonem | Ursopro | Ursowin | Usibon | Xdator;
  • (IT) Italy: Ac ursod | Ac ursod eg | Biliepar | Coledos | Desocol | Desoxil | Deursil | Deursil rr | Dissolursil | Dozurso | Fraurs | Lentorsil | Litoff | Litursol | Urdes | Ursacol | Ursilon | Ursobil | Ursobil ht | Ursodamor | Ursodiol | Ursofalk | Ursoflor | Ursolac | Ursolisin | Urson;
  • (JO) Jordan: Ursa | Ursofalk;
  • (JP) Japan: Buraue | Chymotamine | Gokumisin | Precoat | Reptor | Rusorol | Shikichol | Ubiron | Urdenacin | Urdeston | Urdex | Ursamic | Urso mitsubishi;
  • (KE) Kenya: Udihep | Udihep forte | Ursocol | Ursoliv;
  • (KR) Korea, Republic of: Ciraedan | Daewoongbio ursodeoxycholic acid | Ganeu | Ganmoru | Liverstal | Sulgidam Freshmint | Sulgidam rose | Udca | Udese | Udici | Ugimax | Urchol | Uro | Ursa | Ursofalk | Urucom | Uruliver | Urusa | Usosan | Wookiton;
  • (KW) Kuwait: Ursofalk;
  • (LB) Lebanon: Ursobil | Ursofalk;
  • (LT) Lithuania: Ursofalk | Ursogrix | Ursosan;
  • (LU) Luxembourg: Ursochol | Ursofalk;
  • (LV) Latvia: Ursofalk | Ursogrix | Ursosan;
  • (MX) Mexico: Acido ursodeoxicolico | Coric | Durcox | Kyselin | Nilamsel | Prestalix au | T ruxico | Tripsix | Udca | Urlodil | Ursofalk | Xifhac;
  • (MY) Malaysia: Ursofalk;
  • (NL) Netherlands: Grinterol | Udca | Ursochol | Ursodeoxycholzuur | Ursodeoxycholzuur glenmark | Ursodeoxycholzuur Imphos | Ursodeoxycholzuur Sandoz | Ursodeoxycholzuur strides | Ursofalk | Ursonorm;
  • (NO) Norway: Destolit | Ursochol | Ursodeoxycholic acid orion | Ursofalk;
  • (NZ) New Zealand: Actigall | Ursofalk | Ursosan;
  • (PE) Peru: Clotipide | Coleretik | Urdecole | Ursobil | Ursocel | Ursofalk | Ursoflow;
  • (PH) Philippines: Actibile | Ambisol | Axialith | Choledeo | Destone | Lupibile | Udcacid | Urlyx | Urodil | Ursa | Ursential | Ursodox | Ursofalk | Ursolin | Ursoliv | Ursomax | Ursotrol | Ursula | Usosan;
  • (PK) Pakistan: Bilcid | Biledox | Bilex | Bilex forte | Calculix | Cholistone | Galbil | Triptor | Udca | Urolic | Urso | Ursochole | Ursodil | Ursodol | Ursofalk | Ursohep | Ursolic | Ursomax | Ursoton | Ursowin;
  • (PL) Poland: Biliepar | Proursan | Ursocam | Ursofalk | Ursopol | Ursoxyn;
  • (PR) Puerto Rico: Actigall | Reltone | Urso | Urso forte | Ursodiol;
  • (PT) Portugal: Destolit | Ursofalk;
  • (PY) Paraguay: Dexo | Solutrat;
  • (QA) Qatar: Ursofalk;
  • (RO) Romania: Ursochol | Ursofalk | Ursorom | Ursosan;
  • (RU) Russian Federation: Choludexan | Ekurokhol | Exhol | Grinterol | Livodexa | Protecholin | Urbihol | Urcevel | Urdoxa | Ursodeoxychol acid | Ursodex | Ursodez | Ursodiolisin | Ursofalk | Ursolit | Ursoliv | Ursomax | Ursomic | Ursorom C | Ursorom rompharm | Ursosan | Ursosan forte;
  • (SA) Saudi Arabia: Pms-ursodiol C | Urdox | Ursodiol | Ursofalk;
  • (SE) Sweden: Ursochol | Ursodeoxycholic acid orion | Ursofalk | Ursogrix | Ursosan;
  • (SG) Singapore: Ursofalk | Ursolvan;
  • (SI) Slovenia: Ursofalk | Ursosan;
  • (SK) Slovakia: Ursofalk | Ursogrix | Ursomed | Ursosan;
  • (TH) Thailand: Cholemax | Udihep | Ursa | Urso | Ursode | Ursofalk | Ursolin;
  • (TN) Tunisia: Ursobilane | Ursolvan;
  • (TR) Turkey: Deoxykol | Proursan | Safrax | Ursabay | Ursactive | Ursodin | Ursofalk | Ursomed | Ursovef;
  • (TW) Taiwan: Biliepar | Cisbile | Genurso | Gokumisin | Legan | Ligat | Lipo | Sodan | Uliden | Uliso | Urose | Uroso | Urso | Ursocid | Ursodesoxycholic acid | Ursol | Ursolic | Usol;
  • (UA) Ukraine: Choludexan | Grinterol | Ukrliv | Ursochol | Ursodiol | Ursofalk | Ursolisin | Ursonost | Ursosan | Ursosan forte;
  • (UG) Uganda: Udihep | Udihep forte | Ursoliv;
  • (UY) Uruguay: Ursocel | Ursodiol | Ursofalk;
  • (VE) Venezuela, Bolivarian Republic of: Ursobilane;
  • (VN) Viet Nam: Asopus | Prohepatis | Tatridat | Urdoc | Uruso;
  • (ZA) South Africa: Ursofalk | Ursotan
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