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Ursodeoxycholic acid (ursodiol): Drug information

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

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Reltone;
  • Urso 250 [DSC];
  • Urso Forte
Brand Names: Canada
  • AG-Ursodiol;
  • GLN-Ursodiol;
  • JAMP-Ursodiol;
  • NRA-Ursodiol;
  • PMS-Ursodiol;
  • PMS-Ursodiol C;
  • Urso DS [DSC];
  • Urso [DSC]
Pharmacologic Category
  • Gallstone Dissolution Agent
Dosing: Adult
Gallstone dissolution

Gallstone dissolution (capsules): Note: For use in symptomatic patients who are unable or unwilling to undergo cholecystectomy; most effective in individuals with small (eg, ≤10 mm), noncalcified gallstones (Ref).

Oral: Initial: 10 mg/kg/day in 2 to 3 divided doses, with last dose administered at bedtime (Ref); for larger stones (eg, >20 mm), may use up to 15 mg/kg/day (Ref). Duration of therapy depends on dissolution rate as detected on ultrasound; continue therapy for at least 6 months beyond radiographic evidence of dissolution (Ref); long-term therapy may be beneficial in patients with early recurrent stones or those in which surgical intervention is not feasible (Ref). Note: Bedtime administration is important to reduce supersaturated bile and improve small stone dissolution rate (Ref)

Gallstone due to rapid weight loss, prevention

Gallstone due to rapid weight loss, prevention (capsules): Oral: 600 mg/day in 1 or 2 divided doses for 6 months post bariatric surgery or during diet-induced weight loss (eg, >1.5 kg per week) (Ref).

Genetic cholestatic liver disease with pruritus

Genetic cholestatic liver disease with pruritus (off-label use): Note: Genetic cholestatic liver disease includes Alagille syndrome and progressive familial intrahepatic cholestasis (Ref).

Oral: 10 to 20 mg/kg/day in two divided doses; maximum dose 600 mg/day (Ref).

Hepatic sinusoidal obstruction syndrome associated with stem cell transplant, prevention

Hepatic sinusoidal obstruction syndrome associated with stem cell transplant, prevention (capsules) (off-label use): Oral: 12 mg/kg/day or 600 mg/day in 2 divided doses beginning 1 day before the conditioning regimen and continuing for 90 days after transplantation (Ref). Note: If mucositis or nausea interrupt therapy, restart when able to take oral therapies (Ref). Refer to institutional protocols for further information.

Intrahepatic cholestasis of pregnancy

Intrahepatic cholestasis of pregnancy (off-label use): Oral: Initial: 300 mg 2 to 3 times per day or 10 to 15 mg/kg/day in 2 or 3 divided doses; continue until delivery. Improvement in pruritus and liver biochemistries may take ≥10 days; after 2 weeks, dose may be titrated weekly in 300 mg/day increments depending on tolerance and desired clinical endpoint; typical daily dose range is 8 to 21 mg/kg/day (maximum dose: 21 mg/kg/day) (Ref).

Primary biliary cholangitis

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

Recurrence after liver transplantation: (tablets): Oral: 10 to 15 mg/kg/day in 2 divided doses. Note: Initiate within 2 weeks of transplant or when recurrence is suspected; use in combination with appropriate immunosuppressive regimen (Ref).

Primary sclerosing cholangitis

Primary sclerosing cholangitis (off-label use): Note: Despite uncertain benefit, may consider use in patients with persistently elevated (≥6 months) alkaline phosphatase (Ref).

Oral: Initial: 13 to 23 mg/kg/day in 2 to 4 divided doses; may continue if there is a meaningful reduction or normalization in alkaline phosphatase and/or improvement in symptoms within 12 months of treatment (Ref). Note: Some experts do not exceed 20 mg/kg/day secondary to concerns for a higher rate of liver-related complications (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: Liver Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

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

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: Liver Impairment: Pediatric

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:

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 [DSC]

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): $52.00

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

400 mg (per each): $72.80

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

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.

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.

Use: Labeled Indications

Gallstone dissolution (capsules only): Treatment of 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, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety for use of ursodiol beyond 24 months is not established.

Gallstone due to rapid weight loss, prevention (capsules only): Prevention of gallstone formation in obese patients experiencing rapid weight loss.

Primary biliary cholangitis (tablets only): Treatment of patients with primary biliary cholangitis (PBC) (previously referred to as primary biliary cirrhosis).

Use: Off-Label: Adult

Genetic cholestatic liver disease with pruritus; Hepatic sinusoidal obstruction syndrome associated with stem cell transplant, prevention; Intrahepatic cholestasis of pregnancy; Primary sclerosing cholangitis

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

Aluminum Hydroxide: May decrease 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 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

Elobixibat: May decrease absorption of Ursodiol. Risk C: Monitor

Estrogen Derivatives: May decrease therapeutic effects of Ursodiol. Risk C: Monitor

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

Sincalide: Drugs that Affect Gallbladder Function may decrease therapeutic effects 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

Pregnancy Considerations

Outcome data from individual studies and meta-analyses following maternal use of ursodiol for the treatment of intrahepatic cholestasis of pregnancy (ICP) are available (Chappell 2019; Iqbal 2024, Kong 2016; Ovadia 2021; Parízek 2016; Roy 2021; Sepúlveda Marín 2016; Shen 2019; Walker 2020; Zhang 2016). Adverse fetal events have not been observed (SMFM [Lee 2021]).

ICP is associated with adverse maternal effects, including increased bile acid and/or transaminase levels and pruritus without skin rash, which generally occur during the second and third trimester. Increased bile acid levels in patients with ICP are associated with adverse fetal outcomes, including fetal distress, preterm birth, and intrauterine death. Ursodiol improves maternal outcomes. Available data are inconclusive regarding improvement of fetal/neonatal outcomes (Hagenbeck 2021; SMFM [Lee 2021]; SOGC [Hobson 2024]).

Ursodiol is recommended for the treatment of ICP during the second and third trimesters of pregnancy (ACG [Tran 2016]; AGA [Kothari 2024]; SMFM [Lee 2021]; SOGC [Hobson 2024]).

Breastfeeding Considerations

Bile acids, including ursodeoxycholic acid (UDCA, ursodiol) are present in breast milk. Concentrations of UDCA may increase in lactating patients treated with ursodiol (Brites 1998; Šimják 2022).

Total bile acid concentrations are increased in the colostrum of patients with intrahepatic cholestasis of pregnancy (ICP). A study evaluated breast milk collected within 72 hours postpartum in patients treated with ursodiol for ICP during pregnancy. Ursodiol treatment for ICP until delivery decreased the concentrations of total bile acid in the colostrum of 7 women compared to nontreated patients. Ursodeoxycholic acid concentrations were insignificantly elevated in the colostrum and were lower than the maternal serum (Brites 1998). A second study evaluated bile acid concentrations of breast milk in lactating patients treated with ursodiol for IPC (n=15), primary biliary cholangitis (PBC; n=4), or HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count, n=1). Patients were treated with recommended doses of ursodiol at least until postpartum day 3 when maternal serum and breast milk were sampled. When compared to untreated lactating women (n=4), the total bile acid content in breast milk was not significantly different. Authors of this study estimated the total amount of bile acids a breastfed infant would ingest via breast milk would be 126 mcg/day from both ursodiol treated and controls mothers. The proportion of UDCA in breast milk was increased in ursodiol treated mothers (27 mcg) compared to controls (1.9 mcg); however, this represented only 0.0005% of the newborn total bile acid pool (Šimják 2022)

Based on limited case reports, adverse events have not been observed in breastfed infants (Brites 1998; Erol-Coskun 2018; Šimják 2022; Vítek 2010).

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Dietary Considerations

Urso and Urso Forte should be taken with food.

Monitoring Parameters

Gallstone disease: ALT, AST, ultrasound every 6 months for the first year.

Intrahepatic cholestasis of pregnancy: Serum bile acid and liver transaminase prior to therapy (SMFM [Lee 2021]). May repeat every 2 to 4 weeks to evaluate disease progression (SOGC [Hobson 2024]).

Primary biliary cholangitis: Monitor liver chemistries (GGT, AST, ALT, bilirubin, and alkaline phosphatase) monthly for the first 3 months and every 6 months thereafter or as clinically necessary (90% of the improvement usually occurs within 6 to 9 months) (AASLD [Lindor 2019]); baseline vitamin D level (Guo 2015); signs of obstructive GI symptoms.

Primary sclerosing cholangitis: Baseline liver chemistries (bilirubin, ALP, AST, platelets, and PT); repeat at 12 months (or every 6 months in high-risk patients) and as clinically indicated (EASL 2022).

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: 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 | Surliv | Udca | Udihep | Urso | Ursocol | Ursodex | Ursodil | Ursohil | Ursolic | Ursoren | Ursotab;
  • (BE) Belgium: Dozurso | Ursochol | Ursofalk | Ursogrix;
  • (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 | Xuan nuo xin;
  • (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: Clotipide | Urotan | Ursa | 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;
  • (GT) Guatemala: Ursotec forte;
  • (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 | Bileoxy | Bilocid | Cholidol | Estuchol | Fortibile | Gb liv | Gemiuro | Golbi | Hepakind | Hepexa | Levalon | Livanza | Livokind | Livolysin | Livopill ud | Movebile | Open up | Otraliv | Sedogest | Shinoliv | Solubid | Sorbidiol | Sutab | U.d.c.a. | Uclick | Uda | Udc | Udchamp | Udcoliv | Udcros | Udebile | Udgrace | Udicare | Udichol | Udigold | Udigrand | Udihep | Udilink | Udiliv | Udimorr | Udiron | Udivor | Udiwok | Udoxyl | Udxic | Ulyses | Urdiogem | Urdohep | Uricure | Urijon | Urosec | Urs | Ursetor | Ursobiac | Ursocol | Ursodil | Ursodin | Ursodox | Ursodox sr | Ursofalk gr | Ursoford | Ursokem | Ursol | Ursolic | Ursolid | Ursolon | Ursomax | Ursomind | Ursonem | Ursopack | Ursopro | Ursosave | Ursotreat | 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 | Udecol | Udese | Udici | Ugimax | Urchol | Urliver | Uro | Ursa | Ursofalk | Urucom | 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 | Ursofalk t | Xifhac;
  • (MY) Malaysia: Ursofalk | Ursosan;
  • (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: PMS-Ursodiol C | Ursactive | 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 | Ursomax | Ursonost | Ursosan | Ursosan forte;
  • (UG) Uganda: Udihep | Udihep forte | Ursoliv;
  • (UY) Uruguay: Ursocel | Ursodiol | Ursofalk;
  • (VE) Venezuela, Bolivarian Republic of: Acido ursodesoxicolico | Ursobilane;
  • (VN) Viet Nam: Asopus | Beenenit | Cuellar | Maxxhepa urso | Prohepatis | Tatridat | Urdoc | Ursopa | Uruso | Urxyl | Zuiver;
  • (ZA) South Africa: Ursofalk | Ursotan
  1. Actigall (ursodiol) [prescribing information]. Parsippany, NJ: Teva Pharmaceuticals; July 2023.
  2. AG-Ursodiol (ursodiol) tablets [product monograph]. Boucherville, Quebec, Canada: Angita Pharma Inc; September 2023.
  3. Akiyama S, Imamura T, Tamura T, et al. Recurrent common bile duct stones composed of ursodeoxycholic acid: a report of four cases. Intern Med. 2014;53(21):2489-2492. doi:10.2169/internalmedicine.53.2886 [PubMed 25366008]
  4. Al Jefri AH, Abujazar H, Al-Ahmari A, et al. Veno-occlusive disease/sinusoidal obstruction syndrome after haematopoietic stem cell transplantation: Middle East/North Africa regional consensus on prevention, diagnosis and management. Bone Marrow Transplant. 2017;52(4):588-591. doi:10.1038/bmt.2016.300 [PubMed 27892944]
  5. Al Mamari S, Djordjevic J, Halliday JS, Chapman RW. Improvement of serum alkaline phosphatase to <1.5 upper limit of normal predicts better outcome and reduced risk of cholangiocarcinoma in primary sclerosing cholangitis. J Hepatol. 2013;58(2):329-334. doi:10.1016/j.jhep.2012.10.013 [PubMed 23085647]
  6. Angulo P, Dickson ER, Therneau TM, et al. Comparison of three doses of ursodeoxycholic acid in the treatment of primary biliary cirrhosis: a randomized trial. J Hepatol. 1999;30(5):830-835. doi:10.1016/s0168-8278(99)80136-6 [PubMed 10365809]
  7. Arslanoglu S, Moro GE, Tauschel HD, Boehm G. Ursodeoxycholic acid treatment in preterm infants: a pilot study for the prevention of cholestasis associated with total parenteral nutrition. J Pediatr Gastroenterol Nutr. 2008;46(2):228-231. [PubMed 18223390]
  8. ASHP. Standardize 4 Safety Initiative Compounded Oral Liquid Version 1.01. July 2017. https://www.ashp.org/-/media/assets/pharmacy-practice/s4s/docs/s4s-ashp-oral-compound-liquids.ashx?la=en&hash=4C2E4F370B665C028981B61F6210335AD5D0D1D6.
  9. Beuers U, Spengler U, Kruis W, et al. Ursodeoxycholic acid for treatment of primary sclerosing cholangitis: a placebo-controlled trial. Hepatology. 1992;16(3):707-714. doi:10.1002/hep.1840160315 [PubMed 1505913]
  10. Bianchi L, Reichen J. A 20-year-old woman with portal hypertension and a cholestatic syndrome. Hepatology. 1994;20(2):515-522. [PubMed 8045511]
  11. Bonifazi F, Sica S, Angeletti A, et al. Veno-occlusive disease in HSCT patients: consensus-based recommendations for risk assessment, diagnosis, and management by the GITMO group. Transplantation. 2021;105(4):686-694. doi:10.1097/TP.0000000000003569 [PubMed 33273315]
  12. Bosch A, Dumortier J, Maucort-Boulch D, et al. Preventive administration of UDCA after liver transplantation for primary biliary cirrhosis is associated with a lower risk of disease recurrence. J Hepatol. 2015;63(6):1449-1458. doi:10.1016/j.jhep.2015.07.038 [PubMed 26282232]
  13. Bowlus CL, Arrivé L, Bergquist A, et al. AASLD practice guidance on primary sclerosing cholangitis and cholangiocarcinoma. Hepatology. 2023;77(2):659-702. doi:10.1002/hep.32771 [PubMed 36083140]
  14. Brites D, Rodrigues CM. Elevated levels of bile acids in colostrum of patients with cholestasis of pregnancy are decreased following ursodeoxycholic acid therapy [see comments]. J Hepatol. 1998;29(5):743-751. doi:10.1016/s0168-8278(98)80255-9 [PubMed 9833912]
  15. Chappell LC, Bell JL, Smith A, et al; PITCHES study group. Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial. Lancet. 2019;394(10201):849-860. doi:10.1016/S0140-6736(19)31270-X [PubMed 31378395]
  16. Charatcharoenwitthaya P, Pimentel S, Talwalkar JA, et al. Long-term survival and impact of ursodeoxycholic acid treatment for recurrent primary biliary cirrhosis after liver transplantation. Liver Transpl. 2007;13(9):1236-1245. doi:10.1002/lt.21124 [PubMed 17763401]
  17. Chen CY, Tsao PN, Chen HL, Chou HC, Hsieh WS, Chang MH. Ursodeoxycholic acid (UDCA) therapy in very-low-birth-weight infants with parenteral nutrition-associated cholestasis. J Pediatr. 2004;145(3):317-321. [PubMed 15343182]
  18. Cheuk DK, Chiang AK, Ha SY, et al. Interventions for prophylaxis of hepatic veno-occlusive disease in people undergoing haematopoietic stem cell transplantation. Cochrane Database Syst Rev. 2015;(5):CD009311. doi:10.1002/14651858.CD009311.pub2 [PubMed 26017019]
  19. Colombo C, Setchell KD, Podda M, et al. Effects of ursodeoxycholic acid therapy for liver disease associated with cystic fibrosis. J Pediatr. 1990;117(3):482-489. [PubMed 2391610]
  20. Corpechot C, Chazouillères O, Belnou P, et al; Global PBC Study Group. Long-term impact of preventive UDCA therapy after transplantation for primary biliary cholangitis. J Hepatol. 2020;73(3):559-565. doi:10.1016/j.jhep.2020.03.043 [PubMed 32275981]
  21. Debray D, Kelly D, Houwen R, Strandvik B, Colombo C. Best practice guidance for the diagnosis and management of cystic fibrosis-associated liver disease. J Cyst Fibros. 2011;10 Suppl 2:S29-36. [PubMed 21658639]
  22. De Marco G, Sordino D, Bruzzese E, et al. Early treatment with ursodeoxycholic acid for cholestasis in children on parenteral nutrition because of primary intestinal failure. Aliment Pharmacol Ther. 2006;24(2):387-394. [PubMed 16842466]
  23. Deng BC, Lv S, Cui W, et al. Novel ATP8B1 mutation in an adult male with progressive familial intrahepatic cholestasis. World J Gastroenterol. 2012;18(44):6504-6509. doi:10.3748/wjg.v18.i44.6504 [PubMed 23197899]
  24. Di Ciaula A, Wang DQ, Wang HH, Bonfrate L, Portincasa P. Targets for current pharmacologic therapy in cholesterol gallstone disease. Gastroenterol Clin North Am. 2010;39(2):245-264, viii-ix. doi:10.1016/j.gtc.2010.02.005 [PubMed 20478485]
  25. Dignan FL, Wynn RF, Hadzic N, et al; Haemato-oncology Task Force of British Committee for Standards in Haematology; British Society for Blood and Marrow Transplantation. BCSH/BSBMT guideline: diagnosis and management of veno-occlusive disease (sinusoidal obstruction syndrome) following haematopoietic stem cell transplantation. Br J Haematol. 2013;163(4):444-457. doi:10.1111/bjh.12558 [PubMed 24102514]
  26. Dinler G, Kocak N, Yuce A, Gurakan F, Ozen H. Ursodeoxycholic acid therapy in children with cholestatic liver disease. Turk J Pediatr. 1999;41(1):91-98. [PubMed 10770681]
  27. Erol-Coskun H, Karagur N, Akyol F et al. Ursodiol use during breastfeeding: a case report. Reprod Toxicol. 2018;80:59. Abstract. doi:10.1016/j.reprotox.2018.07.070
  28. Essell JH, Schroeder MT, Harman GS, et al. Ursodiol prophylaxis against hepatic complications of allogeneic bone marrow transplantation. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1998;128(12 Pt 1):975-981. doi:10.7326/0003-4819-128-12_part_1-199806150-00002 [PubMed 9625683]
  29. European Association for the Study of the Liver (EASL). EASL clinical practice guidelines on genetic cholestatic liver diseases. J Hepatol. 2024;81(2):303-325. doi:10.1016/j.jhep.2024.04.006 [PubMed 38851996]
  30. European Association for the Study of the Liver (EASL). EASL clinical practice guidelines on sclerosing cholangitis. J Hepatol. 2022;77(3):761-806. doi:10.1016/j.jhep.2022.05.011 [PubMed 35738507]
  31. Expert opinion. Senior Renal Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
  32. Faraci M, Bertaina A, Luksch R, et al. Sinusoidal obstruction syndrome/veno-occlusive disease after autologous or allogeneic hematopoietic stem cell transplantation in children: a retrospective study of the Italian Hematology-Oncology Association-Hematopoietic Stem Cell Transplantation Group. Biol Blood Marrow Transplant. 2019;25(2):313-320. doi:10.1016/j.bbmt.2018.09.027 [PubMed 30266674]
  33. Fearon NM, Kearns EC, Kennedy CA, Conneely JB, Heneghan HM. The impact of ursodeoxycholic acid on gallstone disease after bariatric surgery: a meta-analysis of randomized control trials. Surg Obes Relat Dis. 2022;18(1):77-84. doi:10.1016/j.soard.2021.10.004 [PubMed 34772614]
  34. Geenes V, Lövgren-Sandblom A, Benthin L, et al. The reversed feto-maternal bile acid gradient in intrahepatic cholestasis of pregnancy is corrected by ursodeoxycholic acid. PLoS One. 2014;9(1):e83828. doi:10.1371/journal.pone.0083828 [PubMed 24421907]
  35. Gokmen T, Oguz SS, Bozdag S, Erdeve O, Uras N, Dilmen U. A controlled trial of erythromycin and UDCA in premature infants during parenteral nutrition in minimizing feeding intolerance and liver function abnormalities. J Perinatol. 2012;32(2):123-128. [PubMed 21566568]
  36. Guarino MP, Cocca S, Altomare A, Emerenziani S, Cicala M. Ursodeoxycholic acid therapy in gallbladder disease, a story not yet completed. World J Gastroenterol. 2013;19(31):5029-5034. doi:10.3748/wjg.v19.i31.5029 [PubMed 23964136]
  37. Guerra I, Bujanda L, Castro J, et al; Spanish GETECCU group (ENEIDA Project). Clinical characteristics, associated malignancies and management of primary sclerosing cholangitis in inflammatory bowel disease patients: a multicentre retrospective cohort study. J Crohns Colitis. 2019;13(12):1492-1500. doi:10.1093/ecco-jcc/jjz094 [PubMed 31063540]
  38. Guo GY, Shi YQ, Wang L, et al. Serum vitamin D level is associated with disease severity and response to ursodeoxycholic acid in primary biliary cirrhosis. Aliment Pharmacol Ther. 2015;42(2):221-30. doi: 10.1111/apt.13244 [PubMed 25982180]
  39. Guy JE, Qian P, Lowell JA, Peters MG. Recurrent primary biliary cirrhosis: peritransplant factors and ursodeoxycholic acid treatment post-liver transplant. Liver Transpl. 2005;11(10):1252-12527. doi:10.1002/lt.20511 [PubMed 16184542]
  40. Hagenbeck C, Hamza A, Kehl S, et al. Management of intrahepatic cholestasis of pregnancy: recommendations of the Working Group on Obstetrics and Prenatal Medicine - section on maternal disorders. Geburtshilfe Frauenheilkd. 2021;81(8):922-939. doi:10.1055/a-1386-392 [PubMed 34393256]
  41. Hassan H, Balistreri WF. Neonatal cholestasis. In: Kliegman RM, Geme JS, eds. Nelson Textbook of Pediatrics. 21st ed. Philadelphia, PA: Saunders Elsevier; 2020:chap 383.
  42. Hobson SR, Cohen ER, Gandhi S, et al. Guideline no. 452: diagnosis and management of intrahepatic cholestasis of pregnancy. J Obstet Gynaecol Can. 2024;46(8):102618. doi:10.1016/j.jogc.2024.102618 [PubMed 39089469]
  43. Hofmann AF, Mysels KJ. Bile acid solubility and precipitation in vitro and in vivo: the role of conjugation, pH, and Ca2+ ions. J Lipid Res. 1992;33(5):617-626. [PubMed 1619357]
  44. Iqbal M, Muhammad Z, Akhter N, Shams Alam S. Effects of ursodeoxycholic acid treatment for intrahepatic cholestasis of pregnancy on maternal and fetal outcomes. Cureus. 2024;16(10):e70800. doi:10.7759/cureus.70800 [PubMed 39493201]
  45. Jazrawi RP, Pigozzi MG, Galatola G, Lanzini A, Northfield TC. Optimum bile acid treatment for rapid gall stone dissolution. Gut. 1992;33(3):381-386. doi:10.1136/gut.33.3.381 [PubMed 1568660]
  46. Johnson CE, Nesbitt J. Stability of ursodiol in an extemporaneously compounded oral liquid. Am J Health Syst Pharm. 1995;52(16):1798-1800. [PubMed 8528836]
  47. Kappler M, Espach C, Schweiger-Kabesch A, et al. Ursodeoxycholic acid therapy in cystic fibrosis liver disease--a retrospective long-term follow-up case-control study. Aliment Pharmacol Ther. 2012;36(3):266-273. doi:10.1111/j.1365-2036.2012.05177.x [PubMed 22670841]
  48. Kelly DA, Davenport M. Current management of biliary atresia. Arch Dis Child. 2007;92(12):1132-1135. [PubMed 17878208]
  49. Kermansaravi M, Shikora S, Dillemans B, et al; MOGIPSO Collaborators. The management of biliary disease in patients with severe obesity undergoing metabolic and bariatric surgery-an international expert survey. Obes Surg. 2024;34(4):1086-1096. doi:10.1007/s11695-024-07101-y [PubMed 38400945]
  50. Kim J, Yang B, Paik N, Choe YH, Paik YH. A case of Alagille syndrome presenting with chronic cholestasis in an adult. Clin Mol Hepatol. 2017;23(3):260-264. doi:10.3350/cmh.2016.0057 [PubMed 28683534]
  51. Kohut TJ. Alagille syndrome. Connor RF, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 30, 2024.
  52. Kondrackiene J, Beuers U, Kupcinskas L. Efficacy and safety of ursodeoxycholic acid versus cholestyramine in intrahepatic cholestasis of pregnancy. Gastroenterology. 2005;129(3):894-901. doi:10.1053/j.gastro.2005.06.019 [PubMed 16143129]
  53. Kong X, Kong Y, Zhang F, Wang T, Yan J. Evaluating the effectiveness and safety of ursodeoxycholic acid in treatment of intrahepatic cholestasis of pregnancy: A meta-analysis (a prisma-compliant study) [published correction appears in Medicine (Baltimore). 2017;96(3):e6031]. Medicine (Baltimore). 2016;95(40):e4949. doi:10.1097/MD.0000000000004949 [PubMed 27749550]
  54. Kothari S, Afshar Y, Friedman LS, Ahn J. AGA clinical practice update on pregnancy-related gastrointestinal and liver disease: expert review. Gastroenterology. 2024;167(5):1033-1045. doi:10.1053/j.gastro.2024.06.014 [PubMed 39140906]
  55. Kremer AE, Oude Elferink RP, Beuers U. Pathophysiology and current management of pruritus in liver disease. Clin Res Hepatol Gastroenterol. 2011;35(2):89-97. [PubMed 21809485]
  56. Lanzini A, Facchinetti D, Northfield TC. Maintenance of hepatic bile acid secretion rate during overnight fasting by bedtime bile acid administration. Gastroenterology. 1988;95(4):1029-1035. doi:10.1016/0016-5085(88)90179-5 [PubMed 3410216]
  57. Lee RH, Greenberg M, Metz TD, Pettker CM; Society for Maternal-Fetal Medicine (SMFM). Society for Maternal-Fetal Medicine consult series #53: intrahepatic cholestasis of pregnancy: replaces consult #13, April 2011. Am J Obstet Gynecol. 2021;224(2):B2-B9. doi:10.1016/j.ajog.2020.11.002 [PubMed 33197417]
  58. Lepage G, Paradis K, Lacaille F, et al. Ursodeoxycholic acid improves the hepatic metabolism of essential fatty acids and retinol in children with cystic fibrosis. J Pediatr. 1997;130(1):52-58. [PubMed 9003851]
  59. Levine A, Maayan A, Shamir R, Dinari G, Sulkes J, Sirotta L. Parenteral nutrition-associated cholestasis in preterm neonates: evaluation of ursodeoxycholic acid treatment. J Pediatr Endocrinol Metab. 1999;12(4):549-553. [PubMed 10417972]
  60. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2018 practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019;69(1):394-419. doi:10.1002/hep.30145 [PubMed 30070375]
  61. Lindor KD. Intrahepatic cholestasis of pregnancy. Connor RF, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 30, 2024.
  62. Lindor KD. Ursodiol for primary sclerosing cholangitis. Mayo Primary Sclerosing Cholangitis-Ursodeoxycholic Acid Study Group. N Engl J Med. 1997;336(10):691-695. doi:10.1056/NEJM199703063361003 [PubMed 9041099]
  63. Lindström L, Hultcrantz R, Boberg KM, Friis-Liby I, Bergquist A. Association between reduced levels of alkaline phosphatase and survival times of patients with primary sclerosing cholangitis. Clin Gastroenterol Hepatol. 2013;11(7):841-846. doi:10.1016/j.cgh.2012.12.032 [PubMed 23353641]
  64. Liu SY, Chang LW, Wang J, Xie M, Chen LL, Liu W. Ursodeoxycholic acid prevention on cholestasis associated with total parenteral nutrition in preterm infants: a randomized trial. World J Pediatr. 2022;18(2):100-108. doi:10.1007/s12519-021-00487-0 [PubMed 34988851]
  65. Magouliotis DE, Tasiopoulou VS, Svokos AA, et al. Ursodeoxycholic acid in the prevention of gallstone formation after bariatric surgery: an updated systematic review and meta-analysis. Obes Surg. 2017;27(11):3021-3030. doi:10.1007/s11695-017-2924-y [PubMed 28889240]
  66. Mahadeo KM, Bajwa RPS. Hepatic veno-occlusive disease in children after hematopoietic stem cell transplantation. J Pediatr Intensive Care. 2014;3(3):183-193. doi:10.3233/PIC-14102 [PubMed 31214465]
  67. Mahadeo KM, Bajwa R, Abdel-Azim H, et al. Diagnosis, grading, and treatment recommendations for children, adolescents, and young adults with sinusoidal obstructive syndrome: an international expert position statement. Lancet Haematol. 2020;7(1):e61-e72. doi:10.1016/S2352-3026(19)30201-7 [PubMed 31818728]
  68. Matsui H, Yoshida T, Homma S, et al. Ursodeoxycholic acid triggers primary enterolith growth in a crohn's disease patient with jejunal stenosis. J Anus Rectum Colon. 2021;5(4):433-438. doi:10.23922/jarc.2021-017 [PubMed 34746509]
  69. Meyers RL, Books LS, O’Gorman MA, et al. High-dose steroids, ursodeoxycholic acid, and chronic intravenous antibiotics improve bile flow after Kasai procedure in infants with biliary atresia. J Pediatr Surg. 2003;38(3):406-411. [PubMed 12632357]
  70. Mukai S, Onoe T, Tashiro H, Ohdan H. Small bowel obstruction due to an unconjugated ursodeoxycholic acid enterolith following living donor liver transplantation: Report of a case. Hepatol Res. 2015;45(7):818-822. doi:10.1111/hepr.12401 [PubMed 25091893]
  71. Narkewicz MR, Smith D, Gregory C, Lear JL, Osberg I, Sokol RJ. Effect of ursodeoxycholic acid therapy on hepatic function in children with intrahepatic cholestatic liver disease. J Pediatr Gastroenterol Nutr. 1998;26(1):49-55. [PubMed 9443120]
  72. Negrin RS. Hepatic sinusoidal obstruction syndrome (veno-occlusive disease) in adults. Connor RF, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 30, 2024.
  73. Nittono H, Tokita A, Hayashi M, et al. Ursodeoxycholic acid therapy in the treatment of biliary atresia. Biomed Pharmacother. 1989;43(1): 37-41. [PubMed 2730950]
  74. Ohashi K, Tanabe J, Watanabe R, et al. The Japanese multicenter open randomized trial of ursodeoxycholic acid prophylaxis for hepatic veno-occlusive disease after stem cell transplantation. Am J Hematol. 2000;64(1):32-38. doi:10.1002/(sici)1096-8652(200005)64:1<32::aid-ajh6>3.0.co;2-n [PubMed 10815785]
  75. Olsson R, Boberg KM, de Muckadell OS, et al. High-dose ursodeoxycholic acid in primary sclerosing cholangitis: a 5-year multicenter, randomized, controlled study. Gastroenterology. 2005;129(5):1464-1472. doi:10.1053/j.gastro.2005.08.017 [PubMed 16285948]
  76. Ovadia C, Sajous J, Seed PT, et al. Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a systematic review and individual participant data meta-analysis. Lancet Gastroenterol Hepatol. Published online April 26, 2021. doi:10.1016/S2468-1253(21)00074-1 [PubMed 33915090]
  77. Parízek A, Simják P, Cerný A, et al. Efficacy and safety of ursodeoxycholic acid in patients with intrahepatic cholestasis of pregnancy. Ann Hepatol. 2016;15(5):757-761. doi:10.5604/16652681.1212562 [PubMed 27493115]
  78. Pedersen MR, Greenan G, Arora S, Murali AR, Mayo MJ. Ursodeoxycholic acid decreases incidence of primary biliary cholangitis and biliary complications after liver transplantation: a meta-analysis. Liver Transpl. 2021;27(6):866-875. doi:10.1002/lt.25935 [PubMed 33185320]
  79. Pennesi E, Michels N, Brivio E, et al. Inotuzumab ozogamicin as single agent in pediatric patients with relapsed and refractory acute lymphoblastic leukemia: results from a phase II trial. Leukemia. 2022;36(6):1516-1524. doi:10.1038/s41375-022-01576-3 [PubMed 35468945]
  80. Petroni ML, Jazrawi RP, Pazzi P, et al. Ursodeoxycholic acid alone or with chenodeoxycholic acid for dissolution of cholesterol gallstones: a randomized multicentre trial. The British-Italian Gallstone Study group. Aliment Pharmacol Ther. 2001;15(1):123-128. doi:10.1046/j.1365-2036.2001.00853.x [PubMed 11136285]
  81. Poupon RE, Balkau B, Eschwège E, Poupon R. A multicenter, controlled trial of ursodiol for the treatment of primary biliary cirrhosis. UDCA-PBC Study Group. N Engl J Med. 1991;324(22):1548-1554. doi:10.1056/NEJM199105303242204 [PubMed 1674105]
  82. Qiao F, Ren F, Lu W, et al. A female of progressive familial intrahepatic cholestasis type 3 caused by heterozygous mutations of ABCB4 gene and her cirrhosis improved after treatment of ursodeoxycholic acid: a case report. BMC Med Genomics. 2023;16(1):171. doi:10.1186/s12920-023-01602-y [PubMed 37488596]
  83. Refer to manufacturer's labeling.
  84. Reltone (ursodiol) [prescribing information]. Las Vegas, NV: Intra-Sana Laboratories LLC; November 2020.
  85. Roy A, Premkumar M, Mishra S, et al. Role of ursodeoxycholic acid on maternal serum bile acids and perinatal outcomes in intrahepatic cholestasis of pregnancy. Eur J Gastroenterol Hepatol. 2021;33(4):571-576. doi:10.1097/MEG.0000000000001954 [PubMed 33136720]
  86. Roy-Chowdhury J. Inherited disorders associated with conjugated hyperbilirubinemia in adults. Connor RF, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 30, 2024.
  87. Rust C, Sauter GH, Oswald M, et al. Effect of cholestyramine on bile acid pattern and synthesis during administration of ursodeoxycholic acid in man. Eur J Clin Invest. 2000;30(2):135-139. [PubMed 10651838]
  88. Ruutu T, Carreras E. Hepatic complications. In: Carreras E, Dufour C, Mohty M, Kröger N, eds. The EBMT Handbook: Hematopoietic Stem Cell Transplantation and Cellular Therapies. 7th ed. Cham (CH): Springer; 2019.373-379. [PubMed 32091825]
  89. Ruutu T, Eriksson B, Remes K, et al; Nordic Bone Marrow Transplantation Group. Ursodeoxycholic acid for the prevention of hepatic complications in allogeneic stem cell transplantation. Blood. 2002;100(6):1977-1983. doi:10.1182/blood-2001-12-0159 [PubMed 12200355]
  90. Ruutu T, Juvonen E, Remberger M, et al; Nordic Group for Blood and Marrow Transplantation. Improved survival with ursodeoxycholic acid prophylaxis in allogeneic stem cell transplantation: long-term follow-up of a randomized study. Biol Blood Marrow Transplant. 2014;20(1):135-138. doi:10.1016/j.bbmt.2013.10.014 [PubMed 24141008]
  91. Sepúlveda Marín S, Contreras Maragaño V, Vera C. Is ursodeoxycholic acid effective for intrahepatic cholestasis of pregnancy? Medwave. 2016;16(Suppl 1):e6361. doi:10.5867/medwave.2015.6361 [PubMed 26817509]
  92. Shen Y, Zhou J, Zhang S, et al. Is it necessary to perform the pharmacological interventions for intrahepatic cholestasis of pregnancy? A bayesian network meta-analysis. Clin Drug Investig. 2019;39(1):15-26. doi:10.1007/s40261-018-0717-2 [PubMed 30357607]
  93. Shiffman ML, Kaplan GD, Brinkman-Kaplan V, Vickers FF. Prophylaxis against gallstone formation with ursodeoxycholic acid in patients participating in a very-low-calorie diet program. Ann Intern Med. 1995;122(12):899-905. doi:10.7326/0003-4819-122-12-199506150-00002 [PubMed 7755224]
  94. Šimják P, Petr T, Kaslová B, et al. Author correction: ursodeoxycholic acid use in lactating female patients is associated with clinically negligible concentrations of this bile acid in breast milk. Sci Rep. 2022;12(1):21785. doi:10.1038/s41598-022-26431-4 [PubMed 36526705]
  95. Sokol RJ, Durie PR. Recommendations for management of liver and biliary tract disease in cystic fibrosis. Cystic Fibrosis Foundation Hepatobiliary Disease Consensus Group. J Pediatr Gastroenterol Nutr. 1999;Suppl 1:S1-13. [PubMed 9934970]
  96. Spagnuolo MI, Iorio R, Vegnente A, Guarino A. Ursodeoxycholic acid for treatment of cholestasis in children on long-term total parenteral nutrition: a pilot study. Gastroenterology. 1996;111(3):717-719. [PubMed 8780577]
  97. Stanich PP, Björnsson E, Gossard AA, Enders F, Jorgensen R, Lindor KD. Alkaline phosphatase normalization is associated with better prognosis in primary sclerosing cholangitis. Dig Liver Dis. 2011;43(4):309-313. doi:10.1016/j.dld.2010.12.008 [PubMed 21251891]
  98. Stringer MD, Davison SM, Rajwal SR, McClean P. Kasai portoenterostomy: 12-year experience with a novel adjuvant therapy regimen. J Pediatr Surg. 2007;42(8):1324-1328. [PubMed 17706489]
  99. Tay J, Tinmouth A, Fergusson D, et al. Systematic review of controlled clinical trials on the use of ursodeoxycholic acid for the prevention of hepatic veno-occlusive disease in hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2007;13(2):206-217. doi:10.1016/j.bbmt.2006.09.012 [PubMed 17241926]
  100. Thibault M, McMahon J, Faubert G, et al. Parenteral nutrition-associated liver disease: a retrospective study of ursodeoxycholic Acid use in neonates. J Pediatr Pharmacol Ther. 2014;19(1):42-48. doi:10.5863/1551-6776-19.1.42 [PubMed 24782691]
  101. Tint GS, Salen G, Colalillo A, et al. Ursodeoxycholic acid: a safe and effective agent for dissolving cholesterol gallstones. Ann Intern Med. 1982;97(3):351-356. doi:10.7326/0003-4819-97-3-351 [PubMed 7051912]
  102. Tran TT, Ahn J, Reau NS. ACG clinical guideline: liver disease and pregnancy [published correction appears in Am J Gastroenterol. 2016;111(11):1668]. Am J Gastroenterol. 2016;111(2):176-194. doi:10.1038/ajg.2015.430 [PubMed 26832651]
  103. Ullrich D, Rating D, Schroter W, Hanefeld F, Bircher J. Treatment with ursodeoxycholic acid renders children with biliary atresia suitable for liver transplantation. Lancet. 1987;2(8571):1324. [PubMed 2890915]
  104. Urso 250 and Urso Forte (ursodiol) [prescribing information]. Madison, NJ: Allergan USA Inc; January 2023.
  105. Urso tablets (ursodiol) [prescribing information]. Bridgewater, NJ: Aptalis Pharma US, Inc; June 2013.
  106. Ursodiol capsules, USP [prescribing information]. Pennington, NJ: Zydus Pharmaceuticals USA Inc; July 2023.
  107. Vítek L, Zelenková M, Brůha R. Safe use of ursodeoxycholic acid in a breast-feeding patient with primary biliary cirrhosis. Dig Liver Dis. 2010;42(12):911-912. doi:10.1016/j.dld.2010.06.002 [PubMed 20619755]
  108. Wales PW, Allen N, Worthington P, George D, Compher C; American Society for Parenteral and Enteral Nutrition, Teitelbaum D. A.S.P.E.N. clinical guidelines: support of pediatric patients with intestinal failure at risk of parenteral nutrition-associated liver disease. JPEN J Parenter Enteral Nutr. 2014;38(5):538-557. doi:10.1177/0148607114527772 [PubMed 24696095]
  109. Walker KF, Chappell LC, Hague WM, Middleton P, Thornton JG. Pharmacological interventions for treating intrahepatic cholestasis of pregnancy. Cochrane Database Syst Rev. 2020;7(7):CD000493. doi:10.1002/14651858.CD000493.pub3 [PubMed 32716060]
  110. Warner S, Kelly DA. Liver failure. In: Wyllie R, Hyams J, Kay M, eds. Pediatric Gastrointestinal and Liver Disease. 6th ed. Elsevier; 2021:chap 77.
  111. Weinsier RL, Wilson LJ, Lee J. Medically safe rate of weight loss for the treatment of obesity: a guideline based on risk of gallstone formation. Am J Med. 1995;98(2):115-117. doi:10.1016/S0002-9343(99)80394-5 [PubMed 7847427]
  112. Willot S, Uhlen S, Michaud L, et al. Effect of ursodeoxycholic acid on liver function in children after successful surgery for biliary atresia. Pediatrics. 2008;122(6):e1236-e1241. doi:10.1542/peds.2008-0986 [PubMed 19029197]
  113. Wong ZH, Davenport M. What happens after Kasai for biliary atresia? A European multicenter survey. Eur J Pediatr Surg. 2019;29(1):1-6. doi:10.1055/s-0038-1668146 [PubMed 30130826]
  114. Wunsch E, Trottier J, Milkiewicz M, et al. Prospective evaluation of ursodeoxycholic acid withdrawal in patients with primary sclerosing cholangitis. Hepatology. 2014;60(3):931-940. doi:10.1002/hep.27074 [PubMed 24519384]
  115. Yamashiro Y, Ohtsuka Y, Shimizu T. Effects of ursodeoxycholic acid treatment on essential fatty acid deficiency in patients with biliary atresia. J Pediatr Surg. 1994;29(3):425-428. [PubMed 8201513]
  116. Zakko SF. Overview of nonsurgical management of gallbladder stones. Connor RF, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 30, 2024.
  117. Zapata R, Sandoval L, Palma J, et al. Ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy. A 12-year experience. Liver Int. 2005;25(3):548-554. doi:10.1111/j.1478-3231.2004.0996.x [PubMed 15910492]
  118. Zhang Y, Lu L, Victor DW, Xin Y, Xuan S. Ursodeoxycholic acid and S-adenosylmethionine for the treatment of intrahepatic cholestasis of pregnancy: a meta-analysis. Hepat Mon. 2016;16(8):e38558. doi:10.5812/hepatmon.38558 [PubMed 27799965]
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