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Ursodeoxycholic acid (ursodiol): Drug information

Ursodeoxycholic acid (ursodiol): Drug information
(For additional information see "Ursodeoxycholic acid (ursodiol): Patient drug information" and see "Ursodeoxycholic acid (ursodiol): Pediatric 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;
  • Urso DS
Pharmacologic Category
  • Gallstone Dissolution Agent
Dosing: Adult
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 (Magouliotis 2017).

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 (Ruutu 2002; Ruutu 2013). 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 (ACG [Tran 2016]; SMFM [Lee 2021]) or 500 mg twice daily, gradually increase in increments of 500 mg/day (range: 500 mg to 2,000 mg/day in divided doses) (Chappell 2019); 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 (AASLD [Lindor 2019]).

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

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 (Kelly 2007; Meyers 2003; Nittono 1989; Stringer 2007; Yamashiro 1994). Some patients may require higher doses (Wong 2019); 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) (Willot 2008).

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 (Columbo 1990; Debray 2011; Kappler 2012; Lepage 1997; Sokol 1999; Warner 2021).

Parenteral nutrition-induced cholestasis, treatment

Parenteral nutrition-induced cholestasis, treatment: Limited data available (ASPEN [Wales 2014]): Infants and Children: Oral: 30 mg/kg/day in 3 divided doses (Chen 2004; De Marco 2006; Spagnuolo 1996).

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 (Dinler 1999; Hassan 2020; Narkewicz 1998). 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 (Narkewicz 1998). 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 (Dinler 1999).

Veno-occlusive disease following hematopoietic stem cell transplantation, prevention

Veno-occlusive disease (sinusoidal obstruction syndrome) following hematopoietic stem cell transplantation, prevention: Limited data available (Al Jefri 2017; EBMT [Ruutu 2019]; Mahadeo 2020); efficacy results variable (Cheuk 2005); 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 (Faraci 2019; Mahadeo 2014; Pennesi 2022; Ruutu 2002).

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: Older Adult

Refer to adult dosing.

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]

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

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Urso: 250 mg

Urso DS: 500 mg

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 (AASLD [Lindor 2019]; Rust 2000). 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 (Rust 2000).

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

Gallstones (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.

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

Gallstone prevention post–bariatric surgery; Hepatic sinusoidal obstruction syndrome associated with stem cell transplant, prevention; Intrahepatic cholestasis of pregnancy

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

Ursodiol may be confused with ulipristal

Adverse Reactions

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

>10%:

Central nervous system: Headache (≤25%), dizziness (17%)

Gastrointestinal: Diarrhea (≤27%), constipation (≤26%), dyspepsia (≤17%), nausea (≤17%)

Neuromuscular & skeletal: Back pain (≤12%)

Respiratory: Upper respiratory tract infection (≤16%)

1% to 10%:

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

Endocrine & metabolic: Hyperglycemia (1%)

Gastrointestinal: Vomiting (≤10%), peptic ulcer (1%)

Genitourinary: Urinary tract infection (7%)

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

Hepatic: Cholecystitis (5%)

Hypersensitivity: Hypersensitivity reaction (5%)

Infection: Viral infection (9%)

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

Renal: Increased serum creatinine (1%)

Respiratory: Pharyngitis (≤8%), bronchitis (7%), cough (7%), flu-like symptoms (7%)

<1%, postmarketing, and/or case reports: Abdominal distress, abdominal pain, abnormal hepatic function tests, angioedema, anorexia, biliary colic, esophagitis, facial edema, fever, hepatobiliary disease, increased gamma-glutamyl transferase, increased liver enzymes, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, increased serum bilirubin, jaundice, laryngeal edema, malaise, metallic taste, myalgia, peripheral edema, pruritus, transaminases increased, urticaria, weakness

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.

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

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]).

Breastfeeding Considerations

Ursodiol may be present in breast milk (Brites 1998).

Total bile acid concentrations are increased in the colostrum of patients with intrahepatic cholestasis of pregnancy (ICP). 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).

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

Primary biliary cholangitis: Monitor LFTs (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).

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

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%)

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.

Brand Names: International
  • Adursal (FI);
  • Axialith (PH);
  • Canlin (TW);
  • Cholemax (TH);
  • Destolit (MT);
  • Deursil (IT);
  • Dexo (PY);
  • Dozurso (BE);
  • Estazor (ID);
  • Galcholic (VN);
  • Homan (VN);
  • Lupible (PH);
  • Taurolite (CN);
  • Triptor (LK);
  • Udihep (LK, TH);
  • Uldeso (HK);
  • Urdafalk (ID);
  • Urdek (ID);
  • Urosan (BE, JP);
  • Ursa (JO, PH);
  • Ursacol (BR, CO, IT);
  • Ursilon (VN);
  • Ursimex (VN);
  • Urso (IN, LK);
  • Ursobilane (ES);
  • Ursocel (EC);
  • Ursochol (BE, CH, EG, ES, ID, IS, LU, NL, NO, UA);
  • Ursodox (LK, PH);
  • Ursofalk (AE, AR, AT, AU, BE, BG, CL, CN, CO, CR, CY, CZ, DE, EE, GR, GT, HK, HN, HR, HU, IE, IL, KR, KW, LB, LU, MT, MX, MY, NI, NZ, PA, PE, PH, PK, PT, RO, SA, SE, SI, SK, SV, TH, TR, UA, UY);
  • Ursolic (TW);
  • Ursolin (TH);
  • Ursolit (IL);
  • Ursoliv (PH);
  • Ursolvan (FR);
  • Ursopol (PL);
  • Ursosan (JP, RU, UA)


For country code abbreviations (show table)
  1. Actigall (ursodiol) [prescribing information]. Irvine, CA: Allergan; May 2018.
  2. 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]
  3. 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]
  4. 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.
  5. 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]
  6. 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]
  7. 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]
  8. 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]
  9. 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]
  10. 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]
  11. 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]
  12. 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]
  13. 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]
  14. 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]
  15. 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
  16. 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]
  17. 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]
  18. 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]
  19. 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]
  20. 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.
  21. 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]
  22. 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]
  23. Kelly DA, Davenport M. Current management of biliary atresia. Arch Dis Child. 2007;92(12):1132-1135. [PubMed 17878208]
  24. 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]
  25. 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]
  26. 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]
  27. 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]
  28. 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]
  29. 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]
  30. 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]
  31. 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]
  32. 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]
  33. 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]
  34. 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]
  35. 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]
  36. 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]
  37. 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]
  38. 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]
  39. 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]
  40. 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]
  41. Reltone (ursodiol) [prescribing information]. Las Vegas, NV: Intra-Sana Laboratories LLC; November 2020.
  42. 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]
  43. 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]
  44. 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]
  45. 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]
  46. 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]
  47. 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]
  48. 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]
  49. 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]
  50. 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]
  51. 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]
  52. 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]
  53. 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]
  54. 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]
  55. Urso 250 and Urso Forte (ursodiol) [prescribing information]. Irvine, CA: Allergan USA Inc; June 2018.
  56. Urso 250 and Urso Forte (ursodiol) [prescribing information]. Madison, NJ: Allergan USA Inc; May 2021.
  57. Urso and Urso DS (ursodiol) [product monograph]. Mont-St-Hilaire, Quebec, Canada: Aptalis Pharma Canada Inc; August 2014.
  58. Urso tablets (ursodiol) [prescribing information]. Bridgewater, NJ: Aptalis Pharma US, Inc; June 2013.
  59. 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]
  60. 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]
  61. 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]
  62. 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.
  63. 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]
  64. 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]
  65. 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]
  66. 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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