| legal_CA = <!-- / Schedule I, II, III, IV, V, VI, VII, VIII -->
* Strength of Evidence:
| legal_UK = <!-- GSL / P / POM / CD / Class A, B, C -->
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
* Dosing Information
| legal_status =
| dependency_liability =
:* Dosage
| routes_of_administration =
}}
=====Condition2=====
{{SI}}
'''Ursodiol''', also known as '''ursodeoxycholic acid''' and the [[abbreviation]] '''UDCA''', is one of the secondary [[bile acid]]s, which are metabolic byproducts of intestinal bacteria. Primary bile acids are produced by the [[liver]] and stored in the [[gall bladder]]. When secreted into the colon, primary bile acids can be metabolized into secondary bile acids by intestinal bacteria. Primary and secondary bile acids help the body [[digestion|digest]] [[fat|fats]]. Ursodeoxycholic acid helps regulate [[cholesterol]] by reducing the rate at which the [[intestine]] absorbs cholesterol molecules while breaking up [[micelle]]s containing cholesterol. Because of this property, ursodeoxycholic acid is used to treat (cholesterol) [[gallstone]]s non-surgically.
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=* Condition1
<!--Warnings-->
|warnings=* Description
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
|administration=* Oral
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
|overdose====Acute Overdose===
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Pharmacology-->
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*
<!--Structure-->
|structure=*
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
While some bile acids are known to be colon tumor promoters (eg. deoxycholic acid), others such as ursodeoxycholic acid are chemopreventive, perhaps by inducing cellular differentiation and/or cellular senescence in colon epithelial cells.<ref>{{cite journal |author=Akare S, Jean-Louis S, Chen W, Wood DJ, Powell AA, Martinez JD |title=Ursodeoxycholic acid modulates histone acetylation and induces differentiation and senescence |journal=Int. J. Cancer |volume=119 |issue=12 |pages=2958–69 |year=2006 |pmid=17019713 |doi=10.1002/ijc.22231}}</ref>
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
Ursodeoxycholic acid has also been shown experimentally to suppress [[immune system|immune response]] such as immune cell [[phagocytosis]]. Increased quantities of systemic (throughout the body, not just in the digestive system) ursodeoxycholic acid can be toxic.
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
Bile acids are important signaling molecules that help regulate the regrowth of [[liver]] tissue, recent research has shown. Ursodeoxycholic acid has been used as an experimental tool in liver regrowth studies. There is a possible link between the immune-repression and liver-regeneration properties of this substance, but clinical studies have yet to confirm these suspicions.
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
==As a pharmaceutical==
<!--Clinical Studies-->
Ursodeoxycholic acid goes by the trade names '''Actigall''', '''Ursofalk''', '''Urso''', and '''Urso Forte'''. At least in Italy, it is marketed under the name '''Deursil'''.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
Ursodeoxycholic acid can be chemically synthesized and was brought to market by the Montreal-based [[Axcan Pharma]] in 1998, which continues to market the drug.
<!--How Supplied-->
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
The drug reduces [[cholesterol]] absorption and is used to dissolve (cholesterol) [[gallstone]]s in [[patient]]s who want an alternative to [[surgery]]. The drug is very expensive, however, and if the patient stops taking it, the gallstones recur. For these reasons, it has not supplanted surgical treatment by [[cholecystectomy]].
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
It is used to treatment [[primary biliary cirrhosis]] and other [[cholestatic]] diseases.<ref name=smith17335678>{{cite journal |author=Smith T, Befeler AS |title=High-dose ursodeoxycholic acid for the treatment of primary sclerosing cholangitis |journal=Current gastroenterology reports |volume=9 |issue=1 |pages=54–9 |year=2007 |pmid=17335678 |doi=}}</ref><ref>{{cite journal |author=Jackson H, Solaymani-Dodaran M, Card TR, Aithal GP, Logan R, West J |title=Influence of ursodeoxycholic acid on the mortality and malignancy associated with primary biliary cirrhosis: A population-based cohort study |journal= |volume=46 |issue=4 |pages=1131–1137 |year=2007 |pmid=17685473 |doi=10.1002/hep.21795}}</ref>
<!--Brand Names-->
In children it is used in [[biliary atresia]],<ref name=smith17335678/> which is a cause of [[neonatal jaundice]].
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
Ursodeoxycholic acid reduces elevated liver enzyme levels by facilitating bile flow through the liver and protecting liver cells.
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
The drug is generally not derived from animals. However, it is believed more than 12,000 [[bile bear]]s are kept on farms in China, Vietnam and South Korea for the purpose of harvesting ursodeoxycholic acid.<ref name="BBC">{{cite news| author = Richard Black | date = 11 Jun 2007 | publisher = [[BBC News]] | url= http://news.bbc.co.uk/2/hi/science/nature/6742671.stm|title=BBC Test kit targets cruel bear trade}}</ref> Ursodeoxycholic acid is found in large quantities in [[bear bile]].
<!--Drug Shortage Status-->
|drugShortage=
}}
{{PillImage
|fileName=No image.jpg
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
<!--Pill Image-->
==References==
<references/>
==External links==
* [http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a699047.html Ursodeoxycholic acid information] at [[MedlinePlus]]
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Black Box Warning
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Ursodiol is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
Dosing Information
Dosage
Condition2
Dosing Information
Dosage
Condition3
Dosing Information
Dosage
Condition4
Dosing Information
Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Ursodiol in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ursodiol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Ursodiol in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Ursodiol in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ursodiol in pediatric patients.
Contraindications
Condition1
Warnings
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Ursodiol in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Ursodiol in the drug label.
