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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Ursodiol - Drugs and Lactation Database (LactMed®) - NCBI Bookshelf</title>
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<meta name="citation_inbook_title" content="Drugs and Lactation Database (LactMed®) [Internet]">
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<meta name="citation_title" content="Ursodiol">
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<meta name="citation_publisher" content="National Institute of Child Health and Human Development">
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<meta name="citation_date" content="2024/08/15">
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<meta name="citation_keywords" content="ursodiol">
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<meta name="citation_keywords" content="ursodeoxycholic acid">
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<meta name="citation_keywords" content="Actigall">
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<meta name="citation_keywords" content="Ursofalk">
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<meta name="citation_keywords" content="Ursolvan">
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<meta name="citation_keywords" content="Delursan">
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<meta name="citation_keywords" content="Destolit">
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<meta name="citation_keywords" content="Ursochol">
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<meta name="citation_keywords" content="ursodeoxycholate">
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<meta name="citation_keywords" content="Urso Forte">
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<meta name="citation_keywords" content="Cholit-ursan">
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<meta name="citation_keywords" content="Ursobilin">
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<meta name="citation_keywords" content="Ursodamor">
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<meta name="citation_keywords" content="Litursol">
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<meta name="citation_keywords" content="Solutrat">
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<meta name="citation_keywords" content="Arsacol">
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<meta name="citation_keywords" content="Deursil">
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<meta name="citation_keywords" content="Ursacol">
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<meta name="citation_keywords" content="Lyeton">
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<meta name="citation_keywords" content="UrSO">
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<meta name="citation_keywords" content="Peptarom">
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<meta name="citation_keywords" content="Ursodesoxycholic acid">
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<meta name="citation_keywords" content="Urso DS">
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<meta name="citation_keywords" content="128-13-2">
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<meta name="citation_keywords" content="Acido ursodeoxicolico">
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<meta name="citation_keywords" content="Acido ursodeossicolico">
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<meta name="citation_keywords" content="Acide ursodesoxycholique">
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<meta name="citation_keywords" content="Acidum ursodeoxycholicum">
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<meta name="citation_keywords" content="Urso 250">
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<meta name="citation_keywords" content="Ursocholic acid, deoxy-">
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<meta name="citation_keywords" content="7-beta-Hydroxylithocholic acid">
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<meta name="citation_keywords" content="Ursodiol [USAN:USP]">
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<meta name="citation_keywords" content="3,7-Dihydroxycholan-24-oic acid">
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<meta name="citation_keywords" content="Acido ursodeossicolico [Italian]">
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<meta name="citation_keywords" content="3-alpha,7-beta-Dioxycholanic acid">
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<meta name="citation_keywords" content="UNII-724L30Y2QR">
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<meta name="citation_keywords" content="3alpha,7beta-Dihydroxy-5beta-cholan-24-oic acid">
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<meta name="citation_keywords" content="3-alpha,7-beta-Dihydroxycholanic acid">
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<meta name="citation_keywords" content="CCRIS 5502">
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<meta name="citation_keywords" content="Acido ursodeoxicolico [INN-Spanish]">
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<meta name="citation_keywords" content="Acidum ursodeoxycholicum [INN-Latin]">
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<meta name="citation_keywords" content="Acide ursodesoxycholique [INN-French]">
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<meta name="citation_keywords" content="Ursodeoxycholic acid [INN]">
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<meta name="citation_keywords" content="NSC 683769">
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<meta name="citation_keywords" content="NSC 657950">
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<meta name="citation_keywords" content="EINECS 204-879-3">
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<meta name="citation_keywords" content="BRN 3219888">
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<meta name="citation_keywords" content="724L30Y2QR">
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<meta name="citation_keywords" content="3-alpha,7-beta-Dihydroxy-5-beta-cholanoic acid">
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<meta name="citation_keywords" content="EC 204-879-3">
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<meta name="citation_keywords" content="4-10-00-01604 (Beilstein Handbook Reference)">
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<meta name="citation_keywords" content="17-beta-(1-Methyl-3-carboxypropyl)etiocholane-3-alpha,7-beta-diol">
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<meta name="citation_keywords" content="5-beta-Cholan-24-oic acid, 3-alpha,7-beta-dihydroxy-">
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<meta name="citation_keywords" content="Cholan-24-oic acid, 3,7-dihydroxy-, (3alpha,5beta,7beta)-">
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<meta name="citation_keywords" content="Cholan-24-oic acid, 3,7-dihydroxy-, (3-alpha,5-beta,7-beta)- (9CI)">
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<meta name="DC.Title" content="Ursodiol">
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<meta name="DC.Date" content="2024/08/15">
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<meta name="description" content="Ursodiol is naturally present in human milk. Because of the low levels of ursodiol (ursodeoxycholic acid) in breastmilk after exogenous administration, amounts ingested by the infant are small and are not expected to cause any adverse effects in breastfed infants.[1,2] Ursodiol has been given directly to newborns to safely and successfully treat prolonged neonatal jaundice.[3] No special precautions are required.">
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<meta name="og:description" content="Ursodiol is naturally present in human milk. Because of the low levels of ursodiol (ursodeoxycholic acid) in breastmilk after exogenous administration, amounts ingested by the infant are small and are not expected to cause any adverse effects in breastfed infants.[1,2] Ursodiol has been given directly to newborns to safely and successfully treat prolonged neonatal jaundice.[3] No special precautions are required.">
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class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><div class="fm-sec"><h1 id="_NBK501389_"><span class="title" itemprop="name">Ursodiol</span></h1><p class="fm-aai"><a href="#_NBK501389_pubdet_">Publication Details</a></p><p><em>Estimated reading time: 4 minutes</em></p></div></div><div class="jig-ncbiinpagenav body-content whole_rhythm" data-jigconfig="allHeadingLevels: ['h2'],smoothScroll: false" itemprop="text"><p>CASRN: 128-13-2</p><a href="https://pubchem.ncbi.nlm.nih.gov/substance/134974576" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=134974576" alt="image 134974576 in the ncbi pubchem database" /></a><div id="LM510.Drug_Levels_and_Effects"><h2 id="_LM510_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM510.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>Ursodiol is naturally present in human milk. Because of the low levels of ursodiol (ursodeoxycholic acid) in breastmilk after exogenous administration, amounts ingested by the infant are small and are not expected to cause any adverse effects in breastfed infants.[<a class="bibr" href="#LM510.REF.1" rid="LM510.REF.1">1</a>,<a class="bibr" href="#LM510.REF.2" rid="LM510.REF.2">2</a>] Ursodiol has been given directly to newborns to safely and successfully treat prolonged neonatal jaundice.[<a class="bibr" href="#LM510.REF.3" rid="LM510.REF.3">3</a>] No special precautions are required.</p></div><div id="LM510.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> A woman received oral ursodiol 750 mg daily throughout pregnancy for primary biliary cirrhosis. She continued ursodiol postpartum and ursodiol was undetectable in her breastmilk by HPLC assay. Details of milk collection and assay limits were not reported.[<a class="bibr" href="#LM510.REF.4" rid="LM510.REF.4">4</a>]</p><p>Seven mothers with intrahepatic cholestasis of pregnancy were given oral ursodiol 14 mg/kg daily beginning an average of 14 days prior to delivery and continuing postpartum. Colostrum samples taken in the first 72 hours postpartum contained an average of 118 mcg/L. The mothers treated with ursodiol had levels of bile acids in colostrum that were much less elevated than 9 untreated control women with cholestasis of pregnancy.[<a class="bibr" href="#LM510.REF.5" rid="LM510.REF.5">5</a>]</p><p>A woman with primary biliary cirrhosis developed severe pruritus and elevated serum bile acids 3 weeks postpartum. Ursodiol was started at a dose of 500 mg (7.5 mg/kg) daily and increased to 1500 mg (25 mg/kg) daily over the next 8 weeks. Total bile acids in breastmilk increased from 0.5 micromole/L to 1 micromole/L after 8 weeks of therapy; after 16 weeks, total bile acids in milk were 0.6 micromole/L. Ursodiol milk levels were undetectable before drug initiation, 63 mcg/L at an ursodiol dose of 500 mg daily after 2 weeks, 118 mcg/L with a dose of 1 gram daily after 4 weeks, 79 mcg/L with a dose of 1.5 grams daily after 11 weeks, and 196 mcg/L with a dose of 1.5 grams daily after 19 weeks.[<a class="bibr" href="#LM510.REF.6" rid="LM510.REF.6">6</a>] This patient was included in the following study: Twenty patients were taking ursodiol for cholestasis in daily dosages of 500 to 1500 mg or 13 to 15 mg/kg, depending on the condition. Milk samples were obtained on day 3 postpartum from the patients as well as 4 normal volunteers who were not taking ursodiol. No difference in the total bile acid concentration in breastmilk was found between the two groups of patients (3.2 micromolar), although the proportion of ursodiol was higher in the milk of mothers taking the drug (1.5 vs 21.5%). The authors estimated that a breastfed neonate would have a daily intake of 27 mcg of ursodiol, which would represent 0.0005% of the total newborn bile acid pool.[<a class="bibr" href="#LM510.REF.2" rid="LM510.REF.2">2</a>]</p><p><i>Infant Levels.</i> Relevant published information was not found as of the revision date.</p></div><div id="LM510.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>One breastfed (extent not stated) infant developed normally over the first 6 months of life during maternal ursodiol therapy of 750 to 1000 mg daily.[<a class="bibr" href="#LM510.REF.4" rid="LM510.REF.4">4</a>]</p><p>Seven women who were taking ursodiol 14 mg/kg daily near term and postpartum. They reported no adverse reactions in their breastfed infants during the early postpartum period.[<a class="bibr" href="#LM510.REF.5" rid="LM510.REF.5">5</a>]</p><p>A mother receiving oral ursodiol 250 mg 3 times daily for primary biliary cirrhosis reportedly breastfed her infant normally, although the extent and duration of breastfeeding was not stated.[<a class="bibr" href="#LM510.REF.7" rid="LM510.REF.7">7</a>]</p><p>A woman with primary biliary cirrhosis developed severe pruritus and elevated serum bile acids 3 weeks postpartum. Ursodiol was started at a dose of 500 mg (7.5 mg/kg) daily, increasing to 1500 mg (25 mg/kg) daily over the next 8 weeks. Psychomotor development of her breastfed (extent not stated) infant was normal, and no apparent side effects were observed in the infant.[<a class="bibr" href="#LM510.REF.6" rid="LM510.REF.6">6</a>]</p><p>A retrospective review of the medical records of pregnant patients at a hospital in Ankara, Türkiye who had a diagnosis of primary biliary cirrhosis found 8 patients who took ursodiol postpartum in doses of 13–15 mg/kg daily. “Most” of the patients breastfed their infants (extent not stated). No infant side effects were reported.[<a class="bibr" href="#LM510.REF.8" rid="LM510.REF.8">8</a>]</p><p>A woman was breastfeeding her 8-day-old preterm infant 10 times daily for about 15 minutes each time. The infant was born by cesarean section at 34 weeks of gestation with a weight of 3600 grams. She was diagnosed with cholestasis, type 1 diabetes, and hypothyroidism. She was treated with ursodiol 500 mg daily, insulin levemir and aspart, and levothyroxine. She was also taking cefuroxime, flurbiprofen, a combination of acetaminophen, propyphenazone, and caffeine. The mother took the ursodiol for a total of 12 days, cefuroxime and the analgesic combination for 10 days and flurbiprofen for 15 days. No adverse effects were noticed during the period of ursodiol treatment.[<a class="bibr" href="#LM510.REF.9" rid="LM510.REF.9">9</a>]</p><p>Twenty nursing mothers were taking ursodiol for cholestasis in daily dosages of 500 to 1500 mg or 13 to 15 mg/kg, depending on the condition. Ursodiol was discontinued 3 days postpartum. No apparent side effects were observed in any newborn infant based on standard clinical examination during early postnatal period, and no deterioration in postnatal development was observed during routine 1-year follow-up on routine pediatric examinations.[<a class="bibr" href="#LM510.REF.2" rid="LM510.REF.2">2</a>]</p></div><div id="LM510.Effects_on_Lactation_and_Breastmil"><h3>Effects on Lactation and Breastmilk</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="LM510.References"><h3>References</h3><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="LM510.REF.1">de Vries
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E, Beuers
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U. Ursodeoxycholic acid in pregnancy?
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J Hepatol
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2019;71:1237-45.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/31479696" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31479696</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>2.</dt><dd><div class="bk_ref" id="LM510.REF.2">Šimják
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P, Petr
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T, Kaslová
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B, et al.
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Ursodeoxycholic acid use in lactating female patients is associated with clinically negligible concentrations of this bile acid in breast milk.
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Sci Rep
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2022;12:19543.
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[<a href="/pmc/articles/PMC9666662/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9666662</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/36379995" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36379995</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>3.</dt><dd><div class="bk_ref" id="LM510.REF.3">Ozdemir
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A, Kurtoglu
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S, Halis
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H, et al.
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An evaluation of ursodeoxycholic acid treatment in prolonged unconjugated hyperbilirubinemia due to breast milk.
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Niger J Clin Pract
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2023;26:1226-33.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/37794533" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37794533</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>4.</dt><dd><div class="bk_ref" id="LM510.REF.4">Rudi
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J, Schonig
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T, Stremmel
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W.
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[Therapy with ursodeoxycholic acid in primary biliary cirrhosis in pregnancy]. Z Gastroenterol
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1996;34:188-91.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/8650973" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 8650973</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>5.</dt><dd><div class="bk_ref" id="LM510.REF.5">Brites
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D, Rodrigues
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CM. Elevated levels of bile acids in colostrum of patients with cholestasis of pregnancy are decreased following ursodeoxycholic acid therapy.
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J Hepatol
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1998;29:743-51.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/9833912" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 9833912</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>6.</dt><dd><div class="bk_ref" id="LM510.REF.6">Vítek
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L, Zelenkova
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M, Bruha
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R. Safe use of ursodeoxycholic acid in a breast-feeding patient with primary biliary cirrhosis.
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Dig Liver Dis
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2010;42:911-2.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/20619755" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20619755</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>7.</dt><dd><div class="bk_ref" id="LM510.REF.7">Goh
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SK, Gull
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SE, Alexander
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GJ. Pregnancy in primary biliary cirrhosis complicated by portal hypertension: Report of a case and review of the literature.
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BJOG
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2001;108:760-2.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/11467706" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11467706</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>8.</dt><dd><div class="bk_ref" id="LM510.REF.8">Efe
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C, Kahramanoglu-Aksoy
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E, Yilmaz
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B, et al.
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Pregnancy in women with primary biliary cirrhosis.
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Autoimmun Rev
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2014;13:931-5.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/24879082" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24879082</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>9.</dt><dd><div class="bk_ref" id="LM510.REF.9">Erol-Coskun
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H, Karagur
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N, Akyol
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F, et al.
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Ursodiol use during breastfeeding: A case report.
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Reprod Toxicol
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2018;80:59. doi:10.1016/j.reprotox.2018.07.070 [<a href="http://dx.crossref.org/10.1016/j.reprotox.2018.07.070" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl></dl></div></div><div id="LM510.Substance_Identification"><h2 id="_LM510_Substance_Identification_">Substance Identification</h2><div id="LM510.Substance_Name"><h3>Substance Name</h3><p>Ursodiol</p></div><div id="LM510.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>128-13-2</p></div><div id="LM510.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Bile Acids and Salts</p><p>Cholagogues and Choleretics</p><p>Cholic Acids</p><p>Gastrointestinal Agents</p></div></div><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_top_margin"><p><b>Disclaimer: </b>Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.</p></p></div></dd></dl></dl></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK501389_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Revision: <span itemprop="dateModified">August 15, 2024</span>.</p><h3>Copyright</h3><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a><p class="small"><b>Attribution Statement:</b> LactMed is a registered trademark of the U.S. Department of Health and Human Services.</p></div></div><h3>Publisher</h3><p><a href="https://www.nlm.nih.gov/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute of Child Health and Human Development</a>, Bethesda (MD)</p><h3>NLM Citation</h3><p>Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. Ursodiol. [Updated 2024 Aug 15].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/lactmed/LM1142/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M75,30 c-80,60 -80,0 0,60 c-30,-60 -30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Prev</text></svg></a></div><div class="small-screen-next"><a href="/books/n/lactmed/LM1032/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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