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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Rosuvastatin - Drugs and Lactation Database (LactMed®) - NCBI Bookshelf</title>
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<meta name="citation_title" content="Rosuvastatin">
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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="2025/02/15">
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<meta name="citation_keywords" content="Ezallor">
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<meta name="citation_keywords" content="HSDB 7317">
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<meta name="citation_keywords" content="(E,3R,5S)-7-[4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid">
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<meta name="description" content="Levels of rosuvastatin in milk are low, and one case of an older infant breastfed during maternal rosuvastatin therapy found no adverse effects. The consensus opinion is that women taking a statin should not breastfeed because of a concern with disruption of infant lipid metabolism. However, others have argued that children homozygous for familial hypercholesterolemia are treated with statins beginning at 1 year of age, that statins have low oral bioavailability, and risks to the breastfed infant are low, especially with rosuvastatin and pravastatin.[1] Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.">
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<meta name="og:description" content="Levels of rosuvastatin in milk are low, and one case of an older infant breastfed during maternal rosuvastatin therapy found no adverse effects. The consensus opinion is that women taking a statin should not breastfeed because of a concern with disruption of infant lipid metabolism. However, others have argued that children homozygous for familial hypercholesterolemia are treated with statins beginning at 1 year of age, that statins have low oral bioavailability, and risks to the breastfed infant are low, especially with rosuvastatin and pravastatin.[1] Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.">
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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="_NBK501362_"><span class="title" itemprop="name">Rosuvastatin</span></h1><p class="fm-aai"><a href="#_NBK501362_pubdet_">Publication Details</a></p><p><em>Estimated reading time: 2 minutes</em></p></div></div><div class="jig-ncbiinpagenav body-content whole_rhythm" data-jigconfig="allHeadingLevels: ['h2'],smoothScroll: false" itemprop="text"><p>CASRN: 287714-41-4</p><a href="https://pubchem.ncbi.nlm.nih.gov/substance/135084331" 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=135084331" alt="image 135084331 in the ncbi pubchem database" /></a><div id="LM486.Drug_Levels_and_Effects"><h2 id="_LM486_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM486.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>Levels of rosuvastatin in milk are low, and one case of an older infant breastfed during maternal rosuvastatin therapy found no adverse effects. The consensus opinion is that women taking a statin should not breastfeed because of a concern with disruption of infant lipid metabolism. However, others have argued that children homozygous for familial hypercholesterolemia are treated with statins beginning at 1 year of age, that statins have low oral bioavailability, and risks to the breastfed infant are low, especially with rosuvastatin and pravastatin.[<a class="bibr" href="#LM486.REF.1" rid="LM486.REF.1">1</a>] Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.</p></div><div id="LM486.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> A woman with familial hypercholesterolemia was started on rosuvastatin 40 mg daily on day 33 postpartum. On one unspecified day after beginning rosuvastatin, the breastmilk rosuvastatin concentration was about 22 mcg/L at 21 hours after the previous dose. One hour after the dose, the breastmilk concentration was 15.2 mcg/L, and 7 hours after the dose, the breastmilk concentration was 29.4 mcg/L. Breastmilk concentrations were also measured on day 4 at 3 hours after the dose, day 24 at 3.8 hours after the dose, and on day 80 at 21 hours after the dose. All of these concentrations were in the range of 21 to 22 mcg/L.[<a class="bibr" href="#LM486.REF.2" rid="LM486.REF.2">2</a>]</p><p>Rosuvastatin was being initiated in a nursing mother who was 13 months postpartum and weaning her infant. She began with a dose of 20 mg daily at bedtime. After 5 days of therapy, she donated 8 milk samples over a 24-hour period. The trough milk concentration was 16.6 mcg/L at 5 hours after the dose and remained relatively constant until about 15 hours after the dose. The peak milk concentration of 58.6 mcg/L occurred 17 hours after the dose. The authors calculated a daily infant dosage of 4.63 mcg/kg, which corresponded to a weight-adjusted 1.5% of the maternal dose.[<a class="bibr" href="#LM486.REF.3" rid="LM486.REF.3">3</a>]</p><p><i>Infant Levels.</i> Relevant published information was not found as of the revision date.</p></div><div id="LM486.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>A mother with familial hypercholesterolemia hypothyroidism stopped treatment of hyperlipidemia before pregnancy and lactation. At 13 months postpartum she began rosuvastatin 10 mg daily. At the time, the infant was receiving solid foods with 3 to 4 daytime breastfeeds and 2 to 3 nighttime breastfeeds. Lipid parameters in the infant were obtained at baseline and 1 and 5 months after the start of rosuvastatin. All lipid parameters (total cholesterol, triglycerides, HDL and LDL) remained in the normal range over the 5 months. All developmental parameters were normal except for weight at the 97<sup>th</sup> percentile at 18 months.[<a class="bibr" href="#LM486.REF.4" rid="LM486.REF.4">4</a>]</p></div><div id="LM486.Effects_on_Lactation_and_Breastmil"><h3>Effects on Lactation and Breastmilk</h3><p>A possible case of rosuvastatin-induced gynecomastia has been reported. Serum prolactin was not measured.[<a class="bibr" href="#LM486.REF.5" rid="LM486.REF.5">5</a>]</p></div><div id="LM486.Alternate_Drugs_to_Consider"><h3>Alternate Drugs to Consider</h3><p><a href="/books/n/lactmed/LM515/?report=reader">Cholestyramine</a>, <a href="/books/n/lactmed/LM516/?report=reader">Colesevelam</a>, <a href="/books/n/lactmed/LM514/?report=reader">Colestipol</a></p></div><div id="LM486.References"><h3>References</h3><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="LM486.REF.1">Holmsen
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ST, Bakkebo
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T, Seferowicz
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M, et al.
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Statins and breastfeeding in familial hypercholesterolaemia.
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Tidsskr Nor Laegeforen
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2017;137:686-7.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/28551957" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28551957</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>2.</dt><dd><div class="bk_ref" id="LM486.REF.2">Schutte
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AE, Symington
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EA, du Preez, JL. Rosuvastatin is transferred into human breast milk: A case report.
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Am J Med
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2013;126:e7-8.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/23968910" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23968910</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>3.</dt><dd><div class="bk_ref" id="LM486.REF.3">Lwin
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EMP, Leggett
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C, Ritchie
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U, et al.
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Transfer of rosuvastatin into breast milk: Liquid chromatography-mass spectrometry methodology and clinical recommendations.
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Drug Des Devel Ther
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2018;12:3645-51.
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[<a href="/pmc/articles/PMC6211583/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6211583</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/30464396" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30464396</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>4.</dt><dd><div class="bk_ref" id="LM486.REF.4">Karatekin
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Ş, Şenol
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E.
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Neurodevelopmental and growth follow-up of an infant exposed to rosuvastatin by lactation: A case report.
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Breastfeed Med
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2025.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/39866136" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 39866136</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>5.</dt><dd><div class="bk_ref" id="LM486.REF.5">Oteri
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A, Catania
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MA, Travaglini
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R, et al.
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Gynecomastia possibly induced by rosuvastatin.
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Pharmacotherapy
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2008;28:549-51.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/18363539" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 18363539</span></a>]</div></dd></dl></dl></div></div><div id="LM486.Substance_Identification"><h2 id="_LM486_Substance_Identification_">Substance Identification</h2><div id="LM486.Substance_Name"><h3>Substance Name</h3><p>Rosuvastatin</p></div><div id="LM486.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>287714-41-4</p></div><div id="LM486.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Anticholesteremic Agents</p><p>Antilipemic Agents</p><p>Hydroxymethylglutaryl-CoA Reductase Inhibitors</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="_NBK501362_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Revision: <span itemprop="dateModified">February 15, 2025</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-. Rosuvastatin. [Updated 2025 Feb 15].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/lactmed/LM241/?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/LM733/?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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