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<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE" /><meta name="citation_inbook_title" content="LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]" /><meta name="citation_title" content="Red Yeast Rice" /><meta name="citation_publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases" /><meta name="citation_date" content="2018/06/04" /><meta name="citation_pmid" content="31643497" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK548168/" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Red Yeast Rice" /><meta name="DC.Type" content="Text" /><meta name="DC.Publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases" /><meta name="DC.Date" content="2018/06/04" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK548168/" /><meta name="description" content="Red yeast rice is bright reddish-purple fermented rice which is used as a dietary supplement, predominantly as a cholesterol lowering agent. The reddish-purple color derives from the mold Monascus purpureus. Red yeast rice use has been associated with very rare instances of acute, clinically apparent liver injury." /><meta name="og:title" content="Red Yeast Rice" /><meta name="og:type" content="book" /><meta name="og:description" content="Red yeast rice is bright reddish-purple fermented rice which is used as a dietary supplement, predominantly as a cholesterol lowering agent. The reddish-purple color derives from the mold Monascus purpureus. Red yeast rice use has been associated with very rare instances of acute, clinically apparent liver injury." /><meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK548168/" /><meta name="og:site_name" content="NCBI Bookshelf" /><meta name="og:image" content="https://www.ncbi.nlm.nih.gov/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-livertox-lrg.png" /><meta name="twitter:card" content="summary" /><meta name="twitter:site" content="@ncbibooks" /><meta name="bk-non-canon-loc" content="/books/n/livertox/RedYeastRice/" /><link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK548168/" /><link rel="stylesheet" href="/corehtml/pmc/css/figpopup.css" type="text/css" media="screen" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books.min.css" type="text/css" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books_print.min.css" type="text/css" media="print" /><style type="text/css">p a.figpopup{display:inline !important} .bk_tt {font-family: monospace} .first-line-outdent .bk_ref {display: inline} .body-content h2, .body-content .h2 {border-bottom: 1px solid #97B0C8} .body-content h2.inline {border-bottom: none} a.page-toc-label , .jig-ncbismoothscroll a {text-decoration:none;border:0 !important} .temp-labeled-list .graphic {display:inline-block !important} .temp-labeled-list img{width:100%}</style><script type="text/javascript" src="/corehtml/pmc/js/jquery.hoverIntent.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/common.min.js?_=3.18"> </script><script type="text/javascript" src="/corehtml/pmc/js/large-obj-scrollbars.min.js"> </script><script type="text/javascript">window.name="mainwindow";</script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/book-toc.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/books.min.js"> </script><meta name="book-collection" content="NONE" />
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<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. </p></div><div class="iconblock clearfix whole_rhythm no_top_margin bk_noprnt"><a class="img_link icnblk_img" title="All Drug Records" href="/books/n/livertox/"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-livertox-lrg.png" alt="Cover of LiverTox" height="100px" width="80px" /></a><div class="icnblk_cntnt eight_col"><h2>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].</h2><a data-jig="ncbitoggler" href="#__NBK548168_dtls__">Show details</a><div style="display:none" class="ui-widget" id="__NBK548168_dtls__"><div>Bethesda (MD): <a href="https://www.niddk.nih.gov/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute of Diabetes and Digestive and Kidney Diseases</a>; 2012-.</div></div><div class="half_rhythm"><ul class="inline_list"><li style="margin-right:1em"><a class="bk_cntns" href="/books/n/livertox/">Drug Records</a></li></ul></div><div class="bk_noprnt"><form method="get" action="/books/n/livertox/" id="bk_srch"><div class="bk_search"><label for="bk_term" class="offscreen_noflow">Search term</label><input type="text" title="Search this book" id="bk_term" name="term" value="" data-jig="ncbiclearbutton" /> <input type="submit" class="jig-ncbibutton" value="Search this book" submit="false" style="padding: 0.1em 0.4em;" /></div></form></div></div><div class="icnblk_cntnt two_col"><div class="pagination bk_noprnt"><a class="active page_link prev" href="/books/n/livertox/Ravulizumab/" title="Previous page in this title">< Prev</a><a class="active page_link next" href="/books/n/livertox/Regorafenib/" title="Next page in this title">Next ></a></div></div></div></div></div>
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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><h1 id="_NBK548168_"><span class="title" itemprop="name">Red Yeast Rice</span></h1><p class="small">Last Update: <span itemprop="dateModified">June 4, 2018</span>.</p></div><div class="body-content whole_rhythm" itemprop="text"><div id="RedYeastRice.OVERVIEW"><h2 id="_RedYeastRice_OVERVIEW_">OVERVIEW</h2><div id="RedYeastRice.Introduction"><h3>Introduction</h3><p>Red yeast rice is bright reddish-purple fermented rice which is used as a dietary supplement, predominantly as a cholesterol lowering agent. The reddish-purple color derives from the mold Monascus purpureus. Red yeast rice use has been associated with very rare instances of acute, clinically apparent liver injury.</p></div><div id="RedYeastRice.Background"><h3>Background</h3><p>Red yeast rice is a traditional Chinese medicine used as an aid to digestion and revitalizing agent. More recently, red yeast rice was shown to have a cholesterol lowering effect and was marketed as a natural means of treating hyperlipidemia. However, chemical characterization of the components of red yeast rice (monascus purpureus) demonstrated the presence of several monacolins, one of which (monacolin K) is chemically identical to lovastatin, a commercially available HMG-coenzyme A inhibitor widely used in the management of hyperlipidemia. While concentrations of lovastatin in commercial preparations of red yeast rice extract are variable, some have pharmacologically active concentrations of lovastatin. Controlled trials have shown that red yeast rice extract can lower total serum and LDL cholesterol. However, these same preparations have also been linked to rare cases of myopathy and liver injury similar to what occurs with lovastatin. Red yeast rice extracts are available over-the-counter in multiple formulations and with variable concentrations of monacolins. The FDA has ruled that red yeast rice extracts that have more than trace amounts of monacolin K (lovastatin) cannot be sold as a dietary supplement, but some products with detectable levels of lovastatin are commercially available. The other components of red yeast rice may have independent effects of lipid levels.</p></div><div id="RedYeastRice.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In prospective controlled trials, red yeast rice extract formulations have not been associated with serum enzyme elevations or clinically apparent liver injury. However, there have been isolated case reports of liver injury in patients on red yeast rice extracts. A proportion of patients with liver injury attributed to red yeast rice extract were reported to have similar episodes of serum enzyme elevations during conventional lovastatin therapy.</p><p><a class="def" href="/books/n/livertox/glossary/def-item/glossary.likelihood-score/">Likelihood score</a>: C (probable rare cause of clinically apparent liver injury).</p></div><div id="RedYeastRice.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>Both the liver injury and myopathies attributed to red yeast rice extracts are probably due to the presence of lovastatin in concentrations of 1 to 10 mg per tablet. Lovastatin is metabolized in the liver via CYP 3A4 and its liver injury is likely due to a toxic or immunogenic metabolite.</p></div><div id="RedYeastRice.Outcome_and_Management"><h3>Outcome and Management</h3><p>The reported cases of liver injury attributed to red yeast rice have been mild-to-moderate in severity and self-limited in course. There have been no cases of acute liver failure or vanishing bile duct syndrome attributed to red yeast rice. Persons with liver injury attributed to red yeast rice extracts should avoid exposure to lovastatin, but switching to other statins may be safe, although it should be done with caution.</p><p>Drug Class: <a href="/books/n/livertox/HerbalDietarySuppl/">Herbal and Dietary Supplements</a></p><p>See also: <a href="/books/n/livertox/Lovastatin/">Lovastatin</a></p></div></div><div id="RedYeastRice.CASE_REPORT"><h2 id="_RedYeastRice_CASE_REPORT_">CASE REPORT</h2><div id="RedYeastRice.Case_1._Acute_hepatitis_due"><h3>Case 1. Acute hepatitis due to red yeast rice.</h3><p>[Case from: Navarro VJ, Barnhart H, Bonkovsky HL, Davern T, Fontana RJ, Grant L, Reddy KR, et al. Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network. Hepatology 2014; 60:1399-408. <a href="https://www.ncbi.nlm.nih.gov/pubmed/25043597" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">PubMed Citation</a>]</p><p>A 67 year old woman with hypercholesterolemia developed abnormal liver tests 7 weeks after starting red yeast rice. She had a history of abnormal liver tests in the past, but routine testing before starting red yeast rice revealed minimal elevations of <a class="def" href="/books/n/livertox/glossary/def-item/glossary.alanine-aminotransferase-alt-/">ALT</a> levels (47 U/L), but normal values for <a class="def" href="/books/n/livertox/glossary/def-item/glossary.aspartate-aminotransferase-ast-/">AST</a>, alkaline phosphatase and bilirubin. She did not drink alcohol, had no risk factors for viral hepatitis and no history of drug allergies. Her past medical history included hypertension, aortic valve replacement, hysterectomy, hypothyroidism, osteoporosis and previous urinary tract infections. Her other medications included valsartan, hydrochlorothiazide, low dose aspirin, thyroid extract, multivitamins, calcium, magnesium, zinc and Metamucil, all of which she had taken for more than a year. Laboratory testing initially showed an ALT of 479 U/L, AST 330 U/L, alkaline phosphatase 228 U/L and total bilirubin 0.7. She felt well and had no new symptoms. The red yeast rice was continued and she was followed as an outpatient. Over the next two weeks, however, her liver tests worsened and the red yeast rice was stopped. She subsequently developed fatigue, nausea, dark urine and jaundice (Table). Tests for acute hepatitis A, B, C and E were negative as were routine autoantibodies. Serum albumin ws 4.0 g/dL and globulins 2.3 g/dL. An abdominal ultrasound and CT scan were normal with normal liver size and texture and no evidence of biliary obstruction or masses. She underwent a liver biopsy that showed acute hepatocellular injury without fibrosis, consistent with either a drug induced liver injury or autoimmune hepatitis. She was monitored on no therapy and gradually improved. When seen one year after stopping the botanical product, she was asymptomatic and all liver tests were normal.</p><div id="RedYeastRice.Key_Points"><h4>Key Points</h4><div id="RedYeastRice.T1" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548168/table/RedYeastRice.T1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__RedYeastRice.T1_lrgtbl__"><table><tbody><tr><td rowspan="1" colspan="1" style="font-weight:bold;vertical-align:top;">Medication:</td><td rowspan="1" colspan="1" style="vertical-align:top;">Red yeast rice</td></tr><tr><td rowspan="1" colspan="1" style="font-weight:bold;vertical-align:top;">Pattern:</td><td rowspan="1" colspan="1" style="vertical-align:top;">Hepatocellular (R ratio=6.8)</td></tr><tr><td rowspan="1" colspan="1" style="font-weight:bold;vertical-align:top;">Severity:</td><td rowspan="1" colspan="1" style="vertical-align:top;">2+ (jaundice, not hospitalized)</td></tr><tr><td rowspan="1" colspan="1" style="font-weight:bold;vertical-align:top;"><a class="def" href="/books/n/livertox/glossary/def-item/glossary.latency/">Latency</a>:</td><td rowspan="1" colspan="1" style="vertical-align:top;">7 weeks</td></tr><tr><td rowspan="1" colspan="1" style="font-weight:bold;vertical-align:top;">Recovery:</td><td rowspan="1" colspan="1" style="vertical-align:top;">Approximately 4 months</td></tr><tr><td rowspan="1" colspan="1" style="font-weight:bold;vertical-align:top;">Other medications:</td><td rowspan="1" colspan="1" style="vertical-align:top;">Valsartan, hydrochlorothiazide, aspirin, thyroid extract</td></tr></tbody></table></div></div></div><div id="RedYeastRice.Laboratory_Values"><h4>Laboratory Values</h4><div id="RedYeastRice.T2" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548168/table/RedYeastRice.T2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__RedYeastRice.T2_lrgtbl__"><table><tbody><tr><th id="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">Time After<br />Starting</th><th id="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">Time After<br />Stopping</th><th id="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><a class="def" href="/books/n/livertox/glossary/def-item/glossary.alanine-aminotransferase-alt-/">ALT</a><br />(U/L)</th><th id="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">Alk P<br />(U/L)</th><th id="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;"><a class="def" href="/books/n/livertox/glossary/def-item/glossary.bilirubin/">Bilirubin</a><br />(mg/dL)</th><th id="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:top;">Other</th></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Pre</td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;"></td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">47</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">106</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">0.5</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;"></td></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">7 weeks</td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">-7</td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">479</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">228</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">0.7</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;"></td></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">8 weeks</td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">2 days</td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">864</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">356</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">1.0</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">INR 1.0</td></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;"></td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">9 days</td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">1101</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">413</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">0.6</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">Liver biopsy</td></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">12 weeks</td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">37 days</td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">1185</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">290</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">6.3</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;"></td></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">14 weeks</td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">48 days</td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">970</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">294</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">4.2</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;"></td></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">15 weeks</td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">55 days</td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">861</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">169</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">3.5</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">INR 1.0</td></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">16 weeks</td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">62 days</td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">620</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">150</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">2.7</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;"></td></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">17 weeks</td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">69 days</td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">643</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">161</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">3.1</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;"></td></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">18 weeks</td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">76 days</td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">582</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">146</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">3.2</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;"></td></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">19 weeks</td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">83 days</td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">482</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">143</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">4.1</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;"></td></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">4 months</td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">90 days</td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">451</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">154</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">3.7</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">INR 1.0</td></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">1 year</td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">1 year</td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">20</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">106</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">0.8</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;"></td></tr><tr><td headers="hd_b_RedYeastRice.T2_1_1_1_1" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">
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<b>Normal Values</b>
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</td><td headers="hd_b_RedYeastRice.T2_1_1_1_2" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;"></td><td headers="hd_b_RedYeastRice.T2_1_1_1_3" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">
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<b><45</b>
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</td><td headers="hd_b_RedYeastRice.T2_1_1_1_4" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">
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<b><125</b>
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</td><td headers="hd_b_RedYeastRice.T2_1_1_1_5" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;">
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<b><1.2</b>
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</td><td headers="hd_b_RedYeastRice.T2_1_1_1_6" rowspan="1" colspan="1" style="text-align:center;vertical-align:middle;"></td></tr></tbody></table></div></div></div><div id="RedYeastRice.Comment"><h4>Comment</h4><p>This patient developed an acute hepatitis arising about 2 months after starting red yeast rice for hypercholesterolemia. The hepatitis was mild-to-moderate in severity, but was prolonged which raised the question of autoimmune hepatitis. Against this diagnsosis was the absence of autoantibodies and normal serum globulin levels. She did not receive corticosteroids and ultimately the liver injury resolved. This case was reviewed by an expert causality committee and was judged to be "highly likely" drug induced liver injury from red yeast rice.</p></div></div></div><div id="RedYeastRice.PRODUCT_INFORMATION"><h2 id="_RedYeastRice_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><div id="RedYeastRice.BPI" class="box"><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Red Yeast Rice – Generic</p><p>
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<b>DRUG CLASS</b>
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</p><p>Herbal and <a class="def" href="/books/n/livertox/glossary/def-item/glossary.dietary-supplements/">Dietary Supplements</a></p><p>SUMMARY INFORMATION</p><p>
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<a href="https://nccih.nih.gov/health/redyeastrice" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Fact Sheet at National Center for Complementary and Integrative Health, NIH</a>
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</p></div></div><div id="RedYeastRice.CHEMICAL_FORMULA_AND_STRUCT"><h2 id="_RedYeastRice_CHEMICAL_FORMULA_AND_STRUCT_">CHEMICAL FORMULA AND STRUCTURE</h2><div id="RedYeastRice.T3" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548168/table/RedYeastRice.T3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__RedYeastRice.T3_lrgtbl__"><table><thead><tr><th id="hd_h_RedYeastRice.T3_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">DRUG</th><th id="hd_h_RedYeastRice.T3_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">CAS REGISTRY NUMBER</th><th id="hd_h_RedYeastRice.T3_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_RedYeastRice.T3_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_RedYeastRice.T3_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Red Yeast Rice<br /> Monacolin K<br /> (Lovastatin)</td><td headers="hd_h_RedYeastRice.T3_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">R400000000</td><td headers="hd_h_RedYeastRice.T3_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">Unspecified</td><td headers="hd_h_RedYeastRice.T3_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">Not Applicable</td></tr></tbody></table></div></div></div><div id="RedYeastRice.ANNOTATED_BIBLIOGRAPHY"><h2 id="_RedYeastRice_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 04 June 2018</p><ul class="first-line-outdent"><li><div class="bk_ref" id="RedYeastRice.R1">Zimmerman HJ. Unconventional drugs. Miscellaneous drugs and diagnostic chemicals. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 731-4.<div><i>(Expert review of hepatotoxicity published in 1999; several herbal medications are discussed, but not red yeast rice).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R2">Seeff L, Stickel F, Navarro VJ. Hepatotoxicity of herbals and dietary supplements. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, p. 631-58.<div><i>(Review of hepatotoxicity of herbal and dietary supplements [HDS]; red yeast rice is not discussed).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R3">Stedman C. Herbal hepatotoxicity. Semin Liver Dis 2002; 22: 195-206. [<a href="https://pubmed.ncbi.nlm.nih.gov/12016550" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12016550</span></a>]<div><i>(Review and description of patterns of liver injury, including discussion of potential risk factors, and herb-drug interactions).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R4">Keithley JK, Swanson B, Sha BE, Zeller JM, Kessler HA, Smith KY. A pilot study of the safety and efficacy of cholestin in treating HIV-related dyslipidemia. Nutrition 2002; 18: 201-4. [<a href="https://pubmed.ncbi.nlm.nih.gov/11844656" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11844656</span></a>]<div><i>(In a controlled trial of cholestin [~5 mg of lovastatin] vs placebo for 8 weeks in 12 patients with hyperlipidemia, there were no changes in "hepatic function").</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R5">Roselle H, Ekatan A, Tzeng J, Sapienza M, Kocher J. Symptomatic hepatitis associated with the use of herbal red yeast rice. Ann Intern Med 2008; 149: 516-7. [<a href="https://pubmed.ncbi.nlm.nih.gov/18838736" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 18838736</span></a>]<div><i>(62 year old woman developed fever, nausea and fatigue 4 months after starting red yeast rice extract [ALT 211 U/L, bilirubin and Alk P not given], resolving within several months of stopping).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R6">Grieco A, Miele L, Pompili M, Biolato M, Vecchio FM, Grattagliano I, Gasbarrini G. Acute hepatitis caused by a natural lipid-lowering product: when "alternative" medicine is no "alternative" at all. J Hepatol 2009; 50: 1273-7. [<a href="https://pubmed.ncbi.nlm.nih.gov/19398239" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19398239</span></a>]<div><i>(63 year old woman with ALT elevations after 6 months of lovastatin use, developed fatigue 6 months after starting a cholesterol lowering herbal preparation containing red yeast rice extract [bilirubin 1.9 mg/dL, ALT 1760 U/L, Alk P 722 U/L], resolving over the next 6 months, but with persistence of ALT elevations).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R7">Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, Yang H, Rochon J; Drug Induced Liver Injury Network (DILIN). Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology 2008; 135: 1924-34. [<a href="/pmc/articles/PMC3654244/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3654244</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/18955056" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 18955056</span></a>]<div><i>(Among 300 cases of drug induced liver disease in the US collected between 2004 and 2008, 9% of cases were attributed to herbal medications, but no case was attributed to red yeast rice).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R8">Navarro VJ. Herbal and dietary supplement hepatotoxicity. Semin Liver Dis 2009; 29: 373-382. [<a href="https://pubmed.ncbi.nlm.nih.gov/19826971" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19826971</span></a>]<div><i>(Overview of the regulatory environment, clinical patterns, and future directions in research with HDS; red yeast rice is not listed as a potential hepatotoxin).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R9">Jacobsson I, Jönsson AK, Gerdén B, Hägg S. Spontaneously reported adverse reactions in association with complementary and alternative medicine substances in Sweden. Pharmacoepidemiol Drug Saf 2009; 18: 1039-47. [<a href="https://pubmed.ncbi.nlm.nih.gov/19650152" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19650152</span></a>]<div><i>(Review of 778 spontaneous reports of adverse reactions to herbals to Swedish Registry; no instance was linked to red yeast rice extracts).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R10">Becker DJ, Gordon RY, Halbert SC, French B, Morris PB, Rader DJ. Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial. Ann Intern Med 2009; 150: 830-9. [<a href="https://pubmed.ncbi.nlm.nih.gov/19528562" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19528562</span></a>]<div><i>(Controlled trial of red yeast rice extract vs placebo in 62 patients who had stopped statin therapy because of myalgias, found similar rates of myalgias [7% vs 3%] and no change in ALT or AST levels in both groups).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R11">Halbert SC, French B, Gordon RY, Farrar JT, Schmitz K, Morris PB, Thompson PD, et al. Tolerability of red yeast rice (2,400 mg twice daily) versus pravastatin (20 mg twice daily) in patients with previous statin intolerance. Am J Cardiol 2010; 105: 198-204. [<a href="https://pubmed.ncbi.nlm.nih.gov/20102918" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20102918</span></a>]<div><i>(43 patients with myalgias due to statin use were treated with pravastatin or red rice extract for 24 weeks; discontinuation due to myalgias occurred in 5% on red yeast rice extract and 9% on pravastatin, and mean ALT levels were similar between the 2 groups).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R12">Venero CV, Venero JV, Wortham DC, Thompson PD. Lipid-lowering efficacy of red yeast rice in a population intolerant to statins. Am J Cardiol 2010; 105: 664-6. [<a href="https://pubmed.ncbi.nlm.nih.gov/20185013" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20185013</span></a>]<div><i>(Retrospective analysis of 25 patients who were treated with red yeast rice extract for hyperlipidemia; 2 patients had ALT elevations before treatment, which persisted during follow up, but were never >2 times ULN).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R13">Reuben A, Koch DG, Lee WM; Acute Liver Failure Study Group. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology 2010; 52: 2065-76. [<a href="/pmc/articles/PMC3992250/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3992250</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/20949552" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20949552</span></a>]<div><i>(Among 1198 patients with acute liver failure enrolled in a US prospective study between 1998 and 2007, 133 [11%] were attributed to drug induced liver injury, of which 12 [9%] were due to herbals, including several herbal mixtures, usnic acid, Ma Huang, black cohosh, and Hydroxycut, but not red yeast rice).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R14">Gordon RY, Cooperman T, Obermeyer W, Becker DJ. Marked variability of monacolin levels in commercial red yeast rice products: buyer beware! Arch Intern Med 2010; 170: 1722-7. [<a href="https://pubmed.ncbi.nlm.nih.gov/20975018" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20975018</span></a>]<div><i>(Among 12 red yeast rice extracts commercially available in the US, total monacolin concentrations varied from 0.3-11.1 mg/capsule, monacolin K by 0.1-10.1 mg/capsule, and citrinin [which is nephrotoxic] was present in 4).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R15">Yang CW, Mousa SA. The effect of red yeast rice(Monascus purpureus) in dyslipidemia and other disorders. Complement Ther Med 2012; 20: 466-74. [<a href="https://pubmed.ncbi.nlm.nih.gov/23131380" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23131380</span></a>]<div><i>(Review of literature on efficacy of red yeast rice products found 22 clinical trials; no discussion of safety, ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R16">Teschke R, Wolff A, Frenzel C, Schulze J, Eickhoff A. Herbal hepatotoxicity: a tabular compilation of reported cases. Liver Int 2012; 32: 1543-56. [<a href="https://pubmed.ncbi.nlm.nih.gov/22928722" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22928722</span></a>]<div><i>(A systematic compilation of all publications on the hepatotoxicity of specific herbals identified 185 publications on 60 different herbs, herbal drugs and supplements; one implicated red yeast rice [Roselle 2008]). </i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R17">Sartore G, Burlina S, Ragazzi E, Ferraresso S, Valentini R, Lapolla A. Mediterranean diet and red yeast rice supplementation for the management of hyperlipidemia in statin-intolerant patients with or without type 2 diabetes. Evid Based Complement Alternat Med 2013; 2013: 743473. Epub 2013 Dec 23. [<a href="/pmc/articles/PMC3884966/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3884966</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/24454511" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24454511</span></a>]<div><i>(Among 171 patients with dyslipidemia who were intolerant of statins and were treated with a mediterranean diet with or without red yeast rice for 24 weeks, there was no increase in ALT or AST in any subject).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R18">Li Y, Jiang L, Jia Z, Xin W, Yang S, Yang Q, Wang L. A meta-analysis of red yeast rice: an effective and relatively safe alternative approach for dyslipidemia. PLoS One 2014; 9: e98611. [<a href="/pmc/articles/PMC4045580/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4045580</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/24897342" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24897342</span></a>]<div><i>(Metaanalysis of 13 randomized controlled trials of red yeast rice found that it lowered LDL cholesterol levels, but had no effect on HDL cholesterol, and serum ALT and AST levels were significantly higher with red yeast rice treatment groups).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R19">Navarro VJ, Barnhart H, Bonkovsky HL, Davern T, Fontana RJ, Grant L, Reddy KR, et al. Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network. Hepatology 2014; 60:1399-408. [<a href="/pmc/articles/PMC4293199/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4293199</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/25043597" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25043597</span></a>]<div><i>(Among 85 cases of HDS associated liver injury [not due to anabolic steroids] enrolled in a US prospective study between 2004 and 2013, the single most commonly implicated herbal agent was green tea extract and only one case was exposed to red yeast rice).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R20">Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al.; United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. Gastroenterology 2015; 148: 1340-52. [<a href="/pmc/articles/PMC4446235/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4446235</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/25754159" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25754159</span></a>]<div><i>(Among 899 cases of drug induced liver injury enrolled in a prospective database between 2004 and 2012, HDS were implicated in 145 [16%], the single major herbal cause being green tea extract and one case attributed to red yeast rice).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R21">Red yeast rice: muscle and liver disorders. Prescrire Int 2015; 24: 156. [<a href="https://pubmed.ncbi.nlm.nih.gov/26436170" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26436170</span></a>]<div><i>(Between 2009 and 2013, 30 adverse events due to red yeast rice were reported to a French Nutrivigilance Registry, including 9 cases of muscle damage [1 rhabdomyolysis], 8 of liver injury, and 1 of Stevens Johnson syndrome which were attributed to monacolin K found in amounts of 0.1 to 10 mg per tablet).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R22">García-Cortés M, Robles-Díaz M, Ortega-Alonso A, Medina-Caliz I, Andrade RJ. Hepatotoxicity by dietary supplements: A tabular listing and clinical characteristics. Int J Mol Sci 2016; 17. pii: E537. <em>(Listing of published cases of liver injury from HDS products, does not list red yeast rice).</em> [<a href="/pmc/articles/PMC4848993/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4848993</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/27070596" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27070596</span></a>]</div></li><li><div class="bk_ref" id="RedYeastRice.R23">Mazzanti G, Moro PA, Raschi E, Da Cas R, Menniti-Ippolito F. Adverse reactions to dietary supplements containing red yeast rice: assessment of cases from the Italian surveillance system. Br J Clin Pharmacol 2017; 83: 894-908. <em> (Between 2002 and 2015, 9 cases of drug induced liver injury attributed to red yeast rice were reported to an Italian surveillance system, cases usually arising within 90 days and resolving with stopping; 6 hospitalizations but no deaths</em>. [<a href="/pmc/articles/PMC5346868/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5346868</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/28093797" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28093797</span></a>]<div><i>).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R24">Cicero AFG, Fogacci F, Rosticci M, Parini A, Giovannini M, Veronesi M, D'Addato S, et al. Effect of a short-term dietary supplementation with phytosterols, red yeast rice or both on lipid pattern in moderately hypercholesterolemic subjects: a three-arm, double-blind, randomized clinical trial. Nutr Metab (Lond) 2017; 14: 61. [<a href="/pmc/articles/PMC5613479/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5613479</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/29021813" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29021813</span></a>]<div><i> (Among 90 patients with hyperlipidemia treated for 8 weeks, LDL cholesterol levels decreased with red yeast rice but not phytosterols; no mention of adverse events or ALT changes).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R25">Vega M, Verma M, Beswick D, Bey S, Hossack J, Merriman N, Shah A, et al.; Drug Induced Liver Injury Network (DILIN). The incidence of drug- and herbal and dietary supplement-induced liver injury: preliminary findings from gastroenterologist-based surveillance in the population of the State of Delaware. Drug Saf 2017; 40: 783-7. [<a href="/pmc/articles/PMC5699929/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5699929</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/28555362" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28555362</span></a>]<div><i>(A prospective, population based registry of cases of drug induced liver injury occurring in Delaware during 2014, identified 20 cases [2.7 per 100,000] overall, including 6 due to HDS products, all of which were proprietary multiingredient products and none mentioned red yeast rice as a component).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R26">Brown AC. Liver toxicity related to herbs and dietary supplements: Online table of case reports. Part 2 of 5 series. Food Chem Toxicol 2017; 107 (Pt A): 472-501. [<a href="https://pubmed.ncbi.nlm.nih.gov/27402097" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27402097</span></a>]<div><i> (Description of an online compendium of cases of liver toxicity attributed to HDS products, lists one published case linked to red yeast rice [Roselle 2008]).</i></div></div></li><li><div class="bk_ref" id="RedYeastRice.R27">Raschi E, Girardi A, Poluzzi E, Forcesi E, Menniti-Ippolito F, Mazzanti G, De Ponti F. Adverse events to food supplements containing red yeast rice: comparative analysis of FAERS and CAERS reporting systems. Drug Saf 2018 Mar 26. [Epub ahead of print] [<a href="https://pubmed.ncbi.nlm.nih.gov/29582393" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29582393</span></a>]<div><i>(Analysis of two large US surveillance systems for adverse events reported between 2004 and 2017 found 1459 reports mentioning red yeast rice, only 1% of which were designated a hepatobiliary related; no details provided).</i></div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div>
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<div xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Views</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="PDF_download" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/NBK548168/?report=reader">PubReader</a></li><li><a href="/books/NBK548168/?report=printable">Print View</a></li><li><a data-jig="ncbidialog" href="#_ncbi_dlg_citbx_NBK548168" data-jigconfig="width:400,modal:true">Cite this Page</a><div id="_ncbi_dlg_citbx_NBK548168" style="display:none" title="Cite this Page"><div class="bk_tt">LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Red Yeast Rice. [Updated 2018 Jun 4].<span class="bk_cite_avail"></span></div></div></li><li><a href="/books/NBK548168/pdf/Bookshelf_NBK548168.pdf">PDF version of this page</a> (125K)</li><li><a href="#" class="toggle-glossary-link" title="Enable/disable links to the glossary">Disable Glossary Links</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>New and Updated</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="source-links" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="https://pubmed.ncbi.nlm.nih.gov/?term=%22LiverTox%22+AND+pmcbook&sort=date&size=200" ref="pagearea=source-links&targetsite=external&targetcat=link&targettype=uri">In PubMed</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Bulk Download</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="source-links" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="https://ftp.ncbi.nlm.nih.gov/pub/litarch/29/31/" ref="pagearea=source-links&targetsite=external&targetcat=link&targettype=uri">Bulk download LiverTox data from FTP</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Overviews</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="source-links" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/n/livertox/intro/">Introduction</a></li><li><a href="/books/n/livertox/ClinicalCourse/">Clinical Course</a></li><li><a href="/books/n/livertox/ClinicalOutcome/">Clinical Outcomes</a></li><li><a href="/books/n/livertox/ImmuneFeatures/">Immune Features</a></li><li><a href="/books/n/livertox/Phenotypes_intro/">Phenotypes</a></li><li><a href="/books/n/livertox/Causality/">Causality</a></li><li><a href="/books/n/livertox/DrugCategory/">Likelihood Scale</a></li><li><a href="/books/n/livertox/Severity/">Severity Grading</a></li><li><a href="/books/n/livertox/CaseReport/">Writing a Case Report</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Support Links</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="source-links" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/n/livertox/">LiverTox Homepage</a></li><li><a href="/books/n/livertox/masterlistintro/">Master List of LiverTox Drugs [with Metadata]</a></li><li><a href="/books/n/livertox/drugliverinjury/">LiverTox Drugs by Drug Class</a></li><li><a href="/books/n/livertox/aboutus/">About LiverTox</a></li><li><a href="/books/n/livertox/editorsandreviewers/">Editors and Review Committee</a></li><li><a href="/books/n/livertox/alert/">Meetings and News</a></li><li><a href="/books/n/livertox/abbreviation/">Abbreviations Used</a></li><li><a href="/books/n/livertox/glossary/">Glossary</a></li><li><a href="/books/n/livertox/resource/">Information Resources</a></li><li><a href="/books/n/livertox/disclaimer/">User/Medical Advice Disclaimer</a></li><li><a href="/books/n/livertox/Contactus/">Contact Us</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>OTHER REFERENCE LINKS</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="document-links" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li>
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<a href="https://www.ncbi.nlm.nih.gov/sites/entrez?cmd=search&db=pubmed&pubmedfilters=true&term=(Red+Yeastr+Rice)+AND+Human%5BMH%5D+AND+(drug+induced+liver+injury+OR+jaundice/CI+OR+bile+duct+diseases/CI+OR+liver/DE+OR+liver+diseases/CI)+AND+(%221900/1/1%22%5BEDat%5D%3A%222999/12/31%22%5BEDat%5D)" ref="pagearea=document-links&targetsite=external&targetcat=link&targettype=uri">Recent References on Red Yeast Rice: from PubMed.gov</a>
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<a href="https://clinicaltrials.gov/ct2/results?term=Red+Yeastr+Rice" ref="pagearea=document-links&targetsite=external&targetcat=link&targettype=uri">Trials on Red Yeast Rice: from ClinicalTrials.gov</a>
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Epub 2005 Nov 11.</em></div></div></li><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/23131380" ref="ordinalpos=1&linkpos=4&log$=relatedreviews&logdbfrom=pubmed"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> The effect of red yeast rice (Monascus purpureus) in dyslipidemia and other disorders.</a><span class="source">[Complement Ther Med. 2012]</span><div class="brieflinkpop offscreen_noflow"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> The effect of red yeast rice (Monascus purpureus) in dyslipidemia and other disorders.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">Yang CW, Mousa SA. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">Complement Ther Med. 2012 Dec; 20(6):466-74. Epub 2012 Aug 17.</em></div></div></li><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/27038957" ref="ordinalpos=1&linkpos=5&log$=relatedreviews&logdbfrom=pubmed"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> Functional food red yeast rice (RYR) for metabolic syndrome amelioration: a review on pros and cons.</a><span class="source">[World J Microbiol Biotechnol. ...]</span><div class="brieflinkpop offscreen_noflow"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> Functional food red yeast rice (RYR) for metabolic syndrome amelioration: a review on pros and cons.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">Patel S. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">World J Microbiol Biotechnol. 2016 May; 32(5):87. Epub 2016 Apr 2.</em></div></div></li></ul><a class="seemore" href="/sites/entrez?db=pubmed&cmd=link&linkname=pubmed_pubmed_reviews&uid=31643497" ref="ordinalpos=1&log$=relatedreviews_seeall&logdbfrom=pubmed">See reviews...</a><a class="seemore" href="/sites/entrez?db=pubmed&cmd=link&linkname=pubmed_pubmed&uid=31643497" ref="ordinalpos=1&log$=relatedarticles_seeall&logdbfrom=pubmed">See all...</a></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Recent Activity</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="recent_activity" id="Shutter"></a></div><div class="portlet_content"><div xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" id="HTDisplay" class=""><div class="action"><a href="javascript:historyDisplayState('ClearHT')">Clear</a><a href="javascript:historyDisplayState('HTOff')" class="HTOn">Turn Off</a><a href="javascript:historyDisplayState('HTOn')" class="HTOff">Turn On</a></div><ul id="activity"><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=1" href="/portal/utils/pageresolver.fcgi?recordid=67c8e152b15b832ebc135c71">Red Yeast Rice - LiverTox</a><div class="ralinkpop offscreen_noflow">Red Yeast Rice - LiverTox<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=2" href="/portal/utils/pageresolver.fcgi?recordid=67c8e151f4a390645e3533d4">Ravulizumab - LiverTox</a><div class="ralinkpop offscreen_noflow">Ravulizumab - LiverTox<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=3" href="/portal/utils/pageresolver.fcgi?recordid=67c8e150f4a390645e352e45">Rasburicase - LiverTox</a><div class="ralinkpop offscreen_noflow">Rasburicase - LiverTox<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=4" href="/portal/utils/pageresolver.fcgi?recordid=67c8e14fa68b6b5afc77d0e4">Rasagiline - LiverTox</a><div class="ralinkpop offscreen_noflow">Rasagiline - LiverTox<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=5" href="/portal/utils/pageresolver.fcgi?recordid=67c8e14ef4a390645e35246f">Ranolazine - LiverTox</a><div class="ralinkpop offscreen_noflow">Ranolazine - LiverTox<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li></ul><p class="HTOn">Your browsing activity is empty.</p><p class="HTOff">Activity recording is turned off.</p><p id="turnOn" class="HTOff"><a href="javascript:historyDisplayState('HTOn')">Turn recording back on</a></p><a class="seemore" href="/sites/myncbi/recentactivity">See more...</a></div></div></div>
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