Should PCPs Recommend Red Yeast Rice for High Cholesterol?


Red yeast rice is a traditional Chinese culinary and medicinal herb ingredient. The use of red yeast rice dates back to the reign of the Tang Dynasty (around 800 AD). Over the past few centuries, red yeast rice has been used to improve the digestive process, lower cholesterol, and improve blood circulation.1 In recent years, red mold rice has been offered as an alternative to statin therapy for patients with dyslipidemia.1 However, the safety and side effect profile of using red mold rice is not well established.

What is red yeast rice?

Red yeast rice is made by fermenting boiled rice grains with it Monascus purpureuswho is responsible for the red hue of this supplement. Several chemical components have been isolated from red yeast rice, such as organic acids, sterols, flavonoids, monacolines, and polysaccharides.1 In addition, the pharmacological extracts of red yeast rice can be effective in the treatment of cancer, osteoporosis, diabetes, hyperlipidemia, arteriosclerotic disease, hypertension and fatigue.1

Depending on the fermentation conditions and strains of Monascus purpureus are used to produce red mold rice, 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase-inhibiting monacolines can be produced as metabolites.2 Similar to traditional statins, monacolines inhibit HMG-CoA, the limiting factor for hepatic cholesterol synthesis.3.4 Of particular interest is the production of monacolin K, which is structurally identical to lovastatin and is the most abundant monacolin compound in red yeast rice.4-6 Monacolin K inhibits HMG-CoA activity, which leads to decreased endogenous cholesterol synthesis and decreased blood cholesterol levels.7th

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Statins have long been the mainstay of lipid-lowering therapy. Although these agents are generally well tolerated, some patients are looking to alternative therapies because they experience or are concerned about side effects such as muscle pain, fatigue, gastrointestinal problems and, in rare cases, liver damage.2 The structure of red yeast rice mirrors that of traditional statins.3 Several studies and meta-analyzes have documented the effectiveness of red rice yeast in lowering lipid levels, including low-density lipoprotein cholesterol (LDL-C) and triglycerides.1-3.5-10

In a meta-analysis of 20 randomized studies, Gerards et al. Red mold rice with known monacolin K content for at least 4 weeks with placebo or an active control group.2 Red yeast rice was up with a 1.02 mmol / L decrease in LDL-C cholesterol (95% CI, -1.20 to -0.83) compared to placebo and a similar decrease in LDL-C as one Statin therapy (0.03 mmol / L; 95% CI, -0.36 to 0.41).2 A subanalysis of 3 studies comparing red mold rice with monacolin K 10 mg daily with statin therapy (pravastatin 40 mg / d, simvastatin 10 mg / d, lovastatin 20 mg / d) showed no significant difference between the interventions: the mean difference in the change scores were 0.03 mmol / L (95% CI, -0.36 to 0.41) for LDL and -0.05 mmol / L (95% CI, -0.28 to 0.18) for total cholesterol.2

While the lipid-lowering properties of red mold rice have shown great promise, safety issues need to be considered, including product-to-product variability in monacolin K levels, the presence of citrinin (a mycotoxin commonly found in food), drug interactions, and possible side effects.

Safety concerns with red yeast rice

The US Food and Drug Administration (FDA) has marked red mold rice as a non-approved drug because the compound can contain significant amounts of monacolin K.3.5 The concentration of Monacolin K in commercially available red yeast products often varies greatly from manufacturer to manufacturer.1,2,5,7,9-11 The FDA has warned companies that red yeast rice products containing more than one trace of monacolin K cannot legally be sold as dietary supplements.5 It is noteworthy that the amount of monacolin-K contained in products is rarely stated on product labels.5 Therefore, the impact on blood cholesterol can be difficult to see in individuals and studies.7th

Of all the chemical constituents isolated from red mold rice, citrinine is of particular importance.1 Citrinine is a secondary polyketide metabolite produced by fungi, including Monascus purpureus. If the cultivation process of monacolin K is faulty, citrinin can form. Citrinine has been linked to kidney damage.1.5.8 In addition, citrinine has been linked to genetic abnormalities.5 An analysis found that 4 out of 11 red yeast supplements sold as dietary supplements contained citrinine.5

Since monacolin K, like many statins, is extensively metabolised by cytochrome P450 3A4 (CYP34A), serious side effects as a result of CYP3A4 potentiation can occur if CYP3A4 inhibitors (clarithromycin, erythromycin, HIV protease inhibitors, ketocondonazole, telithromycin) are taken at the same time. .8,10,12 Musculoskeletal adverse effects are particularly common.8,10,12 Red mold rice ingestion may be associated with a similar risk of liver damage as statins when taken with azathioprine, ciclosporine, cimetidine, diclofenac, gemfibrozil, itraconazole, rosiglitazone, valproic acid, statins, and methotrexate.8.13.14 Taking red mold rice and anticoagulants at the same time can increase the risk of bleeding.fifteen

Similar to statins, reported side effects of red mold rice include myopathies, rhabdomyolysis, liver dysfunction, gastrointestinal discomfort, peripheral neuropathy, erectile dysfunction, and skin reactions.1-3,7,10,16 In the meta-analysis by Gerards et al. the risk of myopathies, liver abnormalities, and kidney damage did not differ between the red mold rice and control groups, which included active controls such as statin therapy.2


Red yeast rice has gained popularity in recent years, particularly for treating dyslipidemia. However, before recommending the use of red yeast rice for those with dyslipidemia, the risks and benefits should be carefully weighed by both nontraditional and traditional health care providers.

Patricia Dempsey, DNP, APN-BC, PPCNP-BC, is a Subject Professor and Interim Program Director for MSN at the Marjorie K. Unterberg School of Nursing and Health Studies, Monmouth University, West Long Branch, New Jersey.


1. Zhu B, Qi F, Wu J, Yin G, Hua J, Zhang Q, Qin L. Red yeast rice: a systematic review of the traditional uses, chemistry, pharmacology, and quality control of an important Chinese folk medicine. Front Pharmacol. 2019; 10: 1449. doi: 10.3389 / fphar.2019.01449

2. Gerards MC, Terlou RJ, Yu H, Koks CH, Gerdes VE. The traditional Chinese lipid lowering agent red yeast rice leads to a significant reduction in LDL, but the safety is uncertain – a systematic review and meta-analysis. arteriosclerosis. 2015; 240 (2): 415-23. doi: 10.1016 / j.atherosclerosis.2015.04.004

3. Peng D, Fong A, Pelt AV. Original research: The effects of red yeast rice supplementation on cholesterol levels in adults. Am J Nurs. 2017; 117 (8): 46-54. doi: 10.1097 / 01.NAJ.0000521973.38717.2e

4. DW Lachenmeier, YB Monakhova, T. Kuballa et al. NMR evaluation of the total statin content and the HMG-CoA reductase inhibition in food supplements with red yeast rice (Monascus spp.). Chin med. 2012; 7: 8. doi: 10.1186 / 1749-8546-7-8

5. National Health Institutes. Red yeast rice. Updated July 2013. Accessed December 6, 2021.

6. Ong YC, Aziz Z. Systematic review of red mold rice versus simvastatin in dyslipidemia. J Clin Pharm Ther. 2016; 41 (2): 170-9. doi: 10.1111 / jcpt.12374

7. Heinz T, Schuchardt JP, Möller K, Hadji P, Hahn A. Low daily dose of 3 mg monacolin K from RYR reduces the concentration of LDL-C in a randomized, placebo-controlled intervention. Nutr Res. 2016; 36 (10): 1162-1170. doi: 10.1016 / j.nutres.2016.07.005

8. Cicero AFG, Fogacci F, Zambon A. Red yeast rice for hypercholesterolemia: JACC Focus Seminar. J Am Coll Cardio. 2021; 77 (5): 620-628. doi: 10.1016 / j.jacc.2020.11.056

9. Ross SM. Red Yeast Rice: The Effectiveness Of Monascus purpureus Yeast used to treat hyperlipidemia, a modifiable risk factor for cardiovascular disease. Holistic nursing practice. 2017; 31 (1): 52-58. doi: 10.1097 / HNP.000000000000192

10. EFSA Panel on Food Additives and Added Foods (ANS), Younes M, Aggett P, Aguilar F, et al. Scientific opinion on the safety of monacolins in red yeast rice. EFSA J.. 2018; 16 (8): e05368. doi: 10.2903 / j.efsa.2018.5368

11. Gordon RY, Cooperman T, Obermeyer W, Becker DJ. Significant variability in the monacolin content in commercial red mold rice products: buyers watch out! Arch Intern Med. 2010; 170 (19): 1722-7. doi: 10.1001 / archinternmed.2010.382

12. Rowan CG, Brunelli SM, Munson J, et al. Clinical significance of drug interaction between statins and CYP3A4 inhibitors: a retrospective cohort study in The Health Improvement Network. Pharmacoepidemiol Drug Saf. 2012; 21 (5): 494-506. doi: 10.1002 / pds.3199

13th LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. National Institute for Diabetes and Digestive and Kidney Diseases; 2012-. Red yeast rice. Updated June 4, 2018.

14. Mount Sinai. Health library: red yeast rice.

15. Mazzanti G, Moro PA, Raschi E, Da Cas R, Menniti-Ippolito F. Side effects on red yeast rice supplements: evaluation of cases from the Italian surveillance system. Br J Clin Pharmacol. 2017; 83 (4): 894-908. doi: 10.1111 / bcp.13171

16. Mazzanti G, Moro PA, Raschi E, DaCas R, Menniti-Ippolito F. Side effects of red yeast rice supplements: evaluation of cases from the Italian surveillance system. Br J Clin Pharmacol. 2017; 83 (4): 894-908. Doi: 10.1111 / bcp.13171

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