Red Yeast Rice: Cholesterol Effects and the 2024 Kidney-Injury Reports

Red yeast rice is cooked rice that has been fermented with a mold, usually Monascus purpureus. The mold turns the grains a deep red and can fill them with natural compounds called monacolins. One of them, monacolin K, is the same molecule as the prescription cholesterol drug lovastatin. That single fact explains most of what this page covers: why red yeast rice lowers cholesterol in trials, why its side effects look like those of statin drugs, why regulators treat some products as unapproved drugs, and why two products with the same name on the label can contain very different amounts of the active compound. The page also reports the 2024 outbreak of kidney injury in Japan linked to specific contaminated red yeast rice tablets.

Table of Contents

  1. What Red Yeast Rice Is
  2. Traditional Use in Chinese Food and Medicine
  3. Monacolin K Is the Same Molecule as Lovastatin
  4. How Regulators Treat Red Yeast Rice
  5. How Much Monacolin a Product Contains Varies Widely
  6. Citrinin Contamination
  7. What the Cholesterol Trials Found
  8. The Chinese Heart-Attack Survivor Trial
  9. Muscle and Liver Effects and the Statin-Intolerance Trials
  10. The 2024 Kidney-Injury Reports in Japan
  11. Interactions as Sources Describe Them
  12. What Is Not Known
  13. Key Research Papers
  14. Connections
  15. Featured Videos

What Red Yeast Rice Is

Red yeast rice is made by fermenting cooked rice kernels with a mold of the Monascus family, most often Monascus purpureus. A 2019 systematic review of its chemistry counted more than 101 compounds isolated from it, mainly monacolins, pigments, organic acids, sterols, decalin derivatives, flavonoids and polysaccharides (Zhu 2019). The red pigments are what give the rice its colour.

The name is slightly misleading. The United States National Center for Complementary and Integrative Health points out that Monascus purpureus is technically a mold, a fungus made of many-celled filaments, rather than a single-celled yeast. Supplement labels in the United States still use the name "red yeast rice" rather than "red mold rice." The same agency notes that red yeast rice is sold as a food, as a traditional Chinese medicine and as a dietary supplement, and that the amount of monacolin K it contains depends on the strain of mold and the conditions of fermentation (National Center for Complementary and Integrative Health, Red Yeast Rice fact sheet).

A laboratory analysis of authentic and commercial material describes the same dependence: depending on the Monascus strain and how it is fermented, red yeast rice may contain monacolins, pigments and the mold toxin citrinin as by-products of the mold's growth (Avula 2014). Not every red yeast rice is made with the same species. The tablets involved in the 2024 Japanese kidney-injury outbreak were made from red yeast rice produced with a related mold, Monascus pilosus (Yoshinari 2025).

Traditional Use in Chinese Food and Medicine

Red yeast rice has a long history in East Asia. Japanese kidney specialists describe it as traditionally used in Asian cooking (Shinzawa 2025). In Chinese folk medicine, according to a 2019 review of its traditional uses, it has long been used for what that tradition calls blood circulation stasis, for indigestion, for diarrhea and for limb weakness (Zhu 2019). These are descriptions of traditional practice, not trial results. The same review notes that the indigestion and diarrhea uses have never been tested in modern pharmacological trials and calls for such studies.

The modern interest is different from the traditional one. Supplements sold in Europe and North America are marketed almost entirely for cholesterol, because of the monacolin K content described in the next section. The Food and Drug Administration states in a 2020 warning letter that traditional red yeast rice does not contain more than trace amounts of lovastatin, if any. The National Center for Complementary and Integrative Health makes the same point: traditional red yeast rice may contain trace amounts of monacolin K, while some commercial products contain large amounts.

Red yeast rice is itself a fermented rice product. The evidence below concerns red yeast rice and its concentrated extracts sold as supplements, not traditional dishes coloured with it.

Monacolin K Is the Same Molecule as Lovastatin

Statin drugs lower cholesterol by blocking 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, the enzyme the liver uses to build cholesterol. Monacolin K blocks the same enzyme because it is the same molecule as the statin lovastatin. An Italian pharmacology group describes monacolin K as chemically identical to lovastatin (Rigillo 2025), and the Italian surveillance study discussed below describes it the same way (Mazzanti 2017).

A single red yeast rice product can contain several monacolins, not only monacolin K. One analysis of twelve commercial products describes fourteen active monacolins that inhibit cholesterol production in the liver (Gordon 2010). In laboratory tests, an Italian group compared red yeast rice samples with pure lovastatin. The red yeast rice mixtures blocked the cholesterol enzyme more strongly in a test tube than lovastatin alone, which the authors attribute to other monacolins and compounds acting together. In muscle cells grown in the laboratory, the red yeast rice samples had a smaller effect on cell survival and on muscle-damage genes than lovastatin (Rigillo 2025). These were cell and test-tube experiments; the authors state that the clinical effect in people still needs to be firmly established.

Because monacolin K is lovastatin, red yeast rice that contains meaningful amounts of it is, in effect, a low and unmeasured dose of a statin. The site's Cholesterol Management page explains how statins work and how the drugs are compared; the Goldstein and Brown page tells the story of the cholesterol pathway that statins act on.

How Regulators Treat Red Yeast Rice

United States

The Food and Drug Administration's position is set out in its warning letters to supplement sellers. A 2020 warning letter, sent after Food and Drug Administration laboratory analyses found lovastatin in a product sold as a dietary supplement, states that:

The National Center for Complementary and Integrative Health summarises the same position: red yeast rice products with considerable amounts of monacolin K are considered by the Food and Drug Administration to be unapproved new drugs and are not sold legally in the United States, and the agency has sent warning letters on several occasions to companies selling products with enhanced or added lovastatin. The fact sheet also notes that monacolin K and lovastatin levels are not usually printed on labels, so buyers cannot know how much a product contains.

A 2017 study tested whether the Food and Drug Administration's manufacturing standards for dietary supplements had made the monacolin K content of red yeast rice predictable. It concluded that, despite those standards, the strength and composition of red yeast rice supplements sold at mainstream retail stores in the United States remained unpredictable (Cohen 2017).

Europe

In the European Union, a 2024 Belgian analysis reports that the European Commission prohibited red yeast rice supplements whose maximum daily serving exceeds 3 mg of total monacolins, citing safety concerns linked to statins, and lowered the permitted limit for the mold toxin citrinin to 100 micrograms per kilogram (Vanhee 2024). The National Center for Complementary and Integrative Health reports that a 2018 opinion of the European Food Safety Authority concluded that exposure to monacolin K from red yeast rice products could lead to severe side effects and that the panel could not identify a dietary level of monacolins that was guaranteed safe. An Italian analysis from 2021 refers to a European health claim tied to a daily intake of 10 mg of monacolin K (Righetti 2021).

How Much Monacolin a Product Contains Varies Widely

Every laboratory survey of commercial red yeast rice products has found large differences in monacolin content between products sold under the same name.

The authors of the American survey call for better standardisation of products and labelling (Gordon 2010), and the 2017 survey describes product strength as unpredictable (Cohen 2017).

Citrinin Contamination

Citrinin is a toxin made by some molds, including Penicillium, Aspergillus and the Monascus molds used for red yeast rice. A Polish analysis describes it as having toxic effects on the kidney, the liver and the developing embryo and fetus (Twarużek 2021). The American product survey describes it as toxic to the kidneys in animals (Gordon 2010).

Results on how often citrinin turns up in supplements go both ways:

Citrinin was not the cause of the 2024 Japanese kidney injuries. The nationwide Japanese study states that the mold strains used for the implicated tablets did not produce citrinin; the safety concern came from a different contaminant described below (Shinzawa 2025).

What the Cholesterol Trials Found

Red yeast rice lowers low-density lipoprotein (LDL) cholesterol in randomized trials. The size of the effect, and whether it extends to other blood fats, differs between analyses.

An early American trial

In a 12-week double-blind trial at a California university, 83 adults with high cholesterol who were not taking cholesterol drugs received 2.4 g a day of a Chinese red yeast rice supplement or a placebo, alongside a prescribed diet. In the red yeast rice group, total cholesterol fell from an average of 254 mg/dL to 208 mg/dL by week 8, significantly more than with placebo. Low-density lipoprotein cholesterol and triglycerides also fell; high-density lipoprotein cholesterol did not change significantly (Heber 1999).

Meta-analyses

The analyses disagree on triglycerides and high-density lipoprotein cholesterol: one found no significant effect on either (Trogkanis 2024), another found both improved (Rahmani 2023). All three agree on a reduction in low-density lipoprotein cholesterol.

Red yeast rice is also tested in combination supplements alongside berberine and other ingredients. The site's Berberine for Cholesterol and Cardiovascular Health page covers those combination trials; the figures on this page refer to red yeast rice on its own unless stated.

The Chinese Heart-Attack Survivor Trial

The largest outcome trial of red yeast rice is the China Coronary Secondary Prevention Study. It tested a partially purified Chinese red yeast rice extract in people who had already had a heart attack. Nearly 5,000 patients with average low-density lipoprotein cholesterol levels were randomly assigned to the extract or a placebo daily for an average of 4.5 years (Lu 2008).

A 2020 meta-analysis of seven studies with 10,699 heart-attack patients whose cholesterol was borderline high found that red yeast rice extract at 1,200 mg a day was associated with fewer non-fatal heart attacks (risk ratio 0.42), fewer artery-reopening procedures (risk ratio 0.58) and fewer sudden deaths (risk ratio 0.71), with low-density lipoprotein cholesterol 20.70 mg/dL lower (Sungthong 2020). Follow-up in those studies ranged from 4 weeks to 4.5 years.

These outcome results come from one standardised extract tested in a Chinese population. The product surveys described earlier show that commercial red yeast rice products differ widely in their monacolin content (Gordon 2010; Cohen 2017).

Muscle and Liver Effects and the Statin-Intolerance Trials

Statin drugs can cause muscle pain and, rarely, serious muscle breakdown (rhabdomyolysis) and liver injury. Because red yeast rice contains a statin, researchers have asked whether it carries the same risks. Controlled trials and spontaneous-report databases give different pictures.

Randomized trials

Reports from everyday use

The National Center for Complementary and Integrative Health states that red yeast rice products containing significant amounts of monacolin K can have the same potential side effects as statin drugs, including muscle, kidney and liver damage, as well as digestive problems such as diarrhea, nausea and stomach pain. Spontaneous reports cannot show how often a reaction happens, only that it has been reported; the trials, by contrast, were short and enrolled selected volunteers.

The 2024 Kidney-Injury Reports in Japan

In late 2023 and early 2024, Japanese doctors began seeing kidney injury in people taking specific red yeast rice tablets marketed for lowering cholesterol (Shinzawa 2025). Reports of serious food poisoning linked to the tablets were made public from late March 2024 (Yoshinari 2025). A case series published in 2024 states that, following the first identified case, 76 possibly related deaths and 492 hospitalizations had been reported in Japan (Chikasue 2025). These problems were tied to particular contaminated production, not to red yeast rice as a whole; the contaminant is described below.

What the kidney damage looked like

The injury mainly hit the kidney tubules, the small channels that reclaim salts, sugar and other substances from urine. Many patients developed Fanconi syndrome, a tubule failure in which the body loses potassium, phosphate, uric acid and glucose into the urine and the blood turns acidic.

What the contamination was

Puberulic acid, a compound that was not expected in the product, was detected in tablets linked to the poisoning. Scientists from Japan's National Institute of Health Sciences inspected the factory that made the red yeast rice and found a Penicillium mold, Penicillium adametzioides, in wipe samples. In the laboratory this mold grew on rice already covered with the red yeast rice mold, Monascus pilosus, and produced puberulic acid. The authors conclude that the mold lived in the factory and accidentally contaminated the red yeast rice culture, so that contaminated tablets were made and caused the outbreak (Yoshinari 2025).

A separate analysis found two previously unknown compounds, possibly related to lovastatin, in product samples linked to adverse-event reports. Both were found in every sample that also contained puberulic acid. The authors describe their route into the product as under investigation (Tanaka 2024). The nationwide study states that further research is needed to establish definitive cause and long-term outcomes (Shinzawa 2025).

Japanese kidney specialists who reported the cases describe the main lesson as the need for long-term kidney follow-up of affected people and for rigorous safety evaluation of dietary supplements (Shinzawa 2025; Doi 2026). A 2025 review of red yeast rice case reports published between 2020 and 2025 found that Fanconi syndrome and kidney dysfunction were the main adverse events, mostly reported from Japan (Shaleha 2025). The site's Renal Tubular Acidosis page explains the acid-handling side of tubule failure.

Interactions as Sources Describe Them

The National Center for Complementary and Integrative Health states that red yeast rice products can have the same types of drug interactions as statin drugs, and so may interfere with certain medicines or increase the chance of side effects.

A case report from Italy describes a 70-year-old woman taking several medicines, including the antidepressant sertraline and the statin rosuvastatin, who developed rhabdomyolysis after she started a dietary supplement containing monacolin K. Using a standard drug-interaction scoring scale, the authors judged the reaction possibly related to an interaction between the three. Her symptoms and blood tests returned to normal after all three were stopped (Russo 2016). In the Italian surveillance data, more than half of the people with a suspected reaction (28 of 52) were taking other medicines at the time (Mazzanti 2017).

Taking red yeast rice together with a prescribed statin means taking two statins at once. The Italian product survey also found small amounts of a second statin, simvastatin, in most of the supplements it tested (Righetti 2021). The National Center for Complementary and Integrative Health states that there are no studies on the safety of red yeast rice during pregnancy or breastfeeding.

What Is Not Known

Key Research Papers

  1. Zhu B, Qi F, Wu J, Yin G, Hua J, Zhang Q, et al. 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. PubMed PMID: 31849687
  2. Shaleha RR, Yuliana A, Amin S, Levita J, Sumiwi SA. Monascus purpureus Red Yeast Rice: A Review of the in vitro and in vivo Pharmacological Activities, Studies in Humans, and Case Reports. Clin Pharmacol. 2025;17:269-289. PubMed PMID: 40927271
  3. Heber D, Yip I, Ashley JM, Elashoff DA, Elashoff RM, Go VL. Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement. Am J Clin Nutr. 1999;69(2):231-6. PubMed PMID: 9989685
  4. Rigillo G, Baini G, Bruni R, Puja G, Miraldi E, Pani L, et al. Red Yeast Rice or Lovastatin? A Comparative Evaluation of Safety and Efficacy Through a Multifaceted Approach. Phytother Res. 2025;39(1):264-281. PubMed PMID: 39511729
  5. Avula B, Cohen PA, Wang YH, Sagi S, Feng W, Wang M, et al. Chemical profiling and quantification of monacolins and citrinin in red yeast rice commercial raw materials and dietary supplements using liquid chromatography-accurate QToF mass spectrometry: Chemometrics application. J Pharm Biomed Anal. 2014;100:243-253. PubMed PMID: 25168220
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  7. Cohen PA, Avula B, Khan IA. Variability in strength of red yeast rice supplements purchased from mainstream retailers. Eur J Prev Cardiol. 2017;24(13):1431-1434. PubMed PMID: 28641460
  8. Righetti L, Dall'Asta C, Bruni R. Risk Assessment of RYR Food Supplements: Perception vs. Reality. Front Nutr. 2021;8:792529. PubMed PMID: 34950692
  9. Twarużek M, Ałtyn I, Kosicki R. Dietary Supplements Based on Red Yeast Rice-A Source of Citrinin? Toxins (Basel). 2021;13(7):497. PubMed PMID: 34357969
  10. Vanhee C, Jacobs B, Canfyn M, Malysheva SV, Willocx M, Masquelier J, et al. Quality Control and Safety Assessment of Online-Purchased Food Supplements Containing Red Yeast Rice (RYR). Foods. 2024;13(12):1919. PubMed PMID: 38928859
  11. Lu Z, Kou W, Du B, Wu Y, Zhao S, Brusco OA, et al. Effect of Xuezhikang, an extract from red yeast Chinese rice, on coronary events in a Chinese population with previous myocardial infarction. Am J Cardiol. 2008;101(12):1689-93. PubMed PMID: 18549841
  12. Sungthong B, Yoothaekool C, Promphamorn S, Phimarn W. Efficacy of red yeast rice extract on myocardial infarction patients with borderline hypercholesterolemia: A meta-analysis of randomized controlled trials. Sci Rep. 2020;10(1):2769. PubMed PMID: 32066811
  13. Trogkanis E, Karalexi MA, Sergentanis TN, Kornarou E, Vassilakou T. Safety and Efficacy of the Consumption of the Nutraceutical "Red Yeast Rice Extract" for the Reduction of Hypercholesterolemia in Humans: A Systematic Review and Meta-Analysis. Nutrients. 2024;16(10):1453. PubMed PMID: 38794691
  14. Rahmani P, Melekoglu E, Tavakoli S, Malekpour Alamdari N, Rohani P, Sohouli MH. Impact of red yeast rice supplementation on lipid profile: a systematic review and meta-analysis of randomized-controlled trials. Expert Rev Clin Pharmacol. 2023;16(1):73-81. PubMed PMID: 36259545
  15. Li P, Wang Q, Chen K, Zou S, Shu S, Lu C, et al. Red Yeast Rice for Hyperlipidemia: A Meta-Analysis of 15 High-Quality Randomized Controlled Trials. Front Pharmacol. 2021;12:819482. PubMed PMID: 35111069
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  17. 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(12):830-9, W147-9. PubMed PMID: 19528562
  18. Halbert SC, French B, Gordon RY, Farrar JT, Schmitz K, Morris PB, 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(2):198-204. PubMed PMID: 20102918
  19. 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(4):894-908. PubMed PMID: 28093797
  20. Raschi E, Girardi A, Poluzzi E, Forcesi E, Menniti-Ippolito F, Mazzanti G, et al. Adverse Events to Food Supplements Containing Red Yeast Rice: Comparative Analysis of FAERS and CAERS Reporting Systems. Drug Saf. 2018;41(8):745-752. PubMed PMID: 29582393
  21. Russo R, Gallelli L, Cannataro R, Perri M, Calignano A, Citraro R, et al. When Nutraceuticals Reinforce Drugs Side Effects: A Case Report. Curr Drug Saf. 2016;11(3):264-6. PubMed PMID: 26830519
  22. Uchiyama K, Otani M, Chigusa N, Sugita K, Matsuoka R, Hosoya K, et al. Acute Kidney Injury Associated With Red Yeast Rice (Beni-kōji) Supplement: A Report of Two Cases. Kidney Med. 2024;6(11):100908. PubMed PMID: 39507393
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PubMed Topic Searches

  1. PubMed: red yeast rice meta-analysis cholesterol
  2. PubMed: red yeast rice puberulic acid
  3. PubMed: red yeast rice kidney injury Fanconi syndrome
  4. PubMed: red yeast rice citrinin
  5. PubMed: red yeast rice monacolin K content
  6. PubMed: red yeast rice statin intolerance

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