Red yeast rice: a statin drug in a supplement, with none of the quality control

Red yeast rice lowers LDL cholesterol, and in trials against statins it did about as well. A meta-analysis of 20 randomized studies found LDL fell by 39 mg/dL (95% CI 32 to 46; metric: 1.02 mmol/L, 0.83 to 1.20) against placebo, with a difference of only 1.2 mg/dL (0.03 mmol/L) against statin therapy, and safety was poorly assessed in most of those studies. Two more meta-analyses agree on the size. LDL fell by 28.94 mg/dL across 24 treatment arms, and by 35.82 mg/dL across 14 double-blind trials lasting 4 to 24 weeks, with products and monacolin doses that differed between trials. Red yeast rice contains monacolin K, which is identical to the statin drug lovastatin, so it is not a substitute for a prescribed statin. How much of it you get is the problem. Twelve US products labeled 600 mg per capsule held anywhere from 0.10 to 10.09 mg of monacolin K, a hundredfold range, and 4 had raised levels of citrinin, a kidney toxin, in lab tests from 2006 to 2008. The EU now bans products with 3 mg or more of monacolins per daily portion and revoked its cholesterol claim in 2024.

How much is actually in it

• Lab tests of 12 US red yeast rice products found monacolin K ranging 100-fold, from 0.10 to 10.09 mg per capsule, and the kidney toxin citrinin in 4 of them. — 12 commercial RYR formulations labeled 600 mg/capsule (n = 12 products) Evidence D source
  Monacolin K 0.10-10.09 mg/capsule; total monacolins 0.31-11.15 mg; citrinin elevated in 4 of 12

What it does to your health

• A meta-analysis of randomized trials with 24 treatment arms found red yeast rice lowered LDL cholesterol by about 29 mg/dL and total cholesterol by about 33 mg/dL. — Adults in randomized controlled trials of red yeast rice, 24 treatment arms, search to December 2021 (n = 24 treatment arms) Evidence A source
  LDL-C WMD -28.94 mg/dL (95% CI -32.90 to -24.99); TC -33.16 mg/dL (95% CI -37.69 to -28.63); TG -23.36 mg/dL; HDL-C +2.49 mg/dL
• Across 20 randomized studies of products with known monacolin K content, red yeast rice lowered LDL by 39 mg/dL (1.02 mmol/L) against placebo, about as much as a statin, but safety reporting was poor. — Randomized studies of red yeast rice with known monacolin K content vs placebo or active control, search to November 2014 (n = 20 studies) Evidence A source
  LDL -39 mg/dL (95% CI -46 to -32; metric: -1.02 mmol/L, -1.20 to -0.83) vs placebo; vs statin 1.2 mg/dL (95% CI -14 to 16; metric: 0.03 mmol/L, -0.36 to 0.41); liver and kidney injury 0-5%, not different from control
• In a network meta-analysis of 131 trials with 13,062 people comparing ten cholesterol supplements, red yeast rice was among the two most effective at lowering LDL and total cholesterol. — Adults in 131 randomized trials of artichoke, berberine, bergamot, garlic, green tea, plant sterols, policosanols, red yeast rice, silymarin or spirulina (n = 13062) Evidence A source
  LDL-C reductions across nutraceuticals -6.6 to -47 mg/dL (-0.17 to -1.21 mmol/L) vs placebo; red yeast rice -0.94 mmol/L (-36.4 mg/dL), second after bergamot
• In a Chinese trial of nearly 5,000 people after a heart attack, a red yeast rice extract taken for about 4.5 years cut major coronary events from 10.4% to 5.7%. — Chinese patients with previous myocardial infarction and average LDL-C, Xuezhikang (partially purified red yeast rice extract) or placebo, mean 4.5 years (n = nearly 5000) Evidence B source
  Major coronary events 10.4% placebo vs 5.7% Xuezhikang, absolute -4.7%, relative -45%; CV mortality -30%, total mortality -33%
• In a 12-week trial in 142 people with high cholesterol, 3 mg of monacolin K a day from red yeast rice lowered LDL by 14.8%. — Non-statin-treated adults with LDL-C 160 to 220 mg/dL (4.14 to 5.69 mmol/L), 3 mg monacolin K plus 200 microgram folic acid daily or placebo, 12 weeks (n = 142) Evidence B source
  LDL-C -14.8%, TC -11.2% (P < .001) in the supplement group; no change with placebo
• A meta-analysis of RCTs found red yeast rice lowered LDL cholesterol by about 29 mg/dL and total cholesterol by 33 mg/dL in adults. — adults in RCTs with 24 treatment arms, searched to December 2021 (n = 24 arms) Evidence A source
  LDL-C WMD -28.94 mg/dl (-32.90, -24.99); TC -33.16 mg/dl (-37.69, -28.63); TG -23.36; HDL +2.49
• A meta-analysis of 14 double-blind trials found red yeast rice extract cut LDL by about 36 mg/dL over 4 to 24 weeks, without changing HDL or triglycerides. — Fourteen double-blinded clinical trials, 4-24 weeks (n = 14 trials) Evidence A source
  TC -37.43 mg/dL (-47.08, -27.79); LDL-C -35.82 mg/dL (-43.36, -28.29); HDL, TG not changed
• In an 8-week RCT in 52 physicians and spouses, a red yeast rice extract lowered LDL by 36 mg/dL (22%) versus placebo. — 52 physicians and their spouses with a total cholesterol level of > 200 mg/dL (n = 52) Evidence B source
  LDL -36 mg/dL (22%), TC -37 mg/dL (15%) vs no change with placebo, p < 0.001
• In 18 Japanese adults with mild dyslipidemia, 200 mg a day of red yeast rice (2 mg monacolin K) for 8 weeks lowered LDL by 37 mg/dL (0.96 mmol/L) versus 0.20 with diet alone. — Eighteen patients without known cardiovascular disease, 8 weeks (n = 18) Evidence B source
  LDL median -0.96 [-1.05, -0.34] vs -0.20 [-0.62, 1.19] mmol/L, p=0.030

Safety, limits and interactions

• A 2024 review of 12 randomized trials with 769 adults found monacolin K at 2 to 10 mg a day lowered LDL in every trial, for up to 12 weeks, with side effects reported in 3 trials. — Adults over 18 with hypercholesterolemia in 12 RCTs, monacolin K 2 to 10 mg/day, maximum 12 weeks (n = 769) Evidence A source
  All 12 trials showed lower LDL and total cholesterol (p < 0.05) regardless of dose; 3 trials reported adverse effects; no pooled estimate
• A safety meta-analysis of 53 randomized trials with 8535 people found red yeast rice did not raise the odds of muscle problems compared with control. — 8535 subjects in 53 RCTs (4437 red yeast rice, 4303 control), moderately hypercholesterolemic (n = 8535) Evidence A source
  Musculoskeletal disorders OR 0.94 (95% CI 0.53 to 1.65); non-musculoskeletal adverse events OR 0.59 (95% CI 0.50 to 0.69); serious adverse events OR 0.54 (95% CI 0.46 to 0.64)
• In a 4-week pilot trial in 60 patients, red yeast rice lowered lipids about as much as simvastatin but did not raise muscle fatigue scores, while simvastatin did. — Dyslipidemic patients with low to moderate cardiovascular risk, simvastatin (33) or red yeast rice (27) for 4 weeks (n = 60) Evidence B source
  Fatigue score rose with simvastatin, unchanged with red yeast rice; similar lipid lowering in both groups; effect sizes not in abstract
• The European Food Safety Authority could not identify any intake of monacolins from red yeast rice that is free of safety concerns, noting severe reactions at doses as low as 3 mg a day. — general population and vulnerable subgroups in the EU Evidence E source
  Significant safety concern at 10 mg/day; individual severe adverse reactions at 3 mg/day; risks include rhabdomyolysis and liver injury; no safe intake identified
• Japanese case reports from 2024 describe kidney injury with Fanconi syndrome in people taking a contaminated red yeast rice supplement, improving only partly after stopping it. — Three adults (47 to 59 years) who took Benikoji CholesteHelp for 4 months to 2 years (n = 3) Evidence D source
  Fanconi syndrome and renal impairment (worst eGFR 17.7 mL/min/1.73 m2); improved after discontinuation, but function stayed below pre-onset values in 2 of 3
• A meta-analysis of 20 randomized studies found red yeast rice lowered LDL by 39 mg/dL (1.02 mmol/L), similar to statins, but safety reporting was mostly poor. — 20 randomized studies with known monacolin K content (n = 20 studies) Evidence A source
  LDL -39 mg/dL (-1.02 mmol/L) [-1.20; -0.83] vs placebo; vs statin 1.2 mg/dL (0.03 mmol/L) [-0.36; 0.41]; liver and kidney injury 0-5%, no difference
• Pooling 53 RCTs with 8,535 people, red yeast rice did not raise the odds of muscle problems (OR 0.94). — 53 RCTs comprising 112 treatment arms, 8535 subjects (n = 8535) Evidence A source
  Musculoskeletal disorders OR 0.94 (0.53, 1.65); non-MuD OR 0.59; SAE OR 0.54 vs control
• Japan's 2024 Beni Koji red yeast rice supplement crisis was linked to 76 possible deaths and 492 hospitalizations, and a case report adds 3 kidney injuries. — 3 patients who took the product for 2 weeks to 7 months (n = 3) Evidence D source
  Acute kidney injury with Fanconi syndrome; improved after stopping and prednisolone

What people believe that the data does not support

• The EU refused a health claim that monacolin K from red yeast rice helps maintain normal LDL cholesterol. — food labeling in the European Union Evidence E source
  Status Non-authorized for Monacolin K in SYLVAN BIO red yeast rice and the LDL-cholesterol claim
• The EU revoked its cholesterol claim for red yeast rice in 2024 and bans daily portions with 3 mg or more of monacolins. — EU Register entry POL-HC-6421 Evidence E source
  Revoked; monacolins >=3 mg per daily portion prohibited
• The EU did not authorize a claim that monacolin K from a branded red yeast rice maintains normal LDL cholesterol. — EU Register entry POL-HC-11241 Evidence E source
  Non-authorized

Who this works differently for

• The US National Institutes of Health advises against red yeast rice in pregnancy and breastfeeding, and warns it can share the drug interactions of statins. — people who are pregnant or lactating; people taking other medicines Evidence E source
  Not recommended in pregnancy or lactation (no safety studies); same types of drug interactions as statins; citrinin contamination common in a 2021 product analysis
• In 40 children aged 8-16 with inherited high cholesterol, red yeast rice (3 mg monacolins) with policosanols for 8 weeks cut LDL by 25% versus placebo. — 40 children affected by heterozygous FH and FCH, aged 8-16 years (n = 40) Evidence B source
  TC -18.5%, LDL-C -25.1%, apoB -25.3% vs placebo (p<0.001); no change in AST, ALT, CK
• A case report describes muscle breakdown (rhabdomyolysis) in a kidney transplant patient taking red yeast rice with cyclosporine. — a stable renal-transplant recipient (n = 1) Evidence D source
  Rhabdomyolysis resolved after stopping the product; proposed CYP450 interaction

What is still unknown

• In the 2023 SPORT trial in 190 adults, a retail red yeast rice supplement did not lower LDL more than placebo after 28 days, while rosuvastatin 5 mg cut it by 35%. — Adults without ASCVD, LDL-C 70 to 189 mg/dL, raised 10-year ASCVD risk, randomized to rosuvastatin 5 mg, placebo or one of six supplements for 28 days (n = 190) Evidence B source
  Rosuvastatin vs placebo LDL-C -35.2% (95% CI -41.3% to -29.1%); no supplement, red yeast rice included, differed from placebo

The bottom line

Lower doses have been tested too, as trial doses and not a portion to take. In 18 Japanese adults with raised LDL managed by diet alone, 200 mg a day of red yeast rice gave 2 mg monacolin K. Over 8 weeks it lowered LDL by a median 37 mg/dL (0.96 mmol/L), against 7.7 mg/dL (0.20 mmol/L) with diet only, in a very small trial with no placebo. In an 8-week placebo-controlled trial in 52 physicians and their spouses with total cholesterol above 200 mg/dL, an extract with 5 mg monacolin K plus coenzyme Q10 lowered LDL by 36 mg/dL, or 22%. Across 24 arms, triglycerides also fell by 23.36 mg/dL and HDL rose by 2.49 mg/dL. The 14-trial analysis found no change in either. The EU also refused a claim that monacolin K from one branded red yeast rice maintains normal LDL, a regulatory decision that says nothing either way about whether LDL falls. Who should be careful. Red yeast rice capsules are dietary supplements, which in the US the FDA does not approve as medicines before they are sold. EFSA could not identify any intake of monacolins that is free of safety concerns, and it noted severe reactions at doses as low as 3 mg a day, with muscle breakdown and liver injury among the risks. The US National Institutes of Health advises against red yeast rice in pregnancy and breastfeeding, and warns it can share the drug interactions of statins. Anyone who already takes a statin or other regular medicine, is pregnant or breastfeeding, or has liver or kidney disease should talk to a doctor before using it. Pooling 53 trials with 8,535 people, red yeast rice did not raise the odds of muscle problems, odds ratio 0.94 (95% CI 0.53 to 1.65), from short trials that cannot catch rare severe events. A kidney transplant patient taking cyclosporine developed rhabdomyolysis, a breakdown of muscle, while on red yeast rice, and it resolved after stopping the product. That is a single case, and the authors only propose an interaction through the cytochrome P450 system. In the 20-study meta-analysis, liver and kidney injury was reported in 0 to 5 percent of people, no different from control, in studies where safety was poorly assessed. In Japan in 2024, a Beni Koji red yeast rice supplement was linked to 76 possibly related deaths and 492 hospitalizations. Those deaths are reports with no established cause. One report describes 3 people with acute kidney injury after taking it for 2 weeks to 7 months, who improved after stopping. In 40 children aged 8 to 16 with inherited high cholesterol, a supplement of red yeast rice with 3 mg monacolins and policosanols cut LDL by 25.1% against placebo without changing liver or muscle enzymes. That was a mixture of two ingredients, tested for 8 weeks in children with an inherited condition inside a trial, and it says nothing about giving red yeast rice to children for years.

Sources

1. ryrr8-08 · product analysis
   There was marked variability in the 12 RYR products in total monacolins (0.31-11.15 mg/capsule), monacolin K (lovastatin) (0.10-10.09 mg/capsule), and monacolin KA (0.00-2.30 mg/capsule). Four products had elevated levels of citrinin.
   Arch Intern Med, 2010 · checked 2026-10-03
2. ev-ryr-01 · meta-analysis of RCTs
   RESULTS: Pooled data showed significant effectiveness in lowering TC (WMD: -33.16 mg/dl, 95% CI: -37.69, -28.63, P < 0.001), LDL-C (WMD: -28.94 mg/dl, 95% CI: -32.90, -24.99, P < 0.001), and TG (WMD: -23.36 mg/dl, 95% CI: -31.30, -15.43, P < 0.001) concentration and increasing HDL-C concentration (WMD: 2.49 mg/dl, 95% CI: 1.48, 3.49, P < 0.001) following RYR supplementation.
   Expert Rev Clin Pharmacol, 2023 · checked 2026-10-06
3. ev-ryr-02 · meta-analysis of RCTs
   RYR lowered LDL cholesterol with 1.02 mmol/L [-1.20; -0.83] compared to placebo.
   Atherosclerosis, 2015 · checked 2026-10-06
4. ev-ryr-03 · network meta-analysis of RCTs
   The most effective approaches in terms of LDL-C- and TC-lowering were bergamot and RYR (-1.21 [-46.8 mg/dl] and -0.94 [-36.4 mg/dl] mmol/l) reduction respectively.
   Pharmacol Res, 2022 · checked 2026-10-06
5. ev-ryr-06 · RCT
   Frequencies of the primary end point were 10.4% in the placebo group and 5.7% in the XZK-treated group, with absolute and relative decreases of 4.7% and 45%, respectively.
   Am J Cardiol, 2008 · checked 2026-10-06
6. ev-ryr-08 · RCT
   A significant (P < .001) reduction of LDL-C (-14.8%), total cholesterol (-11.2%), and homocysteine (-12.5%) was determined in the supplement group after 12 weeks.
   Nutr Res, 2016 · checked 2026-10-06
7. ryrr8-01 · meta-analysis of RCTs
   Pooled data showed significant effectiveness in lowering TC (WMD: -33.16 mg/dl, 95% CI: -37.69, -28.63, P < 0.001), LDL-C (WMD: -28.94 mg/dl, 95% CI: -32.90, -24.99, P < 0.001), and TG (WMD: -23.36 mg/dl, 95% CI: -31.30, -15.43, P < 0.001) concentration and increasing HDL-C concentration (WMD: 2.49 mg/dl, 95% CI: 1.48, 3.49, P < 0.001) following RYR supplementation.
   Expert Rev Clin Pharmacol, 2023 · checked 2026-10-03
8. ryrr8-04 · meta-analysis of RCTs
   Fourteen double-blinded clinical trials were identified. The interventions lasted 4-24 weeks. ... RYR extract consumption statistically significantly reduced total cholesterol (mean absolute reduction: 37.43 mg/dL; 95% confidence interval [CI]: -47.08, -27.79) and low-density lipoprotein cholesterol (LDL-C; mean absolute reduction: 35.82 mg/dL; 95% CI: -43.36, -28.29), but not high-density lipoprotein cholesterol, triglycerides and apolipoproteins A-I and B.
   Nutrients, 2024 · checked 2026-10-03
9. ryrr8-05 · RCT
   In a double blind placebo controlled randomized trial, 52 physicians and their spouses with a total cholesterol level of > 200 mg/dL were randomly allocated to receive a RYR extract or placebo for 8 weeks. ... LDL (low density lipoprotein) cholesterol was lowered with 36 mg/dL (22%) and total cholesterol with 37 mg/dL (15%) in the intervention group.
   BMC Complement Altern Med, 2013 · checked 2026-10-03
10. ryrr8-06 · RCT
    Eighteen patients without known cardiovascular disease and unsatisfactory low-density lipoprotein cholesterol (3.96±0.19 mmol/L) controlled only by diet therapy were randomly allocated to receive low dose red yeast rice (200 mg/day) containing 2 mg monacolin K or diet therapy alone for 8 weeks. ... Low-density lipoprotein cholesterol decreased significantly in the red yeast rice group than in the diet therapy group (median [interquartile range]: control -0.20 [-0.62, 1.19] mmol/L vs. red yeast rice -0.96 [-1.05, -0.34] mmol/L, p=0.030).
    Asia Pac J Clin Nutr, 2021 · checked 2026-10-03
11. ev-ryr-04 · systematic review of RCTs
    Low doses of monacolin K equal to 3mg/day exert potential cholesterol-lowering effects although the number of relative studies is limited.
    Semergen, 2024 · checked 2026-10-06
12. ev-ryr-05 · meta-analysis of RCTs
    Monacolin K administration was not associated with increased risk of MuD (odds ratio (OR) = 0.94, 95% confidence interval (CI) 0.53,1.65).
    Pharmacol Res, 2019 · checked 2026-10-06
13. ev-ryr-09 · RCT
    At the end of study, the fatigue score was significantly increased in patients treated with simvastatin, whereas no significant change was observed in patients receiving red yeast rice.
    BMC Cardiovasc Disord, 2017 · checked 2026-10-06
14. ev-ryr-10 · agency scientific opinion
    On the basis of the information available and several uncertainties highlighted in this opinion, the Panel was unable to identify a dietary intake of monacolins from RYR that does not give rise to concerns about harmful effects to health, for the general population, and as appropriate, for vulnerable subgroups of the population.
    EFSA ANS Panel, Scientific opinion on the safety of monacolins in red yeast rice, EFSA Journal 2018;16(8):5368 · checked 2026-10-06
15. ev-ryr-12 · case series
    We present three cases wherein renal dysfunction improved within a few months of supplement discontinuation, without immunosuppressive therapy.
    CEN Case Rep, 2025 · checked 2026-10-06
16. ryrr8-02 · meta-analysis of RCTs
    Twenty studies were analyzed. Quality of safety assessment was low in the majority of studies. RYR lowered LDL cholesterol with 1.02 mmol/L [-1.20; -0.83] compared to placebo. Effect of RYR on LDL was not different from statin therapy (0.03 mmol/L [-0.36; 0.41]).
    Atherosclerosis, 2015 · checked 2026-10-03
17. ryrr8-03 · meta-analysis of RCTs
    Data were pooled from 53 RCTs comprising 112 treatment arms, which included 8535 subjects, with 4437 in the RYR arm and 4303 in the control one. Monacolin K administration was not associated with increased risk of MuD (odds ratio (OR) = 0.94, 95% confidence interval (CI) 0.53,1.65).
    Pharmacol Res, 2019 · checked 2026-10-03
18. ryrr8-09 · case report
    Following the identification of the first case of acute kidney injury (AKI) caused by the product, 76 possibly related deaths and 492 hospitalizations have been reported in Japan. We herein demonstrate 3 cases of AKI with renal tubular acidosis and Fanconi syndrome following consumption of the product for 2 weeks to 7 months.
    Am J Kidney Dis, 2025 · checked 2026-10-03
19. ev-ryr-13 · regulatory register entry
    POL-HC-11241 Monacolin K in SYLVAN BIO red yeast rice Monacolin K from red yeast rice contributes to the maintenance of normal blood LDL-cholesterol concentrations Non-authorised
    EU Register on nutrition and health claims, claim POL-HC-11241, snapshot 2026-09-21 · checked 2026-10-06
20. ryrr8-11 · EU claims register
    POL-HC-6421 Monascus purpureous (red yeast rice) Monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol levels Following the amendment of Annex III of Regulation (EC) 1925/2006 as regards monacolins from red yeast rice, by which monacolins have been placed in Part B of Annex III, under ‘Restricted substances’, the use of monacolins from red yeast rice at levels of 3mg and more per portion of the product recommended for daily consumption is prohibited. Consequently, the health claim on monacolin K from red yeast rice related to the contribution to the maintenance of normal blood cholesterol levels, under the daily intake of 10 mg of monacolin K from red yeast rice (Entry ID: 1648, 1700), has been revoked from the Union list of permitted health claims with Commission Regulation (EU) 2024/2041. Revoked
    EU Register on nutrition and health claims, claim POL-HC-6421, snapshot 2026-09-21 · checked 2026-10-03
21. ryrr8-12 · EU claims register
    POL-HC-11241 Monacolin K in SYLVAN BIO red yeast rice Monacolin K from red yeast rice contributes to the maintenance of normal blood LDL-cholesterol concentrations Non-authorised
    EU Register on nutrition and health claims, claim POL-HC-11241, snapshot 2026-09-21 · checked 2026-10-03
22. ev-ryr-11 · agency position
    Red yeast rice products are not recommended for those who are pregnant or lactating.
    NIH National Center for Complementary and Integrative Health, Red Yeast Rice: What You Need To Know, updated November 2022 · checked 2026-10-06
23. ryrr8-07 · randomized crossover trial
    40 children affected by heterozygous Familial Hypercholesterolemia (FH) (n=24) and Familial Combined Hyperlipidemia (FCH) (n=16), aged 8-16 years, were enrolled in a double-blind, randomized, placebo-controlled, cross-over trial. ... The dietary supplement, compared with the placebo, significantly reduced total cholesterol by 18.5% (p<0.001), LDL-C levels by 25.1% (p<0.001), and apolipoprotein B by 25.3% (p<0.001) when patients were considered as a whole group.
    Nutr Metab Cardiovasc Dis, 2011 · checked 2026-10-03
24. ryrr8-10 · case report
    Rice fermented with red yeast contains several types of mevinic acids, including monacolin K, which is identical to lovastatin. We postulate that the interaction of cyclosporine and these compounds through the cytochrome P450 system resulted in the adverse effect seen in this patient.
    Transplantation, 2002 · checked 2026-10-03
25. ev-ryr-07 · RCT
    None of the dietary supplements demonstrated a significant decrease in LDL-C compared with placebo.
    J Am Coll Cardiol, 2023 · checked 2026-10-06