Does red yeast rice lower cholesterol?

Yes, when the product contains enough monacolin K. In 20 randomized studies of red yeast rice with known monacolin K content, LDL cholesterol fell by 39 mg/dL (95% CI 32 to 46; metric: 1.02 mmol/L, 0.83 to 1.20) against placebo, and the effect did not differ from statin therapy. The same review rated the safety reporting in most of those studies as poor. Whether a bottle from a shop does the same, and how safe it is, are the real questions.

Established. Standardized red yeast rice lowers LDL cholesterol. A meta-analysis with 24 treatment arms found a drop of 28.94 mg/dL (95% CI 24.99 to 32.90), and 14 double-blind trials lasting 4 to 24 weeks found 35.82 mg/dL. In a network meta-analysis of 131 trials with 13,062 people comparing ten cholesterol supplements, it ranked second, at 36 mg/dL (0.94 mmol/L), behind bergamot on a small evidence base.

What the trials found

The dose that does this is small. A 2024 review of 12 randomized trials in 769 adults with high cholesterol found that 2 to 10 mg of monacolin K a day lowered LDL in every trial, for up to 12 weeks, without pooling a number. In 142 people with high cholesterol, 3 mg of monacolin K a day for 12 weeks lowered LDL by 14.8 percent, in a supplement that also contained folic acid. That trial reports the change within the group, not an absolute gap against placebo. In 18 Japanese adults with mild dyslipidemia, 2 mg a day for 8 weeks lowered LDL by 37 mg/dL (0.96 mmol/L) against 0.20 with diet alone, in a trial too small to lean on and with no placebo.

Only one trial has counted heart attacks. In China, nearly 5,000 people who had already had a heart attack took a partially purified red yeast rice extract or placebo for about 4.5 years. Major coronary events fell from 10.4 percent to 5.7 percent, an absolute drop of 4.7 points and a relative drop of 45 percent. That extract was a standardized pharmaceutical-grade product, and this is the only event trial we found, run in a single country.

Unsettled. A shop-bought product may do nothing. 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 5 mg of rosuvastatin cut it by 35 percent, a figure the abstract gives only in percent. The trial was short and the abstract does not say how much monacolin the product held. Laboratory tests of 12 US products, from 2006 to 2008, found monacolin K ranging from 0.10 to 10.09 mg per capsule, a hundredfold spread. A US government fact sheet reports a range of 0.09 to 5.48 mg per 1,200 mg.

Who should be careful

Within trials, harms looked rare. A safety meta-analysis of 53 randomized trials with 8535 people found no rise in the odds of muscle problems (OR 0.94, 95% CI 0.53 to 1.65), though those trials were small, short and built to measure cholesterol rather than rare harms. In a 4-week pilot trial in 60 patients, muscle fatigue scores rose on simvastatin and stayed level on red yeast rice, a comparison too short and open to settle the question.

Not for everyone. The European Food Safety Authority could not identify any intake of monacolins from red yeast rice that is free of safety concerns. It noted individual severe reactions at doses as low as 3 mg a day, with muscle breakdown and liver injury among the risks. Its opinion rests on case reports and on the pharmacology of lovastatin.

In pregnancy and breastfeeding the advice is to stay away. The US National Institutes of Health says red yeast rice is not recommended for people who are pregnant or lactating, because no safety studies exist. It also warns that red yeast rice can share the drug interactions of statins. Monacolin K is the same compound as the cholesterol drug lovastatin. One case report describes muscle breakdown in a kidney transplant patient who took it with cyclosporine.

Product quality is a risk of its own. Four of the 12 US products tested held raised levels of citrinin, a kidney toxin. In Japan in 2024, a contaminated red yeast rice supplement was followed by reports of 76 possibly related deaths and 492 hospitalizations. Those are reported numbers, and the deaths were not each shown to be caused by the product. Case series from that event describe kidney injury with Fanconi syndrome that improved after stopping, in two of three cases only partly. The cause was contamination in one manufacturer's product rather than monacolin itself.

Children are a special case. In 40 children aged 8 to 16 with inherited high cholesterol, a red yeast rice product combined with policosanols cut LDL by 25 percent against placebo over 8 weeks, an effect of the mixture, reported in percent only. We found no card on the safety of red yeast rice alone in children.

What expert bodies say

The European Union restricts red yeast rice. It revoked its cholesterol claim for red yeast rice in 2024 and bans daily portions with 3 mg or more of monacolins. It also refused a claim that monacolin K from a branded red yeast rice helps maintain normal LDL cholesterol, and the register gives no reasons for that refusal. EFSA's opinion, quoted above, found no intake free of concern. In the United States, the National Institutes of Health warns against use in pregnancy and about statin-type drug interactions.

How we searched

What would change this answer

• A trial of heart attacks or deaths outside China, using a product people can actually buy. The one event trial used a standardized extract.
• Products labeled and standardized for monacolin content. Until then, the dose in a capsule is a guess.
• Trials in pregnancy, in children on red yeast rice alone, and in older adults. We found none, and ClinicalTrials.gov held no records for red yeast rice or monacolin, so none is registered there.

Other findings and practical notes for the product itself are on the red yeast rice page.

Sources

1. ev-ryr-01 · Meta-analysis or systematic review · systematic review and meta-analysis of randomized controlled trials · n = 24 treatment arms
   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.
   
   Who: Adults in randomized controlled trials of red yeast rice, 24 treatment arms, search to December 2021
   Effect: 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
   Certainty: Products and monacolin doses varied widely; many trials were Chinese and short. Effect larger in people with dyslipidemia.
   Expert Rev Clin Pharmacol, 2023 · checked 2026-10-06 · we read the abstract
2. ev-ryr-02 · Meta-analysis or systematic review · systematic review and meta-analysis of randomized studies · n = 20 studies
   RYR lowered LDL cholesterol with 1.02 mmol/L [-1.20; -0.83] compared to placebo.
   
   Who: Randomized studies of red yeast rice with known monacolin K content vs placebo or active control, search to November 2014
   Effect: 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
   Certainty: Quality of safety assessment low in most studies; authors call safety uncertain.
   Atherosclerosis, 2015 · checked 2026-10-06 · we read the abstract
3. ev-ryr-03 · Meta-analysis or systematic review · random effects network meta-analysis of randomized trials · n = 13062
   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.
   
   Who: Adults in 131 randomized trials of artichoke, berberine, bergamot, garlic, green tea, plant sterols, policosanols, red yeast rice, silymarin or spirulina
   Effect: 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
   Certainty: Indirect comparisons; bergamot ranked first on a small evidence base. Search to February 2021.
   Pharmacol Res, 2022 · checked 2026-10-06 · we read the abstract
4. ev-ryr-04 · Meta-analysis or systematic review · systematic review of randomized controlled trials, PubMed and Cochrane 2012-2023 · n = 769
   Low doses of monacolin K equal to 3mg/day exert potential cholesterol-lowering effects although the number of relative studies is limited.
   
   Who: Adults over 18 with hypercholesterolemia in 12 RCTs, monacolin K 2 to 10 mg/day, maximum 12 weeks
   Effect: all 12 trials showed lower LDL and total cholesterol (p < 0.05) regardless of dose; 3 trials reported adverse effects; no pooled estimate
   Certainty: No pooled effect size; trials short. Authors advise routine monitoring at any dose.
   Semergen, 2024 · checked 2026-10-06 · we read the abstract
5. ev-ryr-05 · Meta-analysis or systematic review · systematic review and meta-analysis of randomized controlled trials · n = 8535
   Monacolin K administration was not associated with increased risk of MuD (odds ratio (OR) = 0.94, 95% confidence interval (CI) 0.53,1.65).
   
   Who: 8535 subjects in 53 RCTs (4437 red yeast rice, 4303 control), moderately hypercholesterolemic
   Effect: 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)
   Certainty: Trials were small and short, built to show lipid effects, not rare harms; case reports and the EFSA opinion (ev-ryr-10) point the other way for rare severe reactions.
   Pharmacol Res, 2019 · checked 2026-10-06 · we read the abstract
6. ev-ryr-06 · Randomized controlled trial(s) · multicentre randomized placebo-controlled trial (China Coronary Secondary Prevention Study) · n = nearly 5000
   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.
   
   Who: Chinese patients with previous myocardial infarction and average LDL-C, Xuezhikang (partially purified red yeast rice extract) or placebo, mean 4.5 years
   Effect: major coronary events 10.4% placebo vs 5.7% Xuezhikang, absolute -4.7%, relative -45%; CV mortality -30%, total mortality -33%
   Certainty: A standardized pharmaceutical-grade extract, not a typical retail supplement; single country; the only event trial.
   Am J Cardiol, 2008 · checked 2026-10-06 · we read the abstract
7. ev-ryr-07 · Randomized controlled trial(s) · single-center prospective randomized single-blind trial, NCT04846231 · n = 190
   None of the dietary supplements demonstrated a significant decrease in LDL-C compared with placebo.
   
   Who: 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
   Effect: rosuvastatin vs placebo LDL-C -35.2% (95% CI -41.3% to -29.1%); no supplement, red yeast rice included, differed from placebo
   Certainty: Only 28 days and one commercial product per supplement; the monacolin content of the tested product is not given in the abstract.
   J Am Coll Cardiol, 2023 · checked 2026-10-06 · we read the abstract
8. ev-ryr-08 · Randomized controlled trial(s) · randomized double-blind placebo-controlled trial · n = 142
   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.
   
   Who: 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
   Effect: LDL-C -14.8%, TC -11.2% (P < .001) in the supplement group; no change with placebo
   Certainty: The supplement also contained folic acid; within-group changes reported in the abstract.
   Nutr Res, 2016 · checked 2026-10-06 · we read the abstract
9. ev-ryr-09 · Randomized controlled trial(s) · single-center randomized pilot trial, NCT01686451 · n = 60
   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.
   
   Who: Dyslipidemic patients with low to moderate cardiovascular risk, simvastatin (33) or red yeast rice (27) for 4 weeks
   Effect: fatigue score rose with simvastatin, unchanged with red yeast rice; similar lipid lowering in both groups; effect sizes not in abstract
   Certainty: Pilot, 4 weeks, open comparison; not designed to detect rare myopathy.
   BMC Cardiovasc Disord, 2017 · checked 2026-10-06 · we read the abstract
10. ev-ryr-10 · Position of an expert body · EFSA ANS Panel scientific opinion on the safety of monacolins in red yeast rice, 2018 · n = —
    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.
    
    Who: general population and vulnerable subgroups in the EU
    Effect: 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
    Certainty: Built on case reports and lovastatin pharmacology; it led the EU to cap monacolins below 3 mg/day in 2022 (Regulation 2022/860, not carded, EUR-Lex unavailable).
    EFSA ANS Panel, Scientific opinion on the safety of monacolins in red yeast rice, EFSA Journal 2018;16(8):5368 · checked 2026-10-06 · we read the abstract
11. ev-ryr-11 · Position of an expert body · NCCIH consumer fact sheet, Red Yeast Rice: What You Need To Know, last updated November 2022 · n = —
    Red yeast rice products are not recommended for those who are pregnant or lactating.
    
    Who: people who are pregnant or lactating; people taking other medicines
    Effect: not recommended in pregnancy or lactation (no safety studies); same types of drug interactions as statins; citrinin contamination common in a 2021 product analysis
    Certainty: Position without its own analysis. Also states monacolin K content of retail products ranged from 0.09 to 5.48 mg per 1,200 mg.
    NIH National Center for Complementary and Integrative Health, Red Yeast Rice: What You Need To Know, updated November 2022 · checked 2026-10-06 · we read the page
12. ev-ryr-12 · Laboratory or animal data · case series · n = 3
    We present three cases wherein renal dysfunction improved within a few months of supplement discontinuation, without immunosuppressive therapy.
    
    Who: Three adults (47 to 59 years) who took Benikoji CholesteHelp for 4 months to 2 years
    Effect: 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
    Certainty: Contamination of one manufacturer's product (puberulic acid per Japanese health ministry, seen only in news, not carded), not an effect of monacolin itself; shows that product quality is a real risk.
    CEN Case Rep, 2025 · checked 2026-10-06 · we read the abstract
13. ev-ryr-13 · Position of an expert body · EU Register on nutrition and health claims, entry POL-HC-11241, snapshot of 2026-09-21 · n = —
    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
    
    Who: food labeling in the European Union
    Effect: status Non-authorized for Monacolin K in SYLVAN BIO red yeast rice and the LDL-cholesterol claim
    Certainty: The register also lists a canceled monacolin claim; the register carries no reasons, so a refusal is not evidence of no LDL effect. Level E.
    EU Register on nutrition and health claims, claim POL-HC-11241, snapshot 2026-09-21 · checked 2026-10-06 · we read the row
14. ryrr8-04 · Meta-analysis or systematic review · systematic review and meta-analysis of double-blind trials · n = 14 trials
    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.
    
    Who: Fourteen double-blinded clinical trials, 4-24 weeks
    Effect: TC -37.43 mg/dL (-47.08, -27.79); LDL-C -35.82 mg/dL (-43.36, -28.29); HDL, TG not changed
    Certainty: 2012-2022, different preparations
    Nutrients, 2024 · checked 2026-10-03 · we read the abstract
15. ryrr8-06 · Randomized controlled trial(s) · multicentre randomized trial, 8 weeks · n = 18
    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).
    
    Who: Eighteen patients without known cardiovascular disease, 8 weeks
    Effect: LDL median -0.96 [-1.05, -0.34] vs -0.20 [-0.62, 1.19] mmol/L, p=0.030
    Certainty: very small sample, no placebo (diet only)
    Asia Pac J Clin Nutr, 2021 · checked 2026-10-03 · we read the abstract
16. ryrr8-07 · Randomized controlled trial(s) · double-blind randomized placebo-controlled crossover trial · n = 40
    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.
    
    Who: 40 children affected by heterozygous FH and FCH, aged 8-16 years
    Effect: TC -18.5%, LDL-C -25.1%, apoB -25.3% vs placebo (p<0.001); no change in AST, ALT, CK
    Certainty: mixture with policosanols; 8 weeks; the EU advises not giving it under 18
    Nutr Metab Cardiovasc Dis, 2011 · checked 2026-10-03 · we read the abstract
17. ryrr8-08 · Laboratory or animal data · laboratory analysis of commercial products · n = 12 products
    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.
    
    Who: 12 commercial RYR formulations labeled 600 mg/capsule
    Effect: monacolin K 0.10-10.09 mg/capsule; total monacolins 0.31-11.15 mg; citrinin elevated in 4 of 12
    Certainty: 2006-2008, US market; the composition may have changed
    Arch Intern Med, 2010 · checked 2026-10-03 · we read the abstract
18. ryrr8-09 · Laboratory or animal data · case report · n = 3
    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.
    
    Who: 3 patients who took the product for 2 weeks to 7 months
    Effect: acute kidney injury with Fanconi syndrome; improved after stopping and prednisolone
    Certainty: death counts are reported, not causally established; the cause was contamination (puberulic acid, web), not monacolin itself
    Am J Kidney Dis, 2025 · checked 2026-10-03 · we read the abstract
19. ryrr8-10 · Laboratory or animal data · case report · n = 1
    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.
    
    Who: a stable renal-transplant recipient
    Effect: rhabdomyolysis resolved after stopping the product; proposed CYP450 interaction
    Certainty: one case; the mechanism is the authors' hypothesis
    Transplantation, 2002 · checked 2026-10-03 · we read the abstract
20. ryrr8-11 · Position of an expert body · regulatory decision · n = —
    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
    
    Who: EU Register entry POL-HC-6421
    Effect: Revoked; monacolins >=3 mg per daily portion prohibited
    Certainty: Reg (EU) 2022/860 and 2024/2041
    EU Register on nutrition and health claims, claim POL-HC-6421, snapshot 2026-09-21 · checked 2026-10-03 · we read the dataset