Red yeast rice
Summary
Red yeast rice lowers LDL cholesterol in trials (grade B), because its monacolin K is the drug lovastatin. That also brings statin side effects and interactions. Monacolin K content varied more than 60-fold between 26 US brands, a third of products in another test had elevated levels of citrinin (a toxin that damages the kidneys in animals), and EFSA could not identify an intake that raises no safety concern.
Key facts
- LDL −0.87 mmol/L (about −34 mg/dL) vs placebo across 13 RCTs (n = 804)[1]
- Monacolin K is identical to lovastatin; the FDA says products with added or enhanced lovastatin cannot be sold as supplements[10][11]
- Monacolin K ranged 0.09–5.48 mg per 1,200 mg across 28 US brands; 2 had none[5]
- Elevated citrinin, a mycotoxin that damages the kidneys in animals, in 4 of 12 products tested[4]
- The EU bans 3 mg or more of monacolins per daily portion after EFSA could not identify a safe intake level[9][12]
- 3 graded human outcomes on this page
- October 13, 2026
How it works
EstablishedMonacolin K inhibits HMG-CoA reductase, the enzyme blocked by statins, slowing cholesterol production in the liver; EFSA judged monacolin K in lactone form identical to lovastatin.[9][11]
What the human research says
Human trials only, one row per outcome. The form column shows what each trial actually tested. Grades follow our evidence-grading policy.
At a glance: strongest evidence per outcome
| Outcome | Grade | Effect | Strongest evidence | Rows |
|---|---|---|---|---|
| Cholesterol | Grade B | Improved | Meta-analysis of 13 trials · n = 804 · 2014 | 2 rows |
| Heart | Grade C | Improved | RCT · n = 2,704 · 2010 | 1 row |
Every graded row
| Outcome | Effect | Grade | Best evidence | PMID |
|---|---|---|---|---|
| LDL cholesterol in dyslipidaemia | Improved | Grade B | Meta-analysis · n = 804 · 2014 Adults with dyslipidaemia in 13 placebo-controlled RCTs Form: Red yeast rice (excluding Xuezhikang and Zhibituo) · Dose: Varied by trial · Duration: Varied LDL −0.87 mmol/L (95% CI −1.03 to −0.71), total cholesterol −0.97 mmol/L and triglycerides −0.23 mmol/L vs placebo; HDL unchanged. No serious side effects reported in the trials. | 24897342 (opens PubMed)Source [1] |
| Coronary events after heart attack (hypertensive subgroup) | Improved | Grade C | RCT · n = 2,704 · 2010 Chinese adults with hypertension and previous heart attack (CCSPS subgroup) Form: Xuezhikang (partially purified red yeast rice extract) · Dose: 0.6 g twice daily · Duration: Mean 4.5 years Coronary events 43% lower, coronary deaths 30% lower and all-cause mortality 35.8% lower than placebo. | 20350253 (opens PubMed)Source [3] |
| LDL cholesterol in people who stopped statins for muscle pain | Improved | Grade C | RCT · n = 62 · 2009 Adults with dyslipidaemia who stopped statins because of myalgia (community cardiology practice) Form: Red yeast rice plus lifestyle programme · Dose: 1,800 mg twice daily · Duration: 24 weeks LDL fell 35 mg/dL at 24 weeks vs 15 mg/dL with placebo (P = 0.011); muscle enzyme (CPK) and pain scores did not differ. | 19528562 (opens PubMed)Source [2] |
Forms
| Form | Elemental % | Absorption (human data) | GI tolerance | Studied for |
|---|---|---|---|---|
| Red yeast rice capsules (US/EU supplements) | Varies[5] | Monacolin K content is unpredictable: 0.09–5.48 mg per 1,200 mg in 28 US brands.[5] | Myopathy, rhabdomyolysis and liver injury have been reported to surveillance systems.[6][8] | LDL lowering in small trials |
| Xuezhikang (Chinese red yeast rice extract) | Varies[3] | A partially purified extract containing statin-like monacolins.[3] | Reported as well tolerated in the CCSPS trial.[3] | Coronary outcomes in China |
| Beni-koji tablets (Japan) | Varies[7] | Japanese red yeast rice products marketed for cholesterol.[7] | Kobayashi Pharmaceutical products recalled in 2024 after kidney injury cases.[7][13] | Not studied for benefit here |
Studied doses
Doses studied in human trials ranged from 1,200 mg/day of Xuezhikang extract for about 4.5 years to 3,600 mg/day of red yeast rice for 24 weeks; monacolin content was not standardised across products.[2][3]
Interactions
Published interactions only: each row cites a source. No row means none was found in our sources, not that a combination is safe.
Medicines
- Strong CYP3A4 inhibitorsDrug labelLovastatin, the same molecule as monacolin K, is a CYP3A4 substrate and its label contraindicates these drugs because they raise myopathy risk.[11]
- Gemfibrozil and cyclosporineDrug labelThe lovastatin label says to avoid gemfibrozil and notes cyclosporine raises statin levels.[11]
- Statins and other cholesterol drugsNIH fact sheetNCCIH notes red yeast rice can have the same drug interactions and side effects as statins; combining doubles up on the same mechanism. The lovastatin label also urges caution with fibrates and niacin at 1 g/day or more, which can cause muscle damage on their own.[10][11]
Other supplements
- Grapefruit juiceDrug labelGrapefruit juice raised lovastatin blood levels in label studies.[11]
Who should be careful
- Pregnancy and breastfeeding
- NCCIH says red yeast rice is not recommended; lovastatin is contraindicated in pregnancy and lactation.[10][11]
Talk to your pharmacist or clinician before starting a supplement, especially if you take prescription medicines.
Regulatory warnings
- FDA (2007)
- Warned consumers not to buy three red yeast rice products found to contain lovastatin, calling them unapproved new drugs.[14]
Japan 2024: beni-koji kidney injury
- What happened
- Kobayashi Pharmaceutical recalled Beni-koji Choleste-Help and two related products in March 2024 after kidney injury reports; Japan ordered their disposal.[13]
- Clinical picture
- In 192 patients surveyed, 94% had eGFR below 60 with Fanconi-like tubular damage; 87% still had eGFR below 60 at last follow-up.[7]
Frequently asked questions
Does red yeast rice lower cholesterol?
Yes, products with enough monacolin K lower LDL in trials, by about 0.87 mmol/L in pooled data, because monacolin K is lovastatin.[1][10]
Is red yeast rice safe?
It carries statin-type risks (muscle and liver injury), unpredictable strength and possible citrinin contamination; EFSA could not identify a safe intake.[4][5][9]
Can I combine red yeast rice with a statin?
NCCIH notes it has the same interactions and side effects as statins, so combining doubles the same mechanism; discuss with a prescriber.[10]
What happened with red yeast rice in Japan?
In 2024 Kobayashi Pharmaceutical recalled beni-koji products after kidney injury reports; a nationwide survey found lasting kidney damage in many patients.[7][13]
Why do red yeast rice brands differ so much?
Testing of 28 US brands found monacolin K ranging more than 60-fold per 1,200 mg, and two brands had none.[5]
Sources
- [1]A meta-analysis of red yeast rice: an effective and relatively safe alternative approach for dyslipidemia.. PLoS One, 2014. meta-analysis
- [2]Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial.. Ann Intern Med, 2009. RCT
- [3]Impact of Xuezhikang on coronary events in hypertensive patients with previous myocardial infarction from the China Coronary Secondary Prevention Study (CCSPS).. Ann Med, 2010. RCT
- [4]Marked variability of monacolin levels in commercial red yeast rice products: buyer beware!. Arch Intern Med, 2010. observational
- [5]Variability in strength of red yeast rice supplements purchased from mainstream retailers.. Eur J Prev Cardiol, 2017. observational
- [6]Adverse reactions to dietary supplements containing red yeast rice: assessment of cases from the Italian surveillance system.. Br J Clin Pharmacol, 2017. observational
- [7]A nationwide questionnaire study evaluated kidney injury associated with Beni-koji tablets in Japan.. Kidney Int, 2025. observational
- [8]Adverse Events to Food Supplements Containing Red Yeast Rice: Comparative Analysis of FAERS and CAERS Reporting Systems.. Drug Saf, 2018. observational
- [9]Scientific opinion on the safety of monacolins in red yeast rice (EFSA ANS Panel). European Food Safety Authority, 2018. safety-communication
- [10]Red Yeast Rice: What You Need To Know. NIH National Center for Complementary and Integrative Health, 2022. fact-sheet
- [11]Lovastatin tablets: prescribing information (contraindications and drug interactions). DailyMed, US National Library of Medicine, 2026. label
- [12]Commission Regulation (EU) 2022/860 on monacolins from red yeast rice. European Commission (EUR-Lex), 2022. guideline
- [13]Information for adverse events: Beni-koji (red yeast rice) supplements from Kobayashi Pharmaceutical. Ministry of Health, Labour and Welfare, Japan, 2024. safety-communication
- [14]FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol. US Food and Drug Administration (archived), 2007. safety-communication
What changed
- Editorial evidence re-review: product-variability figure corrected to the source (more than 60-fold across 26 US brands), citrinin wording matched to the abstract (elevated levels; nephrotoxic in animals), EFSA wording matched to its conclusion, insight reworded to what NCCIH and product testing support, and the lovastatin label's fibrate/niacin caution added. EFSA, EU 2022/860, MHLW beni-koji and DailyMed lovastatin claims re-checked against the primary pages.
- Second-pass self-review: every PMID re-checked against NCBI esummary (title, year, no retraction or expression-of-concern flag), every dose, n and duration re-read against the PubMed abstract or PMC full text, grades held conservative, and interactions limited to what a cited source supports.
- First draft. Source titles and years taken from NCBI E-utilities esummary; abstracts read for every evidence row.