⚠ Regulatory caution
📰Read the full Red Yeast Rice evidence review on GMJ News →Complete clinical article, references and updates on news.gmj.ge. This page is the structured safety summary.⚠ HIGH RISK — see overview [1]
ℹ️ Not obtained from food. Not applicable — this is not obtained from food in meaningful amounts; supplementation is the practical route.
🔬 Lab interpreter
ℹ️ No validated blood test. There is no established laboratory test to assess status or guide dosing for this ingredient. Clinical response and symptoms are the practical guide.
⚕ For professionals — confirm ranges against your local laboratory.
Clinical verdict
Red yeast rice IS lovastatin — chemically identical. LDL reduction ~25% (meta-analysis of 93 RCTs). Three critical problems: (1) FDA considers it an unapproved drug; (2) monacolin K content varies 0–75× between products — some contain none, some contain prescription-equivalent doses; (3) citrinin (nephrotoxin) contamination in some products. If it works, it's because it IS a statin — with ALL statin side effects (myopathy, hepatotoxicity, rhabdomyolysis). Patients avoiding statins but taking RYR are unknowingly taking a statin [1].
1 How much do I need?
👤 Adults: Specific dosage data under clinical review
👴 Elderly: Specific dosage data under clinical review
🤰 Pregnancy: See guidance
CONTRAINDICATED — lovastatin/monacolin K is FDA Category X (teratogenic). Same as all statins [1].
👦 Pediatric: See guidance
Not recommended [1].
🏃 Athletes: Standard dose
⚖️ Obesity: Standard dose
Fat-soluble compounds may require dose adjustment in obesity.
🩺 Renal: Consult specialist
Dose adjustment may be needed in renal impairment.
🌱 Vegan: Standard dose
How to take
🍽 Timing: See overview [1].
💊 With food: See overview [1].
🚫 Avoid: See overview for contraindications [1].
2 Which form?
| Form | Bioavailability | Vegan | Cost |
|---|---|---|---|
| ['Various', 'see overview', 'See overview for forms and risks [1].'] | Standard | Check label |
3 Common questions
Key safety point ▼
Red yeast rice IS lovastatin — chemically identical. LDL reduction ~25% (meta-analysis of 93 RCTs). Three critical problems: (1) FDA considers it an unapproved drug; (2) monacolin K content varies 0–75× between products — some contain none, some contain prescription-equivalent doses; (3) citrinin (nephrotoxin) contamination in some products. If it works, it's because it IS a statin — with ALL statin side effects (myopathy, hepatotoxicity, rhabdomyolysis). Patients avoiding statins but taking RYR are unknowingly taking a statin [1].
4 Clinical evidence
Strong
See overview [1]. HIGH
Moderate
See overview [1]. MODERATE
Insufficient
See overview [1]. LOW
5 Safety, toxicity & adverse events
Absolute contraindications
✕ Pregnancy and lactation — it contains a statin (monacolin K = lovastatin)
✕ Active liver disease
✕ Concurrent statins or strong CYP3A4 inhibitors — additive statin toxicity (myopathy)
Relative
⚠ Same risks/interactions as statins (myopathy, rhabdomyolysis, liver effects)
⚠ Grapefruit and fibrates/gemfibrozil — raised toxicity
⚠ Monacolin content varies widely and citrinin (nephrotoxin) contamination is possible
🚩 Red flags
● HIGH RISK — see overview for critical safety alerts [1]
6 Interactions
Drug interactions
ALL statin interactions apply Major
Mechanism: Monacolin K IS lovastatin. CYP3A4 metabolized. Grapefruit, azole antifungals, macrolides, etc. SAME drug interaction profile as prescription lovastatin [1].
7 US supplement products
80
on-market products containing Red Yeast Rice (NIH DSLD)
Brands carrying Red Yeast Rice (51)
Click a brand to see its Red Yeast Rice products.
8 Frequently paired with
9 Cite this page
Vancouver: Pkhakadze G. Red Yeast Rice — safety profile [Internet]. Tbilisi: PHIG; 2026 [cited 2026 Oct 17]. Available from: https://supplement.ge/ingredients/red-yeast-rice/
APA 7th: Pkhakadze, G. (2026). Red Yeast Rice — Safety profile. Public Health Institute of Georgia. https://supplement.ge/ingredients/red-yeast-rice/
📋 Editorial information
Author: Prof. G. Pkhakadze, MD, MPH, PhD
Institution: Public Health Institute of Georgia (PHIG)
Affiliation: David Tvildiani Medical University (DTMU)
First published: January 2026
Last reviewed: 2026-05-29
Next review: April 2027
References: 2 cited sources
COI: SupplementIndex receives no funding from supplement manufacturers. All content independently authored by PHIG.
Process: Systematic literature review
📄 License & reuse
Published under Creative Commons Attribution 4.0 International (CC BY 4.0). You may share and adapt for any purpose with attribution.
Pkhakadze G. "Red Yeast Rice — Safety Profile." SupplementIndex, PHIG, 2026. https://supplement.ge/ingredients/red-yeast-rice/ CC BY 4.0.
GP
Prof. G. Pkhakadze, MD, MPH, PhD
Professor of Public Health · Head of Department, DTMU
Editor-in-Chief, Georgian Medical Journal (ISSN 3088-4322)
Chair, Public Health Institute of Georgia · UEMS Public Health Section
Educational and public health purposes. CC BY 4.0. Consult your healthcare provider before starting any supplement. Corrections: info@accreditation.ge. Publisher: PHIG