ArticleEFSA journal. European Food Safety Authority2018
Scientific opinion on the safety of monacolins in red yeast rice.
Article in EFSA journal. European Food Safety Authority, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 69 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
69 citing papers in PubMed, 1 synthesis or guideline pooled it, 105 citations in OpenAlex.
- Effects of the combination of red yeast rice-containing commercial Chinese polyherbal preparation with statins for dyslipidemia: a systematic review and meta-analysis.Frontiers in pharmacology · 2024Pooled it
- Trial
- The Effect of Nattokinase-Monascus Supplements on Dyslipidemia: A Four-Month Randomized, Double-Blind, Placebo-Controlled Clinical Trial.Nutrients · 2023Trial
- Trial
- Trial
- Effect of Dietary Supplementation with EufortynNutrients · 2022Trial
- Effectiveness and safety of red yeast rice predominated by monacolin K β-hydroxy acid form for hyperlipidemia treatment and management.Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan · 2022 · on this mapTrial
- A Randomized, Double-Blinded, Placebo-Controlled, Clinical Study of the Effects of a Nutraceutical Combination (LEVELIP DUONutrients · 2020Trial
- Chemical Profiling and In Vitro Cytotoxicity Assessment of Commercial Red Yeast Rice Ingredients.Foods (Basel, Switzerland) · 2026Article
- Article
- Research Progress, Safety Regulation and Application Prospects in Health Food Development of Red Yeast Rice-Derived Bioactive Compounds: A Critical Narrative Review.Foods (Basel, Switzerland) · 2026Review
- Selected Nutraceuticals in Metabolic Syndrome: Molecular Mechanisms and Clinical Implications.Biomedicines · 2026Review
- Natural Extract Combination Modulates Intestinal Barrier and Hepatic Cholesterol via the Gut-Liver Axis In Vitro.Pharmaceutics · 2026Article
- Beyond Cholesterol Lowering: Clinical Caution, Personalization, and Nutritional Integration in Statin Therapy.Nutrients · 2026Review
- Approaches to Authenticating Products Containing Red Yeast Rice Extract (Monacolin K).Molecules (Basel, Switzerland) · 2026Review
- Hepatic Cholesterol Regulation Through Multi-Botanical Extract Targeting of the PCSK9-LDLr-SREBP-2 Axis in HepG2 Cells.Biomedicines · 2026Article
- Potential Role of Red Yeast Rice in the Prevention and Treatment of Alzheimer's Disease.International journal of medical sciences · 2026Review
- Pigment Formation byJournal of agricultural and food chemistry · 2025Article
- Red yeast rice with monacolin K for the improvement of hyperlipidemia: A narrative review.World journal of clinical cases · 2025Review
- Effect of red yeast rice on the growth of male SD rats: a 90-day feeding study.Toxicological research · 2025Article
9 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the safety of monacolins in red yeast rice (RYR) and to provide advice on a dietary intake of monacolins that does not give rise to concerns about harmful effects to health. The Panel reviewed the scientific evidences available as well as the information provided by interested parties in response of a public 'Call for data' launched by EFSA. The Panel considered that monacolin K in lactone form is identical to lovastatin, the active ingredient of several medicinal products authorised for the treatment of hypercholesterolaemia in the EU. On the basis of the information available, the Panel concluded that intake of monacolins from RYR via food supplements, could lead to estimated exposure to monacolin K within the range of the therapeutic doses of lovastatin. The Panel considered that the available information on the adverse effects reported in humans were judged to be sufficient to conclude that monacolins from RYR when used as food supplements were of significant safety concern at the use level of 10 mg/day. The Panel further considered that individual cases of severe adverse reactions have been reported for monacolins from RYR at intake levels as low as 3 mg/day. The Panel concluded that exposure to monacolin K from RYR could lead to severe adverse effects on musculoskeletal system, including rhabdomyolysis, and on the liver. In the reported cases, the product contained other ingredients in addition to RYR. However, these reported effects in particular musculoskeletal effects, have both occurred after ingestion of monacolin K and lovastatin independently. 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.