ArticleBritish journal of clinical pharmacology2017
Adverse reactions to dietary supplements containing red yeast rice: assessment of cases from the Italian surveillance system.
Article in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
39 citing papers in PubMed, 1 synthesis or guideline pooled it, 79 citations in OpenAlex.
- Red Yeast Rice: A Systematic Review of the Traditional Uses, Chemistry, Pharmacology, and Quality Control of an Important Chinese Folk Medicine.Frontiers in pharmacology · 2019Pooled it
- Chemical Profiling and In Vitro Cytotoxicity Assessment of Commercial Red Yeast Rice Ingredients.Foods (Basel, Switzerland) · 2026Article
- Approaches to Authenticating Products Containing Red Yeast Rice Extract (Monacolin K).Molecules (Basel, Switzerland) · 2026Review
- Signals of Adverse Reactions to Herbal Medicines: Evidence and Document Analysis Based on a Scoping Review.Drug safety · 2025Article
- Navigating the Effects of Anti-Atherosclerotic Supplements and Acknowledging Associated Bleeding Risks.International journal of molecular sciences · 2025Review
- Effect of red yeast rice on the growth of male SD rats: a 90-day feeding study.Toxicological research · 2025Article
- Scientific Opinion on additional scientific data related to the safety of monacolins from red yeast rice submitted pursuant to Article 8(4) of Regulation (EC) No 1925/2006.EFSA journal. European Food Safety Authority · 2025Article
- 2024 update on postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia.Archives of medical science : AMS · 2025Article
- Efficacy, side effects, adherence, affordability, and procurement of dietary supplements for treating hypercholesterolemia: a narrative review.Journal of health, population, and nutrition · 2024Review
- Review
- Rhabdomyolysis or Severe Acute Hepatitis Associated with the Use of Red Yeast Rice Extracts: an Update from the Adverse Event Reporting Systems.Current atherosclerosis reports · 2023Review
- Red Yeast Rice for the Improvement of Lipid Profiles in Mild-to-Moderate Hypercholesterolemia: A Narrative Review.Nutrients · 2023Review
- Rhabdomyolysis Related to Red Yeast Rice Ingestion.Cureus · 2023Article
- Nutraceutical Approaches to Dyslipidaemia: The Main Formulative Issues Preventing Efficacy.Nutrients · 2022Review
- Elevation of transaminases associated with teriparatide treatment: a case report.European journal of hospital pharmacy : science and practice · 2022Review
- The Role of Nutraceutical Supplements, Monacolin K and Astaxanthin, and Diet in Blood Cholesterol Homeostasis in Patients with Myopathy.Biomolecules · 2022Observational
- A descriptive study of commercial herbal dietary supplements used for dyslipidemia-Sales data and suspected adverse reactions.Phytotherapy research : PTR · 2022Article
- Analysis of Monacolins and Berberine in Food Supplements for Lipid Control: An Overview of Products Sold on the Italian Market.Molecules (Basel, Switzerland) · 2021Article
- Red yeast rice (Monascus purpureus) supplements: Case series assessment of spontaneously reported cases to The Netherlands Pharmacovigilance Centre Lareb.British journal of clinical pharmacology · 2021Article
- Herb-induced liver injury (HILI) with 12,068 worldwide cases published with causality assessments by Roussel Uclaf Causality Assessment Method (RUCAM): an overview.Translational gastroenterology and hepatology · 2021Review
Corrections and comments
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Authors and funding
5 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsRed yeast rice (RYR) is contained in dietary supplements for patients with dyslipidemia. RYR supplements contain monacolin K, which is chemically identical to lovastatin, a licensed drug with a well-known risk profile. We aim to describe the safety profile of RYR by analysing spontaneous reports of suspected adverse reactions (ARs).
methodsWithin the Italian Surveillance System of Natural Health Products, suspected ARs were collected and evaluated by a multidisciplinary group of experts to assess causality using the WHO-UMC system or the CIOMS/RUCAM score, for hepatic reactions. The public version of the WHO-Vigibase was also queried.
resultsFrom April 2002 to September 2015, out of 1261 total reports, 52 reports concerning 55 ARs to RYR dietary supplements were collected. ARs consisted in myalgia and/or increase in creatine phosphokinase (19), rhabdomyolysis (1), liver injury (10), gastrointestinal reactions (12), cutaneous reactions (9) and other reactions (4). Women were involved in 70% of cases. In 13 cases, the reaction required hospitalization, and 28 patients were taking other medications. Dechallenge was positive in 40 reactions (73%), rechallenge was positive in 7. Causality resulted as certain (1), probable (31, 56%), possible (18, 34%), unlikely (3) or unassessable (2). Similar distribution emerged from the WHO-Vigibase.
conclusionsThe potential safety signals of myopathies and liver injury raise the hypothesis that the safety profile of RYR is similar to that of statins. Continuous monitoring of dietary supplements should be promoted to finally characterize their risk profile, thus supporting regulatory bodies for appropriate actions.
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