{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T05:03:28Z","timestamp":1784178208326,"version":"3.55.0"},"reference-count":67,"publisher":"MDPI AG","issue":"14","license":[{"start":{"date-parts":[[2026,7,14]],"date-time":"2026-07-14T00:00:00Z","timestamp":1783987200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"EHPM","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Nutrients"],"abstract":"<jats:p>Background and Objectives: Red yeast rice (RYR)-containing food supplements are widely used for mild-to-moderate hypercholesterolemia, but their post-marketing safety remains relevant. This study characterized their safety profile within a structured multicompany nutrivigilance framework. Methods: Spontaneous reports of suspected adverse events (AEs) associated with RYR-containing food supplements were collected between 12 December 2022 and 31 May 2024. Cases were documented using a structured case report form, medically reviewed, and classified for causality according to the World Health Organization\u2013Uppsala Monitoring Centre framework. Exposure was estimated from cumulative manufacturing and sales data. Results: A total of 148 AE reports were collected from 12 European countries. Estimated exposure corresponded to 608,815 exposed subject-periods over 18 months, based on cumulative manufacturing and sales data and recommended daily dosage. Mean age was 65.3 \u00b1 13.3 years; among reports with available age, 58.1% occurred in individuals aged \u226570 years. Gastrointestinal events were most frequent (45.9%), followed by arthromyalgia (16.9%) and hypersensitivity reactions (10.8%). Most events were mild or moderate (97.9%); severe and serious events accounted for 0.7% and 1.4%, respectively. Both serious AEs occurred in individuals aged \u226570 years. The estimated exposure-based reporting rate was 0.02% for all AEs and 0.0003% for serious AEs. Conclusions: Within a structured post-marketing nutrivigilance framework, RYR-containing food supplements showed a low reporting frequency of AEs relative to estimated exposure, with most events being mild or moderate. Future research should strengthen harmonized nutrivigilance systems and integrate product-specific exposure data, formulation characteristics, and post-marketing safety monitoring to support more precise risk assessment.<\/jats:p>","DOI":"10.3390\/nu18142302","type":"journal-article","created":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T01:05:58Z","timestamp":1784077558000},"page":"2302","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Post-Marketing Nutrivigilance of Red Yeast Rice-Containing Food Supplements: Spontaneous Adverse Event Reports and Exposure-Based Reporting Rate Estimates"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4367-3884","authenticated-orcid":false,"given":"Arrigo Francesco Giuseppe","family":"Cicero","sequence":"first","affiliation":[{"name":"Hypertension and Cardiovascular Risk Research Center, Medical and Surgical Sciences Department, Alma Mater Studiorum University of Bologna, 40130 Bologna, Italy"},{"name":"Cardiovascular Medicine Unit, Heart, Chest and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7853-0042","authenticated-orcid":false,"given":"Federica","family":"Fogacci","sequence":"additional","affiliation":[{"name":"Hypertension and Cardiovascular Risk Research Center, Medical and Surgical Sciences Department, Alma Mater Studiorum University of Bologna, 40130 Bologna, Italy"},{"name":"Department of Medical Pharmacology, Medical Faculty, Ataturk University, 25240 Erzurum, Turkey"},{"name":"Italian Society of Nutraceuticals (SINut), 40100 Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,14]]},"reference":[{"key":"ref_1","unstructured":"(2025). 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