Red yeast rice has been suspected to induce some toxicological side effects. The aim of this systematic review and meta-analysis was to examine the available scientific evidences on the safety of red yeast rice supplementations. Data were pooled from 53 randomized and controlled trial, for a total of 8535 subjects (5537 supplemented with red yeast rice and 4303 controls).

Results showed that red yeast rice was not associated with increased risk of musculoskeletal disorders (OR = 0.94, 95% CI: 0.53-1.65). In addition, reduced risk of non-skeletal musculoskeletal adverse events (OR = 0.59, 95% CI: 0.50-0.69) and serious adverse events (OR = 0.54, 95% CI: 0.46-0.64) have been measured with red yeast rice in comparison to control. Furthermore, increasing the doses of monacolin K was negatively associated with increasing risk of non-skeletal musculoskeletal adverse events.

In conclusion, this large meta-analysis demonstrate that the use of red yeast rice as hypocholesterolemic supplement is not associated with safety concern.

Fogacci F, Banach M, Mikhailidis DP, Bruckert E, Toth PP, Watts GF, Reiner Ž, Mancini J, Rizzo M, Mitchenko O, Pella D, Fras Z, Sahebkar A, Vrablik M, Cicero AFG; Lipid and Blood Pressure Meta-analysis Collaboration (LBPMC) Group the International Lipid Expert Panel (ILEP). SAFETY OF RED YEAST RICE SUPPLEMENTATION: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS. Pharmacol Res. 2019 Mar 4. pii: S1043-6618(19)30317-2.