Red yeast rice has not been approved by the FDA to treat any disease, and it should not be substituted for prescription medications.
Red yeast rice has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of red yeast rice may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. Some marketed herbal supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.
Some cholesterol-lowering medications can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call a doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.
Avoid drinking alcohol while using red yeast rice. Alcohol may increase your risk of liver damage.