Red Yeast Rice: An Introduction (A Fact Sheet from NCCAM)

Excerpts from Red Yeast Rice backgrounder Web page (US National Center for Center for Complementary and Alternative Medicine)

Red yeast rice is a traditional Chinese culinary and medicinal product. In the United States, dietary supplements containing red yeast rice have been marketed to help lower blood levels of cholesterol and related lipids. Red yeast rice products may not be safe; some may have the same side effects as certain cholesterol-lowering drugs, and some may contain a potentially harmful contaminant. This fact sheet provides basic information about red yeast rice, summarizes scientific research on effectiveness and safety, discusses the legal status of red yeast rice, and suggests sources for additional information.

Key Points

• Some red yeast rice products contain substantial amounts of monacolin K, which is chemically identical to the active ingredient in the cholesterol-lowering drug lovastatin. These products may lower blood cholesterol levels and can cause the same types of side effects and drug interactions as lovastatin.
• Other red yeast rice products contain little or no monacolin K. It is not known whether these products have any effect on blood cholesterol levels.
• Consumers have no way of knowing how much monacolin K is present in most red yeast rice products. The labels on these products usually state only the amount of red yeast rice that they contain, not the amount of monacolin K.

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Safety

• The same types of side effects that can occur in patients taking lovastatin as a drug can also occur in patients who take red yeast rice products that contain monacolin K. Potential side effects include myopathy (muscle symptoms such as pain and weakness), rhabdomyolysis (a condition in which muscle fibers break down, releasing substances into the bloodstream that can harm the kidneys), and liver toxicity. Each of these three side effects has been reported in people who were taking red yeast rice.
• Red yeast rice supplements should not be used while pregnant or breastfeeding.
• Lovastatin can interact with a variety of drugs to increase the risk of rhabdomyolysis; these drugs include other cholesterol-lowering agents, certain antibiotics, the antidepressant nefazodone, drugs used to treat fungal infections, and drugs used to treat HIV infection. Red yeast rice containing monacolin K could interact with drugs in the same way.
• If the process of culturing red yeast rice is not carefully controlled, a substance called citrinin can form. Citrinin has been shown to cause kidney failure in experimental animals and genetic damage in human cells. In a 2011 analysis of red yeast rice products sold as dietary supplements, 4 of 11 products were found to contain this contaminant.

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Legal Status of Red Yeast Rice

In 1998, the FDA determined that a red yeast rice product that contained a substantial amount of monacolin K was an unapproved new drug, not a dietary supplement. On several occasions since then, the FDA has taken action against companies selling red yeast rice products that contain more than trace amounts of monacolin K, warning them that it is against the law to market these products as dietary supplements.

The US National Center for Complementary and Alternative Medicine (NCCAM) includes the section Herbs at a Glance.

This  series of fact sheets that provides basic information about specific herbs or botanicals—common names, uses, potential side effects, and resources for more information.

Related Resources

Drugs, Supplements, and Herbal Information 

Learn about your prescription drugs and over-the-counter medicines. Includes side effects, dosage, special precautions, and more.

Browse dietary supplements and herbal remedies to learn about their effectiveness, usual dosage, and drug interactions.

Dietary Supplements Labels Database 

Information about label ingredients in more than 6,000 selected brands of dietary supplements. It enables users to compare label ingredients in different brands. Information is also provided on the “structure/function” claims made by manufacturers.

These claims by manufacturers have not been evaluated by the Food and Drug Administration. Companies may not market as dietary supplements any products that are intended to diagnose, treat, cure or prevent any disease.

Longwood Herbal Task Force
This site has in-depth monographs about herbal products and supplements written by health professionals and students. It provides clinical information summaries, patient fact sheets, and information about toxicity and interactions as well as relevant links. The task force is a cooperative effort of the staff and students from Children’s Hospital, the Massachusetts College of Pharmacy and Health Sciences, and the Dana Farber Cancer Institute.

Related articles

• Beware of Red Yeast Rice (travelwithsandra.wordpress.com)
• Side Effects of Cholesterol-Lowering Treatments (everydayhealth.com)