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Side Effects and Precautions of the Red yeast rice extract


Native to China, red yeast rice extract is the byproduct of Monascus purpureus Went (red yeast) fermenting on rice. Part of the Monascaceae family, Monascus purpureus is identified by its ascospores. The color of the mycelium is initially white, but soon changes to pink and then yellow-orange due to an increase in acidity and the development of hyphae. They explain that as the culture ages, it is characterized by a dark crimson color at the substratum.

General use

Documented as early as 800 A.D., Chinese red yeast rice was used in the preserving, flavoring, and coloring of food and wine. However, in addition to red yeast rice’s culinary properties, it was soon discovered that red yeast rice possessed medicinal properties as well. The ancient Chinese pharmacopoeia, Ben Cao Gang Mu-Dan Shi Bu Yi, published during the Ming Dynasty (1368– 1644), recorded a detailed description of red yeast rice and its manufacture. According to the pharmacopoeia, red yeast rice promotes blood circulation and stimulates the digestive system and spleen. Recent studies of red yeast rice indicate that it contains substances similar to those found in cholesterol-reducing (statin) prescription medications. In addition, research indicates red yeast rice may contain other cholesterol-reducing and be itself an agent useful in lowering cholesterol

Traditional red yeast rice can be purchased in typical Chinese groceries. However, in this form, the extract possesses negligible to very low levels of statin compounds. Instead, manufacturers grow and process the M. purpureus Went under controlled conditions to increase the levels of statin. The powdered extract is then sold in capsule form. In 2001, the Food and Drug Administration (FDA) determined that standardized red yeast rice extract (in this case, Cholestin®; developed by Pharmanex) possessed strong chemical similarities to the drug lovastatin, another cholesterol-reducing drug. Unfortunately, a pharmaceutical company, Merck & Co., trademarked lovastatin as Mevacor®. Because of the similarity, the FDA classified standardized red yeast rice extract as a drug. Under the Dietary Supplement Health Education Act of 1994, it could no longer be sold as a dietary supplement under penalty of law. As such, standardized red yeast rice extract has virtually disappeared from the United States marketplace.


Although there have been several studies on red yeast rice extract, there remains little information regarding its safety for long-term usage. There are also certain medical risks associated with this extract. As such, it is strongly suggested that anyone considering using red yeast rice extract for the prevention and treatment of high cholesterol consult with their physician before doing so. This is particularly important for people suffering from high cholesterol and/or heart disease. A base-line liver enzyme check is recommended beforehand, in addition to subsequent checks thereafter. In general, however, the recommended dose for adults is 600 mg (oral dose), two to four times per day. Additionally, due to the 2001 FDA decision, only a doctor may legally prescribe standardized red yeast rice extract. As such, health-food stores now selling this product are doing so illegally. There are, however, several dietary supplements available to the public, which can be as effective as red yeast rice extract. Pharmanex, for example, has removed red yeast rice extract from their supplement, Cholestin®, and replaced it with other cholesterol-reducing, natural substances. It is advisable to consult with a physician regarding the available options. 


Due to the lack of medical evidence regarding red yeast rice extract’s safety for use by youths and children, it is recommended that it not be given to people younger than age 20. Those at risk of or suffering from liver disease shouldn’t take red yeast rice extract, as it may affect liver function. Due to the product’s statin content, usage is also contraindicated for people with serious infections or physical disorders, who are pregnant or breastfeeding, or have had an organ transplant. 
Side effects Although the risks are low, usage can result in liver damage, kidney toxicity, and rhabdomyolysis (disintegration of skeletal muscle). Side effects are mild, including headache, dizziness, flatulence, heartburn, and stomachache. When the extract is no longer being taken, any side effects fade quickly. 


Because of its statin content, red yeast rice extract should not be taken with other HMG-CoA reductase inhibitors, such as atorvastatin and lovastatin. This interaction would increase the effects of these medications, thus increasing the risk of liver damage. However, niacin supplements can be safely used to enhance the cholesterol-lowering effects. Due to the increased risk of rhabdomyolysis, red yeast rice extract should not be taken with high-dose nicotinic acid (more than 1,000 mg/per day). A physician should be contacted immediately if any muscle pain, tenderness, or weakness is experienced. Alcohol consumption while using red  yeast rice extract should not exceed two drinks a day. Also, grapefruit, grapefruit juice, and grapefruit products (like marmalade) should be strictly avoided. Grapefruit enhances the blood concentration of HMG-CoA reductase inhibitors by as much as 15 times, thus greatly increasing the risk of side effects and liver damage. 


Burnham, T. H., S. L. Sjweain, and R. M. Short (eds.). 
The Review of Natural Products. Facts and Comparisons, 1997. 
Kuhn, Winston. Herbal Therapy and Supplements: A Scientific and Traditional Approach. Lippincott, 2001. 
McKenna, Dennis J., Kerry Hughes, and Kenneth Jones (eds.). 
Natural Dietary Supplements Pocket Reference. Institute for Natural Products Research, 2000.


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