Red yeast rice is a product that is made by fermenting red rice with a certain type of yeast. Red yeast rice is also known as Cholestin, Hypocol, Xuezhikang, or Zhitai.

Red yeast rice supplements are not the same as red yeast rice that is sold in Chinese grocery stores.

Red yeast rice has been used in alternative medicine as a likely effective aid in reducing levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood.

Red yeast rice has been used as a possibly effective aid in reducing the risk of heart disease, heart attacks, or death in people with a history of heart attack.

Red yeast rice has also been used as a possibly effective aid in lowering cholesterol and triglyceride levels in people with human immunodeficiency virus (HIV).

Red yeast rice has been used to treat high blood pressure. However, research has shown that red yeast rice may not be effective in treating this condition.

Other uses not proven with research have included: lowering cholesterol and blood sugar levels in people with diabetes, improving blood circulation, lowering liver enzymes associated with liver damage, and treating diarrhea, indigestion, or other stomach problems.

It is not certain whether red yeast rice is effective in treating any medical condition. Medicinal use of this product has not been approved by the FDA. Red yeast rice should not be used in place of medication prescribed for you by your doctor.

Red yeast rice is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed 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.

Red yeast rice may also be used for purposes not listed in this product guide.

Follow all directions on the product label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Red yeast rice contains an active ingredient called monacolin K, which has the same chemical structure as the active drug in the "statin" cholesterol medicine lovastatin (Advicor, Altoprev, Mevacor). For this reason, red yeast rice supplements may produce the same side effects and drug interactions as statin cholesterol medications produce and may lower the levels of other products such as coenzyme Q-10.

The US Food and Drug Administration (FDA) considers red yeast products that contain more than trace amounts of this statin-identical ingredient to be illegal and unapproved drugs. Red yeast rice products sold within the United States are formulated not to contain high levels of monacolin K. However, red yeast rice with higher levels of monacolin K are still available in other countries.

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to use red yeast rice, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

Red yeast rice works best if you take it with food.

Do not inhale the powder from a red yeast rice capsule. It may cause an allergic reaction.

Call your doctor if the condition you are treating with red yeast rice does not improve, or if it gets worse while using this product.

Store at room temperature away from moisture and heat.

You should not use red yeast rice if you are allergic to it, or:

• if you already take a cholesterol-lowering medication, such as lovastatin, simvastatin, atorvastatin, rosuvastatin, Zocor, Lipitor, Pravachol, Crestor, Vytorin, and many others.

Talk with your healthcare provider before using red yeast rice to lower your cholesterol. You should not use red yeast rice in place of any medication that has been prescribed by your doctor.

Ask a doctor, pharmacist, or other healthcare provider if it is safe for you to use this product if you have or have ever had:

• liver disease; or

• kidney disease.

Red yeast rice has caused birth defects in animals and is considered likely unsafe to use during pregnancy. Do not use this product without medical advice if you are pregnant.

It is not known whether red yeast rice passes into breast milk or if it could harm a nursing baby. Do not use this product without medical advice if you are breastfeeding a baby.

Do not give any herbal/health supplement to a child without medical advice.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Drinking alcohol may increase your risk of liver damage.

Avoid using red yeast rice together with other herbal/health supplements that can harm your liver, such androstenedione, chaparral, comfrey, DHEA, germander, kava, niacin, pennyroyal oil, and others.

Grapefruit may interact with red yeast rice and cause side effects. Avoid consuming grapefruit products.

Avoid taking an herbal supplement containing St. John's wort.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Although not all side effects are known, red yeast rice is thought to be possibly safe when taken as directed for up to 4.5 years.

Stop using red yeast rice and call your healthcare provider at once if you have:

• unexplained muscle pain, tenderness, or weakness;

• fever, unusual tiredness; or

• nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of red yeast rice may include:

• constipation; or

• stomach discomfort.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not take red yeast rice without medical advice if you are using a medication to treat any of the following conditions:

• any type of infection (viral, bacterial, or fungal), including HIV or tuberculosis;

• arthritis, including gold injections;

• cancer;

• depression or a psychiatric disorder;

• high blood pressure, high cholesterol, or a heart condition;

• pain or headaches, especially if you take an NSAID (nonsteroidal anti-inflammatory drugs) aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others);

• prevention of organ transplant rejection; or

• seizures.

This list is not complete. Other drugs may affect red yeast rice, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.