red yeast rice (monascus purpureus) - oral (cont.)
SIDE EFFECTS: Abdominal/stomach pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Tell your doctor immediately if you have any of these rare but serious side effects: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine, persistent nausea/vomiting, dark urine, yellowing eyes/skin.A very serious allergic reaction to this product is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.If you have any of the following health problems, consult your doctor or pharmacist before using this product: liver disease, kidney disease, alcohol use.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with this product. Ask your doctor or pharmacist for more information.Red yeast rice must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately.It is unknown if this product passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this product is not recommended. Consult your doctor before breast-feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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