Red Yeast Rice: Monacolin K, FDA Status and Safety
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Red Yeast Rice (Monascus purpureus): half-life, strengths and approval status

Monacolin content · Approval status · Half-life notes

What is red yeast rice?

Red yeast rice is rice fermented with a mold, usually Monascus purpureus. It is used to lower cholesterol because some products contain monacolin K, which is chemically identical to the prescription statin lovastatin.

Also known as: Monascus purpureus, red mold rice, monacolin K.

What is in it

There is no intake value or upper limit. NCCIH says monacolin K content varies widely and is usually not on the label: in a 2017 analysis of 28 US brands, none listed it, two had none, and the rest ranged more than 60-fold, from 0.09 to 5.48 mg per 1,200 mg of red yeast rice.

Approval status and how it is used

FDA's position, as stated in its warning letters: red yeast rice products with enhanced or added lovastatin cannot be marketed as dietary supplements, because lovastatin was approved as a new drug (Mevacor) in 1987 before any such product was sold as a food or supplement, a position upheld in court in the Cholestin case. FDA also says traditional red yeast rice contains no more than trace amounts of lovastatin, if any. NCCIH notes that products with considerable monacolin K are considered by FDA to be unapproved new drugs.

NCCIH says products with significant monacolin K can have the same side effects as statins, including muscle, kidney and liver damage, and the same drug interactions, and may cause diarrhea, nausea and stomach pain. Some products contain citrinin, a toxin that can damage the kidneys: in a 2021 analysis of 37 products, only one was below the European Union limit, and four contaminated products were labeled citrinin-free. The European Food Safety Authority could not identify a safe intake of monacolins. Red yeast rice is not recommended during pregnancy or breastfeeding.

If you take a statin or another cholesterol medicine, or any medicine that interacts with statins, ask your prescriber before using red yeast rice.

Red yeast rice half-life and time to peak

  • Half-lifeNot listed
  • Time to peak (Tmax)Not listed

We could not find a single published half-life or time to peak for red yeast rice that applies to a supplement dose, so we do not list one. Monacolin K content differs so much between products (NCCIH) that no single figure would apply.

How to track red yeast rice in Dose Track

  1. Add red yeast rice as a custom compound. Start typing its name and Dose Track fills in the details from its research library for you to check, and it sits next to everything else you take.
  2. Log each dose when you take it so your history shows exactly what you took and when.
  3. Set reminders on your own schedule, whether that is daily, weekly or every few days.
  4. Your log is stored on your phone and no account is needed. Data only leaves it for features you choose, like AI answers and lab reading.

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Frequently asked questions

What is the half-life of red yeast rice?+
We could not find a single published half-life or time to peak for red yeast rice that applies to a supplement dose, so we do not list one. Monacolin K content differs so much between products (NCCIH) that no single figure would apply.
Is red yeast rice the same as a statin?+
Monacolin K in red yeast rice is chemically identical to lovastatin, a prescription statin, according to NCCIH. Products with significant monacolin K can have the same side effects and drug interactions as statins. How much a product contains varies widely and is usually not labeled.
Is red yeast rice legal in the US?+
Traditional red yeast rice can be sold. FDA says products with enhanced or added lovastatin cannot be marketed as dietary supplements, because lovastatin was approved as a drug first, and it has sent warning letters to companies selling them.
Can I track red yeast rice in Dose Track?+
Yes. Red yeast rice is in Dose Track's research library, so when you add it as a custom compound its details are filled in for you to check. You can then log each dose next to your other compounds, set reminders on your own schedule, and see your history next to your lab results. Your log is stored on your phone and no account is needed. Data only leaves it for features you choose, like AI answers and lab reading.

Sources

  1. NIH National Center for Complementary and Integrative Health. Red yeast rice (updated November 2022).
  2. FDA. Warning letter to Dr. Sam Robbins, Inc. dba HFL Solutions, LLC (CholesLo red yeast rice), August 28, 2020.
  3. FDA. Questions and answers on dietary supplements.

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