Red Yeast Rice (monascus purpurea) • Guggulipid (commiphora mukul gum resin) • Aspalathus Linearis (rooibos).
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Below is general information about the effectiveness of the known ingredients contained in the product Cholesto Rite. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Cholesto Rite. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY SAFE ...when the prepared gum resin is used orally and appropriately. It has been used with apparent safety in clinical trials for up to 24 weeks (3267,3268,10371). There is insufficient reliable information available about the safety of guggul when used topically.
PREGNANCY: LIKELY UNSAFE
when used orally; avoid using.
Guggul gum resin appears to stimulate menstrual flow and the uterus (12).
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately. Red yeast rice 1.2 grams daily has been used with apparent safety in clinical studies for up to 4.5 years (512,2624,6988,6995,6996,17089,18110,70508,70513) (70520,70525,70530,95664,95666). However, red yeast rice products can contain an HMG-CoA reductase inhibitor identical to lovastatin, and can cause the same side effects as this drug. It is recommended that people taking red yeast rice products be monitored for the same hepatic and muscle-related adverse effects that are seen with lovastatin (98822).
PREGNANCY: LIKELY UNSAFE
when used orally.
The red yeast rice constituent, lovastatin, has induced fetal skeletal malformations in animals (2619). The US Food and Drug Administration (FDA) recommends that most patients discontinue statin therapy during pregnancy due to the risks to the fetus; however, in certain high-risk patients, a prescription statin may be continued during pregnancy (107954).
LACTATION:
Insufficient reliable information available; avoid using.
The US FDA recommends against breastfeeding while taking statins (107954).
LIKELY SAFE ...when used orally in food amounts (6,4120). There is insufficient reliable information available about the safety of rooibos when used orally in medicinal amounts.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Cholesto Rite. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, guggul might increase the risk of bleeding when taken with anticoagulant/antiplatelet drugs.
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Theoretically, guggul might increase the risk of adverse effects when taken with contraceptive drugs.
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In vitro research shows that guggul has estrogen-alpha receptor agonist activity (12444).
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Theoretically, guggul might reduce the effects of CYP3A4 substrates.
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In vitro research shows that guggul constituents known as guggulsterones can induce CYP3A4 (12444).
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Guggul might reduce the effects of diltiazem.
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A small pharmacokinetic study shows that concomitant use of guggul with diltiazem reduces the bioavailability of diltiazem (383).
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Theoretically, guggul might increase the risk of adverse effects when taken with estrogens.
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In vitro research shows that guggul constituents known as guggulsterones have estrogen-alpha receptor agonist activity (12444).
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Guggul might reduce the effects of propranolol.
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A small pharmacokinetic study shows that concomitant use of guggul with propranolol reduces the bioavailability of propranolol (383).
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Theoretically, guggul might increase the effects and adverse effects of rosuvastatin.
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Animal research shows that guggul increases the bioavailability and hypolipidemic effects of rosuvastatin (109584). The mechanism of this interaction is unclear.
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Theoretically, guggul might interfere with tamoxifen therapy.
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In vitro research shows that guggul has estrogen-alpha receptor agonist activity (12444).
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Theoretically, guggul might increase the risk for adverse effects when taken with thyroid hormone therapy.
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Animal research suggests that guggul has thyroid-stimulating effects (8153).
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Theoretically, taking red yeast rice in combination with cyclosporine might increase the risk of myopathy.
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Theoretically, drugs that inhibit the CYP3A4 enzymes might increase levels of lovastatin from red yeast rice.
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Red yeast rice contains varying levels of the statin drug lovastatin, which is metabolized by CYP3A4 (104951). Combining red yeast rice with CYP3A4 inhibitors might increase serum levels of lovastatin from red yeast rice.
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Theoretically, taking red yeast rice in combination with gemfibrozil might increase the risk of rhabdomyolysis.
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Theoretically, concomitant use might increase the risk of liver damage.
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Red yeast rice contains varying levels of the drug lovastatin. Lovastatin can cause liver damage in some people (104951). Some clinical research suggests that supplements containing red yeast rice might increase liver enzyme levels in some, but not all, participants (42692,70491). Cases of acute hepatitis have been associated with red yeast rice (16654,54477). Combining it with hepatotoxic drugs might further increase this risk.
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Theoretically, taking red yeast rice with other statins might increase the risk of potential adverse effects.
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Red yeast rice contains varying levels of the statin drug lovastatin and might result in supratherapeutic levels when used with other statins. Based on evaluation of data from the US Food and Drug Administration's adverse event reporting system (FAERS), it is recommended that red yeast rice products be avoided in people taking prescription statins (98822).
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Theoretically, taking red yeast rice in combination with high-dose niacin might increase the risk of rhabdomyolysis.
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Theoretically, taking rooibos with ACEIs may increase the therapeutic and adverse effects of ACEIs.
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Clinical research in healthy adults shows that taking a single dose of rooibos tea, 400 mL orally, inhibits angiotensin-converting enzyme activity (101253).
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Theoretically, taking rooibos with atorvastatin may increase the therapeutic and adverse effects of atorvastatin.
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Animal research shows that consuming green rooibos extract with atorvastatin daily for 3 weeks increases the maximum plasma concentration of atorvastatin by 6-fold and reduces the clearance of atorvastatin (104211).
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Theoretically, taking rooibos with CYP1A2 substrates may increase the effects of CYP1A2 substrates.
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In vitro research shows that the methanol extract of rooibos leaves and stems inhibits CYP1A2 enzyme activity (101251).
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Theoretically, taking rooibos with CYP2C19 substrates may increase the effects of CYP2C19 substrates.
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In vitro research shows that the methanol extract of rooibos leaves and stems strongly inhibits CYP2C19 enzyme activity (101251).
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Theoretically, taking rooibos with CYP2C9 substrates may increase the effects of CYP2C9 substrates.
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In vitro research shows that the methanol extract of rooibos leaves and stems inhibits CYP2C9 enzyme activity (101251).
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Theoretically, taking rooibos with CYP2D6 substrates may increase the effects of CYP2D6 substrates.
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In vitro research shows that the methanol extract of rooibos leaves and stems inhibits CYP2D6 enzyme activity (101251).
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Theoretically, taking rooibos with CYP3A4 substrates may increase the effects of CYP3A4 substrates.
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In vitro research shows that the methanol extract of rooibos leaves and stems strongly inhibits CYP3A4 enzyme activity (101251).
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Below is general information about the adverse effects of the known ingredients contained in the product Cholesto Rite. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally, guggul seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Belching, bloating, diarrhea, headache, nausea, unpleasant taste, and vomiting. Allergic and non-allergic skin reactions.
Topically: Allergic contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Rhabdomyolysis.
Dermatologic
...Orally, guggul can cause hypersensitivity reactions including rash and pruritus (10371,54457).
Guggul can also cause nonallergic adverse skin reactions. The risk of skin reactions appears to be dose-dependent. In one study, the incidence of skin reactions was 3% with a dosage of 1000 mg three times daily, compared with 15% with a dosage of 2000 mg three times daily. The severity of the reactions ranged from pruritus to swelling and erythema of the face to bullous lesion on the lower legs associated with headaches, myalgias, and pruritus (13662).
Topically, guggul can cause allergic contact dermatitis (54464,54467). Also, in a small clinical study, one patient using a cream containing aqueous extracts of guggul and Allium ampeloprasum as well as sesame oil complained of rash at the application site (105751). It is unclear if this reaction was due to guggul, other ingredients, or other factors.
Gastrointestinal ...Orally, guggul can cause nausea, vomiting, loose stools, diarrhea, belching, bloating, hiccups, and mild gastrointestinal discomfort (3267,8155,8158,10371,52033,54492).
Hepatic ...A case of severe hypertransaminasemia has been reported for a 63-year-old female who took a specific product (Equisterol) containing guggulsterone and red yeast rice extract daily for 6 months. Liver function normalized after discontinuing the supplement. It is unclear if the adverse effect was due to guggulsterone, red yeast, or the combination. However, the patient had previously developed hepatotoxicity while taking lovastatin, and red yeast contains monacolin K, which is identical to lovastatin (54477). Also, a case of acute liver failure requiring liver transplantation has been reported for a previously healthy young female who used a mixed-ingredient dietary supplement containing extracts of green tea, guggul, and usnic acid. It is unclear if the hepatotoxicity was due to guggul or other ingredients; green tea has been associated with hepatotoxicity (54027).
Immunologic
...Orally, guggul can cause hypersensitivity reactions including rash and pruritus (10371,54457).
In a small clinical study, two adults with hyperlipidemia developed a hypersensitivity rash, one with facial edema, within minutes of oral administration of a methanolic extract of guggul, together with Terminalia extract (105741). It is unclear if this reaction was due to guggul, Terminalia, or other factors.
Topically, guggul can cause allergic contact dermatitis (54464,54467).
Musculoskeletal ...There is one case of rhabdomyolysis reported in a patient who took guggul 300 mg three times daily. The patient developed hemoglobinuria within 2 weeks of starting guggul in addition to increased alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase, creatine kinase, and myoglobinemia. The patient did not have any muscular symptoms. The patient's condition improved when guggul was discontinued. The patient had a history of developing elevated creatine kinase levels after taking simvastatin; however, the patient was not taking a statin at the time of this episode of rhabdomyolysis (13029).
Neurologic/CNS ...Orally, guggul can cause headaches (3267,8155,8158,10371,42692,49583). Less commonly, guggul may cause restlessness and apprehension (49583,54492).
General
...Orally, red yeast rice seems to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal discomfort, diarrhea, dizziness, flatulence, headache, heartburn, myopathy, and nausea.
Serious Adverse Effects (Rare):
Orally: There have been reports of hepatotoxicity and rhabdomyolysis, likely related to the lovastatin content of red yeast rice. Contaminated red yeast rice might cause renal toxicity.
Cardiovascular ...Orally, red yeast rice used in combination with other natural ingredients, such as green tea extract and policosanol, has been associated with a case of chest pain and a case of tachycardia requiring hospitalization, in post marketing surveillance (94001).
Dermatologic ...Orally, red yeast rice has been rarely associated with mild cases of pruritus and rash in clinical trials and post marketing surveillance (70531,94001,95664). Two cases of alopecia were reported in patients taking red yeast rice in clinical research (17089).
Gastrointestinal ...Orally, red yeast rice has been associated with mild adverse effects including abdominal discomfort, bloating, heartburn, flatulence, diarrhea or loose stools, nausea, vomiting, abdominal distention or pain, and reduced appetite, in clinical trials and post marketing surveillance (2624,6988,16836,70556,94001,95664). Taking red yeast rice with food may reduce the risk of heartburn, gas, and abdominal discomfort.
Genitourinary
...Orally, red yeast rice has been associated with rare reports of erectile dysfunction (70520).
In one case report, a 39-year-old male developed erectile dysfunction after taking red yeast rice for one week. The dysfunction resolved after discontinuation of red yeast rice (98822).
A case of cystitis has been reported in a patient taking a specific combination product (Limicol, Laboratoire Lescuyer) containing red yeast rice extract, sugar cane extract, dry artichoke leaf extract, dry garlic extract, pine bark extract, vitamin E, riboflavin, and inositol hexanicotinate (89451). However, it is unclear if this event was associated with red yeast rice or other ingredients in the supplement.
Hepatic ...Orally, red yeast rice preparations have been linked to case reports of hepatotoxicity, including increased liver enzymes and acute hepatitis (16654,54477,94001,95664,98822,112644). Since red yeast rice often contains significant concentrations of the statin-like monacolin constituents, including lovastatin, it has the potential to cause similar side effects, including elevated liver enzymes. Clinical trials have shown that red yeast rice intake is associated with mild increases in levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT), which suggests possible liver damage (42692,70491,70513,70531,70547,107952). A case report describes a 62-year-old female who developed mixed hepatocellular and cholestatic hepatitis while taking red yeast rice. Signs and symptoms included fever, dark colored urine, weight loss, hyperbilirubinemia, and elevated ALT levels, all of which resolved after stopping red yeast rice (112089). A small study in various patient populations shows that taking a specific combination product (Armolipid Plus, Rottapharm S.p.A.) containing red yeast rice, berberine, policosanol, and other ingredients modestly increases levels of ALT, but not AST (107953). Clinical reviews of red yeast rice products show the risk of liver injury is comparable to the placebo or active control group, including pravastatin or lovastatin, when taken for up to 24 weeks (95664,95666).
Immunologic
...In one case report, a 58-year-old male presented with complaints of chronic dysphagia from eosinophilic esophagitis 12 months after starting an oral red yeast rice supplement (Artechol) containing monacolin K.
Eosinophilic esophagitis resolved after cessation of red yeast rice (104465).
Inhalation of red yeast rice powder has resulted in one case of anaphylaxis (6997).
Musculoskeletal ...Orally, red yeast rice preparations have been linked to cases of myalgia, muscle spasm, rhabdomyolysis, and myopathy (9587,15017,16654,16834,16836,17089,70475,94001,95664,98822)(103311,112644,112645). Also, elevated creatine kinase levels up to 10 times normal, suggesting muscle injury and inflammation, have been reported in clinical and post-marketing research reports (6988,9587,15017,42692,70530,70567,94001,95664). The risk of muscle injury with red yeast rice seems to be similar to that with statins. In a small 3-month clinical trial in patients with previous statin intolerance, the rate of therapy discontinuation due to myalgia was similar between patients taking a specific red yeast rice product (Red Yeast Rice, Sylvan Bioproducts) 2400 mg twice daily (containing a daily dose of about 10 mg lovastatin) and patients taking pravastatin 20 mg twice daily (17089). However, in one case report, a 53-year-old patient experienced myalgia after 4 months of taking a red yeast rice product containing 4-8 mg lovastatin. Another case report describes a 50-year-old female who developed generalized myalgias and rhabdomyolysis, with elevated creatine phosphokinase, lactate dehydrogenase, and myoglobin levels, while taking red yeast rice (112306). The risk of myopathy seems to depend on the specific red yeast rice formulation and dose used (95903).
Neurologic/CNS ...Orally, red yeast rice has been associated with dizziness, headache, fatigue, and tingling in the extremities (6988,16836,17089,18110,94001). A case of peripheral neuropathy occurred in a 60-year-old male with a gastrointestinal tumor who was taking imatinib 400 mg daily along with red yeast rice for 3 years (89453). Three months after cessation of red yeast rice, symptoms resolved.
Ocular/Otic ...Orally, red yeast rice in combination with policosanol has been associated with one post-marketing report of hazy vision (94001).
Renal ...Orally, red yeast rice contaminated with citrinin may cause renal toxicity. Analyses of red yeast rice products have found that about one-third to two-thirds of these products contain citrinin (9588,17501,95666). Citrinin is a nephrotoxin that results from incorrect rice fermentation processes (9588,17501,70543). In vitro and in animal research, citrinin has been reported to cause kidney damage (70482,70542,70540).
Other ...Orally, red yeast rice has been associated with rare cases of edema (70508,70520,70525).
General
...There is currently a limited amount of information on the adverse effects of roobios.
A thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Hepatotoxicity.
Hepatic ...Orally, large and long-term doses of rooibos tea might cause hepatotoxicity in some susceptible patients. In a case-report, a 37-year-old man drinking 10 cups of rooibos tea daily for over a year presented with hepatic dysfunction and thrombocytopenia (101254).