| Ingredients | Amount Per Serving |
|---|---|
|
(Inositol Hexanicotinate)
|
500 mg |
|
(TRAACS Chromium Nicotinate Glycinate Chelate)
|
200 mcg |
|
(verified Citrinin-free)
(RYR-VA Red Yeast Rice Note: verified Citrinin-free )
|
1200 mg |
| 500 mg | |
|
(Ubiquinone)
|
25 mg |
|
Raw Whole-Food Proprietary Blend
|
100 mg |
|
organic raw whole food Sprout powders
|
|
|
organic Mung Bean
|
|
|
Raw Probiotic Blend
(200 million CFU's)
(Raw Probiotic Blend Note: 200 million CFU's )
|
|
|
( acidophilus )
|
|
|
(B. bifidum )
|
|
|
Raw Plant Enzyme Blend
|
|
|
Invertase
|
|
|
Hemicellulase
|
|
|
Cellulase
|
|
|
Alpha-Galactosidase
(AGS)
|
|
|
Amylase
|
|
|
(acid-stable Protease)
|
|
|
Maltase
|
|
|
(hull)
|
|
|
(fruit)
|
Vegetable Capsule
Below is general information about the effectiveness of the known ingredients contained in the product Cholesterol Health. 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
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Proteolytic enzymes represent a wide group of enzymes that are used alone or in combination. See specific monographs for effectiveness information.
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 Cholesterol Health. 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 used orally and appropriately, short-term. Acai pulp, in a dose of up to 162.5 grams daily, has been used with apparent safety for up to 3 months in clinical research (17731,99400). There is insufficient reliable information available about the safety of acai when used topically.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately. Bifidobacterium bifidum has been safely used alone or in combination with other probiotics in clinical trials lasting up to one year (1731,12775,14338,92255,107580,110972,110974,110978). There is insufficient reliable information available about the safety of non-viable, heat-killed B. bifidum formulations when used orally.
CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages.
Bifidobacterium bifidum has been safely used alone or in combination with other probiotics in clinical trials in infants and children for up to 18 months (161,90286,90602,98736,103436,110971,110976,110924). There is insufficient reliable information available about the safety of B. bifidum in preterm infants with a birth weight under 1000 grams. Cases of bacteremia have occurred rarely in preterm infants given other probiotics (102416,111610,111612,111613,111850,111852,111853). The US Food and Drug Administration (FDA) has issued a warning about cases of serious infections caused by probiotics reported in very preterm or very low birth weight infants under 1000 grams (111610). Similarly, the American Academy of Pediatrics does not support the routine administration of probiotics to these infants due to conflicting data on safety and efficacy (111608).
PREGNANCY: POSSIBLY SAFE
when Bifidobacterium bifidum is used orally and appropriately, short-term.
A combination of B. bifidum, Lactobacillus acidophilus, and Lacticaseibacillus casei has been used with apparent safety for 6 weeks starting at 24-28 weeks' gestation (95416,98430).
LACTATION:
There is insufficient reliable information available about the safety of Bifidobacterium bifidum during lactation.
However, there are currently no reasons to expect safety concerns when used appropriately.
POSSIBLY SAFE ...when used orally and appropriately. Doses up to 240 mg daily have been used safely for up to a year (6252,6253,10622,11457,18281,18284,91104,91105,91106,91111)(96449,103298). Higher doses up to 3200 mg daily have been used safely, short-term (18283,110546). ...when used topically and appropriately. Bromelain has been used safely as a debriding agent for up to 4 hours (18275,91113,103297,108148,108149).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately in medicinal amounts, short-term. Chromium has been safely used in doses up to 1000 mcg daily for up to 6 months (1934,5039,5040,6858,6859,6860,6861,6862,6867,6868)(7135,7137,10309,13053,14325,14440,17224,90057,90061)(90063,94234,95095,95096,95097,98687); however, most of these studies have used chromium doses in a range of 150-600 mcg. The Food and Drug Administration (FDA) and Institute of Medicine (IOM) evaluations of the safety of chromium suggest that it is safe when used in doses of 200 mcg daily for up to 6 months (13241,13242).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, long-term. Chromium has been safely used in a small number of studies at doses of 200-1000 mcg daily for up to 2 years (7060,7135,42618,42628,42666,110605,110607,110609). However, the Food and Drug Administration (FDA) and Institute of Medicine (IOM) evaluations of the safety of chromium suggest that it is safe when used in doses of 200 mcg daily for up to 6 months (13241,13242).
CHILDREN: LIKELY SAFE
when used orally and appropriately in amounts not exceeding the daily adequate intake (AI) levels by age: 0-6 months, 0.
2 mcg; 7-12 months, 5.5 mcg; 1-3 years, 11 mcg; 4-8 years, 15 mcg; males 9-13 years, 25 mcg; males 14-18 years, 35 mcg; females 9-13 years, 21 mcg; females 14-18 years, 24 mcg (7135). POSSIBLY SAFE...when used orally and appropriately in amounts exceeding AI levels. Chromium 400 mcg daily has been used safely for up to 6 weeks (42680).
PREGNANCY: LIKELY SAFE
when used orally and appropriately in amounts not exceeding adequate intake (AI) levels.
The AI for pregnancy is 28 mcg daily for those 14-18 years of age and 30 mcg daily for those 19-50 years of age (7135).
PREGNANCY: POSSIBLY SAFE
when used orally in amounts exceeding the adequate intake (AI) levels.
There is some evidence that patients with gestational diabetes can safely use chromium in doses of 4-8 mcg/kg (1953); however, patients should not take chromium supplements during pregnancy without medical supervision.
LACTATION: LIKELY SAFE
when used orally and appropriately in amounts not exceeding adequate intake (AI) levels.
The AI for lactation is 44 mcg daily for those 14-18 years of age and 45 mcg daily for those 19-50 years of age (7135). Chromium supplements do not seem to increase normal chromium concentration in human breast milk (1937). There is insufficient reliable information available about the safety of chromium when used in higher amounts while breast-feeding.
LIKELY SAFE ...when used orally and appropriately. Coenzyme Q10 has been used safely in studies lasting up to 5 years (2134,6037,6038,6407,8163,8938,8939,8940,15395,17413,17716,96538)(109391). ...when used topically on the gums (2107,2108,8916,8917,8918).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately.
Coenzyme Q10 in doses of 1-10 mg/kg/day has been used safely for up to 9 months under medical supervision (12199,13223,15256,44005,107449).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately.
Coenzyme Q10 100 mg twice daily has been used with apparent safety during pregnancy, starting at 20 weeks gestation until term (17201).
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately, alone or in combination with probiotics, in doses up to 30 grams daily for up to 4 weeks (741,745,8505,90266,107729,107931). ...when a specific FOS product (NutraFlora, Ingredion Inc.) is used orally in combination with calcium at doses up to 3.2 grams daily for up to 24 months (94931).
CHILDREN: POSSIBLY SAFE
when short-chain FOS are included in approved infant formulas for healthy term infants at a level of up to 4 grams/L or 1 gram/kg daily (94929,94930,98651).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately. Garlic has been used safely in clinical studies lasting up to 7 years without reports of significant toxicity (1873,4782,4783,4784,4785,4786,4787,4789,4790,4797)(4798,6457,6897,14447,96008,96009,96014,102016,102670,103479)(107238,107239,107352,108607,110722,111763).
POSSIBLY SAFE ...when used topically. Garlic-containing gels, lipid-soluble garlic extracts, garlic pastes, and garlic mouthwashes have been safely used in clinical research for up to 3 months (4766,4767,8019,15030,51330,51386). ...when used intravaginally. A vaginal cream containing garlic and thyme has been safely used nightly for 7 nights (88387).
POSSIBLY UNSAFE ...when raw garlic is used topically (585). Raw garlic might cause severe skin irritation when applied topically.
PREGNANCY: LIKELY SAFE
when used orally in amounts commonly found in foods (3319).
PREGNANCY: POSSIBLY UNSAFE
when used orally in medicinal amounts.
Garlic is reported to have abortifacient activity (11020). One study also suggests that garlic constituents are distributed to the amniotic fluid after a single dose of garlic (4828). However, there are no published reports of garlic adversely affecting pregnancy. In clinical research, garlic 800 mg daily was used during the third trimester of pregnancy with no reported adverse outcomes (9201,51626). There is insufficient reliable information available about the safety of topical garlic during pregnancy.
LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (3319).
LACTATION: POSSIBLY UNSAFE
when used orally in amounts greater than those found in foods.
Several small studies suggest that garlic constituents are secreted in breast milk, and that nursing infants of mothers consuming garlic are prone to extended nursing (3319,4829,4830). There is insufficient reliable information available about the safety of topical garlic during lactation.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately for up to 8 weeks.
Garlic extract 300 mg three times daily has been used with apparent safety for up 8 weeks in children ages 8-18 years (4796). There is insufficient reliable information available about the safety of garlic when used over longer durations or in higher doses.
CHILDREN: POSSIBLY UNSAFE
when raw garlic is used topically.
Raw garlic might cause severe skin irritation when applied topically (585,51210).
LIKELY SAFE ...when used orally and appropriately with lactose-containing foods. Lactase has Generally Recognized as Safe (GRAS) status in the US when prepared from Candida pseudotropicalis or Kluyveromyces lactis (104108,104109). Lactase has been used safely in doses up to 9900 international units (IU) and up to 13,500 food chemical codex (FCC) units (2371,2372,2373,106669).
CHILDREN: LIKELY SAFE
when used orally and appropriately with lactose-containing foods.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately with lactose-containing foods.
LIKELY SAFE ...when used orally and appropriately. Lactobacillus acidophilus has been safely used as part of multi-ingredient probiotic products in studies lasting up to nine months (1731,6087,14370,14371,90231,90296,92255,103438,12775,107581)(110950,110970,110979,110998,111785,111793). ...when used intravaginally and appropriately. L. acidophilus has been used safely in studies lasting up to 12 weeks (12108,13176,13177,90265). There is insufficient reliable information available about the safety of non-viable, heat-killed L. acidophilus formulations when used orally.
CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages.
Lactobacillus acidophilus has been safely used for up to 5 days (96887). Also, combination probiotics containing L. acidophilus have been used with apparent safety in various doses and durations. L. acidophilus has been combined with Bifidobacterium animalis (HOWARU Protect, Danisco) for up to 6 months in children 3-5 years old (16847), with Bifidobacterium bifidum for 6 weeks (90602,96890), with Bifidobacterium bifidum and Bifidobacterium animalis subsp. lactis (Complete Probiotic Platinum) for 18 months in children 4 months to 5 years of age (103436), and in a specific product (Visbiome, ExeGi Pharma) containing a total of 8 species for 3 months in children 2-12 years old (107497). There is insufficient reliable information available about the safety of L. acidophilus in preterm infants with a birth weight under 1000 grams. Cases of bacteremia have occurred rarely in preterm infants given other probiotics (102416,111610,111612,111613,111850,111852,111853). The US Food and Drug Administration (FDA) has issued a warning about cases of serious infections caused by probiotics reported in very preterm or very low birth weight infants under 1000 grams (111610). Similarly, the American Academy of Pediatrics does not support the routine administration of probiotics to these infants due to conflicting data on safety and efficacy (111608).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately.
A combination of Lactobacillus acidophilus, Lacticaseibacillus casei, and Bifidobacterium bifidum has been used with apparent safety for 6 weeks, starting at 24-28 weeks' gestation (95416,98430).
LACTATION:
There is insufficient reliable information available about the safety of Lactobacillus acidophilus during lactation.
However, there are currently no reasons to expect safety concerns when used appropriately.
There is insufficient reliable information available about the safety of lipase.
CHILDREN: POSSIBLY UNSAFE
when recombinant human bile salt-stimulated lipase (rhBSSL) is used orally by premature infants.
Adding rhBSSL to infant formula or pasteurized breast milk increases the risk for serious gastrointestinal adverse effects in premature infants (101940).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally. Mangosteen has been used with apparent safety at a dose of up to 560 mg daily for 12 weeks (110127). It has also been used with apparent safety in combination with Sphaeranthus indicus (Meratrim, Laila Nutraceuticals) or Indian cassia (Cindura, Laila Nutraceuticals), for a total dose of 800 mg daily for up to 16 weeks (97876,97878,97879,101079). ...when used topically as a single dose. Mangosteen pericarp 4% gel has been applied once along the gum line with apparent safety (97875).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately. Noni juice has been used in doses of up to 200 mL daily with apparent safely in small clinical studies for up to 3 months (11944,17169,65173). However, there have been several case reports of increased liver enzymes and hepatotoxicity in people taking some noni products (13107,14341,14468,17170,17171,17172). In three reports, hepatotoxicity was linked to a specific brand of noni juice (Tahitian Noni Juice, Tahitian Noni International) (14341,17171). It is unclear if potential contaminants or hypersensitivity reactions may be the cause of these events. More evidence is needed to determine if noni increases the risk for hepatotoxicity. There is insufficient reliable information available about the safety of noni fruit extract when used orally or the safety of noni when used topically.
PREGNANCY AND LACTATION:
While animal research is conflicting on the teratogenic effects of noni (65205,65206), there is insufficient reliable information available about the safety of noni in humans; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Papain has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately for medicinal purposes, short-term. Papain has been used in combination with other proteolytic enzymes at a dose of up to 1200 mg daily for up to 9 weeks (964,965,968,67831,67834). ...when used topically as a diluted solution in appropriate doses for up to 20 minutes (67835,67843,67845).
POSSIBLY UNSAFE ...when used orally in large amounts. In excessive doses, papain can cause significant side effects including esophageal perforation (6). ...when raw papain is used topically. Raw papain or papaya latex is a severe irritant and vesicant (6).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
There is some concern that crude papain is teratogenic and embryotoxic (6).
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when pomegranate fruit or fruit juice is used orally and appropriately. Pomegranate juice has been safely used in studies lasting up to 3 years (4912,8310,13022,13023,13690,14137,14388,17329,91693).
POSSIBLY SAFE ...when pomegranate extract is taken orally and appropriately. A specific pomegranate ellagitannin-enriched polyphenol extract (POMx, POM Wonderful) 1-3 grams daily has been safely used for up to 18 months (17729,69261,91686,91695,91697,99100,105269). ...when pomegranate seed oil is used orally and appropriately. Pomegranate seed oil 60 mg daily has been used with apparent safety for up to 12 weeks (91685). ...when a hot water extract of pomegranate seed powder is used orally and appropriately. Pomegranate seed powder 5 grams daily has been used with apparent safety for up to 8 weeks (105270). ...when pomegranate extract is used topically on oral mucosa (13689).
POSSIBLY UNSAFE ...when the pomegranate root, stem, and peel are used orally in large amounts. Bark of the pomegranate root and stem contains the piperidine alkaloids pelletierine, pseudopelletierine, isopelletierine, and methyl isopelletierine. These alkaloids have muscle relaxant properties that have been associated with paralysis and death in animals (13687,13694,13695). Dried pomegranate peel may contain aflatoxin, which is a potent hepatocarcinogen and toxin (92018).
PREGNANCY AND LACTATION: POSSIBLY SAFE
when the fruit or fruit juice is consumed orally and appropriately (13686,105267).
There is insufficient reliable information available regarding the safety of using other forms of pomegranate or other parts of the plant during pregnancy or lactation; avoid using.
POSSIBLY SAFE ...when used orally and appropriately. Various proteolytic enzymes have been safely used orally in clinical research (716,964,965,968,969,6252,6253,10622,11457,18281,18284) (91104,91105,91106,91111,96449). Side effects are typically mild to moderate and most often include gastrointestinal effects. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes. ...when used topically and appropriately. Various proteolytic enzymes have been safely used topically in clinical research (67835,67843,67845,91113). Some proteolytic enzymes might cause allergic reactions when used topically. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in food amounts. Quinoa is a common food source for many people (99147,99148,99149). There is insufficient reliable information available about the safety of quinoa when used in medicinal amounts.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in food amounts.
There is insufficient reliable information available about the safety of quinoa in medicinal amounts; 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 consumed in food amounts (18). Although the fruit contains cyanogenic glycosides, the concentrations are very low (18). There is insufficient reliable information available about the safety of sorghum used in amounts larger than those found in foods.
PREGNANCY AND LACTATION:
Insufficient reliable information available.
Below is general information about the interactions of the known ingredients contained in the product Cholesterol Health. 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, taking acai with antidiabetes drugs might interfere with glycemic control.
 Details
|
Theoretically, taking Bifidobacterium. bifidum with antibiotic drugs might decrease the effectiveness of B. bifidum.
Details
|
Bromelain may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
There is one case report of a patient experiencing minor bruising while taking bromelain with naproxen (14806). Bromelain is thought to have antiplatelet activity (10639,14806,18285,18286,37234). Whether this interaction is of concern with topical bromelain is unclear. Interference with coagulation of burn wounds has been reported in a patient receiving bromelain-based enzymatic debridement. However, observational research has found that topical bromelain debridement is not associated with increases or decreases in laboratory markers of coagulation when compared with surgical debridement (110547).
|
Theoretically, bromelain might increase levels of tetracycline antibiotics.
Details
Laboratory research suggests that bromelain might increase the absorption of tetracycline antibiotics. However, a study in healthy adults reported no difference in tetracycline plasma levels when a 500 mg dose was taken with or without bromelain 80 mg (14296).
|
Theoretically, chromium may have additive effects with antidiabetic agents and increase the risk of hypoglycemia.
Details
|
Theoretically, aspirin might increase chromium absorption.
Details
Animal research suggests that aspirin may increase chromium absorption and chromium levels in the blood (21055).
|
Theoretically, concomitant use of chromium and insulin might increase the risk of hypoglycemia.
Details
|
Chromium might bind levothyroxine in the intestinal tract and decrease levothyroxine absorption.
Details
Clinical research in healthy volunteers shows that taking chromium picolinate 1000 mcg with levothyroxine 1 mg decreases serum levels of levothyroxine by 17% when compared to taking levothyroxine alone (16012). Advise patients to take levothyroxine at least 30 minutes before or 3-4 hours after taking chromium.
|
NSAIDs might increase chromium levels in the body.
Details
Drugs that are prostaglandin inhibitors, such as NSAIDs, seem to increase chromium absorption and retention (7135).
|
Coenzyme Q10 has antioxidant effects. Theoretically, this may reduce the activity of chemotherapy drugs that generate free radicals.
Details
|
Theoretically, coenzyme Q10 might have additive effects with antihypertensive drugs.
Details
|
Coenzyme Q10 is chemically similar to menaquinone and might have vitamin K-like procoagulant effects, which could decrease the effects of warfarin.
Details
Concomitant use of coenzyme Q10 and warfarin might reduce the anticoagulant effects of warfarin (2128,6048,6199). Four cases of decreased warfarin efficacy thought to be due to coenzyme Q10 have been reported (2128,6048,11048). However, there is some preliminary clinical research that suggests coenzyme Q10 might not significantly decrease the effects of warfarin in patients who have a stable INR (11905).
|
Garlic may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
|
Theoretically, taking garlic with antidiabetes drugs might increase the risk of hypoglycemia.
Details
|
Theoretically, taking garlic with antihypertensive drugs might increase the risk of hypotension.
Details
|
Theoretically, garlic might decrease levels and effects of atazanavir.
Details
In a case report, a patient consuming six stir-fried garlic cloves three times weekly developed suboptimal atazanavir levels and increases in HIV viral load. While the exact cause of this interaction is unclear, there is speculation that garlic might decrease the intestinal absorption of atazanavir or increase its metabolism by inducing cytochrome P450 3A4 (CYP3A4) (88388). Until more is known, advise patients not to consume large amounts of garlic while taking atazanavir.
|
Garlic might increase levels of drugs metabolized by CYP2E1.
Details
Clinical research suggests garlic oil can inhibit the activity of CYP2E1 by 39% (10847). Use garlic oil cautiously in patients taking drugs metabolized by these enzymes.
|
Theoretically, garlic products containing allicin might induce intestinal CYP3A4 and inhibit hepatic CYP3A4. This may increase or decrease levels of drugs metabolized by CYP3A4.
Details
Some human research suggests that garlic may induce INTESTINAL CYP3A4, reducing levels of drugs metabolized by this enzyme. This is primarily based on a study showing that taking a specific allicin-containing garlic product (GarliPure Maximum Allicin Formula, Natrol Inc.) twice daily for 3 days reduces saquinavir levels by approximately 50%. It is speculated that the allicin constituent induced CYP3A4 in the gut mucosa (7027,93578). Another study shows that giving docetaxel intravenously, bypassing the CYP3A4 enzymes in the gut mucosa, along with the same specific garlic product for 12 consecutive days, does not affect docetaxel levels (17221). Conversely, there is concern that garlic may inhibit HEPATIC CYP3A4. In a single case report, increased tacrolimus levels and liver injury occurred in a liver transplant patient after taking a specific garlic supplement (Garlicin Cardio, Nature's Way) at up to three times the manufacturer recommended dose for 7 days (96010). Several other studies have evaluated the impact of other garlic formulations on CYP3A4 substrates and have found no effect. Most of the products in these studies provided little or no allicin (10335,10847,15031,94506).
|
Theoretically, garlic might decrease levels of isoniazid.
Details
Animal research suggests that an aqueous extract of garlic reduces isoniazid levels by about 65%. Garlic reduced the maximum concentration (Cmax) and area under the curve (AUC), but not the half-life, of isoniazid. This suggests that garlic extract might inhibit isoniazid absorption across the intestinal mucosa (15031); however, the exact mechanism of this potential interaction is not known.
|
Theoretically, garlic products containing allicin might decrease levels of PIs.
Details
Protease inhibitors are metabolized by cytochrome P450 3A4 (CYP3A4) isoenzymes. There is concern that garlic products containing allicin might induce intestinal CYP3A4, reducing plasma levels of protease inhibitors. This is primarily based on a study showing that taking a specific garlic product (GarliPure Maximum Allicin Formula, Natrol Inc.) twice daily for 3 days reduces levels of saquinavir, a PI, by approximately 50%. It is speculated that the allicin constituent induce CYP3A4 in the gut mucosa (7027,93578). Several studies have evaluated the impact of other garlic formulations on CYP3A4 substrates and have found no effect. Most of the products in these studies provided little or no allicin (10335,10847,15031,94506).
|
Theoretically, garlic containing allicin might decrease levels of saquinavir.
Details
Saquinavir is a substrate of cytochrome P450 3A4 (CYP3A4) isoenzymes. There is concern that garlic products containing allicin might induce intestinal CYP3A4 and cause subtherapeutic levels of saquinavir. This is primarily based on a pharmacokinetic study showing that taking a specific garlic product (GarliPure Maximum Allicin Formula, Natrol Inc.) twice daily for 3 days reduces saquinavir levels by approximately 50%. It is speculated that the allicin constituent induces CYP3A4 in the gut mucosa (7027,93578). Several pharmacokinetic studies have evaluated the impact of other garlic formulations on CYP3A4 substrates and have found no effect. Most of the products in these studies provided little or no allicin (10335,10847,15031,94506). Until more is known about this potential interaction, use garlic containing allicin cautiously in patients taking saquinavir.
|
Theoretically, taking garlic with sofosbuvir might decrease its effectiveness.
Details
Animal research in rats shows that giving aged garlic extract 120 mg/kg orally daily for 14 days decreases the area under the concentration time curve (AUC) after a single sofosbuvir dose of 40 mg/kg by 36%, increases the clearance by 63%, and decreases the plasma concentrations at 1 and 8 hours by 35% and 58%, respectively. This interaction is hypothesized to be due to induction of intestinal P-glycoprotein expression by garlic (109524).
|
Theoretically, garlic might increase levels of tacrolimus.
Details
In one case report, a liver transplant patient taking tacrolimus experienced increased tacrolimus levels and liver injury after taking a specific garlic supplement (Garlicin Cardio, Nature's Way) at up to three times the manufacturer recommended dose for 7 days. It is speculated that garlic inhibited hepatic cytochrome P450 3A4 (CYP3A4), which increased plasma levels of tacrolimus (96010).
|
Theoretically, garlic might increase the risk of bleeding with warfarin.
Details
Raw garlic and a variety of garlic extracts have antiplatelet activity and can increase prothrombin time (586,616,1874,3234,4366,4802,4803,51397). In addition, there is a report of two patients who experienced an increase in a previously stabilized international normalized ratio (INR) with concomitant garlic and warfarin use (51228,51631). However, this report has been subsequently debated due to limited clinical information. Other clinical studies have not identified an effect of garlic on INR, warfarin pharmacokinetics, or bleeding risk (15032,16416). More evidence is needed to determine the safety of using garlic with warfarin.
|
Theoretically, concomitant use of inositol nicotinate with anticoagulant or antiplatelet drugs might increase the risk of bleeding.
Details
|
Theoretically, inositol nicotinate might increase blood glucose levels and may diminish the effects of antidiabetes drugs.
Details
|
Theoretically, concomitant use of inositol nicotinate and statins might increase the risk of myopathy and rhabdomyolysis.
Details
Inositol nicotinate is metabolized to niacin in the body (496). Some case reports have raised concerns that niacin might increase the risk of myopathy and rhabdomyolysis when combined with statins (14508,25918) However, a significantly increased risk of myopathy has not been demonstrated in clinical trials (7388,11689,12033,14509).
|
Theoretically, concomitant use of inositol nicotinate and transdermal nicotine might increase the risk of flushing and dizziness.
Details
|
Theoretically, taking Lactobacillus acidophilus with antibiotic drugs might decrease the effectiveness of L. acidophilus.
Details
L. acidophilus preparations usually contain live and active organisms. Therefore, simultaneously taking antibiotics might kill a significant number of the organisms (1740). Tell patients to separate administration of antibiotics and L. acidophilus preparations by at least two hours.
|
Theoretically, concomitant use of mangosteen with anticoagulant or antiplatelet drugs may increase the risk of bleeding.
Details
|
Theoretically, concomitant use of mangosteen with donepezil might increase the effects of donepezil.
Details
Animal research shows that concomitant use of an aqueous extract of mangosteen pericarp with donepezil increases brain concentrations of donepezil at 4 hours by 64% without associated effects on systemic exposure (106791).
|
Theoretically, combining noni and ACE inhibitors might increase the risk of hyperkalemia.
Details
Noni juice contains significant amounts of potassium, about 6 mEq/100 mL juice (1298). This may increase the risk for hyperkalemia when used in conjunction with ACE inhibitors, which can also increase potassium levels.
|
Theoretically, combining noni and ARBs might increase the risk of hyperkalemia.
Details
Noni juice contains significant amounts of potassium, about 6 mEq/100 mL juice (1298). This may increase the risk for hyperkalemia when used in conjunction with ARBs, which can also increase potassium levels.
|
Theoretically, noni may increase the risk of hypotension when used in combination with antihypertensive drugs.
Details
Preliminary clinical research suggests that drinking noni juice can reduce blood pressure in individuals with hypertension (65231).
|
Theoretically, taking noni with hepatotoxic drugs might increase the risk of liver damage.
Details
|
Theoretically, taking noni fruit juice concomitantly with phenytoin may lower phenytoin levels and increase the risk of seizures.
Details
In one case report, an adult taking phenytoin for partial seizures experienced low serum phenytoin levels while taking noni juice 90-200 mL daily. Serum phenytoin levels increased after decreasing noni juice consumption; similarly, serum phenytoin levels decreased after increasing noni juice consumption. Some researchers believe noni juice may induce cytochrome P450 2C9 enzymes, which would decrease phenytoin levels, but this has not been well studied. Patients may need additional monitoring when starting or stopping noni juice supplementation (106057).
|
Theoretically, combing noni and a potassium-sparing diuretic might increase the risk of hyperkalemia.
Details
Noni juice contains significant amounts of potassium, about 6 mEq/100 mL juice (1298). This may increase the risk for hyperkalemia when used in conjunction with potassium-sparing diuretics, which can also increase potassium levels.
|
Taking noni fruit with ranitidine might increase the levels and clinical effects of ranitidine.
Details
Clinical evidence shows that taking an aqueous extract of noni fruit 30 minutes prior to taking a single oral dose of ranitidine can increase the rate of absorption and plasma concentration of ranitidine (23387).
|
Theoretically, taking noni juice concomitantly with warfarin might decrease the effectiveness of warfarin.
Details
In one case, a 41-year-old patient stabilized on warfarin had a decreased international normalized ratio (INR) following consumption of a specific commercial noni juice product (Noni juice 4 Everything). While the patient was still taking noni juice, an increase in warfarin dose did not produce an increase in INR (14434). However, it should be noted that this particular product contained extracts and derivatives from more than 115 components, many of which contained vitamin K. Furthermore, vitamin K was listed as a separate ingredient of the product, suggesting that the product was possibly fortified with vitamin K. It has not been verified that noni fruit alone contains a significant amount of vitamin K or interacts with warfarin.
|
Theoretically, papain might increase the effects and side effects of warfarin.
Details
In one case report, a patient previously stable on warfarin was found to have an international normalization ratio (INR) of 7.4, which was attributed to ingestion of a supplement containing papain from papaya extract (613).
|
Theoretically, taking pomegranate with ACEIs might increase the risk of adverse effects.
Details
Pomegranate juice is thought to have ACE inhibitor-like effects (8310).
|
Theoretically, taking pomegranate with antihypertensive drugs might increase the risk of hypotension.
Details
|
Theoretically, taking pomegranate with carbamazepine might increase the risk of adverse effects, although research suggests this interaction is unlikely to be clinically significant.
Details
Animal research shows that pomegranate juice may inhibit cytochrome P450 3A4 (CYP3A4) metabolism of carbamazepine and increase levels of carbamazepine by 1.5 times without prolonging the elimination half-life. This suggests that pomegranate juice inhibits intestinal CYP3A4, but might not inhibit hepatic CYP3A4 (13188). However, some human research suggests that pomegranate does not significantly inhibit CYP3A4 drug metabolism in humans (16711,16712,17326).
|
Theoretically, pomegranate might increase levels of drugs metabolized by CYP2C9.
Details
|
Theoretically, pomegranate might increase levels of drugs metabolized by CYP2D6.
Details
In vitro, pomegranate juice inhibits CYP2D6 (13703). However, the clinical significance of this potential interaction in humans is not known.
|
Theoretically, pomegranate might increase levels of drugs metabolized by CYP3A4, but most research suggests this interaction is unlikely to be clinically significant.
Details
Pomegranate contains several polyphenols that have individually been shown to inhibit CYP3A4. However, there is contradictory evidence about the effect of whole pomegranate juice on CYP3A4 activity. In vitro, pomegranate juice significantly inhibits the CYP3A4 enzyme, with comparable inhibition to grapefruit juice (13188,16711,17326). In an animal model, pomegranate juice inhibits CYP3A4 metabolism of carbamazepine and increases levels of carbamazepine by 1.5 times (13188); however, in human volunteers, drinking a single glass of pomegranate juice 240 mL or taking 200 mL daily for 2 weeks does not significantly affect levels of the CYP3A4 substrate midazolam after oral or intravenous administration (16711,17730). Another study in healthy volunteers shows that consuming pomegranate juice 300 mL three times daily for three days also does not significantly affect levels of simvastatin, a CYP3A4 substrate (16712,91696) This suggests that pomegranate is unlikely to significantly affect levels of CYP3A4 substrates in humans (17326).
|
Theoretically, taking pomegranate with rosuvastatin might increase the risk of adverse effects.
Details
In one case, a patient taking rosuvastatin 5 mg every other day in combination with ezetimibe 10 mg daily developed rhabdomyolysis after drinking pomegranate juice 200 mL twice weekly for 3 weeks. This patient had a history of elevated creatine kinase levels while not receiving any statin treatment. This suggests a possible underlying myopathy and predisposition to rhabdomyolysis (14465).
|
Theoretically, pomegranate might increase levels of tolbutamide, although research suggests this interaction is unlikely to be clinically significant.
Details
Animal research shows that pomegranate juice inhibits the cytochrome P450 2C9 (CYP2C9) metabolism of tolbutamide. Pomegranate juice increased tolbutamide levels by 1.2 times without prolonging the elimination half-life. This suggests that pomegranate juice inhibits intestinal CYP2C9, but might not inhibit hepatic CYP2C9 (17327). Despite this evidence, clinical research shows that neither pomegranate juice nor pomegranate extract have a significant effect on CYP2C9 activity in humans (91694). This interaction does not appear to be clinically significant in humans.
|
Theoretically, pomegranate might increase warfarin levels and increase the risk of bleeding. Also, discontinuing regular consumption of pomegranate juice might decrease warfarin levels.
Details
In one case report, a patient had a stable, therapeutic bleeding time, as measured by international normalized ratio (INR), while taking warfarin in combination with pomegranate juice 2-3 times per week. The patient became subtherapeutic within about 10 days after discontinuing pomegranate juice, which required a warfarin dose increase (17328). In another case report, a patient with a stable INR for over one year presented with an INR of 14. The patient noted no changes to medications or diet but did report consuming around 3 liters of pomegranate juice over the previous week. The patient's INR stabilized upon moderation of pomegranate juice consumption (24273). The mechanism of this potential interaction is unclear.
|
Theoretically, taking red yeast rice in combination with cyclosporine might increase the risk of myopathy.
Details
|
Theoretically, drugs that inhibit the CYP3A4 enzymes might increase levels of lovastatin from red yeast rice.
Details
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.
|
Theoretically, taking red yeast rice in combination with gemfibrozil might increase the risk of rhabdomyolysis.
Details
|
Theoretically, concomitant use might increase the risk of liver damage.
Details
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.
|
Theoretically, taking red yeast rice with other statins might increase the risk of potential adverse effects.
Details
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).
|
Theoretically, taking red yeast rice in combination with high-dose niacin might increase the risk of rhabdomyolysis.
Details
|
Below is general information about the adverse effects of the known ingredients contained in the product Cholesterol Health. 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, acai seems to be well tolerated.
Other ...Raw acai fruit and juice can be contaminated with a parasitic protozoan called Trypanosoma cruzi, which causes American trypanosomiasis or Chagas Disease. A Brazilian outbreak of this disease in 2006 was linked to consumption of acai juice (17194,30245).
General
...Orally, Bifidobacterium bifidum seems to be well tolerated by most patients.
Serious Adverse Effects (Rare):
Orally: There is concern that probiotics may cause infections in some people.
Gastrointestinal ...Bloating and flatulence have been reported with probiotic use; however, these adverse effects have not been reported from ingestion of Bifidobacterium bifidum in particular. One case of vomiting and fever has been reported in a clinical study for a single child taking B. bifidum and Lactobacillus acidophilus. It is unclear if the probiotics were the causal agent (90286).
Immunologic ...There have been cases of Bifidobacterium sepsis in critically ill patients (102416,107599). However, these cases are rare and none seem to be due to Bifidobacterium bifidum.
General
...Orally, bromelain seems to be well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, flatulence, gastric upset, headache.
Topically: Pruritus, urticaria.
Dermatologic
...Topically, bromelain may cause dermal allergic reactions including urticaria, pruritus, and skin swelling (9184).
Redness, swelling, burning, pain at the application site, and cellulitis have also been reported rarely (108148,113513). In one case, a fixed drug eruption with pruritis near the groin was reported in a 33-year-old male taking bromelain 50 mg orally daily for 10 days. After discontinuation of bromelain and treatment with topical corticosteroid, the lesion resolved. Upon re-challenge with bromelain, the lesion reappeared in the same area (103300).
In another case report, a 61-year-old male with a history of chronic lower leg ulceration secondary to chronic venous hypertension and recurrent deep vein thrombosis on rivaroxaban presented with a deep-dermal burn on his lower calf. Bromelain-based topical enzymatic debridement agent Nexobrid 2 grams was applied to the burn site. Thirty minutes later, the patient experienced two instances of hemorrhage at the site of debridement. The patient was stabilized and treated with fluids, packed red cells, and tranexamic acid, and then the Nexobrid was removed (111656). Caution should be used in patients with underlying coagulopathies.
Gastrointestinal ...Orally, bromelain may cause gastrointestinal disturbances, including diarrhea, nausea, vomiting, flatulence, and abdominal pain (9184,18274,18282,96216,113513).
Immunologic
...Immunoglobulin E (IgE)-mediated allergic reactions to bromelain may occur (9184).
If inhaled, bromelain may cause sensitization and allergic reactions such as asthma (37199,37215,37233). In case reports of occupational inhalation of bromelain, additional allergic symptoms included difficulty swallowing, throat itching, eye irritation, and rhinitis (37214).
General
...Orally, chromium is generally well tolerated.
Most Common Adverse Effects:
Orally: Gastrointestinal irritation, headaches, insomnia, irritability, mood changes.
Serious Adverse Effects (Rare):
Orally: Rare cases of kidney and liver damage, rhabdomyolysis, and thrombocytopenia have been reported.
Dermatologic
...Orally, chromium-containing supplements may cause acute generalized exanthematous pustulosis (42561), skin rashes (42679), and urticaria (17224).
Also, chromium picolinate or chromium chloride may cause systemic contact dermatitis when taken orally, especially in patients with contact allergy to chromium (6624,90058). In one clinical study, a patient taking chromium nicotinate 50 mcg daily reported itchy palms that improved after the intervention was discontinued. It is unclear of this effect was due to the chromium or another factor (95096).
Topically, hexavalent chromium, which can be present in some cement, leather products, or contaminated soil, may cause allergic contact dermatitis (42645,42789,90060,90064,110606).
A case of lichen planus has been reported for a patient following long-term occupational exposure to chromium (42688).
Endocrine ...Orally, cases of hypoglycemia have been reported for patients taking chromium picolinate 200-1000 mcg daily alone or 200-300 mcg two or three times weekly in combination with insulin (42672,42783). Chromium picolinate has also been associated with weight gain in young females who do not exercise and in those following a weight-lifting program (1938).
Gastrointestinal
...Orally, chromium in the form of chromium picolinate, chromium polynicotinate, chromium-containing brewer's yeast, or chromium-containing milk powder may cause nausea, vomiting, diarrhea, decreased appetite, constipation, flatulence, or gastrointestinal upset (14325,42594,42607,42622,42643,42679).
Long-term exposure to heavy metals, including chromium, has been associated with increased risk of gallbladder disease and cancer (42682,42704).
Genitourinary ...Orally, chromium polynicotinate has been associated with disrupted menstrual cycles in patients taking the supplement to prevent weight gain during smoking cessation (42643).
Hematologic ...Anemia, hemolysis, and thrombocytopenia were reported in a 33 year-old female taking chromium picolinate 1200-2400 mcg daily for 4-5 months (554). The patient received supportive care, blood product transfusions, and hemodialysis and was stabilized and discharged a few days later. Lab values were normal at a one-year follow-up.
Hepatic ...Liver damage has been reported for a 33-year-old female taking chromium picolinate 1200 mcg daily for 4-5 months (554). Also, acute hepatitis has been reported in a patient taking chromium polynicotinate 200 mcg daily for 5 months (9141). Symptoms resolved when the product was discontinued. Two cases of hepatotoxicity have been reported in patients who took a specific combination product (Hydroxycut), which also contained chromium polynicotinate in addition to several herbs (13037).
Musculoskeletal ...Acute rhabdomyolysis has been reported for a previously healthy 24-year-old female who ingested chromium picolinate 1200 mcg over a 48-hour time period (42786). Also, chromium polynicotinate has been associated with leg pain and paresthesia in patients taking the supplement to prevent weight gain during smoking cessation (42643).
Neurologic/CNS ...Orally, chromium picolinate may cause headache, paresthesia, insomnia, dizziness, and vertigo (6860,10309,14325,42594). Vague cognitive symptoms, slowed thought processes, and difficulty driving occurred on three separate occasions in a healthy 35-year-old male after oral intake of chromium picolinate 200-400 mcg (42751). Transient increases in dreaming have been reported in three patients with dysthymia treated with chromium picolinate in combination with sertraline (2659). A specific combination product (Hydroxycut) containing chromium, caffeine, and ephedra has been associated with seizures (10307). But the most likely causative agent in this case is ephedra.
Psychiatric ...Orally, chromium picolinate has been associated with irritability and mood changes in patients taking the supplement to lose weight, while chromium polynicotinate has been associated with agitation and mood changes in patients taking the supplement to prevent weight gain during smoking cessation (6860,42643).
Renal
...Orally, chromium picolinate has been associated with at least one report of chronic interstitial nephritis and two reports of acute tubular necrosis (554,1951,14312).
Laboratory evidence suggests that chromium does not cause kidney tissue damage even after long-term, high-dose exposure (7135); however, patient- or product-specific factors could potentially increase the risk of chromium-related kidney damage. More evidence is needed to determine what role, if any, chromium has in potentially causing kidney damage.
Intravenously, chromium is associated with decreased glomerular filtration rate (GFR) in children who receive long-term chromium-containing total parenteral nutrition - TPN (11787).
Topically, burns caused by chromic acid, a hexavalent form of chromium, have been associated with acute chromium poisoning with acute renal failure (42699). Early excision of affected skin and dialysis are performed to prevent systemic toxicity.
Other ...Another form of chromium, called hexavalent chromium, is unsafe. This type of chromium is a by-product of some manufacturing processes. Chronic exposure can cause liver, kidney, or cardiac failure, pulmonary complications, anemia, and hemolysis (9141,11786,42572,42573,42699). Occupational inhalation of hexavalent chromium can cause ulceration of the nasal mucosa and perforation of the nasal septum, and has been associated with pneumoconiosis, allergic asthma, cough, shortness of breath, wheezing, and increased susceptibility to respiratory tract cancer and even stomach and germ cell cancers (42572,42573,42601,42610,42636,42667,42648,42601,42788,90056,90066). Although rare, cases of interstitial pneumonia associated with chromium inhalation have been reported. Symptoms resolved with corticosteroid treatment (42614).
General
...Orally, coenzyme Q10 is generally well tolerated.
In clinical studies, no serious adverse effects have been reported.
Most Common Adverse Effects:
Orally: Gastrointestinal side effects such as appetite suppression, diarrhea, epigastric discomfort, heartburn, nausea, and vomiting. These generally occur in less than 1% of patients. Some of these adverse effects can be minimized if daily doses above 100 mg are divided.
Cardiovascular ...Palpitations have been reported as being possibly associated with coenzyme Q10 treatment (89421). Death due to myocardial infarction occurred in one Parkinson disease patient taking coenzyme Q10; causality is unclear (15395).
Dermatologic ...Two of 143 participants in a case series reported skin itching after starting treatment with oral coenzyme Q10 (6047). Allergic rash has also been reported (6409,11872). An itching exanthema was seen in two heart failure patients treated with intravenous coenzyme Q10 (44284).
Gastrointestinal ...Gastrointestinal side effects of coenzyme Q10 have included nausea (3365,6409,8907,10152,43982,44172,44179,44330,89421,109392), vomiting (3365,10152,44330,89421), epigastric discomfort (3365,44179,44330,89421), constipation (109392), diarrhea (44179,92904,89421,109392), stomach upset (8940,12170,109387,109388,109392), loss of appetite (2121), heartburn (2121,44179,109392), and flatulence (43982), although this occurs in less than 1% of patients. In one clinical study, gastrointestinal bleeding in association with angiodysplasia has been reported to be possibly related to coenzyme Q10 treatment (89421).
Genitourinary ...An uncomplicated urinary infection was reported in a patient taking oral coenzyme Q10 (nanoQuinon, MSE Pharmazeutika) (44020).
Hematologic ...Thrombocytopenia was noted in one patient treated with oral coenzyme Q10 (44296); however, other factors (viral infection, other medications) may have been responsible for this adverse effect.
Musculoskeletal ...Increased plasma creatine kinase with high-intensity exercise has been reported in patients taking coenzyme Q10 (44303). Muscle pain has been reported rarely in one clinical trial (109392).
Neurologic/CNS ...Headache and dizziness have been reported in human research (3365,11872,43982,44330,109392). Insomnia has been reported as being possibly associated with coenzyme Q10 treatment (89421). Cognitive decline, depression, and sudden falls were reported rarely in a clinical trial of patients with Huntington disease (8940). Increased lethargy was reported for one patient treated with oral coenzyme Q10 (44042). Feeling of internal trembling has been reported in a clinical trial for one patient treated with coenzyme Q10 (44020).
Ocular/Otic
...Visual sensitivity to light has been reported for a patient treated with coenzyme Q10.
However, the association of this effect with coenzyme Q10 treatment was not clear (6409).
A burning sensation has been reported for 10% of patients treated with a topical eye solution containing coenzyme Q10 and alpha-tocopheryl polyethylene glycol 1000 succinate following cataract surgery (44228).
Psychiatric ...Worsening depression has been reported as being possibly associated with oral coenzyme Q10 treatment (89421).
Pulmonary/Respiratory ...Drug-induced pneumonitis was diagnosed in a 61 year-old woman who had been taking coenzyme Q10 and perilla leaf extract for two months (43978). Symptoms improved after she stopped taking the supplements and began taking oral prednisone. Causation from coenzyme Q10 was unclear.
Other ...In a case report, a naval aviator using a supplement containing coenzyme Q10 and niacin had reduced G tolerance (44186). G tolerance was regained with cessation of the supplement.
General
...Orally, FOS are generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, bloating, flatulence.
Gastrointestinal ...Orally, FOS may cause flatulence, belching, abdominal pain, intestinal sounds, constipation, and bloating. These symptoms can occur commonly in some patients, but are generally mild at doses under 10 grams per day (745,750,8509,98651,107931). However, a meta-analysis of 8 small clinical studies shows that taking FOS at doses ranging from 2.5 grams to 15 grams daily for up to 8 weeks does not increase the rate of abdominal pain, bloating, flatulence, or intestinal sounds when compared with control groups (110710).
General
...Orally, garlic is generally well tolerated.
Topically, garlic seems to be well tolerated. Intravenously, there is insufficient reliable information available about adverse effects.
Most Common Adverse Effects:
Orally: Abdominal pain, body odor, flatulence, malodorous breath, and nausea. Allergic reactions in sensitive individuals.
Topically: Burns and dermatitis with fresh garlic.
Serious Adverse Effects (Rare):
Orally: Some case reports raise concerns about increased risk of bleeding with garlic.
Dermatologic
...Orally, garlic may cause pruritus (51316,51474,107239), flushing, and acne (107239).
Oral intake of a specific garlic product containing allicin (Allimax) has been associated with a case of pruritic rash (51474). Enteric-coated garlic tablets standardized to 1.5% allicin have also been associated with a case of pruritus (51316). Garlic has also been associated with a case of superficial pemphigus in a 49-year-old male with type 2 diabetes (51564). Garlic-induced oral ulcers have also been reported (51467).
Topically, garlic may cause contact dermatitis and urticaria (4833,5004,12635,51258,51265,51375,51403,51412,51459,51483)(51511,51512,51530,51616,51617,51618,111769), as well as contact cheilitis (51384). Fresh garlic may be more likely to elicit a reaction than garlic extract. Most reactions have resolved following withdrawal of garlic therapy. In one case report, applying crushed garlic on the neck to help ease a sore throat resulted in an itchy, burning, erythematous lesion in a young female patient. The lesion healed after one week of treatment with topical antibiotics, steroids, and antihistamine ointments (88390). Cases of occupational eczema or dermatitis have been reported in cooks (51303,51210), food handlers (51292), and caterers (51304). According to one case report, dermatitis appeared in chefs exposed to garlic (15033). Treatment with acitretin 25 mg daily or topical psoralen-ultraviolet A (PUVA) for 12 weeks proved effective in mitigating the symptoms. A 34-year-old female with a history of hand dermatitis and paronychia had a worsening of these conditions after peeling raw garlic. She had a positive skin patch test to fresh, raw garlic but not to any other tested allergens, and the conditions resolved when she avoided contact with garlic (105528). Topically, garlic may also cause chemical burns, usually within 12 hours of application. Second- and third-degree chemical burns have been reported in adults, children, and infants exposed to topical garlic, often as an unintended consequence of using garlic medicinally on the skin (585,4832,51226,51230,51252,51281,51377,51418,51468,51495,51536)(51558,51576,51577,88409,96006). A case of painful blisters on the soles of the feet of a 23-year-old Chinese female has been attributed to chemical burns caused by applying crushed raw garlic for 3 hours (51440). Topically, garlic may also cause hyperpigmentation, ulcers, necrotic lesions, facial flushing, and local irritation (4832,15030,51268,51269,108606). In one case report, applying crushed raw garlic to the palatal mucosa for several minutes to relieve mouth pain resulted in a chemical burn that produced a 3 cm necrotic ulcer in an adult female with trigeminal neuralgia (108606).
Gastrointestinal
...Orally, dehydrated garlic preparations or raw garlic may cause malodorous breath (51438,51444), body odor (732,1873,4784,4793,4795,4798,9201,10787,42692,49769)(51269,51316,51467,51602), abdominal pain or fullness, anorexia, diarrhea, constipation, flatulence, belching, heartburn, nausea, unpleasant taste, reflux, and bowel obstruction (1884,6457,6897,9201,49769,51269,51343,51380,51438,51442)(51450,51457,51466,51471,51474,51520,51593,51602,51623,88398)(88405,111766).
Large quantities of garlic may damage the gastrointestinal tract. In one case report, a patient taking garlic for hypertension reported odynophagia and retrosternal pain after taking garlic without any water the previous day. An esophageal lesion 3 cm in length was detected upon endoscopy. The symptoms resolved 3 days after starting a liquid diet and taking lansoprazole 30 mg twice daily and sucralfate four times daily (88389). One case of bowel obstruction was reported in a 66-year-old male who ingested an entire garlic bulb (51525). Esophageal perforation has been reported in at least 17 individuals who consumed entire garlic cloves. In one case the perforation led to mediastinitis and death (102672).
Garlic has also been associated with eosinophilic infiltration of the gastrointestinal tract. In one case report a 42-year-old female presented with symptoms of eosinophilic gastroenteritis, which included pollinosis, asthma, diarrhea, heart burn, peripheral eosinophilia, and urticaria. After stopping use of garlic and sesame, the patient improved (51441). In a case report of eosinophilic esophagitis, garlic was determined to be the causative agent in a patient with long-standing gastrointestinal symptoms. The patient had attempted to treat upper gastrointestinal symptoms as gastrointestinal reflux disease without success for many years. Skin prick testing showed a positive reaction to garlic, of which the patient noted frequent consumption. Marked symptom improvement was noted within 3 weeks of garlic avoidance (88393).
Intravenously, garlic 1 mg/kg of body weight daily diluted into 500 mL saline and administered over 4 hours has been reported to cause abdominal discomfort, vomiting, diarrhea, nausea, anorexia, flatulence, weight loss, and garlicky body odor (51462).
Clinical research suggests that patients with metabolic syndrome taking 1600 mg of powdered garlic by mouth daily for 3 months may experience improved intestinal transit time when compared with placebo, suggesting that garlic powder may reduce symptoms of constipation (110722).
Genitourinary ...Orally, garlic might cause dysuria, hematuria, or polyuria (51438,51450,51467,113618). In one case, an older male with high dietary and supplemental garlic intake at doses of 300-5400 mg daily for 3-4 years developed severe hematuria with clots after undergoing a minimally invasive prostate procedure (113618).
Hematologic
...Oral use of dietary garlic or supplements containing garlic has caused platelet dysfunction, increased fibrinolytic activity, prolonged bleeding time, retrobulbar hemorrhage (bleeding behind the eye) postoperative bleeding, and spinal epidural hematoma (586,587,4801,4802,11325,51397,51473,51491,51532,51534)(51570,51584,51593,51594,113618).
Also, a case of kidney hematoma following extracorporeal shock-wave lithotripsy (SWL) has been reported in a patient with nephrolithiasis who took aged garlic (51630). A case of increased bleeding time that complicated epistaxis management has been reported in a patient taking garlic, aspirin, and milk thistle (51426).
Intravenously, garlic has been associated with the development of thrombophlebitis at the injection site (51462).
Immunologic
...There is a case report of an immediate sensitivity reaction to oral raw garlic, resulting in wheals, in a 31-year-old female.
The patient did not react to cooked garlic, and skin prick tests showed allergy only to raw garlic (96015). Researchers note that at least some allergens in raw garlic are heat labile (88392,96012,96015). This suggests that consuming cooked rather than raw garlic may help avoid this reaction in patients allergic to raw garlic. However, different people react to different allergens in garlic. At least some of these allergens are heat stable (96012). While rare, garlic-induced anaphylaxis has been reported (88392,96012).
Topically, allergic contact dermatitis has been reported in case reports (51406,51498,51510,51519,51560).
Musculoskeletal ...Orally, garlic has been associated with individual cases of gout and low back pain (51474,51467), but it is not clear if these adverse events can be attributed to garlic.
Neurologic/CNS ...Orally, dizziness, insomnia, headaches, diaphoresis, fever, chills, somnolence, increased appetite, euphoria, and weight loss have been reported with garlic (15032,42692,51316,51467,51471,51520). In one case, the smell of garlic was identified as a trigger for migraines in a 32-year-old female. The subject reported fortification spectra along with visual spots for a few seconds followed by instantaneous biparietal, crushing level (10/10) headaches upon exposure to the scent of garlic or onion (88404).
Pulmonary/Respiratory ...Garlic exposure, most notably in occupational settings, may cause asthma and other symptoms such as sneezing, nasal obstruction, rhinorrhea, and sinusitis (40661,51218). A case of minor hemoptysis has been reported for one patient with cystic fibrosis following intake of garlic capsules orally once daily for 8 weeks (51438). A 77-year-old female developed pneumonia related to the intake of one whole black garlic clove daily. The cloves were prepared by heating a whole garlic bulb in a pot for one month. Symptoms included dyspnea and coughing, and test results were positive for lymphocyte-induced stimulation by black garlic and raw garlic. The patient required treatment with oral steroids and was told to avoid garlic (96011).
General
...Orally, inositol nicotinate is generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, constipation, diarrhea, flushing, heartburn, liver enzyme elevation, nausea, vomiting.
Cardiovascular ...Orally, inositol nicotinate is converted to niacin and is therefore likely to cause similar side effects as niacin (496). A prostaglandin-mediated flushing reaction is a common adverse effect of oral niacin. A large pooled analysis of clinical studies shows that up to 70% of people may experience flushing with oral niacin (96211). Although flushing can occur with doses of niacin as low as 30 mg daily, it is more common with the larger doses of 500-2000 mg used for treatment of dyslipidemia (4889,26089,93341,93345). Inositol nicotinate is often promoted as a "no-flush" niacin; however, this benefit has not been demonstrated in clinical trials.
Dermatologic ...Orally, inositol nicotinate is converted to niacin and is therefore likely to cause similar side effects as niacin, including pruritus (496).
Endocrine ...Orally, inositol nicotinate is converted to niacin and is therefore likely to cause similar side effects as niacin (496). Niacin can impair glucose tolerance in a dose-dependent manner. Dosages of niacin 3-5 grams daily appear to increase blood glucose in patients with or without diabetes, while dosages of 1.5 grams or less have minimal effects (12033). Because inositol nicotinate is converted to niacin, it may also impair glucose tolerance (496).
Gastrointestinal ...Orally, inositol nicotinate is converted to niacin and is therefore likely to cause similar side effects as niacin, including gastrointestinal complaints such as nausea, vomiting, bloating, heartburn, diarrhea, and constipation (496). These adverse effects from niacin may be reduced by taking it with meals or antacids, and usually disappear within two weeks of continued therapy (4851,11690,26094).
Hematologic ...Orally, inositol nicotinate is converted to niacin and is therefore likely to cause similar side effects as niacin, including hyperuricemia (496).
Hepatic ...Orally, inositol nicotinate is converted to niacin and is therefore likely to cause similar side effects as niacin (496). Niacin is associated with elevated liver function tests and jaundice, especially with doses of 3 grams daily or more, and when doses are rapidly increased (4458,4863,6243,11690). Because inositol nicotinate is converted to niacin, it may also cause hepatotoxicity (496)
General ...Orally, lactase is generally well tolerated.
Immunologic ...A case of lactase-induced contact dermatitis and immunoglobulin E (IgE)-mediated allergic rhinoconjunctivitis has been reported in a worker exposed to powdered lactase. Allergy to lactase was confirmed by prick test, open application test, and chamber challenge test (96348).
General
...Orally and intravaginally, Lactobacillus acidophilus is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Intravaginally: Vaginal discharge.
Serious Adverse Effects (Rare):
Orally: There is concern that L. acidophilus may cause infections in some people.
Dermatologic ...Orally, in one clinical trial, a combination of Lactobacillus acidophilus La-5, Lacticaseibacillus paracasei subsp. paracasei F19, and Bifidobacterium animalis subsp. lacltis BB-12 was associated with two cases of rash, one with itching. However, it is not clear if these adverse effects were due to L. acidophilus, other ingredients, the combination, or if the events were idiosyncratic (90236).
Gastrointestinal ...Orally, taking Lactobacillus acidophilus in combination with other probiotics may cause gastrointestinal side effects including epigastric discomfort (90239), abdominal pain (90239,90291,111785), dyspepsia (90239), flatulence (107497,107520), bloating (107497,111785), diarrhea (111785), vomiting (107537), and burping (90239); however, these events are uncommon.
Genitourinary ...Intravaginally, cream containing Lactobacillus acidophilus has been shown to cause increased vaginal discharge in about 5% of patients, compared to about 1% of patients receiving placebo cream (90237). Vaginal burning was reported by one person using intravaginal L. acidophilus and Limosilactobacillus fermentum in a clinical trial (111781).
Immunologic ...Since Lactobacillus acidophilus preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients. L. acidophilus has been isolated in some cases of bacteremia, sepsis, splenic abscess, liver abscess, endocarditis, necrotizing fasciitis, pancreatic necrosis, and meningoencephalitis. Most of these cases are thought to be due to the translocation of bacteria from other locations in the body in which they occur naturally, such as the oral cavity and gastrointestinal tract (107543,111782,111792). L. acidophilus endophthalmitis has been reported rarely (111787,111795). In one case, it was related to intravitreal injections for age-related macular degeneration in a 90-year-old female with an intraocular lens (111787). In another, it occurred following cataract surgery (111795).
General
...No adverse effects have been reported in adults.
However, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal adverse effects, such as necrotizing enterocolitis, when recombinant human bile salt-stimulated lipase is used in premature infants.
Gastrointestinal ...Orally, when added to the formula or pasteurized breast milk consumed by premature infants, recombinant human bile salt-stimulated lipase (rhBSSL) can cause gastrointestinal adverse effects, including abdominal distension, flatulence, constipation, colic, abdominal pain, gastroenteritis, vomiting, regurgitation, and rectal bleeding (101940). Premature infants receiving rhBSSL also had a slightly higher rate of necrotizing enterocolitis (NEC) when compared with those receiving placebo. After review by a panel of experts, it was determined that the rate of confirmed or suspected NEC in infants consuming rhBSSL was 3.3%, compared with 0.5% in those receiving placebo. Although this rate of NEC is lower than the historical rate of occurrence in premature infants (11%), a possible increased risk for NEC cannot be ruled out (101940).
General
...Orally, mangosteen is generally well tolerated.
Topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Lactic acidosis.
Dermatologic ...Orally, mangosteen extract up to 560 mg daily has been reported to cause skin rash. It is not known if this side effect was related to mangosteen (97877).
Gastrointestinal ...Orally, mangosteen extract up to 560 mg daily has been reported to cause constipation, abnormal stool, abdominal discomfort, abdominal bloating, salivation, nausea and vomiting, and diarrhea. It is not known if these side effects were related to mangosteen (97877).
Neurologic/CNS ...Orally, mangosteen extract up to 560 mg daily has been reported to cause mild tiredness, headache, dizziness, and malaise. It is not known if these side effects were related to mangosteen (97877).
Pulmonary/Respiratory ...Orally, mangosteen extract up to 560 mg daily has been reported to cause dry throat, flu-like symptoms, cough, and nasal congestion. It is not known if these side effects were related to mangosteen (97877).
Renal ...Orally, mangosteen extract up to 560 mg daily has been reported to cause abnormal urination. It is not known if this side effect was related to mangosteen (97877). In one case report, a patient with chronic kidney disease and metabolic syndrome consumed mangosteen juice daily for 12 months and later presented with severe lactic acidosis. The juice was reported to contain 250 mg of mangosteen with 25 mg alpha-mangostin per ounce. Alpha-mangostin appears to inhibit mitochondrial function, disrupting the electron transport chain and adenosine triphosphate (ATP) production, causing accumulation of reactive oxygen species and inducing apoptosis. Researchers speculate that these effects might have led to lactic acidosis in this patient (16399).
Other ...Orally, mangosteen extract up to 560 mg daily has been reported to cause weight loss. It is not known if this side effect was related to mangosteen (97877).
General
...Orally and topically, noni seems to be generally well tolerated; however, high quality studies of adverse effects have not been conducted.
Most Common Adverse Effects:
Orally: Abdominal discomfort, nausea.
Serious Adverse Effects (Rare)::
Orally: Hepatotoxicity, including liver failure. However, studies have not conclusively identified whether noni, or contaminants in noni products, were responsible for this toxicity.
Gastrointestinal ...Orally, dehydrated noni fruit has been reported to cause nausea and abdominal discomfort (65173).
Hepatic
...Noni has been associated with several cases of hepatotoxicity in previously healthy patients ranging in age from 14 to 62 years (13107,14341,14468,17170,17171,17172).
In two cases, the patients had used a tea or other herbal products containing noni (13107,17172); five had consumed noni juice, specifically Tahitian Noni Juice (Tahitian Noni International) (14341,16648,17171); and two cases involved energy drinks containing several herbal ingredients including noni (17170,90125). Symptoms of liver dysfunction and elevated liver function tests (LFTs) were seen between 2 weeks and 4 months after starting noni. The LFTs started to improve within 2 days of stopping noni and generally normalized within 1 month (13107,14468,17171). Biopsy findings included acute hepatitis, inflammation, hepatocyte necrosis, and hepatocellular cholestasis (14341,17170). One patient, who had a history of prior mild acetaminophen toxicity, had rapidly progressive liver failure after noni ingestion and required transplantation (14341).
Potential product contamination was not ruled out in these case reports. Some researchers theorize that anthraquinones contained in noni could potentially cause hepatotoxicity. Other products containing anthraquinones, such as senna, have been linked to cases of hepatotoxicity. However, analyses of a noni juice product associated with reports of liver damage (Tahitian Noni Juice, Tahitian Noni International) have not detected anthraquinone content (14444). Another analysis of noni fruit puree from which the seeds and skin had been removed had no detectable anthraquinones (92201). However, products containing seed or leaf material had detectable amounts of anthraquinones (92201). The part of the noni plant used might affect hepatotoxicity risk. More evidence is needed to determine if noni causes hepatotoxicity.
General
...Orally and topically, papain seems to be well tolerated when used short-term at appropriate doses.
Taking high oral doses may be unsafe.
Most Common Adverse Effects:
Orally: Allergic reactions in sensitive individuals.
Topically: Urticaria and pruritus in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Esophageal perforation and severe gastritis with high doses.
Dermatologic ...Topically, papain can cause itching (966). Urticarial reactions and itching have been reported in people occupationally exposed to papain, with papain confirmed as the causative agent by skin prick tests or radioallergosorbent tests (RAST) (95533,95534). In a randomized controlled trial assessing the effects of papain, trypsin, and chymotrypsin on adverse effects from radiotherapy, moderate to severe epitheliolysis was more frequent in the enzyme-treated group than the placebo group (67834). It is unclear if this adverse effect is due to papain, other enzymes, or the combination.
Gastrointestinal ...Orally, papain has been associated with diarrhea. In a randomized controlled trial assessing the effects of papain, trypsin, and chymotrypsin on adverse effects from radiotherapy, moderate to severe diarrhea was more frequent in the enzyme-treated group than the placebo group (67834). However, it is unclear if this adverse effect is due to papain, other enzymes, or the combination. Papain has also been associated with gastric ulcers and esophageal perforation in case reports of phytobezoars treated with papain (67848). In general, large amounts of papain can cause esophageal perforation (6). Ingestion of papaya latex (raw papain) can cause severe gastritis.
Genitourinary ...Orally, papain has been associated with hypernatremia in case reports of phytobezoars treated with papain (67848).
Immunologic ...Orally, papain may cause allergic reactions, including itchy watery eyes, runny nose, sneezing, abdominal cramps, sweating, and diarrhea, in individuals sensitive to papain (6,967). Occupational exposure to airborne papain dust may also cause respiratory allergic reactions (95532,95533,95534,95535,95536).
Pulmonary/Respiratory ...Occupational exposure to airborne papain dust may cause respiratory allergic reactions. Symptoms include rhinitis, sneezing, conjunctivitis, dyspnea, wheezing, cough, and asthma. In most cases, papain is confirmed as the causative agent by skin prick tests, radioallergosorbent tests (RAST), or detection of papain-specific immunoglobulin E (IgE) and IgG (95532,95533,95534,95535,95536).
General
...Orally, pomegranate fruit juice is generally well tolerated.
Pomegranate fruit extract and seed oil seem to be well tolerated. Pomegranate root, stem, and peel should not be used orally in large amounts. Topically, pomegranate fruit extract seems to be well tolerated.
Most Common Adverse Effects:
Oral: Diarrhea, flatulence.
Cardiovascular ...In one clinical trial, 2% of patients experienced hyperlipidemia and hypertension after consumption of pomegranate juice (69175). However, most clinical research shows that pomegranate does not increase cholesterol or blood pressure and may actually improve these parameters in some patients (8310,13022,13023,69168,69373,69374).
Dermatologic ...Topically, pomegranate may cause urticaria (hives) in some patients (8445).
Gastrointestinal ...Orally, pomegranate may cause mild gastrointestinal adverse effects. In one clinical study, drinking pomegranate juice 8 ounces daily caused diarrhea and flatulence in 2% of patients (69175). In another clinical study, taking pomegranate extract (POMx, POM Wonderful LLC) 3000 mg daily caused diarrhea in 10% of patients. This dose of pomegranate extract also caused nausea, abdominal pain, constipation, gastrointestinal upset, and vomiting in a small number of patients (91695).
Immunologic
...Orally, pomegranate fruit or seeds may cause allergic reactions.
These allergic reactions occur more commonly in people who are allergic to other plants (7674). In rare cases, pomegranate fruit can cause angioedema. Angioedema seems to occur without warning and in people who have eaten pomegranate for many years. Patients should be told to stop eating pomegranate if swelling of the tongue or face develops (7673). In one report, a patient experienced pomegranate-dependent, exercise-induced anaphylaxis. The patient developed widespread urticaria (hives) and lip edema after eating pomegranate seeds and then exercising (17331). In another report, an atopic patient experienced an allergic reaction to pomegranate fruit. Symptoms included urticaria (hives), facial angioedema, and hypotension (91692).
Topically, pomegranate may cause contact hypersensitivity characterized by urticaria (hives), angioedema, rhinorrhea, red itchy eyes, and dyspnea arising within a few minutes of exposure (8445).
Pulmonary/Respiratory ...Orally, pomegranate juice may cause nasal congestion, but this event is rare. In one clinical study, pomegranate juice was associated with nasal congestion in 2% of patients (69175). There is also one case report of a 7-year-old asthmatic child who developed bronchospasm moments after ingesting several pomegranate seeds (69149).
General
...Orally, proteolytic enzymes are generally well tolerated.
See specific monographs for detailed safety information related to individual proteolytic enzymes.
Most Common Adverse Effects:
Orally: Gastrointestinal upset.
Serious Adverse Effects (Rare):
Topically: Allergic reactions.
Gastrointestinal ...Orally, some patients taking proteolytic enzymes may have gastrointestinal complaints (101517).
Immunologic ...Proteolytic enzymes are commonly found in laundry detergents and pre-spotter products. Rarely, protease specific IgE positive tests possibly related to these products have occurred. Exposure may be airborne or topical (102705). In addition, in case reports, occupational exposure to the airborne proteolytic enzyme pepsin has resulted in allergic rhinoconjunctivitis or asthma (102706,102707).
General ...Orally, quinoa seems to be well-tolerated. Rarely, quinoa can cause allergic reaction in some individuals, including anaphylaxis (99150,99151,96062).
Immunologic ...Orally, allergic reactions to quinoa have been reported (99150,96062). Anaphylaxis and pruritic reactions have occurred in at least two individuals, a 29-year-old female and a 52-year-old male. Quinoa allergy was confirmed in both patients via skin-prick testing with quinoa extract (99150,99151).
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 ...Orally, no adverse effects have been reported; however, a thorough evaluation of safety outcomes has not been conducted.
