Each scoop contains: Vitamin C 17 mg • Folic Acid 400 mcg • Proprietary Fruit Powder Blend 4900 mg: Blueberry , Blackberry , Black Cherry , Black Raspberry juice concentrate , Black Currant , Plum , Elderberry , Bilberry , Fig , Raisins • Fibersol-2 brand Soluble Fiber 2000 mg • Proprietary Vegetable Powder Blend 1250 mg: Eggplant , purple carrot , Purple Cabbage , Beet • Acai fruit powder 400 mg • Camu Camu fruit powder 300 mg • Mangosteen fruit extract (garcinia mangostana, yielding mangostin 30 mg) 300 mg • Gogi berry powder (wolfberry / lycium barbarum) 200 mg • Proprietary "Brain" Blend 100 mg: L-Carnosine , Alpha GPC • P40p brand Pomegranate extract (yielding punicosides 16 mg) 40 mg • Stevia 35 mg. Other Ingredients: Natural Raspberry, Strawberry, Cherry, Vanilla, and Spearmint Flavors, Banana Powder, Cinnamon, Citric Acid.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
Below is general information about the effectiveness of the known ingredients contained in the product Spectra Purples. 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
There is insufficient reliable information available about the effectiveness of blackberry.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of camu camu.
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
There is insufficient reliable information available about the effectiveness of wild cherry.
Below is general information about the safety of the known ingredients contained in the product Spectra Purples. 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.
POSSIBLY SAFE ...when used orally and appropriately. Alpha-GPC has been used with apparent safety at doses of 400 mg three times daily (1200 mg/day) for up to 6 months (12102,12176). ...when used intramuscularly and appropriately. Alpha-GPC has been administered intramuscularly with apparent safety at doses of 1000-1200 mg/day for 28 to 90 days (12100,12102).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used in amounts commonly found in foods.
POSSIBLY SAFE ...when used orally and appropriately for medicinal purposes, short term. Beetroot juice has been safely used in clinical trials in doses of up to 500 mL daily for up to 7 days and a beetroot-based nutritional gel has been used safely in doses of up to 100 grams daily for 8 days (94461,94462,94464,100149,100152,100153).
PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of beets used medicinally during pregnancy and breast-feeding.
LIKELY SAFE ...when used orally and appropriately in amounts commonly found in foods. Bilberry has Generally Recognized As Safe status (GRAS) for use in foods in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately for medicinal purposes. Bilberry fruit extracts have been used with apparent safety in clinical trials at a dose of up to 160 mg daily for up to 6 months (39,40,8139,9739,14280,35472,35510,35512,103190,104192,104195). A higher bilberry extract dose of 1.4 grams daily has been used with apparent safety for up to 4 weeks (104194). Whole bilberries or bilberry juice have also been consumed with apparent safety in quantities of 100-160 grams daily for up to 35 days (35463,91506).
POSSIBLY UNSAFE ...when the leaves are used orally in high doses or for a prolonged period. Death can occur with chronic use of 1.5 gram/kg daily (2).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in the amounts commonly found in foods.
However, there is insufficient reliable information available about the safety of bilberry when used in medicinal amounts during pregnancy and lactation; avoid using.
LIKELY SAFE ...when used orally and appropriately. Black currant juice, leaves, and flowers have Generally Recognized As Safe (GRAS) status in the US (4912). Black currant juice up to 3000 mL daily for up to 3 weeks (17636,35987), black currant extracts 1080 mg daily for 8 weeks (17635,93695), and black currant seed oil products up to 10.5 grams daily for 24 weeks (4016,17634,17638,35990) have also been used safely in clinical research. There is insufficient reliable information about the safety of black currant when used topically.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods (13530).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term. In clinical research, black raspberry fruit extract has been used safely in doses up to 1800 mg daily for up to 12 weeks (96302,96343). Higher doses of black raspberry fruit extract (2500 mg daily) has also been used safely for up to 8 weeks (96303).
POSSIBLY SAFE ...when used topically and appropriately, short-term. In a small clinical trial, a black raspberry bioadhesive gel was used safely in doses of 0.5 grams applied four times daily in the mouth for 3 months (96304).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods.
There is insufficient reliable information available about the safety of black raspberry in medicinal amounts during pregnancy or breast-feeding; avoid using.
LIKELY SAFE ...when the fruit is used orally in amounts commonly found in foods (4912). There is insufficient reliable information available about the safety of blackberry fruit or leaf when used in medicinal amounts.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using in amounts greater than those found in foods.
LIKELY SAFE ...when used orally and appropriately. Blueberry, as the whole fruit, juice, or in a powder formulation, is safe when consumed in amounts commonly found in foods (13533,92387,92388,92394,96467,97181,99139). There is insufficient reliable information available about the safety of blueberry when used topically or when the leaves are used orally.
CHILDREN: LIKELY SAFE
when used orally and appropriately in amounts commonly found in foods (13533,96465).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (13533,107281).
There is insufficient reliable information available about the safety of blueberry for medicinal use; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods.
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (18). ...when used topically and appropriately, short-term. Topical application of cabbage leaves has been general well-tolerated in short-term studies (6781,6782,6783,6784,93671,110558). However, pain, itching, and burning with topical use of cabbage leaves have been reported in some patients leaving cabbage leaf wraps in place for 2-4 hours (93671,93675).
PREGNANCY:
There is insufficient reliable information available about using cabbage in medicinal amounts during pregnancy; avoid using.
LACTATION: LIKELY SAFE
when used topically and appropriately, short-term.
Significant adverse effects have not been reported in short-term studies (6781,6782,6783,6784,93673,93677). There is insufficient reliable information available about using cabbage orally in medicinal amounts during lactation; avoid using.
There is insufficient reliable information available about the safety of camu camu.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately. In clinical trials, carnosine has been used safely at doses of 200-1500 mg daily, alone or in combination with other ingredients (91886,93996,94000,103289). There is insufficient reliable information available about the safety of carnosine when used topically.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately.
Carnosine has been used in with apparent safety in children 3-16 years of age at doses of 500-800 mg daily for up to 8 weeks (39926,100483).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in the amounts typically found in foods. Elderberry has generally recognized as safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when elderberry fruit extract is used orally, short-term. One specific elderberry fruit extract (Sambucol, Nature's Way) has been used with apparent safety for up to 5 days (5260,12235,103831); another (BerryPharma, Iprona AG) has been used with apparent safety for up to 15 days (91374). A specific elderberry fruit extract lozenge (ViraBLOC, HerbalScience) has been used with apparent safety for 2 days (17022). Other elderberry fruit extracts have been used with apparent safety for up to 12 weeks (21141,21142).
POSSIBLY UNSAFE ...when elder tree leaves and stems, or unripe or uncooked elderberries, are consumed. The unripe green fruit, as well as the leaves and stems of the elder tree, contain a cyanide-producing chemical, which can cause serious toxicity (17020,17021,21143,21144,91374). Cooking eliminates the toxin.
CHILDREN: LIKELY SAFE
when consumed in the amounts typically found in foods.
CHILDREN: POSSIBLY SAFE
when used orally for up to 3 days.
A specific fruit extract (Sambucol, Nature's Way) has been used in doses of 15 mL twice daily for 3 days in children 5 years and older (5260,103831).
CHILDREN: POSSIBLY UNSAFE
when unripe or uncooked elderberries are consumed.
The unripe green fruit, as well as the leaves and stems of the elder tree, contain a cyanide-producing chemical , which can cause serious toxicity (17020,17021,21143,21144,91374). Cooking eliminates the toxin.
PREGNANCY AND LACTATION: LIKELY SAFE
when consumed in the amounts typically found in foods.
There is insufficient reliable information available about the safety of elderberry when used for medicinal purposes; avoid using in amounts greater than those found in foods.
LIKELY SAFE ...when the fresh or dried fruit is used orally in amounts commonly found in foods.
POSSIBLY SAFE ...when fig fruit paste is consumed orally in amounts of up to 300 grams daily for up to 8 weeks (99956).
POSSIBLY UNSAFE ...when fig leaf decoctions are used topically. Fig leaf contains psoralens (12579,12581). There have been reports of photodermatitis with burn-like lesions and rashes after fig decoctions were applied prior to sun exposure (49962,49968,49973,49975,49981). There is insufficient reliable information available about the safety of fig leaf when used orally.
PREGNANCY AND LACTATION: LIKELY SAFE
when the fresh or dried fruit is used orally in amounts commonly found in foods.
There is insufficient reliable information available about the safety of fig leaf or fruit used in medicinal amounts during pregnancy and lactation; avoid use.
LIKELY SAFE ...when used orally or parenterally and appropriately. Folic acid has been safely used in amounts below the tolerable upper intake level (UL). The UL for folic acid is based only on supplemental folic acid and is expressed in mcg folic acid. Dietary folate is not included in UL calculations, as dietary folate consumption has not been associated with adverse effects. The UL for folic acid in adults is 1000 mcg (6241). In cases of megaloblastic anemia resulting from folate deficiency or malabsorption disorders such as sprue, oral doses of 1-5 mg per day can also be used safely until hematologic recovery is documented, as long as vitamin B12 levels are routinely measured (6241,7725,8739).
POSSIBLY SAFE ...when L-5-methyltetrahydrofolate (L-5-MTHF), the reduced form of folate, is used orally and appropriately, short-term. L-5-MTHF has been used with apparent safety at a dose of 416 mcg daily for 16 weeks (104913,104914) and a dose of 113 mcg daily for 24 weeks (104920). A specific L-5-MTHF product (Metafolin, Eprova) has been used with apparent safety at a dose of 1.3 mg daily for 12 weeks (104912).
POSSIBLY UNSAFE ...when used orally in large doses, long-term. Clinical research shows that taking folic acid daily in doses of 800 mcg to 1200 mcg for 3-10 years significantly increases the risk of developing cancer and adverse cardiovascular effects compared to placebo (12150,13482,16822,17041). Doses above 1 mg per day should also be avoided if possible to prevent precipitation or exacerbation of neuropathy related to vitamin B12 deficiency (6241,6242,6245). However, there is contradictory evidence suggesting that higher doses may not be harmful. There is some evidence that doses of 5 mg per day orally for up to 4 months can be used safely if vitamin B12 levels are routinely measured (7725). Also, other clinical research suggests that folic acid supplementation at doses up to 5 mg, usually in combination with vitamin B12, does not increase the risk of cancer when taken for 2-7 years (91312). Very high doses of 15 mg per day can cause significant central nervous system (CNS) and gastrointestinal side effects (505).
CHILDREN: LIKELY SAFE
when used orally and appropriately.
Folic acid has been safely used in children in amounts below the tolerable upper intake level (UL). The ULs for folic acid are based only on supplemental folic acid and are expressed in mcg folic acid. Dietary folate is not included in UL calculations, as dietary folate consumption has not been associated with adverse effects. The UL for children is: 1-3 years of age, 300 mcg; 4-8 years of age, 400 mcg; 9-13 years of age, 600 mcg; 14-18 years of age, 800 mcg (6241).
CHILDREN: POSSIBLY SAFE
when L-5-methyltetrahydrofolate (L-5-MTHF), the reduced form of folate, is used orally and appropriately.
One clinical study in infants aged 27 days and younger shows that consuming a formula containing L-5-MTHF (Metafolin, Merck & Cie) 10.4 mcg/100 mL daily has been used with apparent safety for up to 12 weeks (104918).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately.
Folic acid 300-400 mcg is commonly used during pregnancy for prevention of neural tube defects (8739). Miscarriage rates and negative impacts on fetal growth have not been shown to increase with peri-conception supplemental folic acid intakes of 4 mg per day (91320,91322). However, other research shows that taking more than 5 mg per day during pregnancy may reduce development of cognitive, emotional, and motor skills in infants (91318). Also, the tolerable upper intake level (UL) of folic acid for pregnant or lactating women is 800 mcg daily for those 14-18 years of age and 1000 mcg daily for those 19 years and older (6241).
PREGNANCY AND LACTATION: POSSIBLY SAFE
when L-5-methyltetrahydrofolate (L-5-MTHF), the reduced form of folate, is used orally and appropriately, short-term.
L-5-MTHF has been used with apparent safety at a dose of 416 mcg daily for 16 weeks during lactation. Compared to folic acid, this form seems to further increase the folate concentration of red blood cells, but not breast milk (104913,104914).
LIKELY SAFE ...when used orally in amounts commonly found in foods. Grapes and grape skin extracts have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY SAFE ...when the whole fruit of the grape, or extracts of the fruit, seed, or leaf, are used orally and appropriately in medicinal amounts. Grape seed extracts have been used with apparent safety in doses up to 200 mg daily for up to 11 months (9182,53016) and in doses up to 2000 mg daily for up to 3 months (53149,53190). Specific grape fruit extracts (Stilvid, Actafarma; Cognigrape, Bionap srl) have been used with apparent safety in doses up to 250-350 mg daily for 3-12 months or 700 mg daily for 6 months (53254,53256,96198). A specific grape leaf extract (AS 195, Antistax, Boehringer Ingelheim) has been used with apparent safety in doses up to 720 mg daily for up to 3 months (2538,52985,53005,53206). A preparation of dehydrated whole grapes, equivalent to 250 grams of fresh grapes daily, has also been used with apparent safety for up to 30 days (18228). A specific grape seed extract (Enovita; Indena SpA) 150 mg twice daily, standardized to provide at least 95% oligomeric proanthocyanins, has been used with apparent safety for up to 16 weeks (108091) ...when used topically and appropriately. Creams and ointments containing grape seed extract 2% or 5% have been used topically with apparent safety for up to 3 weeks (91539,100955). There is insufficient reliable information available about the safety of other grape plant parts when used topically.
CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in foods.
Grapes and grape skin extracts have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912). However, whole grapes should be eaten with caution in children aged 5 years and under. Whole grapes can be a choking hazard for young children (96193). To reduce the risk of choking, whole grapes should be cut in half or quartered before being given to children. There is insufficient reliable information available about the safety of grape when used in medicinal amounts in children.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods.
There is insufficient reliable information available about the safety of medicinal amounts during pregnancy and breast-feeding; avoid using in amounts greater than what is commonly found in foods.
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.
LIKELY SAFE ...when used orally in the amounts typically found in food.
POSSIBLY SAFE ...when dried plums are used orally as a medicine. Dried plums have been used with apparent safety at doses of up to 100 grams daily for up to 12 months (95271,95272,95280,95281,95295,112402,112403). ...when plum juice or dried plum essence is used orally as a medicine. Plum juice has been consumed with apparent safety at a dose of up to 250 mL daily for up to 12 weeks and up to 90 grams daily for 24 weeks (95293,95294,112402). Dried plum essence has been consumed with apparent safety at a dose of up to 100 mL daily for up to 4 weeks (95274,112402).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using amounts greater than those found in food.
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.
LIKELY SAFE ...when certain stevia constituents, including stevioside and rebaudiosides A, D, and M, are used orally as sweeteners in foods. These constituents have generally recognized as safe (GRAS) status in the US for this purpose (16699,16700,16702,16705,16706,108049). The stevia constituent stevioside has been safely used in doses of up to 1500 mg daily for 2 years (11809,11810,11811). There is insufficient reliable information available about the safety of whole stevia or stevia extracts when used orally. The European Food Safety Authority (EFSA) has determined that the acceptable intake of steviol glycosides is 4 mg/kg daily (106456); however, it is unclear how this relates to the use of whole stevia or stevia extract.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally, topically, intramuscularly, or intravenously and appropriately. Vitamin C is safe when taken orally in doses below the tolerable upper intake level (UL). Tell patients not to exceed the UL of 2000 mg daily (1959,4713,4714,4844). ...when used intravenously or intramuscularly and appropriately. Injectable vitamin C is an FDA-approved prescription product (15).
POSSIBLY UNSAFE ...when used orally in excessive doses. Doses greater than the tolerable upper intake level (UL) of 2000 mg daily can significantly increase the risk of adverse effects such as osmotic diarrhea and gastrointestinal upset (4844).
CHILDREN: LIKELY SAFE
when used orally and appropriately (4844,10352,14443).
CHILDREN: POSSIBLY UNSAFE
when used orally in excessive amounts.
Tell patients not to use doses above the tolerable upper intake level (UL) of 400 mg daily for children ages 1 to 3 years, 650 mg daily for children 4 to 8 years, 1200 mg daily for children 9 to 13 years, and 1800 mg daily for adolescents 14 to 18 years. Higher doses can cause osmotic diarrhea and gastrointestinal upset (4844).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately (4844).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in excessive doses.
Tell patients over age 19 not to use doses exceeding the UL of 2000 mg daily when pregnant or breast-feeding and for those 14-18 years of age not to use doses exceeding 1800 mg daily when pregnant or breast-feeding. Higher doses can cause osmotic diarrhea and gastrointestinal upset. Large doses of vitamin C during pregnancy can also cause newborn scurvy (4844); avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods and beverages. Wild cherry has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately short-term, in limited amounts (12).
POSSIBLY UNSAFE ...when used orally and long-term or in excessive amounts (12,19). The constituent prunasin hydrolyzes to hydrocyanic acid (HCN) (11,12,13,18).
PREGNANCY: LIKELY UNSAFE
when used orally because prunasin is potentially teratogenic (19).
LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Spectra Purples. 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.
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Theoretically, alpha-GPC might decrease the effects of scopolamine.
Details
A small clinical study shows that alpha-GPC can partially counteract the attention and memory impairment effects caused by scopolamine given intramuscularly (12103). Whether alpha-GPC can decrease the beneficial anti-motion sickness effects of the scopolamine patch (Transderm Scop) is unclear.
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Theoretically, bilberry fruit extract might increase the risk of bleeding when taken with anticoagulant or antiplatelet drugs.
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Theoretically, bilberry leaf or fruit extract may increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Animal research suggests that bilberry leaf extract might have blood glucose-lowering activity (1264). Also, one small clinical trial in patients with type 2 diabetes shows that taking bilberry fruit extract 470 mg as a single dose prior to an oral glucose tolerance test lowers plasma glucose levels when compared with placebo (91507).
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Theoretically, bilberry fruit extract might decrease levels of drugs metabolized by CYP2E1.
Details
Animal research shows that exposure to small concentrations of bilberry extract in drinking water for around one month increased CYP2E1 activity by 31%. However, exposure over a 2-month period did not increase CYP2E1 activity (103191). This effect has not been reported in humans.
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Theoretically, bilberry fruit extract might reduce the efficacy of erlotinib.
Details
In vitro research suggests that bilberry fruit extract and its constituents, delphinidin and delphinidin-3-O-glucoside, inhibit the activity of erlotinib (97031). This interaction has not been reported in humans.
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Theoretically, black currant seed oil might increase the risk of bleeding if used in combination with anticoagulant or antiplatelet drugs.
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Theoretically, black currant seed oil might increase the risk of seizure in patients receiving phenothiazines.
Details
Black currant seed oil contains gamma-linolenic acid (GLA). There is some concern that taking supplements containing GLA might cause seizures, or lower the seizure threshold, when taken with phenothiazines, although there is no evidence that black currant seed oil causes seizures (88187). In one report, three patients with schizophrenia who had received phenothiazines developed EEG changes suggestive of temporal lobe epilepsy after starting treatment with GLA, although none experienced an actual seizure (21013). In another report, two patients with schizophrenia who were stabilized on phenothiazines developed seizures when evening primrose 4 grams daily, which contains GLA, was added. One of these patients had a prior history of seizures (21010).
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Theoretically, blueberries or blueberry leaf extracts might increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Theoretically, blueberry juice might increase blood levels of buspirone.
Details
In vitro research shows that blueberry juice can inhibit the metabolism of buspirone, possibly by inhibiting cytochrome P450 3A (CYP3A) enzymes. However, pharmacokinetic research in humans shows that drinking 300 mL of blueberry juice 30 minutes before taking buspirone hydrochloride 10 mg does not significantly affect the concentration or clearance of buspirone (92385).
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Theoretically, blueberry juice might increase blood levels of flurbiprofen.
Details
In vitro research shows that blueberry juice can inhibit the metabolism of flurbiprofen, possibly by inhibiting cytochrome P450 2C9 (CYP2C9) enzymes. However, pharmacokinetic research in humans shows that drinking 300 mL of blueberry juice 30 minutes before taking flurbiprofen 100 mg does not significantly affect the concentration or clearance of flurbiprofen (92385).
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Cabbage might increase clearance and reduce the effects of acetaminophen.
Details
A small clinical study shows that daily consumption of cabbage and Brussels sprout decreases acetaminophen levels by as much as 16%, with some evidence suggesting that this effect is due to increased elimination through glucuronide conjugation (3952).
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Theoretically, cabbage might increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Animal and in vivo research suggests that cabbage might have hypoglycemic effects (25424).
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Theoretically, cabbage might decrease levels of drugs metabolized by CYP1A2.
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Theoretically, cabbage might increase clearance and decrease the effects of drugs metabolized through glucuronide conjugation.
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A small clinical study shows that daily consumption of cabbage and Brussels sprout decreases levels of some drugs metabolized through glucuronide conjugation (3952).
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Cabbage might increase clearance and reduce the effects of oxazepam.
Details
A small clinical study shows that daily consumption of cabbage and brussels sprout decreases oxazepam levels by as much as 17%, with some evidence suggesting that this effect is due to increased elimination through glucuronide conjugation (3952).
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Theoretically, cabbage might decrease the anticoagulant effects of warfarin.
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Cabbage contains vitamin K. If consumed in large quantities, cabbage might decrease the anticoagulant effects of warfarin (19).
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Theoretically, taking carnosine with antidiabetes drugs might increase the risk of hypoglycemia.
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Theoretically, elderberry might interfere with immunosuppressant therapy due to its immunostimulant activity.
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Elderberry has immunostimulant activity, increasing the production of cytokines, including interleukin and tumor necrosis factor (10796).
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Theoretically, fig leaf might enhance the blood glucose lowering effects of hypoglycemic drugs.
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A small clinical study in patients with type 1 diabetes shows that consuming a tea made from fig leaves modestly reduces postprandial glucose levels and insulin requirements (12578).
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Fig leaf may enhance the blood glucose lowering effects of insulin.
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A small clinical study in patients with type 1 diabetes shows that consuming a tea made from fig leaves modestly reduces postprandial glucose levels and insulin requirements (12578).
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Theoretically, high doses of folic acid might increase the toxicity of 5-fluorouracil.
Details
Increases in gastrointestinal side effects of 5-fluorouracil, such as stomatitis and diarrhea, have been described in two clinical studies when leucovorin, a form of folic acid, was administered with 5-fluorouracil (16845).
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Use of high-dose folic acid might contribute to capecitabine toxicity.
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Clinical research suggests that higher serum folate levels are associated with an increased risk for moderate or severe toxicity during capecitabine-based treatment for colorectal cancer (105402). Additionally, in one case report, taking folic acid 15 mg daily might have contributed to increased toxicity, including severe diarrhea, vomiting, edema, hand-foot syndrome, and eventually death, in a patient prescribed capecitabine (16837).
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Folic acid might reduce the efficacy of methotrexate as a cancer treatment when given concurrently.
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Methotrexate exerts its cytotoxic effects by preventing conversion of folic acid to the active form needed by cells. There is some evidence that folic acid supplements reduce the efficacy of methotrexate in the treatment of acute lymphoblastic leukemia, and theoretically they could reduce its efficacy in the treatment of other cancers (9420). Advise cancer patients to consult their oncologist before using folic acid supplements. In patients treated with long-term, low-dose methotrexate for rheumatoid arthritis (RA) or psoriasis, folic acid supplements can reduce the incidence of side effects, without reducing efficacy (768,2162,4492,4493,4494,4546,9369).
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Folic acid might have antagonistic effects on phenobarbital and increase the risk for seizures.
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Folic acid might reduce serum levels of phenytoin in some patients.
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Folic acid may be a cofactor in phenytoin metabolism (4471). Folic acid, in doses of 1 mg daily or more, can reduce serum levels of phenytoin in some patients (4471,4477,4531,4536). Increases in seizure frequency have been reported. If folic acid supplements are added to established phenytoin therapy, monitor serum phenytoin levels closely. If phenytoin and folic acid are started at the same time and continued together, adverse changes in phenytoin pharmacokinetics are avoided (4471,4472,4473,4531). Note that phenytoin also reduces serum folate levels.
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Folic acid might have antagonistic effects on primidone and increase the risk for seizures.
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Folic acid might antagonize the effects of pyrimethamine.
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Folic acid can antagonize the antiparasitic effects of pyrimethamine against toxoplasmosis and Pneumocystis carinii pneumonia. Folic acid doesn't antagonize the effects of pyrimethamine in the treatment of malaria, because malarial parasites cannot use exogenous folic acid. Use folinic acid as an alternative to folic acid when indicated (9380).
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Theoretically, grape extracts may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
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Ingesting grape juice with cyclosporine can reduce cyclosporine absorption.
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A small pharmacokinetic study in healthy young adults shows that intake of purple grape juice 200 mL along with cyclosporine can decrease the absorption of cyclosporine by up to 30% when compared with water (53177). Separate doses of grape juice and cyclosporine by at least 2 hours to avoid this interaction.
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Theoretically, grape juice might reduce the levels of CYP1A2 substrates.
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A small pharmacokinetic study in healthy adults shows that ingestion of 200 mL of grape juice decreases phenacetin plasma levels. This is thought to be due to induction of CYP1A2 (2539).
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It is unclear if grape juice or grape seed extract inhibits CYP2C9; research is conflicting.
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In vitro evidence shows that grape seed extract or grape juice might inhibit CYP2C9 enzymes (11094,53011,53089). However, a small pharmacokinetic study in healthy adults shows that drinking 8 ounces of grape juice once does not affect the clearance of flurbiprofen, a probe-drug for CYP2C9 metabolism (11094). The effects of continued grape juice consumption are unclear.
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Theoretically, grape seed extract may increase the levels of CYP2D6 substrates.
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In vitro evidence suggests that grape seed extract might inhibit CYP2D6 enzymes (53011). However, this interaction has not been reported in humans.
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Theoretically, grape seed extract might increase the levels of CYP2E1 substrates.
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In vitro and animal research suggests that grape seed proanthocyanidin extract inhibits CYP2E1 enzymes (52949). However, this interaction has not been reported in humans.
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It is unclear if grape seed extract inhibits or induces CYP3A4; research is conflicting.
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Theoretically, long-term intake of grape seed extract might decrease the effects of midazolam.
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Animal research shows that subchronic ingestions of grape seed extract can increase the elimination of intravenous midazolam by increasing hepatic CYP3A4 activity. Single doses of grape seed extract do not appear to affect midazolam elimination (53011).
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Grape juice might decrease phenacetin absorption.
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A small pharmacokinetic study in healthy adults shows that ingestion of 200 mL of grape juice decreases phenacetin plasma levels. This is thought to be due to induction of cytochrome P450 1A2 (CYP1A2) (2539).
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Theoretically, concomitant use of mangosteen with anticoagulant or antiplatelet drugs may increase the risk of bleeding.
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Theoretically, concomitant use of mangosteen with donepezil might increase the effects of donepezil.
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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).
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Theoretically, plum juice might have antiplatelet effects.
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Theoretically, taking pomegranate with ACEIs might increase the risk of adverse effects.
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Pomegranate juice is thought to have ACE inhibitor-like effects (8310).
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Theoretically, taking pomegranate with antihypertensive drugs might increase the risk of hypotension.
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Theoretically, taking pomegranate with carbamazepine might increase the risk of adverse effects, although research suggests this interaction is unlikely to be clinically significant.
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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).
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Theoretically, pomegranate might increase levels of drugs metabolized by CYP2C9.
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Theoretically, pomegranate might increase levels of drugs metabolized by CYP2D6.
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In vitro, pomegranate juice inhibits CYP2D6 (13703). However, the clinical significance of this potential interaction in humans is not known.
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Theoretically, pomegranate might increase levels of drugs metabolized by CYP3A4, but most research suggests this interaction is unlikely to be clinically significant.
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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).
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Theoretically, taking pomegranate with rosuvastatin might increase the risk of adverse effects.
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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).
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Theoretically, pomegranate might increase levels of tolbutamide, although research suggests this interaction is unlikely to be clinically significant.
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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.
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Theoretically, pomegranate might increase warfarin levels and increase the risk of bleeding. Also, discontinuing regular consumption of pomegranate juice might decrease warfarin levels.
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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.
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Theoretically, stevia might increase the risk for hypoglycemia when combined with antidiabetes drugs.
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Preliminary clinical research in patients with type 2 diabetes suggests that taking a single dose of stevia extract 1000 mg reduces postprandial blood glucose levels when taken with a meal (11812). However, other clinical research in patients with type 1 or type 2 diabetes suggests that taking stevioside 250 mg three times daily does not significantly affect blood glucose levels or glycated hemoglobin (HbA1C) after three months of treatment (16705).
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Theoretically, combining stevia or stevia constituents with antihypertensive agents might increase the risk of hypotension.
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Theoretically, stevia might decrease clearance and increase levels of lithium.
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High-dose vitamin C might slightly prolong the clearance of acetaminophen.
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A small pharmacokinetic study in healthy volunteers shows that taking high-dose vitamin C (3 grams) 1.5 hours after taking acetaminophen 1 gram slightly increases the apparent half-life of acetaminophen from around 2.3 hours to 3.1 hours. Ascorbic acid competitively inhibits sulfate conjugation of acetaminophen. However, to compensate, elimination of acetaminophen glucuronide and unconjugated acetaminophen increases (6451). This effect is not likely to be clinically significant.
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Theoretically, antioxidant effects of vitamin C might reduce the effectiveness of alkylating agents.
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The use of antioxidants like vitamin C during chemotherapy is controversial. There is concern that antioxidants could reduce the activity of chemotherapy drugs that generate free radicals, such as cyclophosphamide, chlorambucil, carmustine, busulfan, and thiotepa (391). In contrast, some researchers theorize that antioxidants might make chemotherapy more effective by reducing oxidative stress that could interfere with apoptosis (cell death) of cancer cells (14012,14013). More evidence is needed to determine what effect, if any, antioxidants such as vitamin C have on chemotherapy.
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Vitamin C can increase the amount of aluminum absorbed from aluminum compounds.
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Research in animals and humans shows that vitamin C increases aluminum absorption, theoretically by chelating aluminum and keeping it in solution where it is available for absorption (10549,10550,10551,21556). In people with normal renal function, urinary excretion of aluminum will likely increase, making aluminum retention and toxicity unlikely (10549). Patients with renal failure who take aluminum-containing compounds such as phosphate binders should avoid vitamin C supplements in doses above the recommended dietary allowances.
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Theoretically, the antioxidant effects of vitamin C might reduce the effectiveness of antitumor antibiotics.
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The use of antioxidants like vitamin C during chemotherapy is controversial. There is concern that antioxidants could reduce the activity of chemotherapy drugs which generate free radicals, such as doxorubicin (391). In contrast, some researchers theorize that antioxidants might make chemotherapy more effective by reducing oxidative stress that could interfere with apoptosis (cell death) of cancer cells (14012,14013). More evidence is needed to determine what effects, if any, antioxidants such as vitamin C have on chemotherapy.
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Acidification of the urine by vitamin C might increase aspirin levels.
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It has been suggested that acidification of the urine by vitamin C could increase reabsorption of salicylates by the renal tubules, and increase plasma salicylate levels (3046). However, short-term use of up to 6 grams daily of vitamin C does not seem to affect urinary pH or salicylate excretion (10588,10589), suggesting this interaction is not clinically significant.
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Acidification of the urine by vitamin C might increase choline magnesium trisalicylate levels.
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It has been suggested that acidification of the urine by vitamin C could increase reabsorption of salicylates by the renal tubules, and increase plasma salicylate levels (3046,4531). However, short-term use of up to 6 grams daily of vitamin C does not seem to affect urinary pH or salicylate excretion (10588,10589), suggesting this interaction probably is not clinically significant.
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Vitamin C might increase blood levels of estrogens.
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Increases in plasma estrogen levels of up to 55% occur under some circumstances when vitamin C is taken concurrently with oral contraceptives or hormone replacement therapy, including topical products (129,130,11161). It is suggested that vitamin C prevents oxidation of estrogen in the tissues, regenerates oxidized estrogen, and reduces sulfate conjugation of estrogen in the gut wall (129,11161). When tissue levels of vitamin C are high, these processes are already maximized and supplemental vitamin C does not have any effect on estrogen levels. Increases in plasma estrogen levels may occur when patients who are deficient in vitamin C take supplements (11161). Monitor these patients for estrogen-related side effects.
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Theoretically, vitamin C might decrease levels of fluphenazine.
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In one patient there was a clinically significant decrease in fluphenazine levels when vitamin C (500 mg twice daily) was started (11017). The mechanism is not known, and there is no further data to confirm this interaction.
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Vitamin C can modestly reduce indinavir levels.
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One pharmacokinetic study shows that taking vitamin C 1 gram orally once daily along with indinavir 800 mg orally three times daily reduces the area under the concentration-time curve of indinavir by 14%. The mechanism of this interaction is unknown, but it is unlikely to be clinically significant in most patients. The effect of higher doses of vitamin C on indinavir levels is unknown (11300,93578).
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Vitamin C can increase levothyroxine absorption.
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Two clinical studies in adults with poorly controlled hypothyroidism show that swallowing levothyroxine with a glass of water containing vitamin C 500-1000 mg in solution reduces thyroid stimulating hormone (TSH) levels and increases thyroxine (T4) levels when compared with taking levothyroxine alone. This suggests that vitamin C increases the oral absorption of levothyroxine, possibly due to a reduction in pH (102978).
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Vitamin C might decrease the beneficial effects of niacin on high-density lipoprotein (HDL) cholesterol levels.
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A combination of niacin and simvastatin (Zocor) effectively raises HDL cholesterol levels in patients with coronary disease and low HDL levels. Clinical research shows that taking a combination of antioxidants (vitamin C, vitamin E, beta-carotene, and selenium) along with niacin and simvastatin (Zocor) attenuates this rise in HDL, specifically the HDL-2 and apolipoprotein A1 fractions, by more than 50% in patients with coronary disease (7388,11537). It is not known whether this adverse effect is due to a single antioxidant such as vitamin C, or to the combination. It also is not known whether it will occur in other patient populations.
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Acidification of the urine by vitamin C might increase salsalate levels.
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It has been suggested that acidification of the urine by vitamin C could increase reabsorption of salicylates by the renal tubules, and increase plasma salicylate levels (3046). However, short-term use of up to 6 grams/day vitamin C does not seem to affect urinary pH or salicylate excretion (10588,10589), suggesting this interaction probably is not clinically significant.
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High-dose vitamin C might reduce the levels and effectiveness of warfarin.
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Vitamin C in high doses may cause diarrhea and possibly reduce warfarin absorption (11566). There are reports of two people who took up to 16 grams daily of vitamin C and had a reduction in prothrombin time (9804,9806). Lower doses of 5-10 grams daily can also reduce warfarin absorption. In many cases, this does not seem to be clinically significant (9805,9806,11566,11567). However, a case of warfarin resistance has been reported for a patient who took vitamin C 500 mg twice daily. Cessation of vitamin C supplementation resulted in a rapid increase in international normalized ratio (INR) (90942). Tell patients taking warfarin to avoid taking vitamin C in excessively high doses (greater than 10 grams daily). Lower doses may be safe, but the anticoagulation activity of warfarin should be monitored. Patients who are stabilized on warfarin while taking vitamin C should avoid adjusting vitamin C dosage to prevent the possibility of warfarin resistance.
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In vitro research suggests that wild cherry can inhibit cytochrome P450 3A4 (CYP3A4) enzymes (6450). Theoretically, wild cherry might increase levels of drugs metabolized by CYP3A4. However, so far, this interaction has not been reported in humans.
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Some drugs metabolized by CYP3A4 include lovastatin (Mevacor), ketoconazole (Nizoral), itraconazole (Sporanox), fexofenadine (Allegra), triazolam (Halcion), and others.
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Below is general information about the adverse effects of the known ingredients contained in the product Spectra Purples. 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, alpha-GPC seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Stroke.
Dermatologic ...Orally, some patients can experience skin rash (12102). Intramuscularly, alpha-GPC can cause erythema at the injection site (12101).
Gastrointestinal
...Orally, alpha-GPC has been rarely associated with diarrhea, heartburn, nausea, and vomiting (12102).
Intramuscularly, alpha-GPC has been rarely associated with diarrhea, heartburn, nausea, and vomiting (12102).
Neurologic/CNS
...Orally, alpha-GPC has been rarely associated with dizziness, excitation, headache, and insomnia (12102).
Alpha-GPC use for at least 2 months has also been associated with an elevated risk of stroke when compared with non-users or those who used alpha-GPC for less than 2 months (108883).
Intramuscularly, alpha-GPC has been rarely associated with confusion, excitation, fainting, headache, and insomnia (12102).
General
...Orally, beet seems to be well tolerated when used for medicinal purposes, short term.
Most Common Adverse Effects:
Orally: Red stools and red urine.
Serious Adverse Effects (Rare):
Orally: Hypocalcemia and kidney damage when ingested in large amounts.
Endocrine ...Theoretically, ingestion of large quantities of beets could lead to hypocalcemia because of the oxaluric acid content (18).
Gastrointestinal ...Orally, beet juice may cause red stools (94470,97726,100142,100145,105762). This red coloring of the stools is not harmful. Other less common gastrointestinal side effects include loose stools, constipation, and nausea (100149).
Genitourinary ...Orally, beet is known to produce red or pink urine (beeturia) in some people (32569,34134,94464,94470,97725,97726,100142,100145,100152,105762). However, this red coloring of the urine is not harmful.
Neurologic/CNS ...Orally, vivid dreams and worsening headaches have each occurred in one person in a clinical trial, although it is not clear if this is due to beet (97723).
Renal ...Theoretically, ingestion of large quantities of beets could lead to kidney damage due to its oxaluric acid content (18).
General
...Orally, bilberry fruit, juice, and extracts seem to be well tolerated.
Most Common Adverse Effects:
Orally: Dark-colored stools, flatulence, and gastrointestinal discomfort.
Gastrointestinal
...In one small clinical trial, mild-to-moderate flatulence was reported in 33% of patients taking sieved bilberries and concentrated bilberry juice (91506).
However, the patients in this study had ulcerative colitis, and the study lacked a control group, limiting the validity of this finding. In another small clinical study of males with age-related cognitive impairment, temporary adverse gastrointestinal (GI) effects were reported in 13% of patients drinking a combination of bilberry and grape juice. However, the adverse GI effect rate was identical in patients drinking a placebo juice (110641). A post-marketing surveillance report of 2295 patients using bilberry extract (Tegens) found that 1% of patients complained of GI discomfort and less than 1% experienced nausea or heartburn (35500).
Theoretically, fresh bilberry fruit may have laxative effects. One clinical trial noted an increased frequency of bowel movements following the administration of a combination formulation containing aerial agrimony parts, cinnamon quills, powdered bilberry fruit, and slippery elm bark (35462). It is unclear if these effects were due to bilberry, other ingredients, or the combination.
Other ...Orally, bilberry may cause discoloration of feces and the tongue. In one study, a dark-bluish to black discoloration of both the feces and the tongue was observed following consumption of sieved bilberries and concentrated bilberry juice. In one patient, a slight discoloration of the teeth has also been observed (91506). In another study, 50% of patients reported dark green stools after taking bilberry extract 700 mg twice daily for 4 weeks (104194).
General ...Orally, black currant is generally well-tolerated. Topically, there is a limited amount of information on the adverse effects of black currant.
Gastrointestinal ...Of 2154 patients with hyperlipidemia taking black currant seed oil 1. 8 grams twice daily for 6 weeks, 8 reports of mild diarrhea were considered related to the supplement. These adverse reactions were reported 2-10 days after beginning treatment with black currant seed oil (17638).
General ...Blackberry fruit is commonly consumed as a food without reports of adverse effects. However, a thorough evaluation of safety outcomes for blackberry when used as a medicine has not been conducted.
General
...Orally, blueberry is generally well tolerated.
Most Common Adverse Effects:
Orally: Constipation, diarrhea, nausea, and vomiting with freeze-dried blueberries.
Gastrointestinal ...Orally, freeze-dried blueberries may cause constipation, diarrhea, nausea, and vomiting. In one clinical trial, 26% of patients taking freeze-dried blueberries 50 grams daily dropped out in the first week of the study due to gastrointestinal complaints (107278).
General ...Topically, cabbage leaf seems to be well-tolerated.
Dermatologic ...Some preliminary clinical research shows that application of cabbage leaf wraps to knee joints for at least 2 hours daily for 4 weeks is generally well-tolerated. Of the 27 patients using cabbage leaf wraps in this study, one patient reported an itching and burning sensation during the application. This patient was later found to have shingles, which may explain the adverse event (93671). However, in another case, a patient applying fresh Savoy cabbage leaves on his knee to reduce joint pain reported pain and burning after 4 hours of use. Skin patch and prick tests did not indicate an allergic reaction, and the patient's lesion improved with wet dressings, topical antibiotics, and oral antibiotics (93675).
Immunologic ...Topically, cabbage may cause contact dermatitis (93675). Allergic reactions to cabbage-related vegetables are rare. However, anaphylactic reactions to broccoli and cauliflower have been reported. Because the surface proteins believed to cause allergic reactions to brocolli are also found in cabbage, some patients allergic to brocolli or other vegetables in the Brassicaceae family may also be allergic to cabbage (92516).
Other ...Topical application of cabbage leaves to the breasts has been reported to stain clothes and put off an unpleasant smell (6781,6782).
General ...There is currently a limited amount of information on the adverse effects of camu camu. A thorough evaluation of safety outcomes has not been conducted.
General ...Orally and topically, carnosine is generally well tolerated.
Dermatologic ...Orally, rash and itchiness have been reported with carnosine (93997).
Gastrointestinal ...Orally, decreased appetite, dry mouth, and small weight changes have been reported with carnosine (93997).
Musculoskeletal ...Orally, foot and joint pain have been reported with carnosine (93997).
Neurologic/CNS ...Orally, sporadic hyperactivity has been reported with carnosine. This may be alleviated by decreasing the dose (39926). Other adverse effects reported with oral use include sleepiness, slurred speech, lethargy, and feelings of pins and needles (93997).
Psychiatric ...Orally, vivid dreams have been reported with carnosine (93997).
Pulmonary/Respiratory ...Orally, pneumonia has been reported with carnosine (93997).
General
...Orally, elderberry extracts prepared from ripe fruit seem to be well tolerated.
Most Common Adverse Effects:
Orally: When adverse effects occur, they are likely due to ingestion of raw and unripe elderberries, or seeds, leaves, and other plant parts. Due to cyanogenic glycosides, these may cause nausea, vomiting, severe diarrhea, weakness, dizziness, numbness, and stupor. Cooking eliminates the toxin.
Gastrointestinal
...Orally, nausea and vomiting have been reported after consuming a specific elderberry and echinacea product
Vogel Bioforce AG) (95650). However, it is unclear if this was due to the elderberry or Echinacea contained in the product.
Raw and unripe elderberries, and the seeds, leaves, and other elder tree parts might cause nausea, vomiting, or severe diarrhea due to cyanogenic glycosides (17020,17021). Cooking eliminates the toxin.
Hepatic ...In one case report, a 60-year-old female with underlying autoimmune disease presented with autoimmune hepatitis after taking elderberry at an unknown dose for several years. The patient presented with nausea, jaundice, abdominal pain, and abdominal distention. Liver function tests returned to baseline 4 weeks after initiating treatment with prednisone 40 mg daily and discontinuing elderberry (110123).
Immunologic ...Elder tree pollen might cause an allergic reaction characterized by rhinitis and dyspnea in some patients who are allergic to grass pollen. These patients might also experience an allergic reaction to elderberry extracts (11095).
Neurologic/CNS ...Raw and unripe elderberries might cause weakness, dizziness, numbness, and stupor due to cyanogenic glycosides (17020,17021). Cooking eliminates the toxin.
General
...Orally, the fresh or dried fig fruit is well tolerated in amounts commonly found in foods.
A thorough evaluation of safety outcomes has not been conducted when fig fruit is used orally as medicine.
Topically, fig leaf may cause photodermatitis. There is limited reliable information available about the safety of fig fruit or latex when applied topically.
Serious Adverse Effects (Rare):
Orally: Allergy and, in rare cases, anaphylaxis.
Topically: The fig leaf may cause photodermatitis.
Dermatologic
...Topically, fig leaf might cause photodermatitis.
The leaf contains psoralens (12579,12581). Many cases of photodermatitis from fig leaf have been reported (49962,49968,49973,49975,49981). In at least two cases, the burns were serious enough to require hospitalization. Severe anemia and sepsis developed in one patient (49962). Avoid excessive sunlight or ultraviolet light exposure while using products containing fig leaf.
Orally, fig fruit is unlikely to cause photodermatitis (12581).
Immunologic ...Orally, fig fruit can cause allergy and, in rare cases, anaphylaxis (8815,12580). Topically, exposure to fig fruit and leaves can cause contact dermatitis. In some cases, sun exposure can make contact dermatitis worse (12689,99961).
General
...Orally, folic acid is generally well-tolerated in amounts found in fortified foods, as well as in supplemental doses of less than 1 mg daily.
Most Common Adverse Effects:
Orally: At doses of 5 mg daily - abdominal cramps, diarrhea, and rash. At doses of 15 mg daily - bitter taste, confusion, hyperactivity, impaired judgment, irritability, nausea, sleep disturbances.
Serious Adverse Effects (Rare):
Orally: Cancer (long-term use), cardiovascular complications, liver injury, seizures.
All ROAs: Allergic reactions such as bronchospasm and anaphylactic shock.
Cardiovascular ...There is some concern that high oral doses of folic acid might increase the risk of adverse cardiovascular outcomes. Clinical research shows that taking doses of 800 mcg to 1.2 mg/day might increase the risk of adverse cardiovascular events in patients with cardiovascular disease (12150,13482). High doses of folic acid might promote cell growth by providing large amounts of the biochemical precursors needed for cell replication. Overgrowth of cells in the vascular wall might increase the risk of occlusion (12150). Although some research suggests that use of folic acid might increase the need for coronary revascularization, analysis of multiple studies suggests that taking folic acid up to 5 mg/day for up to 24 months does not appear to affect coronary revascularization risk (90798).
Dermatologic ...Orally, folic acid 1-5 mg daily can cause rash (7225,90375,91319). Folic acid 15 mg daily can sometimes cause allergic skin reactions (15).
Gastrointestinal ...Orally, folic acid 5 mg daily can cause abdominal cramps and diarrhea (7225). Folic acid 15 mg daily can sometimes cause nausea, abdominal distention, flatulence, and bitter taste in the mouth (15). In children aged 6-30 months at risk of malnourishment, taking a nutritional supplement (Nutriset Ltd) enriched in folic acid 75-150 mcg daily, with or without vitamin B 12 0.9-1.8 mcg daily, for 6 months increases the likelihood of having persistent diarrhea (90391).
Hepatic ...Liver dysfunction, with jaundice and very high liver enzymes, occurred in a 30-year-old pregnant patient with severe nausea and vomiting taking a folic acid supplement (Folic acid, Nature Made) 400 mcg daily. Based on the timing of ingestion, the lack of other etiological factors, a positive drug-induced lymphocyte stimulation test, and liver function normalization once the folic acid had been stopped, the authors suggest the folic acid supplement was the cause. However, the authors did not determine which substance in the folic acid supplement was responsible and therefore it cannot be determined that folic acid itself was the cause (91309).
Neurologic/CNS ...Orally, folic acid 15 mg daily can sometimes cause altered sleep patterns, vivid dreaming, irritability, excitability, hyperactivity, confusion, and impaired judgment (15). Large doses of folic acid can also precipitate or exacerbate neuropathy in people deficient in vitamin B12 (6243). Use of folic acid for undiagnosed anemia has masked the symptoms of pernicious anemia, resulting in lack of treatment and eventual neurological damage (15). Patients should be warned not to self-treat suspected anemia. There is also some concern that consuming high amounts of folic acid from the diet and/or supplements might worsen cognitive decline in older people. A large-scale study suggests that people over 65 years of age, who consume large amounts of folic acid (median of 742 mcg/day), have cognitive decline at a rate twice as fast as those consuming smaller amounts (median of 186 mcg/day). It's not known if this is directly attributable to folic acid. It is theorized that it could be due to folic acid masking a vitamin B12 deficiency. Vitamin B12 deficiency is associated with cognitive decline (13068). More evidence is needed to determine the significance of this finding. For now, suggest that most patients aim for the recommended folic acid intake of 400 mcg/day.
Oncologic
...There is some concern that high dose folic acid might increase the risk of cancer, although research is unclear and conflicting.
A large-scale population study suggests that taking a multivitamin more than 7 times per week with a separate folic acid supplement significantly increased the risk of prostate cancer (15607). Clinical research also shows that taking folic acid 1 mg daily increase the absolute risk of prostate cancer by 6.4% over a 10-year period when compared with placebo. However, those with a higher baseline dietary intake of folic acid had a lower rate of prostate cancer, but this was not statistically significant. Also, folate and folic acid intake in patients with prostate cancer is not associated with the risk of prostate cancer recurrence after radical prostatectomy (91317). However, it is possible that discrepancies are due to dietary folate versus folic acid intake. Large analyses of population studies suggest that while dietary folate/folic acid is not associated with prostate cancer, high blood folate/folic acid increases the risk of prostate cancer (50411,91316).
Additional clinical research shows that taking folic acid 800 mcg daily, in combination with vitamin B12 400 mcg, significantly increases the risk of developing cancer, especially lung cancer, and all-cause mortality in patients with cardiovascular disease (17041). However, this may be due to vitamin B12, as other observational research found that higher vitamin B12 levels are linked with an increased risk for lung cancer (102383). Meta-analyses of large supplementation trials of folic acid at levels between 0.5-2.5 mg daily also suggest an increased risk of cancer (50497,110318). Also, in elderly individuals, taking folic acid 400 mcg daily with vitamin B12 500 mcg daily increased the risk of cancer. The risk was highest in individuals over 80 years of age and in females and mainly involved gastrointestinal and colorectal cancers (90393).
Not all researchers suspect that high intake of folic acid supplements might be harmful. Some research suggests that increased dietary intake of folic acid, along with other nutrients, might be protective against cancer (16822). A meta-analysis of multiple clinical trials suggests that folic acid supplementation studies with folic acid levels between 500 mcg to 50 mg/day does not increase the risk of general or site-specific cancer for up to 7 years (91312,91321). Also, a post-hoc subgroup analysis of results from clinical research in adults with a history of recent stroke or ischemic attack suggests that taking folic acid, vitamin B12, and vitamin B6 does not increase cancer risk overall, although it was associated with an increased risk of cancer in patients who also had diabetes (90378).
Psychiatric ...Orally, folic acid 15 mg daily can sometimes cause exacerbation of seizure frequency and psychotic behavior (15).
Pulmonary/Respiratory ...Folic acid use in late pregnancy has been associated with an increased risk of persistent and childhood asthma at 3. 5 years in population research (50380). When taken pre-pregnancy or early in pregnancy, population research has not found an association with increased risk of asthma or allergies in childhood (90799,103979). Folic acid use in pregnancy has been associated with a slightly increased risk of wheeze and lower respiratory tract infections up to 18 months of age in population research (50328).
General
...Orally, the whole fruit, as well as the seed, fruit, and leaf extracts, seem to be well tolerated.
Topically, grape seed extracts seem to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, diarrhea, dry mouth, dyspepsia, headache, joint pain, and nausea.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis to grape skin has been reported.
Dermatologic ...Orally, mild hair thinning has been reported in a patient taking a specific grape leaf extract AS195 KG) (2538). Urticaria (hives) has also been reported with this same extract (53206). Cases of contact dermatitis have been reported in grape workers, including those working in California vineyards (53270,53272,53275).
Gastrointestinal ...Orally, abdominal pain and nausea have been reported with use of grape seed extract, but these effects typically occur at rates similar to placebo (9182,13162). In a case report of a 57-year-old man, intermittent nausea, vomiting, and diarrhea occurred over a 10-day period and improved once grape seed extract was stopped (96764). Gastrointestinal adverse effects have also been reported with use of a different grape seed extract (Entelon, Hanlim Pharm). However, the specific types of gastrointestinal effects were not described (100954). A specific grape leaf extract AS195 (Antistax, Boehringer Ingelheim Pharma GmbH & Co. KG) has reportedly caused flatulence, mild constipation, gastrointestinal discomfort, diarrhea, dyspepsia, dry mouth, and retching (2538,52985,53206). Diarrhea, gastrointestinal distress, indigestion, and aversion to taste have been reported with use of Concord grape juice (52972,53166,53175,53181,53199). Loose stools have been reported in a clinical trial of grape pomace (99270). Bowel obstruction caused by intact grapes and grape seeds has been described in case reports (53241,53284,53278). Excessive consumption of grapes, dried grapes, raisins, or sultanas might cause diarrhea due to laxative effects (4201).
Hematologic ...Orally, one case of leg hematoma following a minor trauma was reported in a person using grape leaf extract (2538). Also, one case of bruising was reported in a person drinking Concord grape juice daily for 2 weeks (52972).
Immunologic ...Orally, there is one report of an anaphylactic reaction to oral grape skin extract, which included urticaria and angioedema (4073).
Musculoskeletal ...Orally, musculoskeletal disorders, including back pain, have been reported with use of a specific grape leaf extract AS195 KG) (2538,53206). Joint pain and lumbago have been reported with use of grape seed extract, but these effects occur at rates similar to placebo (91541).
Neurologic/CNS ...Orally, headache has been reported with use of grape seed extract, but this effect occurs at rates similar to placebo (9182,91541). A specific grape leaf extract AS195 (Antistax, Boehringer Ingelheim Pharma GmbH & Co. KG) has reportedly caused dizziness, tiredness, headache, and sleep problems (2538,53206). As a class, nervous system adverse effects have been reported with use of a specific grape seed extract (Entelon, Hanlim Pharm). However, the specific types of adverse neurologic effects were not described (100954).
Ocular/Otic ...Orally, ocular adverse effects have been reported with use of a specific grape seed extract (Entelon, Hanlim Pharm). However, the specific types of ocular adverse effects were not described (100954).
Pulmonary/Respiratory ...Orally, nasopharyngitis and oropharyngeal pain have been reported with use of a specific grape leaf extract AS195 KG) (53206). Sore throat, cough, allergic rhinitis, and nasopharyngitis have been reported with use of grape seed extract, but these effects occur at rates similar to placebo (9182,91541). One case report describes a 16-year-old female who developed increased levels of immunoglobulin E (IgE) following skin-prick exposure to grape vine pollen, as well as positive test responses following bronchial and conjunctival provocation (53301). Reduced forced vital capacity has been described in California grape workers (53080,53081). Occupational eosinophilic lung was diagnosed in a grape grower with a history of asthma. Respiratory exposure to sulfites in grape was implicated as the cause of the adverse reaction (53285).
Other
...Orally, grape products can cause adverse effects due to contamination with pesticides or mycotoxins.
Some evidence has shown that pesticides used in vineyards may remain on grape surfaces post-harvesting. For example, the fungicide folpet sprayed on grapevines has been shown to remain on the grape surface. Although there was minimal penetration of the epicuticular wax, it showed high resistance to washing (52935). Carbaryl has been identified in over 58% of juice samples collected in Canada. This pesticide reportedly occurred more frequently in grape than in other juices. However, estimates of short-term intake were below proposed acute reference doses (53003).
Ochratoxin A is a mycotoxin that is suspected to be nephrotoxic, teratogenic, hepatotoxic and carcinogenic and has been identified in grape juice, frozen grape pulps, and red and white wine sold in Rio de Janeiro, Brazil. However, the highest levels identified in grape products were lower than the established virtually safe dose of 5 ng/kg of body weight daily (53010,53004). Ochratoxin A has also been identified in red, but not white, grape juice marketed in Switzerland, Canada, and the U.S. (53292,53020).
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, plum seems to be well tolerated.
Most Common Adverse Effects:
Orally: Gastrointestinal effects, including flatulence and diarrhea.
Serious Adverse Effects (Rare):
Orally: Allergic reactions. Consumption of dried plums or plum pits has been reported to cause bowel obstruction and esophageal perforation.
Gastrointestinal
...Orally, plum has been reported to cause gastrointestinal issues (95272,95276,95285), including flatulence (95293) and diarrhea (95300).
In one case report, small bowel obstruction with impaction in the terminal ileum occurred in a 10-month old infant who consumed a dried plum. This was likely due to the infant being unable to properly chew the plum (95296).
Consumption of plum pits has also caused serious gastrointestinal adverse effects. Ileal obstruction occurred in a 71-year-old female who swallowed a plum pit (101250). In a young male, ileostomy obstruction due to plum pits has occurred (95298). Swallowing a plum pit has also caused an esophageal perforation in a 75-year-old male (95285).
Immunologic ...Orally, plum has been reported to cause allergic reaction in sensitive individuals (95286,95297).
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, stevia and steviol glycosides appear to be well tolerated.
Most minor adverse effects seem to resolve after the first week of use.
Most Common Adverse Effects:
Abdominal bloating, dizziness, headache, myalgia, nausea, and numbness.
Serious Adverse Effects (Rare):
Allergic reactions.
Gastrointestinal ...Orally, stevia and steviol glycosides such as stevioside, can cause gastrointestinal adverse effects such as abdominal fullness and nausea. However, these generally resolve after the first week of use (11809,11810).
Immunologic ...Theoretically, stevia might cause allergic reactions in individuals sensitive to plants in the Asteraceae/Compositae family (11811). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.
Musculoskeletal ...Orally, stevia and steviol glycosides may cause myalgia, but this generally resolves after the first week of use (11809,11810).
Neurologic/CNS ...Orally, stevia and steviol glycosides may cause headache, dizziness, and numbness (11809,11810).
General
...Orally, intravenously, and topically, vitamin C is well-tolerated.
Most Common Adverse Effects:
Orally: Abdominal cramps, esophagitis, heartburn, headache, osmotic diarrhea, nausea, vomiting. Kidney stones have been reported in those prone to kidney stones. Adverse effects are more likely to occur at doses above the tolerable upper intake level of 2 grams daily.
Topically: Irritation and tingling.
Serious Adverse Effects (Rare):
Orally: There have been rare case reports of carotid inner wall thickening after large doses of vitamin C.
Intravenously: There have been case reports of hyperoxalosis and oxalate nephropathy following high-dose infusions of vitamin C.
Cardiovascular
...Evidence from population research has found that high doses of supplemental vitamin C might not be safe for some people.
In postmenopausal adults with diabetes, supplemental vitamin C intake in doses greater than 300 mg per day is associated with increased risk of cardiovascular mortality. However, dietary intake of vitamin C is not associated with this risk. Also, vitamin C intake is not associated with an increased risk of cardiovascular mortality in patients without diabetes (12498).
Oral supplementation with vitamin C has also been associated with an increased rate of carotid inner wall thickening in men. There is preliminary evidence that supplemental intake of vitamin C 500 mg daily for 18 months can cause a 2.5-fold increased rate of carotid inner wall thickening in non-smoking men and a 5-fold increased rate in men who smoked. The men in this study were 40-60 years old (1355). This effect was not associated with vitamin C from dietary sources (1355).
There is also some concern that vitamin C may increase the risk of hypertension in some patients. A meta-analysis of clinical research suggests that, in pregnant patients at risk of pre-eclampsia, oral intake of vitamin C along with vitamin E increases the risk of gestational hypertension (83450). Other clinical research shows that oral intake of vitamin C along with grape seed polyphenols can increase both systolic and diastolic blood pressure in hypertensive patients (13162).
Dental ...Orally, vitamin C, particularly chewable tablets, has been associated with dental erosion (83484).
Dermatologic ...Topically, vitamin C might cause tingling or irritation at the site of application (6166). A liquid containing vitamin C 20%, red raspberry leaf cell culture extract 0.0005%, and vitamin E 1% (Antioxidant and Collagen Booster Serum, Max Biocare Pty Ltd.) has been reported to cause mild tingling and skin tightness (102355). It is unclear if these effects are due to vitamin C, the other ingredients, or the combination.
Gastrointestinal ...Orally, the adverse effects of vitamin C are dose-related and include nausea, vomiting, esophagitis, heartburn, abdominal cramps, gastrointestinal obstruction, and diarrhea. Doses greater than the tolerable upper intake level (UL) of 2000 mg per day can increase the risk of adverse effects such as osmotic diarrhea and severe gastrointestinal upset (3042,4844,96707,104450). Mineral forms of vitamin C, such as calcium ascorbate (Ester-C), seem to cause fewer gastrointestinal adverse effects than regular vitamin C (83358). In a case report, high dose intravenous vitamin C was associated with increased thirst (96709).
Genitourinary ...Orally, vitamin C may cause precipitation of urate, oxalate, or cysteine stones or drugs in the urinary tract (10356). Hyperoxaluria, hyperuricosuria, hematuria, and crystalluria have occurred in people taking 1 gram or more per day (3042,90943). Supplemental vitamin C over 250 mg daily has been associated with higher risk for kidney stones in males. There was no clear association found in females, but the analysis might not have been adequately powered to evaluate this outcome (104029). In people with a history of oxalate kidney stones, supplemental vitamin C 1 gram per day appears to increase kidney stone risk by 40% (12653). A case of hematuria, high urine oxalate excretion, and the presence of a ureteral stone has been reported for a 9-year-old male who had taken about 3 grams of vitamin C daily since 3 years of age. The condition resolved with cessation of vitamin C intake (90936).
Hematologic ...Prolonged use of large amounts of vitamin C can result in increased metabolism of vitamin C; subsequent reduction in vitamin C intake may precipitate the development of scurvy (15). In one case, a patient with septic shock and a large intraperitoneal hematoma developed moderate hemolysis and increased methemoglobin 12 hours after a high-dose vitamin C infusion. The patient received a blood transfusion and the hemolysis resolved spontaneously over 48 hours (112479).
Neurologic/CNS ...Orally, the adverse effects of vitamin C are dose-related and include fatigue, headache, insomnia, and sleepiness (3042,4844,83475,83476).
Renal ...Hyperoxalosis and oxalate nephropathy have been reported following high-dose infusions of vitamin C. Hyperoxalosis and acute kidney failure contributed to the death of a 76-year-old patient with metastatic adenocarcinoma of the lung who received 10 courses of intravenous infusions containing vitamins, including vitamin C and other supplements over a period of 1 month. Dosages of vitamin C were not specified but were presumed to be high-dose (106618). In another case, a 34-year-old patient with a history of kidney transplant and cerebral palsy was found unresponsive during outpatient treatment for a respiratory tract infection. The patient was intubated for acute hypoxemic respiratory failure, initiated on vasopressors, hydrocortisone, and antibacterial therapy, and received 16 doses of vitamin C 1.5 grams. Serum creatinine level peaked at greater than 3 times baseline and the patient required hemodialysis for oliguria and uncontrolled acidosis. Kidney biopsy revealed oxalate nephropathy with concomitant drug-induced interstitial nephritis (106625). In another case, a 41-year-old patient with a history of kidney transplant presented with fever, nausea, and decreased urine output 4 days after receiving intravenous vitamin C 7 grams for urothelial carcinoma. Serum creatinine levels increased from 1.7 mg/dL to 7.3 mg/dL over those 4 days, and hemodialysis was initiated 3 days after admission due to anuria. Renal biopsy confirmed the diagnosis of acute oxalate nephropathy (109962).
Other ...Intravenously, hypernatremia and falsely elevated ketone levels is reported in a patient with septic shock and chronic kidney disease after a high-dose vitamin C infusion. The hypernatremia resolved over 24 hours after cessation of the infusion (112479).
General ...Orally, large amounts of wild cherry can lead to cyanide toxicity, which can be fatal (18,41565).
Neurologic/CNS ...Orally, large amounts of wild cherry can lead to cyanide toxicity, which can be fatal (18,41565). A case of accidental poisoning has been reported for a 56-year old women who consumed approximately 300 grams of wild cherries that had been steeped in alcohol the evening before symptom onset. The patient presented to the hospital the following day with symptoms including headache, nausea, vomiting, confusion, and severe dyspnea. Eventually the patient became comatose and hypotonic. After regaining consciousness the following day, the patient continued to experience severe sinus bradycardia, as well as disorientation, hallucinations, delusions, and agitation. After about 3 weeks, the patient began to experience blurred vision and tingling sensation of the lower limbs. The symptoms were eventually attributed to cyanide intoxication; the wild cherries the patient had consumed contained 4.7-15 mg/kg cyanide (41565).
