Black Walnut hull • Cascara Sagrada • fennel • Flax Seed • Papaya • Psyllium • Rhubarb • Senna • Slippery Elm • Wormwood • Red Clover .
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Below is general information about the effectiveness of the known ingredients contained in the product Colodin. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Colodin. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when the fruit (nut) is consumed in amounts normally found in food.
POSSIBLY UNSAFE ...when the bark is used orally or topically, due to its juglone content (2). When applied topically, juglone-containing bark can cause skin irritation. When used orally on a daily basis, the juglone-containing bark of a related species (English walnut) is associated with increased risk of tongue cancer and lip leukoplakia (2,12). There is insufficient reliable information available about the safety of the leaf or hull when used orally as a medicine or when applied topically.
PREGNANCY AND LACTATION: LIKELY SAFE
when the fruit (nut) is consumed in amounts normally found in foods.
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when the bark is used orally or topically (12); avoid using.
There is insufficient reliable information available about the safety of black walnut leaf or hull when used orally in medicinal amounts during pregnancy or lactation; avoid using.
LIKELY SAFE ...when used orally with appropriate fluid intake (93216). Blond psyllium preparations have been safely used in doses up to 20 grams per day for up to 6 months (1376,2324,2327,6261,6262,8060,8061,8066,8423,9422) (10095,13102,22961,22962,22963,22964,22966,54260,22968,22969) (22970,22972,22973,22976,22977,22978,22979,22980,22981,22986) (22987,22988,22989,22990,22992,22993,22994,22995,22996,22998) (23402,23403,23404,23405,92198,106859,112994). The U.S. Food and Drug Administration (FDA) requires over-the-counter medicines that contain dry or incompletely hydrated psyllium to carry a warning that they should be taken with at a least a full glass of liquid to reduce the risk of choking. This labeling also applies to foods containing psyllium that are marketed with a health claim regarding coronary heart disease (93217,93218)..
POSSIBLY SAFE ...when used in eye drops. Blond psyllium mucilage has been used with apparent safety in eye drops four times daily for 6 weeks (105274). There is insufficient reliable information available about the safety of blond psyllium when used topically.
LIKELY UNSAFE ...when used orally without adequate fluid intake due to the risk for choking and gastrointestinal obstruction (93218,112998). ...when granular dosage forms containing blond psyllium are used as over the counter (OTC) laxatives. The U.S. Food and Drug Administration (FDA) states that these granular dosage forms are not generally recognized as safe and effective as OTC laxatives due to an increased risk of choking and gastrointestinal obstruction (93219).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Blond psyllium husk has been used with apparent safety in doses up to 12 grams daily for 4 weeks (110763).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately (272).
POSSIBLY SAFE ...when used orally and appropriately, short-term. Cascara sagrada seems to be safe when used for less than one week (272,25023,40087). Cascara sagrada was formerly approved by the US Food and Drug Administration (FDA) as a safe and effective over-the-counter (OTC) laxative, but this designation was removed in 2002 due to a lack of supporting evidence (8229).
POSSIBLY UNSAFE ...when used orally, long-term. Using cascara sagrada for more than 1-2 weeks can lead to dependence, electrolyte loss, and hypokalemia (272).
CHILDREN: POSSIBLY UNSAFE
when used orally in children.
Cascara sagrada should be used cautiously in children due to the risk of electrolyte loss and hypokalemia (272).
PREGNANCY:
Insufficient reliable information available; avoid using.
LACTATION: POSSIBLY UNSAFE
when used orally.
Cascara sagrada is excreted into breast milk and might cause diarrhea (272).
LIKELY SAFE ...when used orally in amounts commonly found in foods. Fennel has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when fennel essential oil or extract is used orally and appropriately, short-term. Twenty-five drops (about 1.25 mL) of fennel fruit extract standardized to fennel 2% essential oil has been safely used four times daily for 5 days (49422). Also, two 100 mg capsules each containing fennel 30% essential oil standardized to 71-90 mg of anethole has been safely used daily for 8 weeks (97498). Powdered fennel extract has been used with apparent safety at a dose of 800 mg daily for 2 weeks (104199). ...when creams containing fennel 2% to 5% are applied topically (49429,92509).
CHILDREN: POSSIBLY SAFE
when combination products containing fennel are used to treat colic in infants for up to one week.
Studied products include up to 20 mL of a fennel seed oil emulsion; a specific product (ColiMil) containing fennel 164 mg, lemon balm 97 mg, and German chamomile 178 mg; and up to 450 mL of a specific tea (Calma-Bebi, Bonomelli) containing fennel, chamomile, vervain, licorice, and lemon balm (16735,19715,49428).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Observational research has found that regular use of fennel during pregnancy is associated with shortened gestation (100513).
LACTATION: POSSIBLY UNSAFE
when used orally.
Case reports have linked consumption of an herbal tea containing extracts of fennel, licorice, anise, and goat's rue to neurotoxicity in two breast-feeding infants. The adverse effect was attributed to anethole, a constituent of fennel and anise (16744). However, levels of anethole were not measured in breastmilk, and the herbal tea was not tested for contaminants. Furthermore, other adverse effects related to use of fennel during lactation have not been reported. However, until more is known, avoid using.
LIKELY SAFE ...when used orally and appropriately for medicinal purposes, short-term. Flaxseed oil has been used safely in doses up to 2 grams daily for up to 6 months. Higher doses of up to 24 grams daily has been safely used for up to 7 weeks (845,3912,5898,14443,16789,16791,16794,16795,17523,101951,101952,101955).
POSSIBLY SAFE ...when used topically for medicinal purposes, short-term. Flaxseed oil has been used safely on the wrist for up to 4 weeks (25691). ...when used in eye drops twice daily for up to 90 days (101953).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Some evidence suggests that flaxseed oil, providing 200 mg of alpha-linolenic acid, can be safely used in children for up to 3 months (14443).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately for medicinal purposes, short-term.
Although flaxseed oil has been used with apparent safety in clinical research in doses of 1-2 grams daily for up to 6 weeks (96432,101957), some population research has found that consuming flaxseed oil during the second and third trimesters of pregnancy is associated with a four-fold increased risk of premature birth (16797).
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when the ripe fruit is used orally in amounts commonly found in foods. Papaya has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when the leaf extract is used orally and appropriately in medicinal amounts, short term. The leaf extract has been used with apparent safety in doses of up to 3300 mg daily for up to 5 days (102799,102800). ...when the ripe fruit is used topically and appropriately, short term. The fruit has been applied with apparent safety to the gingiva or skin for up to 10 days (93090,93091).
POSSIBLY UNSAFE ...when the unripe fruit containing papaya latex and raw papain is used orally. Raw papain has been reported to cause esophageal perforation (6,93083). ...when papaya latex is used topically. Papaya latex, which contains raw papain, is a severe irritant and vesicant (6).
PREGNANCY: LIKELY SAFE
when the ripe fruit is consumed in amounts commonly found in foods.
PREGNANCY: POSSIBLY UNSAFE
when the unripe fruit containing papaya latex is used orally; avoid using.
There is some concern that crude papain, a constituent of papaya latex, is teratogenic and embryotoxic (6); however, this might be due to extraneous substances rather than papain (11). Some evidence also suggests that high doses of papaya seed extract have abortifacient activity and can adversely affect fetal development (67870). Theoretically, eating large amounts of papaya seeds may have similar effects.
LACTATION: LIKELY SAFE
when the ripe fruit is consumed in amounts commonly found in foods.
There is insufficient reliable information available about the safety of using papaya medicinally; avoid using.
LIKELY SAFE ...when used orally in amounts commonly used in foods. Red clover has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912,10372).
POSSIBLY SAFE ...when used orally and appropriately in supplemental amounts. Red clover extracts containing up to 80 mg isoflavones have been used with apparent safety in clinical studies lasting up to 2 years (3375,6127,8925,11089,11091,17091,19540,19556,91524,102901,102840). ...when used topically and appropriately. Red clover extracts have been used topically with apparent safety for up to 4 weeks (102839).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (4912).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in medicinal amounts.
Red clover has estrogenic activity (19555); avoid using. There is insufficient reliable information available about the safety of the topical use of red clover during pregnancy and lactation.
LIKELY SAFE ...when the stalk is used in amounts commonly found in foods and when the root is used as a food flavoring. Rhubarb has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when the root or rhizome is used orally and appropriately in medicinal amounts for up to 2 years (92294,92295,92297). ...when the stalk is used orally and appropriately in medicinal amounts for up to 4 weeks (71351,71363,97920). ...when used topically and appropriately (10437,97919).
POSSIBLY UNSAFE ...when the leaf is used orally. Rhubarb leaf contains oxalic acid and soluble oxalate, which can cause abdominal pain, burning of the mouth and throat, diarrhea, nausea, vomiting, seizures, and death (17).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used in medicinal amounts, rhubarb root is a stimulant laxative; avoid using (12).
LIKELY SAFE ...when used orally and appropriately, short-term. Senna is an FDA-approved nonprescription drug (8424,15429,15431,15442,40086,40088,74535,74545,74548,74562)(74567,74570,74583,74585,74586,74587,74593,74603,74606,74607)(74609,74613,74615,74624,74636,74639,74644,74650,74653,92711)(92712).
POSSIBLY UNSAFE ...when used orally long-term or in high doses. Long-term, frequent use, or use of high doses has been linked to serious side effects including laxative dependence and liver toxicity (13057,13095).
CHILDREN: LIKELY SAFE
when used orally and appropriately, short-term.
Senna is an FDA-approved nonprescription drug for use in children 2 years and older. (15429,15434,15435).
CHILDREN: POSSIBLY UNSAFE
when used orally long-term or in high doses.
Long-term, frequent use, or use of high doses has been linked to serious side effects including laxative dependence and liver toxicity (13057,13095,105956).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately, short-term (15429,24480).
POSSIBLY UNSAFE...when used orally long-term or in high doses. Long-term, frequent use, or use of high doses has been linked to serious side effects including laxative dependence and liver toxicity (13057,13095).
LACTATION: POSSIBLY SAFE
when used orally and appropriately, short term.
Although small amounts of constituents of senna cross into breast milk, senna has been taken while breast-feeding with apparent safety. Senna does not cause changes in the frequency or consistency of infants' stools. (6026,15429,15436,15437,24482,24484,24485,24486,24487,74545).
POSSIBLY SAFE ...when used orally and appropriately (4,12,272,512,1740).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Slippery elm bark has historically been inserted into the cervix to induce abortion. As a result, slippery elm has been reported in some sources to have abortifacient activity. However, there is no reliable information available about whether slippery elm has abortifacient activity when taken orally.
LIKELY SAFE ...when used orally in the amounts commonly found in foods. Wormwood extracts are included in bitters, vermouth, absinthe, and other food or drink products (12814,15007). Wormwood products that are thujone-free have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912); however, products containing thujone might not be safe. Wormwood is described in the pharmacopoeia of various European countries. After being banned for a period of time, it is now allowed in European Union countries; however, beverages must not contain thujone in concentrations greater than 35 mg/kg (12814,15007,86551).
POSSIBLY SAFE ...when wormwood products not containing thujone are used orally in medicinal amounts, short-term (93468,93469). A specific product
POSSIBLY UNSAFE ...when wormwood products containing thujone are used orally. Thujone is a neurotoxin that is present in wormwood oil (12617). Seizures, rhabdomyolysis, and acute kidney failure can occur when as little as 10 mL of wormwood oil is ingested (662,12817).
PREGNANCY:
LIKELY UNSAFE .
.when used orally in amounts greater than those found in foods (662,12817). Some wormwood products contain thujone, a neurotoxin. Theoretically, thujone also has potential uterine and menstrual stimulant effects (12617). There is insufficient reliable information available about the safety of wormwood when used topically during pregnancy.
LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Colodin. 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, blond psyllium might reduce the effects of carbamazepine and increase the risk for convulsions.
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Theoretically, taking blond psyllium at the same time as digoxin might reduce digoxin absorption.
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Theoretically, taking blond psyllium at the same time as ethinyl estradiol might alter levels of estradiol.
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Concurrent use of blond psyllium with ethinyl estradiol results in a slight increase in the extent of ethinyl estradiol absorption and a slower rate of absorption. However, this is unlikely to be clinically significant (12421).
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Theoretically, taking blond psyllium at the same time as lithium might reduce lithium absorption.
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Theoretically, blond psyllium might increase the therapeutic and adverse effects of metformin.
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Concurrent use of blond psyllium with metformin slows and increases metformin absorption (99433). To avoid changes in absorption, take psyllium 30-60 minutes after metformin.
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Theoretically, taking blond psyllium at the same time as olanzapine might reduce olanzapine absorption.
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The fiber in blond psyllium might decrease the absorption of olanzapine. A single case report describes a reduction in the effectiveness of olanzapine when it was taken concomitantly with an unspecified type of psyllium 3 grams orally twice daily. This effect was reversed when psyllium was stopped (106858).
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Theoretically, psyllium might increase, decrease, or have no effect on the absorption of oral drugs.
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Psyllium seems to have variable effects on drug absorption. To avoid changes in absorption, take psyllium 30-60 minutes after oral medications. Animal research shows that blond psyllium delays and increases the absorption of metformin and ethinyl estradiol (12421,99433). Conversely, case reports and animal research suggest that blond psyllium might reduce absorption of lithium, digoxin, olanzapine, and carbamazepine (12,18,272,93214,106858). Finally, some pharmacokinetic studies show that psyllium does not affect the absorption of levothyroxine or warfarin (12420,103940).
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Theoretically, cascara sagrada might increase the risk of hypokalemia when taken with corticosteroids.
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Theoretically, cascara sagrada might decrease the effects of CYP3A4 substrates.
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In vitro research suggests that cascara sagrada can induce CYP3A4 enzymes, albeit to a much lower degree than rifampin, a known CYP3A4 inducer (110704).
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Theoretically, cascara sagrada might cause hypokalemia, potentially increasing the risk of digoxin toxicity.
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Theoretically, cascara sagrada might increase the risk of hypokalemia when taken with diuretic drugs.
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Theoretically, cascara sagrada might have additive adverse effects when taken with stimulant laxatives.
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Cascara sagrada has stimulant laxative effects and might compound fluid and electrolyte losses when taken with stimulant laxatives (19).
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Theoretically, cascara sagrada might increase the risk of bleeding when taken with warfarin.
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Cascara sagrada has stimulant laxative effects (19). In some people, cascara sagrada can cause diarrhea. Diarrhea can increase the effects of warfarin, increase international normalized ratio (INR), and increase the risk of bleeding.
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Theoretically, fennel might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.
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Theoretically, fennel might decrease the levels and clinical effects of ciprofloxacin.
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Animal research shows that fennel reduces ciprofloxacin bioavailability by nearly 50%, possibly due to the metal cations such as calcium, iron, and magnesium contained in fennel. This study also found that fennel increased tissue distribution and slowed elimination of ciprofloxacin (6135). |
Theoretically, taking large amounts of fennel might decrease the effects of contraceptive drugs due to competition for estrogen receptors.
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Theoretically, fennel might increase levels of drugs metabolized by CYP3A4.
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Theoretically, taking large amounts of fennel might interfere with hormone replacement therapy due to competition for estrogen receptors.
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Theoretically, taking large amounts of fennel might decrease the antiestrogenic effect of tamoxifen.
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Some constituents of fennel have estrogenic activity (11), which may interfere with the antiestrogenic activity of tamoxifen. |
Theoretically, using flaxseed oil in combination with anticoagulant or antiplatelet drugs might have additive effects and increase the risk of bleeding.
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Theoretically, combining flaxseed oil with other antihypertensive drugs might have additive effects and increase the risk of hypotension.
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Concomitant use of flaxseed oil and ezetimibe reduces the absorption of alpha-linolenic acid from flaxseed oil.
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In one clinical study, concomitant consumption of ezetimibe 10 mg daily with flaxseed oil 2 grams providing 1 gram of alpha-linolenic acid daily blocked the absorption of alpha-linolenic acid, resulting in an overall reduction in alpha-linolenic plasma levels from baseline (96433).
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Theoretically, papaya extract may increase the levels and clinical effects of amiodarone.
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Animal research in rats shows that a single oral dose of papaya extract, as well as multiple doses of papaya extract daily over 14 days, prior to a single dose of amiodarone delays the time to maximum amiodarone concentration. However, only the 14-day papaya extract regimen increases systemic amiodarone exposure by 60% to 70% (93093). This interaction has not been reported in humans.
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Concomitant use of antidiabetic drugs with fermented papaya can produce additive effects. It is unclear if other forms of papaya have the same effect.
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A small low-quality clinical study in patients with type 2 diabetes who are taking glibenclamide shows that taking a fermented papaya preparation 3 grams daily for 2 months decreases fasting and postprandial blood glucose levels when compared to baseline. Additionally, of the 25 patients in the study, 9 required a reduction in glibenclamide dose (67902).
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Theoretically, consuming large quantities of papaya fruit can reduce the clinical effects of levothyroxine.
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In one case-report, a 37-year-old male with a history of thyroidectomy who was stabilized on levothyroxine for 5 years presented with hypothyroidism after consuming 5-6 papaya fruits daily for 14 days during vacation. In a controlled re-challenge test involving 5-6 papayas daily, the patient remained euthyroid for 7 days, but developed mild hypothyroidism after 14 days. Both times, thyroid levels normalized 40-45 days after discontinuing papaya (93087).
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Theoretically, concomitant use of warfarin with papain-containing papaya extract might increase the effects and side effects of warfarin.
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In one case report, a patient previously stable on warfarin was found to have an international normalization ratio (INR) of 7.4, which was attributed to ingestion of a supplement containing papain from papaya extract (613).
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Although some laboratory research suggests that red clover may have anticoagulant and antiplatelet activity, clinical research has not shown this effect.
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In vitro research suggests that genistein in red clover has antiplatelet effects, and historically, red clover was thought to have anticoagulant effects due to its coumarin content. However, some experts state that this is unlikely as most natural coumarins have not been shown to have anticoagulant effects, and their content in red clover is low (17091,19557,19558,19559). Additionally, some clinical research in postmenopausal patients found no effect on coagulation or prothrombin time with the use of red clover flowering tops 378 mg daily for 12 months or red clover isoflavone (Rimostil) 50 mg daily for 2 years (17091,91524).
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Theoretically, soy might reduce the clearance of caffeine; however, a small clinical study found no effect.
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Red clover contains genistein. Taking genistein 1 gram daily for 14 days seems to inhibit caffeine clearance and metabolism in healthy females (23582). However, this effect does not seem to occur with the lower amounts of genistein found in red clover. A clinical study in healthy postmenopausal individuals shows that taking red clover capsules standardized to contain 60 mg isoflavones twice daily for 14 days does not affect the pharmacokinetics of caffeine (105693).
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Theoretically, red clover might increase levels of drugs metabolized by CYP1A2; however, a small clinical study found no effect.
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In vitro evidence shows that red clover inhibits CYP1A2 (12479). However, a clinical study in healthy postmenopausal individuals shows that taking red clover capsules standardized to contain 60 mg isoflavones twice daily for 14 days does not affect the pharmacokinetics of caffeine, a CYP1A2 probe substrate (105693).
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Theoretically, red clover might increase the levels and clinical effects of drugs metabolized by CYP2C19.
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In vitro evidence suggests that red clover weakly inhibits CYP2C19 (12479). This interaction has not been reported in humans.
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Theoretically, red clover might increase levels of drugs metabolized by CYP2C9; however, a small clinical study found no effect.
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In vitro evidence suggests that red clover might inhibit CYP2C9 (12479). However, a clinical study in healthy postmenopausal individuals shows that taking red clover capsules standardized to contain 60 mg isoflavones twice daily for 14 days does not affect the pharmacokinetics of tolbutamide, a CYP2C9 probe substrate (105693).
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Theoretically, red clover might increase levels of drugs metabolized by CYP3A4; however, a small clinical study found no effect.
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In vitro evidence shows that red clover might inhibit CYP3A4 isoenzymes (6450,12479). However, a clinical study in healthy postmenopausal individuals shows that taking red clover capsules standardized to contain 60 mg isoflavones twice daily for 14 days does not affect the pharmacokinetics of alprazolam, a CYP3A4 probe substrate (105693).
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Theoretically, concomitant use of large amounts of red clover might interfere with estrogen therapy.
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Theoretically, red clover might increase the risk of methotrexate toxicity.
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In a case report, a 52-year-old female receiving weekly methotrexate injections for psoriasis developed symptoms of methotrexate toxicity, including severe vomiting and epigastric pain, after three days of taking red clover 430 mg daily. Toxicity resolved after red clover was discontinued. However, no liver function tests or methotrexate levels were reported (91522).
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Theoretically, the phytoestrogens in red clover might interfere with tamoxifen.
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In vitro and animal research suggests that genistein, a constituent of red clover, might antagonize the antitumor effects of tamoxifen (8192). However, there is some evidence from an animal study that red clover does not reduce the efficacy of tamoxifen (102901). Until more is known, tell patients taking tamoxifen to avoid red clover.
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Theoretically, frequent and high doses of rhubarb might increase the risk of hypokalemia when taken with corticosteroids.
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Theoretically, taking rhubarb with cyclosporine might reduce cyclosporine levels.
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Animal research shows that co-administration of rhubarb decoction 0.25 or 1 gram/kg with cyclosporine 2.5 mg/kg, decreases cyclosporine maximum plasma concentration and overall exposure levels when compared with taking cyclosporine alone. The authors theorize that rhubarb might reduce cyclosporine bioavailability by inducing of P-glycoprotein and/or cytochrome P450 3A4 (92304). However, since rhubarb was administered as a single oral dose and enzyme induction usually occurs after multiple doses, it is possible that cyclosporine absorption was actually reduced via rhubarb's stimulant laxative effects (12). Also, the composition of the rhubarb decoction was not described.
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Theoretically, overuse of rhubarb might increase the risk of adverse effects when taken with digoxin.
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Theoretically, frequent and high doses of rhubarb might increase the risk of hypokalemia.
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Theoretically, concomitant use of rhubarb with potentially hepatotoxic drugs might increase the risk of developing liver damage.
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Theoretically, long-term use of anthraquinones from rhubarb might increase the risk of nephrotoxicity when used with nephrotoxic drugs.
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The anthraquinone constituents of rhubarb have been shown to induce nephrotoxicity in animal research (71322). Additionally, in a case report, a 23-year old female presented with kidney failure after taking 6 tablets of a proprietary slimming agent (found to contain the anthraquinones emodin and aloe-emodin from rhubarb) daily for 6 weeks and then adding diclofenac 25 mg 4 times daily for 2 days. The authors postulate that the anthraquinone constituents of rhubarb contributed to the renal dysfunction, and the addition of diclofenac, a nephrotoxic drug, led to renal failure (15257). Until more is known, advise patients to avoid taking rhubarb if they are taking other potentially nephrotoxic drugs.
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Theoretically, rhubarb might increase the risk for fluid and electrolyte loss when taken with other stimulant laxatives.
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Theoretically, excessive use of rhubarb might increase the risk of bleeding when taken with warfarin.
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Theoretically, senna might increase the risk of adverse effects when taken with digoxin.
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Overuse/abuse of senna increases the risk of adverse effects from cardiac glycosides, such as digoxin, due to potassium depletion (15425).
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Theoretically, senna might increase the risk of hypokalemia when taken with diuretic drugs.
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Overuse of senna might compound diuretic-induced potassium loss and increase the risk for hypokalemia (15425).
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Theoretically, taking senna may interfere with the absorption of exogenous estrogens.
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Theoretically, senna might increase the risk for fluid and electrolyte loss when taken with other stimulant laxatives.
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Theoretically, excessive use of senna might increase the effects of warfarin.
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Senna has stimulant laxative effects and can cause diarrhea. Diarrhea can increase the effects of warfarin, increase international normalized ratio (INR), and increase the risk of bleeding. In one case report, excessive use of senna for 3 weeks resulted in diarrhea, bloody stools, and an elevated INR of 11.9 (16530).
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Theoretically, slippery elm may slow the absorption and reduce serum levels of oral drugs.
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Slippery elm inner bark contains mucilage, which may interfere with the absorption of orally administered drugs (19).
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Theoretically, taking wormwood might interfere with the effects of anticonvulsant drugs.
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Thujone, a constituent of wormwood, has convulsant effects (12816).
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Below is general information about the adverse effects of the known ingredients contained in the product Colodin. 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, black walnut fruit (nut) is well tolerated.
However, the leaf, bark, and hull of black walnut contain high quantities of tannins, which may cause adverse effects when used orally or topically.
Most Common Adverse Effects:
Orally: The leaf, bark, and hull can cause gastrointestinal upset.
Topically: Hull preparations may cause a temporary yellow or brown discoloration at the site of application. The leaf, bark, and hull can cause skin irritation.
Serious Adverse Effects (Rare):
Orally: The bark may increase the risk for tongue cancer or lip leukoplakia when used long-term.
All routes of administration: Allergic reactions, including anaphylaxis.
Dermatologic ...Topically, black walnut leaf, bark, or hull may have an irritating effect on the skin due to tannin content. Black walnut hull preparations might cause a temporary yellow or brown discoloration of the skin at the site of application (12).
Gastrointestinal ...Orally, black walnut leaf, bark, or hull may cause gastrointestinal upset due to tannin content (12). Also, daily use of the juglone-containing bark of a related species (English walnut) is associated with increased risk of tongue cancer and lip leukoplakia (2,12).
Hepatic ...Orally, black walnut leaf, bark, or hull may cause liver damage if taken for extended periods of time due to tannin content (12).
Immunologic ...Tree nuts, which include black walnuts, can cause allergic reactions in sensitive individuals. Due to the prevalence of this allergy in the general population, tree nuts are classified as a major food allergen in the United States (105410).
Renal ...Orally, black walnut leaf, bark, or hull may cause kidney damage if taken for extended periods of time due to tannin content (12).
General
...Orally, blond psyllium is generally well tolerated.
When used as eye drops, blond psyllium seems to be well tolerated.
Most Common Adverse Effects:
Oral: Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, and nausea.
Serious Adverse Effects (Rare):
Oral: Bowel obstruction, esophageal obstruction.
Gastrointestinal ...Orally, blond psyllium can cause transient flatulence, abdominal pain, diarrhea, constipation, dyspepsia, and nausea (1376). Starting with a low dose and slowly titrating to the desired dose can often minimize gastrointestinal side effects. There is some concern that blond psyllium can cause esophageal or bowel obstruction when consumed without adequate water or in patients with swallowing disorders (604,8080,8081,110760,112998). Orally, blond psyllium seed husk powder has been linked to an esophageal obstruction from a bezoar in a 76-year-old male patient with Parkinson's disease and probable dysphagia (110760). Symptoms occurred within hours of taking the psyllium and were resolved when the bezoar was removed. Additionally, blond psyllium-containing foods were linked to an intestinal obstruction in a 26-year-old male who had been consuming them for weight loss (112998). Drainage with an ileus tube successfully removed an obstruction with a thick, gel-like consistency. Tell patients to consume plenty of water when taking blond psyllium. Suggest at least 240 mL of fluid for every 3.5-5 grams of seed husk or 7 grams of seed (1376,8080,8081).
Immunologic
...Some patients can have an allergic response to blond psyllium.
Allergy symptoms include allergic rhinitis, sneezing, conjunctivitis, urticarial rash, itching, flushing, and dyspnea. More serious symptoms include wheezing, facial and body swelling, chest congestion, chest and throat tightness, cough, diarrhea, hypotension, loss of consciousness, and anaphylactic shock. Occupational exposure or repeated ingestion of psyllium can cause sensitization, which can lead to serious allergic reactions (2328,2329,2330,8079,9246,92193). Severe allergic reactions may occur after eating a small quantity of cereal that contains blond psyllium. At least one cereal (Heartwise, Kellogg Co.) has increased the purity of the psyllium it contains, which has decreased the incidence of allergic reactions (9244). A warning of the potential for allergic reactions is on the label of all cereals that contain psyllium (9247). Patients hypersensitive to psyllium usually have marked eosinophilia and an elevated psyllium-specific IgE antibody serum level (2328,2329,92193).
There is concern that individuals allergic to pollen from English plantain weed (Plantain lanceolate) might also react to psyllium husk dust; however, it appears that there is little cross-allergenicity between these plants and is probably mild and of no clinical significance (8057,9244,92193).
Musculoskeletal ...Orally, backache has been reported with the use of psyllium (1376).
Neurologic/CNS ...Orally, headache has been reported with the use of psyllium (1376).
Ocular/Otic ...Ophthalmically, blurred vision or burning haven been reported rarely in patients using eye drops containing blond psyllium mucilage (105274).
Pulmonary/Respiratory ...Orally, rhinitis, increased cough, and sinusitis have been reported with the use of psyllium (1376).
Other ...Blond psyllium has a tendency to plug feeding tubes. This can be avoided if blond psyllium is mixed with water and pushed through the feeding tube in less than 5 minutes (8423).
General
...Orally, cascara sagrada seem to be well tolerated when used appropriately, short-term.
Most Common Adverse Effects:
Orally: Mild abdominal discomfort and cramps.
Serious Adverse Effects (Rare):
Orally: Hepatotoxicity. Fresh or improperly aged cascara sagrada bark can cause severe vomiting.
Endocrine ...Orally, long-term use of cascara sagrada can lead to potassium depletion (4).
Gastrointestinal
...Orally, cascara sagrada can commonly cause mild abdominal discomfort, colic, and cramps (4).
In some cases, chronic use can cause pseudomelanosis coli. Pseudomelanosis coli (pigment spots in intestinal mucosa) is believed to be harmless, usually reverses with discontinuation, and is not directly associated with an increased risk of developing colorectal adenoma or carcinoma (6138).
Fresh or improperly aged cascara sagrada bark can cause severe vomiting due to the presence of free anthrone constituents (2,92307).
Genitourinary ...Orally, long-term use of cascara sagrada can lead to albuminuria and hematuria (4).
Hepatic ...There is some concern about potential liver problems with cascara sagrada. In some cases, cascara sagrada bark 750-1275 mg (containing approximately 21 mg cascaroside) daily in divided doses for three days resulted in cholestatic hepatitis, ascites, and portal hypertension. Symptoms resolved following discontinuation of cascara sagrada (6895,92306).
Musculoskeletal ...Orally, long-term use of cascara sagrada can lead to muscle weakness and finger clubbing (4).
Other ...Orally, long-term use of cascara sagrada can lead to cachexia (4).
General
...Orally and topically, fennel seems to be well tolerated.
Most Common Adverse Effects:
Orally: Gastrointestinal discomfort, photosensitivity, and allergic reactions in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Seizures.
Dermatologic ...Advise patients to avoid excessive sunlight or ultraviolet light exposure while using fennel (19). Allergic reactions affecting the skin such as atopic dermatitis and photosensitivity may occur in patients who consume fennel (6178,49507).
Gastrointestinal ...Orally, fennel may cause gastrointestinal complaints, including nausea and vomiting (19146,104196).
Hematologic ...Methemoglobinemia has been reported in four infants following intoxication related to ingestion of a homemade fennel puree that may have been made from improperly stored fennel (49444).
Immunologic ...A case report describes an 11-year-old male who developed an allergy to fennel-containing toothpaste. Immediately after using the toothpaste, the patient experienced sneezing, coughing, itchy mouth, rhinorrhea, nasal congestion, wheezing, difficulty breathing, and palpitations, which resolved within 10 minutes of spitting out the toothpaste and rinsing the mouth. In challenge tests, the patient reacted to chewing fresh fennel root, but not ground fennel seeds (103822).
Neurologic/CNS ...Orally, fennel oil has been associated with tonic clonic and generalized seizures (12868). New-onset cluster headaches are reported in a 24-year-old female while using a toothpaste containing fennel and camphor for 3 months. The headaches resolved upon stopping the toothpaste (112368). It is unclear if this adverse effect can be attributed to fennel, camphor, or the combination.
Pulmonary/Respiratory ...Orally, fennel and fennel seed have been reported to cause bronchial asthma (49478).
General
...Orally, flaxseed oil is generally well tolerated.
Topically, flaxseed oil seems to be well-tolerated.
Most Common Adverse Effects:
Topically: Itching, redness.
Serious Adverse Effects (Rare):
Orally: Severe allergic reactions such as anaphylaxis.
Endocrine ...Orally, flaxseed oil might cause gynecomastia. In a case report, a 70-year-old male developed gynecomastia after taking flaxseed oil daily for 3 months. Discontinuing flaxseed oil lead to resolution of gynecomastia (105478).
Gastrointestinal ...Orally, flaxseed oil may cause a change in bowel habits, dry mouth, and dyspepsia when taken at a dose of about 5 grams daily. However, these effects have been reported by only a small number of patients (approximately 3%) (16794). High doses of flaxseed oil (30 grams per day and higher) have been associated with loose stools and diarrhea (5898,11025).
Immunologic ...Severe allergic reactions such as anaphylaxis have been reported with flaxseed oil ingestion and also in workers processing flaxseed products (6809).
Ocular/Otic ...Topically, eye drops containing flaxseed oil may cause redness and itching (101953).
Oncologic ...Flaxseed oil has not been linked to increased prostate cancer risk. Although epidemiologic research has found that high dietary intake of alpha-linolenic acid (ALA) is associated with increased prostate cancer risk (1337,2558,7147,7823,12978), this risk does not seem to apply to ALA from plant sources, like flaxseed (12909).
General
...Orally, papaya fruit is well tolerated when consumed in food amounts.
Papaya leaf extract seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Nausea and vomiting from papaya leaf extract.
Topically: Burning sensation from unripe papaya.
Serious Adverse Effects (Rare):
Orally: Severe allergic reactions.
Dermatologic
...Orally, high doses of papaya might cause yellow skin discoloration.
A case of carotenemia has been reported for a 42-year-old female who consumed 1.5-2 papayas daily for 6 months. The condition resolved when she stopped eating papayas (67929).
Topically, unripe papaya fruit may cause occasional burning sensation when applied to skin ulcers (67856).
Gastrointestinal ...Orally, the leaf extract has been reported to cause nausea and vomiting in clinical research (102799). A case of esophageal perforation has been reported for a previously healthy 27-year-old female who used papain, a constituent of papaya latex, to digest a piece of meat stuck in her esophagus (93083).
Immunologic ...Orally, papain, a constituent of raw, unripe papaya, has been reported to cause allergic reactions in sensitive individuals, including itchy watery eyes, runny nose, sneezing, abdominal cramps, sweating, and diarrhea (6,967). Papaya may also cause hypersensitivity reactions such as systemic contact dermatitis, which occur more commonly in people who are allergic to latex (6197,7853,57635). A case of systemic contact dermatitis has been reported for a 55-year-old female with no prior history of atopic disease or drug allergy after ingesting a throat lozenge containing papaya juice (67942).
Other ...In regions with arsenic-contaminated soil, papaya fruits contain a higher mean concentration of arsenic compared with many other forms of vegetation grown in the regions. Eating papaya from these regions is thought to contribute to higher dietary levels of arsenic (32461,67879).
General
...Orally and topically, red clover seems to be well tolerated.
Most Common Adverse Effects:
Orally: Myalgia, nausea, and vaginal spotting.
Dermatologic ...Orally, a specific red clover isoflavone product (Promensil) has been associated with mild cases of psoriasis and thrush, although a direct causal link has not been established (9552).
Gastrointestinal ...Orally, red clover has been reported to cause nausea (8194).
Genitourinary ...In human research, 80 mg, but not 40 mg, of a specific red clover isoflavone product (Promensil) increased the duration of menstrual cycles in patients with mastalgia (9552). Red clover has also been reported to cause vaginal spotting (8194).
Hematologic ...In one case report, a 53-year-old female had a spontaneous subarachnoid hemorrhage associated with the use of an herbal supplement containing red clover, dong quai, and eleuthero. It is not clear if this was due to red clover, another ingredient, the combination of ingredients, or other factors (70419). In another case report, a 55-year-old female with protein S deficiency and systemic lupus erythematosus (SLE) had temporary vision loss in the left eye from hemiretinal vein thrombosis 3 days after taking a combination phytoestrogen product containing red clover 250 mg, wild yam 276 mg, dong quai 100 mg, and black cohosh 250 mg (13155). It is unclear if red clover contributed to this event.
Musculoskeletal ...Orally, red clover has been reported to cause myalgia (8194).
Neurologic/CNS ...Orally, a specific red clover isoflavone product (Medoflavon) has been associated with headache, although with a similar frequency to placebo (19545).
Oncologic ...Due to potential estrogenic effects of red clover isoflavones, there has been some concern that red clover might increase the risk of estrogen-sensitive cancers such as breast cancer or uterine cancer. A meta-analysis of 8 clinical trials suggests that increased intake of red clover- and soy-derived isoflavones may modestly increase mammographic breast density in premenopausal, but not postmenopausal, adults when compared with placebo. However, in a sub-group analysis assessing only isolated red clover isoflavones, there was no change in breast density (70428). Furthermore, a 2015 review by the European Food Safety Authority (EFSA) reported no increase in risk of breast cancer in females taking isoflavone-containing supplements (91725). Similarly, no effect was found on endometrial thickness and histopathological changes in the uterus after up to 36 months of supplementation with 40-120 mg daily of isoflavones from red clover extract (91725).
General
...Orally, rhubarb root and stalk are well tolerated when used in food amounts and seem to be well tolerated when used in medicinal amounts.
Rhubarb leaf contains oxalic acid and can be toxic. Topically, rhubarb seems to be well tolerated.
Most Common Adverse Effects:
Orally: Cramps, diarrhea, gastrointestinal discomfort, nausea, vomiting.
Topically: Rash.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis.
Cardiovascular ...Orally, chronic use or abuse of rhubarb can cause arrhythmias (12).
Dermatologic ...Orally, rhubarb taken alone or in combination with other ingredients has been reported to cause rash (71315,71342). Topically, short term application of a specific product (Pyralvex) containing rhubarb, salicylic acid, and ethanol to the gums has been reported to cause slight burning and dark discoloration of the gums in approximately 1% of patients (71369). It is unclear if this effect is due to rhubarb, other ingredients, or the combination.
Endocrine ...Orally, chronic use or abuse of rhubarb can cause electrolyte loss (especially potassium), hyperaldosteronism, albuminuria, and edema (12).
Gastrointestinal
...Orally, rhubarb can cause cramp-like or spasmodic gastrointestinal discomfort, watery diarrhea, and uterine contractions (18).
Rhubarb, alone or in combination with other ingredients, has also been reported to cause bloating, nausea, diarrhea, vomiting, and stomach upset or pain in clinical studies. Diarrhea is more common with a starting dose of at least 3 grams of extract (71315,71329,71339,71340,71341,71342,71373,92300). Chronic use or abuse of rhubarb can cause inhibition of gastric motility and pseudomelanosis coli (pigment spots in the intestinal mucosa) (12,6138).
Although some research suggests that rhubarb and other anthranoid laxatives might increase the risk of colorectal cancer due to pseudomelanosis coli (30743), more recent research suggests that this condition is harmless, typically reversed with rhubarb discontinuation, and not associated with an increased risk for colorectal adenoma or carcinoma (6138).
Hematologic ...Orally, chronic use or abuse of rhubarb can cause hematuria (12).
Hepatic ...Orally, chronic use of anthraquinone-containing products, such as rhubarb, has been associated with hepatotoxicity (15257). Use of rhubarb specifically has been linked to at least 24 reports of liver injury, although details on the dose of rhubarb and duration of use in these cases are not clear (100963). In one clinical study, rhubarb, taken in combination with other ingredients, has been reported to cause mild to moderate elevations of serum alanine aminotransferase (71315).
Immunologic ...Orally, rhubarb has rarely been reported to cause anaphylaxis (18).
Musculoskeletal ...Orally, chronic use or abuse of rhubarb can cause accelerated bone deterioration and muscular weakness (12).
Renal ...Orally, chronic use or abuse of rhubarb can cause electrolyte loss (especially potassium), albuminuria, hematuria, dehydration, and nephropathies (12). There is one case report of renal failure in a patient who took a product containing rhubarb for six weeks. The patient presented with renal failure two days after starting diclofenac, which is known to have nephrotoxic effects. It is hypothesized that the combination of diclofenac with the anthraquinone constituents of rhubarb precipitated renal dysfunction (15257).
General
...Orally, senna is generally well-tolerated when used short-term in appropriate doses.
Most Common Adverse Effects:
Orally: Abdominal pain and discomfort, cramps, diarrhea, flatulence, nausea, fecal urgency, and urine discoloration.
Serious Adverse Effects (Rare):
Orally: Skin eruptions.
Cardiovascular ...Excessive use can cause potassium depletion and other electrolyte abnormalities (15425). In theory, this could cause potentially dangerous changes in heart rhythm. A small decrease in heart rate was seen in one clinical study (74587).
Dermatologic ...In adults, there are rare case reports of skin eruptions associated with senna, including erythema multiforme, fixed drug eruption, lichenoid reaction, toxic epidermal necrolysis, urticaria, photosensitivity, and contact dermatitis (96558). Infants and young children given senna products have experienced contact reactions on the buttocks due to prolonged exposure to stool while wearing a diaper overnight. These reactions range from erythema with small blisters, to large fluid-filled blisters with skin sloughing, as occurs with second degree burns (96559). In a case series of children treated with senna for chronic constipation, burn-like reactions occurred in 2.2%, typically with higher doses (mean 60 mg/day, range 35.2 to 150 mg/day) (96558,96559). These reactions can be avoided by giving senna early in the day, so that bowel movements occur at a time when diapers can be changed quickly (96559).
Gastrointestinal ...Orally, senna can cause abdominal pain and discomfort, cramps, bloating, flatulence, nausea, fecal urgency, and diarrhea (15427,15434,15435,15436,15439,15440,15441,105955). Chronic use has also been associated with "cathartic colon," radiographically diagnosed anatomical changes to the colon such as benign narrowing, colonic dilation, and loss of colonic folds (15428). The clinical relevance of these findings is unclear. Chronic use can also cause pseudomelanosis coli (pigment spots in intestinal mucosa) which is harmless, usually reverses with discontinuation, and is not associated with an increased risk of developing colorectal adenoma or carcinoma (6138). The cathartic properties of senna leaf are greater than the fruit (15430). Thus, the American Herbal Products Association only warns against long-term use of senna leaf (12).
Hepatic ...Chronic liver damage, portal vein thrombosis, and hepatitis have been reported following oral use of senna alkaloids, such as in tea made from senna leaves (13057,13095,41431,74560,74564,74584,105956). There is a case report of hepatitis in a female who consumed moderate amounts of senna tea. The patient was a poor metabolizer of cytochrome P450 2D6 (CYP2D6). It's thought that moderate doses of senna in this patient led to toxic hepatitis due to the patient's reduced ability to metabolize and eliminate the rhein anthrone metabolites of senna, which are thought to cause systemic toxicity (13057). There is also a case of liver failure, encephalopathy, and renal insufficiency in a female who consumed 1 liter/day of senna tea, prepared from 70 grams of dried senna fruit, over 3 years (13095). In another case report, a 3-year-old female presented with hepatitis that led to pancytopenia after drinking tea made from 2-3 grams dry senna leaves three times or more weekly for over one year (105956).
Immunologic ...In one case report, a 19-year-old male developed anaphylaxis with dyspnea, facial edema, and hives. This reaction was determined to be caused by the senna content in a specific combination product (Delgaxan Plus, Pompadour Ibérica) that the patient ingested (105957).
Musculoskeletal ...Hypertrophic osteoarthropathy, finger clubbing, cachexia, and tetany have been reported from excessive oral senna use in humans (15426,74580,74582,74620,74625).
Renal ...Nephrocalcinosis has been reported as a result of oral senna overuse (74582).
General ...Orally, slippery elm seems to be well tolerated. A thorough evaluation of safety outcomes with topical use of slippery elm has not been conducted.
Dermatologic ...Topically, slippery elm extracts can cause contact dermatitis. The pollen is an allergen (6). Contact dermatitis and urticaria have been reported after exposure to slippery elm or an oleoresin contained in the slippery elm bark (75131).
General
...Wormwood contains thujone, a neurotoxin.
When products containing thujone are used orally in medicinal amounts, wormwood may be unsafe.
Most Common Adverse Effects:
Orally: The oil from wormwood leaves can cause diffuse muscle aches, nausea, and vomiting.
Serious Adverse Effects (Rare):
Orally: The oil from wormwood leaves can cause acute kidney toxicity, rhabdomyolysis, and seizures.
Dermatologic ...Topically, a single case report describes a sensitivity or first degree chemical burn reaction, with facial pain and erythema, after a 50-year-old adult applied a homemade poultice containing wormwood to the face for an unreported length of time (93466).
Gastrointestinal ...Orally, the oil from wormwood leaves can cause nausea and vomiting (662). Use of a home-prepared wormwood extract has been associated with vomiting and severe diarrhea in an infant (93467).
Hematologic ...Orally, use of a home-prepared wormwood extract has been associated with severe metabolic acidosis in an infant (93467).
Immunologic ...Theoretically, wormwood might cause an allergic reaction in people sensitive to the Asteraceae/Compositae family (12815). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.
Musculoskeletal ...Orally, the oil from wormwood leaves can cause diffuse muscle aches and rhabdomyolysis (662).
Neurologic/CNS ...Orally, the oil from wormwood leaves can cause seizures (662).
Renal ...Orally, the oil from wormwood leaves can cause acute kidney toxicity and acute kidney failure (662).
Other ...Chronic ingestion of absinthe, an alcoholic beverage that contains wormwood extract, has been linked to absinthism. Absinthism was first described in the 1800s when absinthe was at its peak levels of consumption. It has been characterized by addiction, gastrointestinal adverse effects, insomnia, auditory and visual hallucinations, tremors, paralysis, epilepsy, and brain damage. There is also increased risk of psychiatric disease and suicide (662,12814,15008). Increasing thujone concentrations of absinthe increases anxiety and decreases attention in healthy individuals (86541). A case of bradyarrhythmias associated with absinthe intoxication has also been reported (86543). However, there is speculation that some of the symptoms of absinthism originally described might be attributed to adulteration with metals or toxic plants such as calamus and tansy, rather than the ingredients usually used in absinthe drinks (15007). Some researchers also suggest that absinthism is not a unique condition and is indistinguishable from alcohol use disorder. In fact, some evidence suggests that the thujone concentrations in the absinthe formulations from the 1800s were too low to cause significant thujone-related toxicities (15008,15009).
