Cha de Bugre hb • Evodia ft • Garcinia ft • Fresh Ginger rt • Pomegranate lf • Guggul gum resin • Horsetail hb • Cornsilk hb.
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 Weight Control Formula. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is insufficient reliable information available about the effectiveness of Cha de Bugre.
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of evodia.
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 Weight Control Formula. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is insufficient reliable information available about the safety of Cha de Bugre.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Corn silk, corn silk extract, and corn silk oil has Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of corn silk when used orally as medicine.
PREGNANCY: POSSIBLY SAFE
when consumed in food.
PREGNANCY: LIKELY UNSAFE
when used orally in larger amounts because it might have uterine stimulant effects (4); avoid using.
LACTATION: POSSIBLY SAFE
when consumed in food amounts.
Insufficient reliable information available when used as medicine; avoid using.
There is insufficient reliable information available about the safety of evodia when used orally. In animal studies, evodia has induced QT interval prolongation and Torsade de pointes (97035). It is not clear what dose, if any, is required to produce a similar effect in humans.
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Active constituents in evodia have uterine stimulant activity in animal models. Evodia might also decrease litter size in animal models (15229). Theoretically, taking evodia during pregnancy might adversely affect pregnancy outcome.
LACTATION:
Insufficient reliable information available; avoid using.
There is insufficient reliable information available about the safety of garcinia extract when used orally. However, there is some concern about liver toxicity. There are numerous case reports of elevated liver enzymes and symptoms of liver toxicity in patients who have taken garcinia alone or in combination with other ingredients for as little as one week. In at least two reports, hepatotoxicity occurred in patients who were taking garcinia alone. Most other reports occurred in patients taking multi-ingredient products (13037,53511,93380,93381,93384,93385,93392,93393,93394,96535)(102544,102545,111241).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately. Ginger has been safely used in multiple clinical trials (721,722,723,5343,7048,7084,7085,7400,7623,11346)(12472,13080,13237,13244,17369,17928,17929,89889,89890,89894)(89895,89898,89899,90102,96252,96253,96259,96260,96669) (101760,101761,101762,103359,107903).
POSSIBLY SAFE ...when used topically and appropriately, short-term (89893,89897).
CHILDREN: LIKELY SAFE
when consumed in the amounts typically found in foods.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Ginger powder has been used with apparent safety at a dose of up to 750 mg daily for 4 days in girls aged 14-18 years (96255).
PREGNANCY: LIKELY SAFE
when consumed in the amounts typically found in foods.
Ginger is considered a first-line nonpharmacological treatment option for nausea in pregnancy by the American College of Obstetrics and Gynecology (ACOG) (111601). However, it should not be used long-term or without medical supervision and close monitoring.
PREGNANCY: POSSIBLY SAFE
when used for medicinal purposes.
Despite some early reports of adverse effects (721,7083) and one observational study suggesting that taking dried ginger and other herbal supplements during the first 20 weeks of pregnancy marginally increased the chance of stillbirth (96254), most research shows that ginger is unlikely to cause harm to the baby. The risk for major malformations in infants of parents who took ginger when pregnant does not appear to be higher than the baseline rate of 1% to 3% (721,1922,5343,11346,13071,13080,96254). Also, other research suggests that ginger intake during various trimesters does not significantly affect the risk of spontaneous abortion, congenital malformations, stillbirth, perinatal death, preterm birth, low birth weight, or low Apgar scores (18211,90103). Ginger use has been associated with an increase in non-severe vaginal bleeding, including spotting, after week 17 of pregnancy (18211).
LACTATION: LIKELY SAFE
when consumed in the amounts typically found in foods.
There is insufficient reliable information available about the safety of ginger when used for medicinal purposes; avoid amounts greater than those found in foods.
POSSIBLY SAFE ...when the prepared gum resin is used orally and appropriately. It has been used with apparent safety in clinical trials for up to 24 weeks (3267,3268,10371). There is insufficient reliable information available about the safety of guggul when used topically.
PREGNANCY: LIKELY UNSAFE
when used orally; avoid using.
Guggul gum resin appears to stimulate menstrual flow and the uterus (12).
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY UNSAFE ...when horsetail products containing thiaminase are used orally, long-term. Thiaminase is an enzyme that destroys thiamine, which could theoretically lead to thiamine deficiency. In Canada, horsetail products are required to be thiaminase-free (105301).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when pomegranate fruit or fruit juice is used orally and appropriately. Pomegranate juice has been safely used in studies lasting up to 3 years (4912,8310,13022,13023,13690,14137,14388,17329,91693).
POSSIBLY SAFE ...when pomegranate extract is taken orally and appropriately. A specific pomegranate ellagitannin-enriched polyphenol extract (POMx, POM Wonderful) 1-3 grams daily has been safely used for up to 18 months (17729,69261,91686,91695,91697,99100,105269). ...when pomegranate seed oil is used orally and appropriately. Pomegranate seed oil 60 mg daily has been used with apparent safety for up to 12 weeks (91685). ...when a hot water extract of pomegranate seed powder is used orally and appropriately. Pomegranate seed powder 5 grams daily has been used with apparent safety for up to 8 weeks (105270). ...when pomegranate extract is used topically on oral mucosa (13689).
POSSIBLY UNSAFE ...when the pomegranate root, stem, and peel are used orally in large amounts. Bark of the pomegranate root and stem contains the piperidine alkaloids pelletierine, pseudopelletierine, isopelletierine, and methyl isopelletierine. These alkaloids have muscle relaxant properties that have been associated with paralysis and death in animals (13687,13694,13695). Dried pomegranate peel may contain aflatoxin, which is a potent hepatocarcinogen and toxin (92018).
PREGNANCY AND LACTATION: POSSIBLY SAFE
when the fruit or fruit juice is consumed orally and appropriately (13686,105267).
There is insufficient reliable information available regarding the safety of using other forms of pomegranate or other parts of the plant during pregnancy or lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Weight Control Formula. 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 corn silk with antidiabetes drugs might increase the risk of hypoglycemia.
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Animal research in diabetic mice shows that taking corn silk extract lowers fasting blood glucose levels (103365).
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Taking corn silk extract with antihypertensive drugs might increase the risk of hypotension.
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Clinical research in both hypertensive and normotensive adults shows that taking corn silk extract lowers systolic and diastolic blood pressure (93869).
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Taking corn silk with corticosteroids might increase the risk of hypokalemia.
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Taking corn silk with diuretic drugs might increase the risk of adverse effects such as hyponatremia and hypokalemia.
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Theoretically, suddenly stopping, starting, or changing corn silk treatment may alter the effects of warfarin.
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Corn silk contains vitamin K. Individuals taking warfarin should consume a consistent daily amount of corn silk to maintain consistent anticoagulation (19).
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Theoretically, taking evodia with antiplatelet or anticoagulant drugs might increase the risk of bruising and bleeding.
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Theoretically, evodia might decrease the levels and clinical effects of caffeine.
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In animal models, evodia extract decreases caffeine levels by up to 71%. Evodia extract induces hepatic cytochrome P450 1A2 (CYP1A2) enzyme, of which caffeine is a substrate (15241).
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Theoretically, evodia might decrease the levels and clinical effects of chlorzoxazone.
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Animal research shows that administration of rutaecarpine, a constituent of evodia, with chlorzoxazone reduces the area under the curve (AUC) of chlorzoxazone by 84% and increases its clearance by 646%. This interaction is likely due to induction of cytochrome P450 2E1 (CYP2E1) by rutaecarpine (107913).
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Theoretically, drugs that inhibit CYP1A2 might increase the levels and clinical effects of evodia.
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The evodia constituent rutaecarpine is metabolized by CYP1A2 (15253).
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Evodia might reduce the levels and clinical effects of CYP1A2 substrates through induction of CYP1A2.
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Theoretically, evodia might reduce the levels and clinical effects of CYP2E1 substrates through induction of CYP2E1.
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Animal research suggests that rutaecarpine, a constituent of evodia, induces CYP2E1 activity. In rats, rutaecarpine increases markers of CYP2E1 activity, and administration of rutaecarpine with chlorzoxazone, a known CYP2E1 substrate, reduces the area under the curve (AUC) of chlorzoxazone by 84% and increases its clearance by 646% (107913).
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Theoretically, taking CYP3A4 inducers might decrease the levels and clinical effects of evodia.
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Animal research shows that concomitant administration of dexamethasone, a known CYP3A4 inducer, with the alkaloid constituents of evodia significantly reduces the area under the curve (AUC), maximum concentration (Cmax), and half-life of these constituents (107911).
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Theoretically, CYP3A4 inhibitors might increase the levels and clinical effects of evodia.
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Animal research shows that concomitant administration of ketoconazole, a known CYP3A4 inhibitor, with the alkaloid constituents of evodia significantly increases the area under the curve (AUC), maximum concentration (Cmax), and half-life of these constituents (107911).
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Theoretically, evodia might increase the levels and clinical effects of CYP3A4 substrates.
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In vitro research shows that evodia extract inhibits hepatic CYP3A4 (15236). This effect has not been reported in humans.
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Theoretically, evodia might have an additive effect with drugs that prolong the QT interval, potentially increasing the risk of ventricular arrhythmias.
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Evodia has demonstrated dose-dependent activity as a proarrhythmic agent in animal and in vitro studies. Evodia infusion in animals extends the action duration potential and induces prolongation of the QT interval and Torsade de pointes (97035).
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Theoretically, evodia might decrease the levels and clinical effects of theophylline.
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The evodia constituent rutaecarpine decreases theophylline levels and half-life by about 70% in animal models (15227). This constituent appears to induce hepatic cytochrome P450 1A2 (CYP1A2) enzyme activity, of which theophylline is a substrate (15227,15230). Rutaecarpine is the primary active constituent of evodia; however, it is not known if the whole crude extract of evodia also causes this interaction.
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Theoretically, hydroxycitric acid (HCA), the main active ingredient in garcinia, might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.
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HCA inhibits platelet aggregation in vitro. The inhibitory effect seems to be greater in platelets extracted from diabetic subjects than non-diabetic subjects (26862).
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Theoretically, hydroxycitric acid (HCA), the main active ingredient in garcinia, might have additive effects with antidiabetes drugs and increase the risk of hypoglycemia.
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Theoretically, concomitant use with other potentially hepatotoxic drugs might increase the risk of developing liver damage.
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There have been reports of acute hepatitis with elevated liver enzymes associated with garcinia, when taken alone or in combination with other ingredients (13037,53511,93380,93381,93384,93392,93393,93394,102544,102545). Case reports collected from the Drug Induced Liver Injury Network suggest this risk may be greater in people who carry the HLA B*35:01 allele (108401).
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Theoretically, combining garcinia with other serotonergic drugs might increase the risk of serotonergic side effects, including serotonin syndrome.
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In one report, a patient experienced serotonin syndrome after taking garcinia extract (60% hydroxycitric acid) 1000 mg daily in combination with escitalopram 20 mg, which had been taken for a year. The patient was switched to sertraline 50 mg daily and again experienced serotonin syndrome (23545).
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Ginger may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs. However, research is conflicting.
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Laboratory research suggests that ginger inhibits thromboxane synthetase and decreases platelet aggregation (7622,12634,20321,20322,20323,96257). However, this has not been demonstrated unequivocally in humans, with mixed results from clinical trials (96257). Theoretically, excessive amounts of ginger might increase the risk of bleeding when used with anticoagulant/antiplatelet drugs.
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Theoretically, taking ginger with antidiabetes drugs might increase the risk of hypoglycemia.
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Theoretically, taking ginger with calcium channel blockers might increase the risk of hypotension.
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Some animal and in vitro research suggests that ginger has hypotensive and calcium channel-blocking effects (12633). Another animal study shows that concomitant administration of ginger and the calcium channel blocker amlodipine leads to greater reductions in blood pressure when compared with amlodipine alone (107901).
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Theoretically, when taken prior to cyclosporine, ginger might decrease cyclosporine levels.
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In an animal model, ginger juice taken 2 hours prior to cyclosporine administration reduced the maximum concentration and area under the curve of cyclosporine by 51% and 40%, respectively. This effect was not observed when ginger juice and cyclosporine were administered at the same time (20401).
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Theoretically, ginger might increase the levels of CYP1A2 substrates.
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In vitro research shows that ginger inhibits CYP1A2 activity (111544). However, this interaction has not been reported in humans.
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Theoretically, ginger might increase the levels of CYP2B6 substrates.
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In vitro research shows that ginger inhibits CYP2B6 activity (111544). However, this interaction has not been reported in humans.
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Theoretically, ginger might increase the levels of CYP2C9 substrates.
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In vitro research shows that ginger inhibits CYP2C9 activity (111544). However, this interaction has not been reported in humans.
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Ginger might increase or decrease the levels of CYP3A4 substrates.
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In vitro research and some case reports suggest that ginger inhibits CYP3A4 activity (111544,111644). Three case reports from the World Health Organization (WHO) adverse drug reaction database describe increased toxicity in patients taking ginger and cancer medications that are CYP3A4 substrates (imatinib, dabrafenib, and crizotinib). However, the causality of this interaction is unclear due to the presence of multiple interacting drugs and routes of administration (111644).
Conversely, other in vitro research suggests that ginger induces CYP3A4 activity, leading to reduced levels of CYP3A4 substrates (111404). However, this interaction has not been reported in humans. |
Theoretically, ginger might increase levels of losartan and the risk of hypotension.
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In animal research, ginger increased the levels and hypotensive effects of a single dose of losartan (102459). It is not clear if ginger alters the concentration or effects of losartan when taken continuously. Additionally, this interaction has not been shown in humans.
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Theoretically, ginger might increase levels of metronidazole.
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In an animal model, ginger increased the absorption and plasma half-life of metronidazole. In addition, the elimination rate and clearance of metronidazole was significantly reduced (20350).
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Ginger may have antiplatelet effects and increase the risk of bleeding if used with nifedipine.
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Clinical research shows that combined treatment with ginger 1 gram plus nifedipine 10 mg significantly inhibits platelet aggregation when compared to nifedipine or ginger alone (20324).
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Ginger might increase the absorption and blood levels of P-glycoprotein (P-gp) substrates.
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In vitro research and case reports suggest that ginger inhibits drug efflux by P-gp, potentially increasing absorption and serum levels of P-gp substrates (111544,111644). Two case reports from the World Health Organization (WHO) adverse drug reaction database describe increased toxicity in patients taking ginger and cancer medications that are P-gp substrates (trametinib, crizotinib). However, the causality of this interaction is unclear due to the presence of multiple interacting drugs and routes of administration (111644).
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Ginger might increase the risk of bleeding with phenprocoumon.
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Phenprocoumon, a warfarin-related anticoagulant, might increase the international normalized ratio (INR) when taken with ginger. There is one case report of a 76-year-old woman with a stable INR on phenprocoumon that increased to greater than 10 when she began consuming dried ginger and ginger tea (12880).
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Ginger might increase the risk of bleeding with warfarin.
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Laboratory research suggests that ginger might inhibit thromboxane synthetase and decrease platelet aggregation (7622,12634,20321,20322,20323). In one case report, ginger increased the INR when taken with phenprocoumon, which has similar pharmacological effects as warfarin (12880). In another case report, ginger increased the INR when taken with a combination of warfarin, hydrochlorothiazide, and acetaminophen (20349). A longitudinal analysis suggests that taking ginger increases the risk of bleeding in patients taking warfarin for at least 4 months (20348). However, research in healthy people suggests that ginger has no effect on INR, or the pharmacokinetics or pharmacodynamics of warfarin (12881,15176). Until more is known, monitor INRs closely in patients taking large amounts of ginger.
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Theoretically, guggul might increase the risk of bleeding when taken with anticoagulant/antiplatelet drugs.
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Theoretically, guggul might increase the risk of adverse effects when taken with contraceptive drugs.
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In vitro research shows that guggul has estrogen-alpha receptor agonist activity (12444).
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Theoretically, guggul might reduce the effects of CYP3A4 substrates.
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In vitro research shows that guggul constituents known as guggulsterones can induce CYP3A4 (12444).
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Guggul might reduce the effects of diltiazem.
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A small pharmacokinetic study shows that concomitant use of guggul with diltiazem reduces the bioavailability of diltiazem (383).
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Theoretically, guggul might increase the risk of adverse effects when taken with estrogens.
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In vitro research shows that guggul constituents known as guggulsterones have estrogen-alpha receptor agonist activity (12444).
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Guggul might reduce the effects of propranolol.
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A small pharmacokinetic study shows that concomitant use of guggul with propranolol reduces the bioavailability of propranolol (383).
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Theoretically, guggul might increase the effects and adverse effects of rosuvastatin.
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Animal research shows that guggul increases the bioavailability and hypolipidemic effects of rosuvastatin (109584). The mechanism of this interaction is unclear.
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Theoretically, guggul might interfere with tamoxifen therapy.
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In vitro research shows that guggul has estrogen-alpha receptor agonist activity (12444).
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Theoretically, guggul might increase the risk for adverse effects when taken with thyroid hormone therapy.
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Animal research suggests that guggul has thyroid-stimulating effects (8153).
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Theoretically, taking horsetail with antidiabetes drugs might increase the risk of hypoglycemia.
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Theoretically, taking horsetail with diuretic drugs might increase potassium loss and the risk of hypokalemia.
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Laboratory research shows that various species of horsetail have diuretic properties (13574,13575). Due to its diuretic effects, there has been concern that taking horsetail along with potassium-depleting diuretics might increase the risk for hypokalemia. However, pharmacokinetic research in humans shows that taking horsetail 900 mg daily for 4 days does not affect urinary excretion of electrolytes, including potassium and sodium, despite having a diuretic effect similar to taking hydrochlorothiazide 25 mg daily (92288). It is unclear if taking horsetail for a longer duration would affect electrolyte levels. Until more is known, use with caution.
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Theoretically, horsetail might decrease the levels and clinical effects of efavirenz.
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In two case reports, patients were found to have detectable viral loads when taking horsetail-containing supplements along with an antiretroviral regimen that included efavirenz. In one case, the antiretroviral regimen included zidovudine, lamivudine, and efavirenz; in the other case, the regimen consisted of emtricitabine, tenofovir disoproxil fumarate, and efavirenz. One month after discontinuing horsetail, the viral loads became undetectable in both cases. The exact mechanism of this interaction is unknown (97573). It is also unclear if this interaction is specific to efavirenz or if it is related to various components of antiretroviral therapy.
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Theoretically, horsetail might increase the levels and adverse effects of lithium.
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Animal research suggests that horsetail has diuretic properties (13574). Theoretically, due to these potential diuretic effects, horsetail might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.
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Theoretically, horsetail might decrease the levels and clinical effects of NRTIs.
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In two case reports, patients were found to have detectable viral loads when taking horsetail-containing supplements along with an antiretroviral therapy. In one case, the antiretroviral regimen included zidovudine, lamivudine, and efavirenz; in the other case, the regimen consisted of emtricitabine, tenofovir disoproxil fumarate, and efavirenz. One month after discontinuing the supplement, the viral loads became undetectable in both cases. The exact mechanism of these interactions is unknown (97573). It is also unclear if these interactions are specific to NRTIs or if they are related to various components of antiretroviral therapy.
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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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Below is general information about the adverse effects of the known ingredients contained in the product Weight Control Formula. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
...None reported.
General
...Orally, adverse effects to corn silk seem to be rare; however, a thorough safety evaluation has not been conducted.
Most Common Adverse Effects:
Orally: Hypokalemia, hyponatremia.
Dermatologic ...Topically, corn silk can cause dermatitis and urticaria (4).
Endocrine ...Orally, corn silk has been reported to cause hypokalemia with prolonged use (4).
Renal ...Orally, corn silk extract can increase urinary volume and increase the excretion of sodium and potassium (93869).
General ...There is no reliable evidence regarding the safety of evodia from clinical trials. In animal studies, evodia has induced QT prolongation and Torsade de pointes (97035).
Cardiovascular ...In animal studies, evodia acts as a proarrhythmic agent with a dose-dependent effect. Evodia infusion has resulted in QT prolongation and Torsade de pointes (97035). It is not clear what dose of evodia, if any, is required to produce a similar effect in humans.
General
...Orally, garcinia and its constituent, hydroxycitric acid (HCA), seem to be generally well tolerated in clinical research.
Most Common Adverse Effects:
Orally: Diarrhea, gastrointestinal discomfort, headache, and nausea.
Serious Adverse Effects (Rare):
Orally: Garcinia has been linked with cases of hepatotoxicity and liver failure. There have also been rare cases of mania and pancreatitis.
Cardiovascular
...There is a case report of a 48-year-old female who developed acute necrotizing eosinophilic myocarditis (ANEM) after using a garcinia supplement orally for 2.
5 weeks. On admission to hospital, she was hypotensive and had an elevated serum troponin level, progressing to fulminant heart failure, acute kidney failure, and sustained ventricular arrhythmias. She recovered after treatment with extra-corporeal membrane oxygenation (ECMO) and high-dose corticosteroids (88160). Although the patient had no prior medical history and was not taking any medications, this cannot conclusively be attributed to garcinia.
When taken orally, a specific formulation of the multi-ingredient product Hydroxycut (Iovate Health Sciences Inc.), which was available until 2009, has been associated with malignant hypertension and hypertensive retinopathy. Hydroxycut contains caffeine, garcinia, gymnema, green tea, glucomannan, guarana extract, and willow bark. The suspected causal agent is caffeine, which is dosed at 600 mg daily if Hydroxycut is taken as recommended; however, the responsibility of the other ingredients cannot be ruled out (16527).
Endocrine ...In one case report, a 56-year-old female with pre-existing diabetes, hepatitis C, and hypertension developed diabetic ketoacidosis (DKA) and pancreatitis after taking an unknown amount of garcinia and African mango for one month. Upon admission, she presented with altered mental status, elevated serum glucose and lipase, and high anion gap metabolic acidosis. After 3 days of intensive supportive care, the DKA and pancreatitis resolved. The suspected probable causal agent was garcinia; however, African mango cannot be ruled out (97341). There have been at least 3 other cases of acute pancreatitis associated with use of garcinia (unknown dose) for 2 weeks and up to 7 months in adults ages 36-82 years (105056,105058,105071).
Gastrointestinal ...Orally, garcinia and its active constituent hydroxycitric acid (HCA) have caused mild and infrequent nausea, diarrhea, and other gastrointestinal symptoms (728,11977,19153,88158,88159).
Hepatic
...Orally, garcinia and its constituent hydroxycitric acid (HCA) might cause liver toxicity.
Several cases of acute liver toxicity have been reported in patients taking garcinia supplements (93392,93393,93394,95573,102544,102545,104431,111241). Reported doses of garcinia extract range from 480-1800 mg daily, providing up to 900 mg HCA daily (93392,93394,95573,102544,104431). However, not all experts agree that HCA plays a causal role in the hepatotoxicity associated with garcinia supplements; some suggest other mechanisms may be in play, such as immune-mediated processes (95576,108401). In most cases, patients presented with a hepatocellular pattern of toxicity and symptoms of abdominal pain, coagulopathy, jaundice, and elevated transaminases after taking garcinia for several weeks to several months (93393,93394,95573,102544,102545,104431,108401,111241). In most of these cases, there was no evidence of other natural causes of liver disease, such as viral hepatitis. Some of these patients used acetaminophen at recommended doses for limited durations, suggesting that a potential synergistic effect may occur when multiple hepatotoxic agents are used concomitantly.
The Drug-Induced Liver Injury Network has identified 22 cases (11 moderate; 7 severe) of liver injury from garcinia, with 5 cases occurring with garcinia alone, 16 cases occurring in combination with green tea, and 1 case occurring in combination with ashwagandha. Clinical presentations of liver injury related to garcinia closely resemble green tea-related liver injury. Most patients (82%) presented with a hepatocellular pattern of enzyme elevations. The median age of these case reports was 35 years, 41% identified as Hispanic, and most patients were overweight but not obese. In case reports involving garcinia alone, the carrier frequency on HLAB*35:01 was 60%, which is higher than the carrier frequency found in reports of liver injury due to other supplements (19%) and in population controls (11%). Within 3 months of injury onset, 1 patient required liver transplantation and 1 patient died from liver injury (108401).
There have been at least four cases of liver failure requiring transplantation associated with garcinia supplements (93392,95573,98425,104431). In one case related specifically to garcinia, a 52-year-old female had been taking a combination product (USA Nutra Labs) providing garcinia 1000 mg daily, standardized to 60% HCA. The supplement also provided calcium 50 mg, chromium 200 mcg, and potassium 50 mg. Symptoms started within a few weeks of initiation of the product (93392). In another case, a 34-year-old Hispanic male experienced acute liver failure requiring transplant after taking a specific garcinia product (Garcinia Cambogia 5:1 Extract, Swanson Vitamins) 160 mg three times daily before meals for 5 months (95573). In other reports, one 26-year-old male and one female presented to the emergency room with liver failure after 2-7 months of taking a supplement containing garcinia and green tea, with or without whey protein, Veldt raisin, and coffea arabica (98425,104431).
There have also been numerous cases of acute liver toxicity associated with combination products containing garcinia, such as Hydroxycut (Iovate Health Sciences Inc) (13037,53511,93380,93381,93384,93385,96535,98425,104431). Available until 2009, Hydroxycut contained garcinia, green tea, chromium, caffeine, calcium, potassium, and gymnema. A currently available garcinia-containing combination product called Seryburn Day Triple has also been associated with supplement-induced liver injury. (13037,93380,93381,95570,95572,95575,111241). In most of these cases, patients had elevated levels of liver enzymes without evidence of chronic liver disease. Patients usually developed symptoms within 1-12 weeks of taking the product. The clinical pattern of liver damage was often hepatocellular. Most cases reported altered liver enzyme values including ALT, AST, bilirubin, alkaline phosphatase, and international normalized ratio. In most cases, symptoms resolved with near normalization of enzyme levels once the garcinia-containing combination product was discontinued (13037,53511,93380,93381,93384,95567,95572,95575,111241).
However, there is one report of transplant related to Hydroxycut use (93381). As the suspected causal agents, garcinia and green tea were removed from the product during reformulation in 2009 (13037,53511,93380,93381,93384). Hepatotoxicity has been reported in at least one new formulation of Hydroxycut not containing garcinia (93394). Consequently, some experts believe that there is not enough information to attribute hepatotoxicity from this product to garcinia or HCA (95576). Also, in some cases, causality of hepatotoxicity was less clear because patients were taking many other supplements and drugs (95570).There is also a report of fatal liver failure in an obese female taking montelukast while also taking two dietary supplements containing multiple ingredients, including garcinia, gymnema, chromium, bitter orange, and many others. The authors speculated that the combination of montelukast with one or more ingredients in these dietary supplements may have resulted in liver failure (93385).
Musculoskeletal ...Orally, garcinia-containing products have been associated with rhabdomyolysis. There is a case report of a patient who developed rhabdomyolysis 3 hours after ingestion of an herbal product containing ephedra, guarana, chitosan, gymnema, garcinia, and chromium (19154). Since there were multiple ingredients, the effect cannot be conclusively attributed to garcinia. Another case of rhabdomyolysis has been reported for a patient taking an undetermined formulation of Hydroxycut at a dose of 4 caplets daily, naproxen sodium 220 mg as needed for pain, dextroamphetamine daily for 5 days, and hydrocodone-acetaminophen and cyclobenzaprine for pain. Two weeks later, after stopping Hydroxycut and receiving supportive care, the rhabdomyolysis resolved. Hydroxycut was determined to be possibly associated with the rhabdomyolysis (95566). Since Hydroxycut contains multiple ingredients and garcinia content was possible but not confirmed, a causal relationship with garcinia could not be determined.
Neurologic/CNS ...Orally, garcinia and its active constituent hydroxycitric acid (HCA) may cause headache and dizziness (11977). A 35-year-old female reported ocular complications, headache, dizziness, and nausea after taking garcinia extract, providing more than 500 mg of HCA, three times daily for one week. The patient's neurologic symptoms resolved one day after discontinuing the garcinia extract (102546). It is unclear if these neurologic adverse effects were separate from or related to the patient's visual disturbances.
Ocular/Otic ...In one case, a 35-year-old female presented with ocular pain in both eyes, decreased vision in the left eye, headache, dizziness, and nausea after taking garcinia extract orally for one week. Ophthalmologic testing was consistent with adverse ocular effects, showing myopic shift with anterior chamber shallowing and swelling of retinal nerve fiber and macula. The patient reported taking a garcinia product containing hydroxycitric acid 500 mg three times daily, which was more than double the recommended dose per the product label. Symptoms resolved upon discontinuation of the garcinia extract and treatment with oral and topical steroids (102546).
Psychiatric ...Orally, garcinia supplements have been linked to several cases of mania. Typically, symptoms develop 1-8 weeks after starting garcinia. In a report of three patients, symptoms included reduced need for sleep, increased activities and spending, delusions of grandiosity, pressured speech, and agitation. Two of the patients were previously diagnosed with bipolar disorder, and use of garcinia was believed to precipitate episodes during stable phases of the disease. The third patient had no history of bipolar disorder, and use of garcinia was thought to possibly have unmasked previously undiagnosed primary bipolar disorder. In all three cases, recovery included discontinuation of garcinia (95568). In a separate case report, a 23-year-old male taking a specific combination product containing garcinia (Hydroxycut) 1-2 capsules daily for 1 month presented to the emergency room with mania. The patient had no history of bipolar disorder. Although the patient was started on risperidone and clonazepam, symptoms resolved following discontinuation of the supplement. Treatment was discontinued within 4 days of initiation, and the patient remained asymptomatic (95574). A 22-year-old female with no history of bipolar disorder developed mania and psychosis, presenting 10 days after starting Garcinia Cambogia Plus (Apex Vitality Health) 500-1500 mg daily, and Cleanse and Detox (Apex Vitality Health). The latter supplement contains raspberry ketones, licorice root, pumpkin seed, buckthorn root, Cascara sagrada, Irvingia gabonensis, rhubarb, pectin, Lactobacillus acidophilus, and aloe. Symptoms improved upon stopping the supplements and starting lithium and quetiapine (99421).
General
...Orally, ginger is generally well tolerated.
However, higher doses of 5 grams per day increase the risk of side effects and reduce tolerability. Topically, ginger seems to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal discomfort, burping, diarrhea, heartburn, and a pepper-like irritant effect in the mouth and throat. However, some of these mild symptoms may be reduced by ingesting encapsulated ginger in place of powdered ginger.
Topically: Dermatitis in sensitive individuals.
Cardiovascular ...Orally, use of ginger resulted in mild arrhythmia in one patient in a clinical trial (16306).
Dermatologic
...Orally, ginger can cause hives (17933), as well as bruising and flushing (20316) or rash (20316).
Topically, ginger can cause dermatitis in sensitive individuals (12635,46902).
Gastrointestinal
...Orally, common side effects of ginger include nausea (17933,22602,89898,101761), belching (10380,103359), dry mouth (103359), dry retching (10380), vomiting (10380), burning sensation (10380), oral numbness (22602), abdominal discomfort (5343,89898,96253), heartburn (5343,7624,12472,16306,20316,51845,89894,89895,89898,89899)(101760,101761,101762,111543), diarrhea (5343,101760), constipation (89898,101760,101761), or a transient burning or "chilly hot" sensation of the tongue and throat (52076).
Orally, Number Ten, a specific product composed of rhubarb, ginger, astragalus, red sage, and turmeric, can increase the incidence of loose stools (20346).
Four cases of small bowel obstruction due to ginger bolus have been reported following the ingestion of raw ginger without sufficient mastication (chewing). In each case, the bolus was removed by enterotomy. Ginger is composed of cellulose and therefore is resistant to digestion. It can absorb water, which may cause it to swell and become lodged in narrow areas of the digestive tract (52115).
Genitourinary ...In one clinical trial, some patients reported increased menstrual bleeding while taking a specific ginger extract (Zintoma, Goldaru) 250 mg four times daily orally for 3 days (17931). An "intense" urge to urinate after 30 minutes was reported in two of eight patients given 0.5-1 gram of ginger (7624). However, this effect has not been corroborated elsewhere. Dysuria, flank pain, perineal pain, and urinary stream interruption have been reported in a 43-year-old male who drank ginger tea, containing 2-3 teaspoons of dry ginger, daily over 15 years. The adverse effects persisted for 4 years and were not associated with increases in urinary frequency or urgency. Upon discontinuing ginger, the patient's symptoms began to improve within one week and completely resolved after eight weeks, with no relapses six months later (107902).
Immunologic ...In one case report, a 59-year-old Japanese female with multiple allergic sensitivities developed pruritus and then anaphylactic shock after taking an oral ginger-containing herbal supplement for motion sickness (Keimei Gashinsan, Keimeido). The patient had used this supplement previously for over 20 years with no allergic reaction. The authors theorized the development of a cross-reactivity to ginger after the use of an oral supplement containing zedoary and turmeric, which are also in the Zingiberaceae family (102463).
Neurologic/CNS ...Orally, ginger may cause sedation, drowsiness, or dizziness (16306,17933,51845).
General
...Orally, guggul seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Belching, bloating, diarrhea, headache, nausea, unpleasant taste, and vomiting. Allergic and non-allergic skin reactions.
Topically: Allergic contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Rhabdomyolysis.
Dermatologic
...Orally, guggul can cause hypersensitivity reactions including rash and pruritus (10371,54457).
Guggul can also cause nonallergic adverse skin reactions. The risk of skin reactions appears to be dose-dependent. In one study, the incidence of skin reactions was 3% with a dosage of 1000 mg three times daily, compared with 15% with a dosage of 2000 mg three times daily. The severity of the reactions ranged from pruritus to swelling and erythema of the face to bullous lesion on the lower legs associated with headaches, myalgias, and pruritus (13662).
Topically, guggul can cause allergic contact dermatitis (54464,54467). Also, in a small clinical study, one patient using a cream containing aqueous extracts of guggul and Allium ampeloprasum as well as sesame oil complained of rash at the application site (105751). It is unclear if this reaction was due to guggul, other ingredients, or other factors.
Gastrointestinal ...Orally, guggul can cause nausea, vomiting, loose stools, diarrhea, belching, bloating, hiccups, and mild gastrointestinal discomfort (3267,8155,8158,10371,52033,54492).
Hepatic ...A case of severe hypertransaminasemia has been reported for a 63-year-old female who took a specific product (Equisterol) containing guggulsterone and red yeast rice extract daily for 6 months. Liver function normalized after discontinuing the supplement. It is unclear if the adverse effect was due to guggulsterone, red yeast, or the combination. However, the patient had previously developed hepatotoxicity while taking lovastatin, and red yeast contains monacolin K, which is identical to lovastatin (54477). Also, a case of acute liver failure requiring liver transplantation has been reported for a previously healthy young female who used a mixed-ingredient dietary supplement containing extracts of green tea, guggul, and usnic acid. It is unclear if the hepatotoxicity was due to guggul or other ingredients; green tea has been associated with hepatotoxicity (54027).
Immunologic
...Orally, guggul can cause hypersensitivity reactions including rash and pruritus (10371,54457).
In a small clinical study, two adults with hyperlipidemia developed a hypersensitivity rash, one with facial edema, within minutes of oral administration of a methanolic extract of guggul, together with Terminalia extract (105741). It is unclear if this reaction was due to guggul, Terminalia, or other factors.
Topically, guggul can cause allergic contact dermatitis (54464,54467).
Musculoskeletal ...There is one case of rhabdomyolysis reported in a patient who took guggul 300 mg three times daily. The patient developed hemoglobinuria within 2 weeks of starting guggul in addition to increased alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase, creatine kinase, and myoglobinemia. The patient did not have any muscular symptoms. The patient's condition improved when guggul was discontinued. The patient had a history of developing elevated creatine kinase levels after taking simvastatin; however, the patient was not taking a statin at the time of this episode of rhabdomyolysis (13029).
Neurologic/CNS ...Orally, guggul can cause headaches (3267,8155,8158,10371,42692,49583). Less commonly, guggul may cause restlessness and apprehension (49583,54492).
General
...There is limited clinical research evaluating the safety of horsetail.
Most Common Adverse Effects:
Orally: Abdominal distension, increased bowel movements, and nausea.
Dermatologic ...In one case report, a patient developed seborrheic dermatitis after topical application of horsetail, requiring treatment with local epinephrine and oral antihistamines. The nicotine component of horsetail was determined to be the likely cause of this reaction (13563).
Gastrointestinal ...Orally, horsetail has been associated with mild gastrointestinal side effects including abdominal distension, increased frequency of bowel movements, and nausea (55576). Orally, chronic consumption of horsetail infusion has been associated with acute pancreatitis. In a case report, a 56-year-old female presenting with recurrent mild acute pancreatitis every 6-7 months, previously thought to be drug-induced, discontinued ingesting horsetail infusions. The patient had a history of bilateral adrenal gland removal and was being treated for hypertension, dyslipidemia, and hormone replacement, and then self-medicated with horsetail infusions. After discontinuing horsetail infusions, there were no further recurrences of pancreatitis during a 14-month follow-up (97574).
Hepatic ...In one case report, a patient with asymptomatic hepatitis B developed symptomatic liver failure following consumption of boiled horsetail juice 500 mL daily for 2 weeks. Liver enzymes returned to normal following discontinuation of the juice (92291). It is not known if the horsetail juice was contaminated or mixed with other ingredients.
Immunologic ...Horsetail has been associated with cross-allergenicity with carrots (13577).
Renal ...There are at least 4 case reports of hyponatremia thought to be at least partially associated with horsetail consumption. In one case report, an elderly patient who had taken oral horsetail 15 mg daily for 10 years presented with hyponatremia and syndrome of inappropriate secretion of antidiuretic hormone (SIADH) secondary to reduced oral intake and nausea for the previous 2 days. Horsetail was thought to be a contributing factor. The patient's symptoms resolved after 5 days of treatment with oral sodium chloride and fluid restriction (108851).
Other ...Crude horsetail contains thiaminase, which can cause thiamine deficiency with prolonged consumption. Canadian Equisetum arvense products are required to be certified as free from thiaminase-like activity (55579,105301). In one case report, the development of autism in a child exposed to both horsetail and alcohol during pregnancy was thought to be caused by thiamine deficiency attributed to this combination (92292). However, it is not known if other genetic or environmental factors were involved in the development of this condition in utero.
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).