Four capsules contain: Citrimax 2000 mg • Mahuang extract 334 mg • Guarana extract 910 mg • Willow Bark extract 100 mg • L-Carnitine 100 mg • Chromium Picolinate 300 mcg.
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 Thermo Cuts. 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
Below is general information about the safety of the known ingredients contained in the product Thermo Cuts. 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 used orally and appropriately in medicinal amounts, short-term. Chromium has been safely used in doses up to 1000 mcg daily for up to 6 months (1934,5039,5040,6858,6859,6860,6861,6862,6867,6868)(7135,7137,10309,13053,14325,14440,17224,90057,90061)(90063,94234,95095,95096,95097,98687); however, most of these studies have used chromium doses in a range of 150-600 mcg. The Food and Drug Administration (FDA) and Institute of Medicine (IOM) evaluations of the safety of chromium suggest that it is safe when used in doses of 200 mcg daily for up to 6 months (13241,13242).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, long-term. Chromium has been safely used in a small number of studies at doses of 200-1000 mcg daily for up to 2 years (7060,7135,42618,42628,42666,110605,110607,110609). However, the Food and Drug Administration (FDA) and Institute of Medicine (IOM) evaluations of the safety of chromium suggest that it is safe when used in doses of 200 mcg daily for up to 6 months (13241,13242).
CHILDREN: LIKELY SAFE
when used orally and appropriately in amounts not exceeding the daily adequate intake (AI) levels by age: 0-6 months, 0.
2 mcg; 7-12 months, 5.5 mcg; 1-3 years, 11 mcg; 4-8 years, 15 mcg; males 9-13 years, 25 mcg; males 14-18 years, 35 mcg; females 9-13 years, 21 mcg; females 14-18 years, 24 mcg (7135). POSSIBLY SAFE...when used orally and appropriately in amounts exceeding AI levels. Chromium 400 mcg daily has been used safely for up to 6 weeks (42680).
PREGNANCY: LIKELY SAFE
when used orally and appropriately in amounts not exceeding adequate intake (AI) levels.
The AI for pregnancy is 28 mcg daily for those 14-18 years of age and 30 mcg daily for those 19-50 years of age (7135).
PREGNANCY: POSSIBLY SAFE
when used orally in amounts exceeding the adequate intake (AI) levels.
There is some evidence that patients with gestational diabetes can safely use chromium in doses of 4-8 mcg/kg (1953); however, patients should not take chromium supplements during pregnancy without medical supervision.
LACTATION: LIKELY SAFE
when used orally and appropriately in amounts not exceeding adequate intake (AI) levels.
The AI for lactation is 44 mcg daily for those 14-18 years of age and 45 mcg daily for those 19-50 years of age (7135). Chromium supplements do not seem to increase normal chromium concentration in human breast milk (1937). There is insufficient reliable information available about the safety of chromium when used in higher amounts while breast-feeding.
LIKELY UNSAFE ...when used orally. Ephedra can cause severe life-threatening or disabling adverse effects in some people. Ephedra is banned in the US. Several case reports have linked ephedra to serious side effects including hypertension, myocardial infarction (MI), seizure, stroke, psychosis, and others (1276,2729,6486,6998,9167,10689). Prolonged use or use of high doses might increase the risk of serious adverse effects (2729). Some suggest that ephedra is only harmful when used inappropriately in excessive doses or for prolonged periods. However, there are several cases of significant adverse events in patients who used ephedra short-term in relatively low doses ranging from 20-60 mg of ephedra alkaloids (2729,6486). There is some evidence that people who take doses greater than 32 mg per day might have more than triple the risk of hemorrhagic stroke, including subarachnoid hemorrhage and intracerebral hemorrhage (9167). It is not possible to determine who is at the greatest risk. However, people with pre-existing conditions such as cardiovascular disease or those using ephedra products in combination with other stimulants such as caffeine, might be at increased risk.
CHILDREN: LIKELY UNSAFE
when used orally.
Ephedra has been linked to several cases of severe side effects (6486).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally.
Ephedra has been linked to several cases of severe side effects (1276,2729,6486,6998,9167,10689).
LIKELY SAFE ...when consumed in amounts typically found in foods. Guarana has Generally Recognized as Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately, short-term (12). Guarana contains caffeine. According to a review by Health Canada, and a subsequent large meta-analysis conducted in the US, doses of caffeine up to 400 mg daily are not associated with significant adverse cardiovascular, bone, behavioral, or reproductive effects in healthy adults (11733,98806). The US Dietary Guidelines Advisory Committee states that there is strong and consistent evidence that consumption of caffeine 400 mg daily is not associated with increased risk of major chronic diseases, such as cardiovascular disease or cancer, in healthy adults (98806).
POSSIBLY UNSAFE ...when used orally long-term or in high doses. Guarana contains a significant amount of caffeine. Chronic use, especially in large amounts, can produce tolerance, habituation, psychological dependence, and other significant adverse effects. Acute use of high doses, typically above 400 mg per day, has been associated with significant adverse effects such as tachyarrhythmias and sleep disturbances (11832,95503,98806). These effects would not be expected to occur with the consumption of decaffeinated guarana.
LIKELY UNSAFE ...when used orally in very high doses. The fatal acute oral dose of caffeine is estimated to be 10-14 grams (150-200 mg per kilogram). Serious toxicity can occur at lower doses depending on variables in caffeine sensitivity such as smoking, age, or prior caffeine use (11832,54425).
PREGNANCY: POSSIBLY SAFE
when consumed in amounts commonly found in foods.
Due to the caffeine content of guarana, intake should be closely monitored during pregnancy to ensure moderate consumption. Although it is not considered a teratogen, caffeine crosses the placenta and causes dose-dependent increases in fetal blood concentrations (4260). The use of caffeine during pregnancy is controversial; however, moderate consumption has not been associated with clinically important adverse fetal effects (2708,2709,2710,2711,9606,11733,16014,16015,98806). In some studies, consuming amounts over 200 mg daily is associated with a significantly increased risk of miscarriage (16014). This increased risk may be most likely to occur in individuals with genotypes that confer a slow rate of caffeine metabolism (98806). According to a review by Health Canada, and a subsequent large meta-analysis conducted in the US, caffeine can be safely consumed in doses up to 300 mg daily without an increased risk of spontaneous abortion, stillbirth, preterm birth, fetal growth retardation, or congenital malformations (11733,98806). However, some research has also found that intrauterine exposure to even modest amounts of caffeine, based on maternal blood levels during the first trimester, is associated with a shorter stature in children ages 4-8 years (109846). Advise individuals to keep caffeine consumption below 300 mg daily during pregnancy.
PREGNANCY: POSSIBLY UNSAFE
when used orally in amounts over 300 mg daily.
Although it is not considered a teratogen, caffeine crosses the placenta and causes dose-dependent increases in fetal blood concentrations (4260,98806). Consumption of caffeine in amounts over 300 mg daily is associated with a significantly increased risk of miscarriage in some studies (16014,98806). Advise keeping caffeine consumption from all sources below 300 mg daily. High maternal doses of caffeine throughout pregnancy have resulted in symptoms of caffeine withdrawal in newborn infants (9891). High doses of caffeine have also been associated with spontaneous abortion, premature delivery, and low birth weight (2709,2711).
LACTATION: POSSIBLY SAFE
when used orally in amounts commonly found in foods.
Due to the caffeine content of guarana, intake should be closely monitored when breast-feeding. Breast milk concentrations of caffeine are thought to be approximately 50% of serum concentrations (9892).
LACTATION: POSSIBLY UNSAFE
when used orally in large amounts.
Consumption of guarana might cause irritability and increased bowel activity in nursing infants (6026). Large doses or excessive intake of guarana should be avoided when breast-feeding.
LIKELY SAFE ...when used orally and appropriately. L-carnitine has been safely used in clinical trials lasting up to 12 months (1947,3620,3621,3623,3624,3625,3626,3627,3628,3629) (3630,3639,4949,8047,9790,12352,16104,16105,16106,16107) (16109,16110,23437,26496,26499,58150,58156,58161,58169,58182) (58189,58204,58207,58209,58213,58294,58523,58554,58556,58647) (58679,58715,58778,58793,58830,58831,58882,59023,59029,59043) (90624,90633,104177,111872,111876,111883,111884,111891,111898). ...when used parenterally as an FDA-approved prescription medicine. Avoid using D-carnitine and DL-carnitine. These forms of carnitine can act as competitive inhibitors of L-carnitine and may cause symptoms of L-carnitine deficiency (1946).
CHILDREN: POSSIBLY SAFE
when used orally or intravenously and appropriately.
L-carnitine has been safely used orally in children for up to 6 months (1433,3622,58166,58502,58981,59188,111887,111900,115351). It has also been safely used orally and intravenously in preterm infants (3633,3634,3635,3636,3637,58163,58190,58800,58902,59097)(59161).
PREGNANCY:
Insufficient reliable information available; avoid using.
LACTATION: POSSIBLY SAFE
when used orally.
Supplemental doses of L-carnitine have been given to infants in breast milk and formula with no reported adverse effects. The effects of large doses used while nursing are unknown, but L-carnitine is secreted in the breast milk (3616).
POSSIBLY SAFE ...when used orally and appropriately, short-term. Willow bark has been used safely for up to 12 weeks (6456,12474,12475,12804,12811,86473,91406).
CHILDREN: POSSIBLY UNSAFE
when used orally for viral infections.
Salicylic acid and aspirin are contraindicated in children with viral infections (12801). Although Reye's syndrome has not been reported, the salicin constituent in willow bark is similar to aspirin and might pose the same risk.
PREGNANCY:
Insufficient reliable information available; avoid using.
LACTATION: POSSIBLY UNSAFE
when used orally.
Willow bark contains salicylates which are excreted in breast milk and have been linked to adverse effects in breast-fed infants (12802,12803).
Below is general information about the interactions of the known ingredients contained in the product Thermo Cuts. 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, chromium may have additive effects with antidiabetic agents and increase the risk of hypoglycemia.
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Theoretically, aspirin might increase chromium absorption.
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Animal research suggests that aspirin may increase chromium absorption and chromium levels in the blood (21055).
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Theoretically, concomitant use of chromium and insulin might increase the risk of hypoglycemia.
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Chromium might bind levothyroxine in the intestinal tract and decrease levothyroxine absorption.
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Clinical research in healthy volunteers shows that taking chromium picolinate 1000 mcg with levothyroxine 1 mg decreases serum levels of levothyroxine by 17% when compared to taking levothyroxine alone (16012). Advise patients to take levothyroxine at least 30 minutes before or 3-4 hours after taking chromium.
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NSAIDs might increase chromium levels in the body.
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Drugs that are prostaglandin inhibitors, such as NSAIDs, seem to increase chromium absorption and retention (7135).
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Theoretically, ephedra may reduce the effects of anticonvulsants.
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Ephedra has been associated with reports of seizure (13304).
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Theoretically, taking ephedra with antidiabetes drugs might interfere with blood glucose control.
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One study in animals shows that some components of ephedra may lower blood glucose levels (48835). However, most human research suggests that ephedra and ephedrine, a component of ephedra, can raise blood glucose levels and might decrease the effectiveness of drug therapy (3719,12857,48810). Monitor blood glucose concentrations closely.
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Theoretically, large amounts of ephedra might increase the cardiac inotropic effects of beta-agonists.
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Theoretically, ephedra might decrease levels of drugs metabolized by CYP1A2.
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Some animal research suggests that ephedra induces CYP1A2 and increases the clearance of CYP1A2 substrates such as caffeine (91808).
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Theoretically, concomitant use might reduce the levels and clinical effects of dexamethasone.
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Theoretically, concomitant use might increase the risk of hypertension.
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The ephedrine contained in ephedra might cause excessive vasoconstriction and hypertension when used in combination with ergot derivatives (6009).
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Theoretically, concomitant use might have additive adverse hepatotoxic effects.
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Concomitant use might increase the risk of serious adverse effects.
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Use of ephedra with caffeine or other methylxanthines such as theophylline might increase the risk of stimulatory adverse effects (8641,24180). There is also some evidence that using ephedra with caffeine might increase the risk of serious life-threatening or debilitating adverse effects such as hypertension, myocardial infarction (MI), stroke, seizures, and death (1275,6486,10307,48751,54423,54429).
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Theoretically, concomitant use might increase the risk of serious adverse effects.
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Theoretically, ephedra might have an additive effect with drugs that prolong the QT interval.
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Even in healthy volunteers, EKG changes including prolonged QT interval and premature atrial contractions have been reported with ingestion of recommended doses of ephedra (11135,11708). Ephedra may have an additive effect with drugs that prolong the QT interval. This may increase the risk of ventricular arrhythmias (11355,48765).
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Theoretically, concomitant use might increase the risk for serious adverse effects.
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Theoretically, guarana might decrease the vasodilatory effects of adenosine and interfere with its use prior to stress testing.
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Guarana contains caffeine. Caffeine is a competitive inhibitor of adenosine at the cellular level. However, caffeine does not seem to affect supplemental adenosine because high interstitial levels of adenosine overcome the antagonistic effects of caffeine (11771). It is recommended that methylxanthines and methylxanthine-containing products be stopped 24 hours prior to pharmacological stress tests (11770). However, methylxanthines appear more likely to interfere with dipyridamole (Persantine) than adenosine-induced stress testing (11771).
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Theoretically, alcohol might increase the levels and adverse effects of caffeine.
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Guarana contains caffeine. Concomitant use of alcohol can increase caffeine serum concentrations and the risk of caffeine adverse effects. Alcohol reduces caffeine metabolism (6370).
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Theoretically, guarana may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
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Theoretically, taking guarana with antidiabetes drugs might interfere with blood glucose control.
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Theoretically, concomitant use might increase the clinical effects of beta-adrenergic agonists.
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Guarana contains caffeine. Theoretically, concomitant use of large amounts of caffeine might increase cardiac inotropic effects of beta-agonists (15).
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Theoretically, guarana might reduce the effects of carbamazepine and increase the risk for convulsions.
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Animal research suggests that taking caffeine can lower the anticonvulsant effects of carbamazepine and can induce seizures when given to animals in doses above 400 mg/kg (23559,23561). Human research has shown that taking caffeine 300 mg in three divided doses along with carbamazepine 200 mg reduces the bioavailability of carbamazepine by 32% and prolongs the plasma half-life of carbamazepine two-fold in healthy individuals (23562).
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Theoretically, concomitant use might increase the effects and adverse effects of caffeine in guarana.
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Guarana contains caffeine. Cimetidine decreases the rate of caffeine clearance by 31% to 42% (11736).
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Theoretically, guarana might increase the levels and adverse effects of clozapine and acutely exacerbate psychotic symptoms.
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Guarana contains caffeine. Caffeine can increase the effects and toxicity of clozapine. Caffeine doses of 400-1000 mg per day inhibit clozapine metabolism (5051). Clozapine is metabolized by cytochrome P450 1A2 (CYP1A2). Researchers speculate that caffeine might inhibit CYP1A2. However, there is no reliable evidence that caffeine affects CYP1A2. There is also speculation that genetic factors might make some patients more sensitive to the interaction between clozapine and caffeine (13741).
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Theoretically, concomitant use might increase the effects and adverse effects of caffeine found in guarana.
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Theoretically, concomitant use might increase the levels and adverse effects of caffeine.
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Theoretically, guarana might decrease the vasodilatory effects of dipyridamole and interfere with its use prior to stress testing.
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Guarana contains caffeine. Caffeine might inhibit dipyridamole-induced vasodilation (11770,11772). It is recommended that methylxanthines and methylxanthine-containing products be stopped 24 hours prior to pharmacological stress tests (11770). Methylxanthines appear more likely to interfere with dipyridamole than adenosine-induced stress testing (11771).
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Theoretically, disulfiram might increase the risk of adverse effects from caffeine.
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In human research, disulfiram decreases the clearance and increases the half-life of caffeine (11840).
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Theoretically, using guarana with diuretic drugs might increase the risk of hypokalemia.
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Theoretically, concomitant use might increase the risk for stimulant adverse effects.
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Guarana contains caffeine. Use of ephedrine with caffeine can increase the risk of stimulatory adverse effects. There is evidence that using ephedrine with caffeine might increase the risk of serious life-threatening or debilitating adverse effects such as hypertension, myocardial infarction, stroke, seizures, and death (1275,6486,10307).
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Theoretically, estrogens might increase the levels and adverse effects of caffeine.
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Guarana contains caffeine. Estrogen inhibits caffeine metabolism (2714).
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Theoretically, guarana might reduce the effects of ethosuximide and increase the risk for convulsions.
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Guarana contains caffeine. Animal research shows that caffeine 92.4 mg/kg can decrease the anticonvulsant activity of ethosuximide (23560). This effect has not been observed in humans.
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Theoretically, guarana might reduce the effects of felbamate and increase the risk for convulsions.
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Guarana contains caffeine. Animal research shows that a high dose of caffeine 161.7 mg/kg can decreases the anticonvulsant activity of felbamate (23563). This effect has not been observed in humans.
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Theoretically, fluconazole might increase the levels and adverse effects of caffeine.
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Guarana contains caffeine. Fluconazole decreases caffeine clearance by approximately 25% (11022).
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Theoretically, guarana might increase the levels and adverse effects of flutamide.
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Guarana contains caffeine. In vitro evidence shows that caffeine can inhibit the metabolism of flutamide (23553). However, this effect has not been reported in humans.
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Theoretically, fluvoxamine might increase the levels and adverse effects of caffeine.
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Guarana contains caffeine. Fluvoxamine reduces caffeine metabolism (6370).
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Theoretically, abrupt guarana withdrawal might increase the levels and adverse effects of lithium.
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Theoretically, metformin might increase the levels and adverse effects of caffeine.
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Guarana contains caffeine. Animal research shows that metformin can reduce caffeine metabolism (23571). However, this effect has not been reported in humans.
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Theoretically, methoxsalen might increase the levels and adverse effects of caffeine.
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Guarana contains caffeine. Methoxsalen can reduce caffeine metabolism (23572).
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Theoretically, mexiletine might increase the levels and adverse effects of caffeine.
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Theoretically, concomitant use might increase the risk of a hypertensive crisis.
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Guarana contains caffeine. Caffeine has been shown to inhibit MAO-A and -B in laboratory studies (37724,37877,37912,38108). Concomitant intake of large amounts of caffeine with MAOIs might precipitate a hypertensive crisis (15). In a case report, a patient that consumed 10-12 cups of caffeinated coffee and took the MAOI tranylcypromine presented with severe hypertension (91086). Hypertension was resolved after the patient switched to drinking decaffeinated coffee.
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Theoretically, concomitant use might increase the risk of hypertension.
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Guarana contains caffeine. Concomitant use of caffeine and nicotine has been shown to have additive cardiovascular effects, including increased heart rate and blood pressure. Blood pressure was increased by 10.8/12.4 mmHg when the agents were used concomitantly (36549).
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Theoretically, guarana might decrease the effects of pentobarbital.
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Theoretically, guarana might reduce the effects of phenobarbital and increase the risk for convulsions.
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Theoretically, phenothiazines might increase the levels and adverse effects of caffeine.
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Theoretically, phenylpropanolamine might increase the risk of hypertension, as well as the levels and adverse effects of caffeine.
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Theoretically, guarana might reduce the effects of phenytoin and increase the risk for convulsions.
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Theoretically, guarana might increase the levels and clinical effects of pioglitazone.
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Guarana contains caffeine. Animal research suggests that caffeine can modestly increase the maximum concentration, area under the curve, and half-life of pioglitazone, and also reduce its clearance. This increased the antidiabetic effects of pioglitazone (108812). However, the exact mechanism of this interaction is unclear.
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Theoretically, quinolone antibiotics might increase the levels and adverse effects of caffeine.
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Theoretically, concomitant use might increase the levels and adverse effects of both caffeine and riluzole.
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Guarana contains caffeine. Caffeine and riluzole are both metabolized by cytochrome P450 1A2 (CYP1A2), and concomitant use might reduce the metabolism of one or both agents (11739).
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Theoretically, concomitant use might increase stimulant adverse effects.
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Guarana contains caffeine. Due to the central nervous system (CNS) stimulant effects of caffeine, concomitant use with stimulant drugs can increase the risk of adverse effects (11832).
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Theoretically, terbinafine might increase the levels and adverse effects of caffeine.
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Guarana contains caffeine. Terbinafine decreases the clearance of intravenous caffeine by 19% (11740).
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Theoretically, guarana might increase the levels and adverse effects of theophylline.
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Guarana contains caffeine. Large amounts of caffeine might decrease theophylline clearance by 23% to 29% (11741).
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Theoretically, guarana might increase the levels and adverse effects of tiagabine.
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Guarana contains caffeine. Animal research shows that chronic caffeine administration can increase the serum concentrations of tiagabine. However, concomitant use does not seem to reduce the antiepileptic effects of tiagabine (23561).
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Theoretically, ticlopidine might increase the levels and adverse effects of caffeine.
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Guarana contains caffeine. In vitro evidence shows that ticlopidine can inhibit the metabolism of caffeine (23557). However, this interaction has not been reported in humans.
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Theoretically, guarana might reduce the effects of valproate and increase the risk for convulsions.
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Theoretically, verapamil might increase the levels and adverse effects of caffeine.
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Verapamil increases plasma caffeine concentrations by 25% (11741).
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Theoretically, L-carnitine might increase the anticoagulant effects of acenocoumarol.
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L-carnitine might enhance the anticoagulant effects of acenocoumarol, an oral anticoagulant similar to warfarin, but shorter-acting (9878,12165). There are at least two case reports of INR elevation with concomitant use. In one case, a 33-year-old male with a previously stable INR had an elevated INR of 4.65 after L-carnitine was started and continued for 10 weeks. INR normalized after discontinuation of the L-carnitine-containing product (12165).
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Theoretically, L-carnitine might decrease the effectiveness of thyroid hormone replacement.
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Theoretically, L-carnitine might increase the anticoagulant effects of warfarin.
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Theoretically, willow bark might result in additive adverse effects associated with acetazolamide.
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Willow bark contains salicin, a plant salicylate. Human case reports suggests that a combination of acetazolamide and salicylate increases unbound plasma levels of acetazolamide, as well as adverse effects related to acetazolamide (86481).
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Theoretically, willow bark might increase the risk of bleeding when taken with anticoagulant/antiplatelet drugs.
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Willow bark has antiplatelet effects, but less so than aspirin (12810).
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Theoretically, willow bark might increase the effects and adverse effects of aspirin.
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Willow bark contains salicin, a plant salicylate. It might have an additive effect when taken with other salicylate-containing drugs such as aspirin (12808).
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Theoretically, willow bark might increase the effects and adverse effects of choline magnesium trisalicylate.
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Willow bark contains salicin, a plant salicylate. It might have an additive effect when taken with other salicylate-containing drugs such as choline magnesium trisalicylate (12808).
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Theoretically, willow bark might increase the effects and adverse effects of salsalate.
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Willow bark contains salicin, a plant salicylate. It might have an additive effect when taken with other salicylate-containing drugs such as salsalate (12808).
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Below is general information about the adverse effects of the known ingredients contained in the product Thermo Cuts. 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, chromium is generally well tolerated.
Most Common Adverse Effects:
Orally: Gastrointestinal irritation, headaches, insomnia, irritability, mood changes.
Serious Adverse Effects (Rare):
Orally: Rare cases of kidney and liver damage, rhabdomyolysis, and thrombocytopenia have been reported.
Dermatologic
...Orally, chromium-containing supplements may cause acute generalized exanthematous pustulosis (42561), skin rashes (42679), and urticaria (17224).
Also, chromium picolinate or chromium chloride may cause systemic contact dermatitis when taken orally, especially in patients with contact allergy to chromium (6624,90058). In one clinical study, a patient taking chromium nicotinate 50 mcg daily reported itchy palms that improved after the intervention was discontinued. It is unclear of this effect was due to the chromium or another factor (95096).
Topically, hexavalent chromium, which can be present in some cement, leather products, or contaminated soil, may cause allergic contact dermatitis (42645,42789,90060,90064,110606).
A case of lichen planus has been reported for a patient following long-term occupational exposure to chromium (42688).
Endocrine ...Orally, cases of hypoglycemia have been reported for patients taking chromium picolinate 200-1000 mcg daily alone or 200-300 mcg two or three times weekly in combination with insulin (42672,42783). Chromium picolinate has also been associated with weight gain in young females who do not exercise and in those following a weight-lifting program (1938).
Gastrointestinal
...Orally, chromium in the form of chromium picolinate, chromium polynicotinate, chromium-containing brewer's yeast, or chromium-containing milk powder may cause nausea, vomiting, diarrhea, decreased appetite, constipation, flatulence, or gastrointestinal upset (14325,42594,42607,42622,42643,42679).
Long-term exposure to heavy metals, including chromium, has been associated with increased risk of gallbladder disease and cancer (42682,42704).
Genitourinary ...Orally, chromium polynicotinate has been associated with disrupted menstrual cycles in patients taking the supplement to prevent weight gain during smoking cessation (42643).
Hematologic ...Anemia, hemolysis, and thrombocytopenia were reported in a 33 year-old female taking chromium picolinate 1200-2400 mcg daily for 4-5 months (554). The patient received supportive care, blood product transfusions, and hemodialysis and was stabilized and discharged a few days later. Lab values were normal at a one-year follow-up.
Hepatic ...Liver damage has been reported for a 33-year-old female taking chromium picolinate 1200 mcg daily for 4-5 months (554). Also, acute hepatitis has been reported in a patient taking chromium polynicotinate 200 mcg daily for 5 months (9141). Symptoms resolved when the product was discontinued. Two cases of hepatotoxicity have been reported in patients who took a specific combination product (Hydroxycut), which also contained chromium polynicotinate in addition to several herbs (13037).
Musculoskeletal ...Acute rhabdomyolysis has been reported for a previously healthy 24-year-old female who ingested chromium picolinate 1200 mcg over a 48-hour time period (42786). Also, chromium polynicotinate has been associated with leg pain and paresthesia in patients taking the supplement to prevent weight gain during smoking cessation (42643).
Neurologic/CNS ...Orally, chromium picolinate may cause headache, paresthesia, insomnia, dizziness, and vertigo (6860,10309,14325,42594). Vague cognitive symptoms, slowed thought processes, and difficulty driving occurred on three separate occasions in a healthy 35-year-old male after oral intake of chromium picolinate 200-400 mcg (42751). Transient increases in dreaming have been reported in three patients with dysthymia treated with chromium picolinate in combination with sertraline (2659). A specific combination product (Hydroxycut) containing chromium, caffeine, and ephedra has been associated with seizures (10307). But the most likely causative agent in this case is ephedra.
Psychiatric ...Orally, chromium picolinate has been associated with irritability and mood changes in patients taking the supplement to lose weight, while chromium polynicotinate has been associated with agitation and mood changes in patients taking the supplement to prevent weight gain during smoking cessation (6860,42643).
Renal
...Orally, chromium picolinate has been associated with at least one report of chronic interstitial nephritis and two reports of acute tubular necrosis (554,1951,14312).
Laboratory evidence suggests that chromium does not cause kidney tissue damage even after long-term, high-dose exposure (7135); however, patient- or product-specific factors could potentially increase the risk of chromium-related kidney damage. More evidence is needed to determine what role, if any, chromium has in potentially causing kidney damage.
Intravenously, chromium is associated with decreased glomerular filtration rate (GFR) in children who receive long-term chromium-containing total parenteral nutrition - TPN (11787).
Topically, burns caused by chromic acid, a hexavalent form of chromium, have been associated with acute chromium poisoning with acute renal failure (42699). Early excision of affected skin and dialysis are performed to prevent systemic toxicity.
Other ...Another form of chromium, called hexavalent chromium, is unsafe. This type of chromium is a by-product of some manufacturing processes. Chronic exposure can cause liver, kidney, or cardiac failure, pulmonary complications, anemia, and hemolysis (9141,11786,42572,42573,42699). Occupational inhalation of hexavalent chromium can cause ulceration of the nasal mucosa and perforation of the nasal septum, and has been associated with pneumoconiosis, allergic asthma, cough, shortness of breath, wheezing, and increased susceptibility to respiratory tract cancer and even stomach and germ cell cancers (42572,42573,42601,42610,42636,42667,42648,42601,42788,90056,90066). Although rare, cases of interstitial pneumonia associated with chromium inhalation have been reported. Symptoms resolved with corticosteroid treatment (42614).
General
...Orally, ephedra is frequently associated with adverse reactions and is banned in the US.
In some cases, adverse effects can be severe or life-threatening. Large studies looking at the safety of ephedra have not been performed. Since most of the adverse effect data are from case reports, it is impossible to determine the overall incidence of these adverse effects. It is also difficult to determine which patient groups might be most likely to experience an adverse event.
Most Common Adverse Effects:
Orally: Anorexia, anxiety, difficulty concentrating, difficulty urinating, dizziness, dry mouth, flushing, headache, heartburn, hyperthermia, hypertension, insomnia, irritability, nausea, personality changes, polydipsia, restlessness, tachycardia, tingling, and vomiting.
Serious Adverse Effects (Rare):
Orally: Cardiac arrest, cardiac arrhythmia, cardiomyopathy, heart failure, hepatotoxicity, myocardial infarction, myopathies, psychosis, seizure, stroke, and sudden death.
Cardiovascular
...The use of ephedra causes a 2.
2- to 3.6-fold increase in the risk of developing psychiatric, autonomic, or gastrointestinal (GI) symptoms and cardiac palpitations (9740,48878). Orally, ephedra use has been associated with cardiomyopathy (1270,48801), hypersensitivity myocarditis (1271,6487,48738,48739), chest tightness, myocardial infarction (6486), cardiac arrest and sudden death (1274,6486), hypertension, tachycardia, and cardiac arrhythmias (6009,8643,35749,35750,37689,48736,48737,48805,48847,48870,48872). Ephedrine abuse has led to heart failure (48813). Even in healthy volunteers, EKG changes including prolonged QT interval and premature atrial contractions can occur with ingestion of recommended doses of ephedra containing products (11135,11708). In a review of 926 cases reported to the FDA of possible adverse effects of ephedra, 37 patients had serious or fatal adverse reactions. Ephedra use was temporally related to 16 strokes, 10 myocardial infarctions, and 11 sudden deaths. These effects occurred in people aged 30-56 years. There is some evidence that people who take doses greater than 32 mg daily might have more than triple the risk of hemorrhagic stroke, including subarachnoid hemorrhage and intracerebral hemorrhage, when compared with those taking doses of less than 32 mg daily (9167,48771).
Ephedrine, the primary active ingredient in ephedra, has been associated with coronary artery spasm, myocardial injury with pulmonary edema, and cardiovascular collapse (48867,48872,48783). However, several clinical trials evaluating ephedrine-caffeine combinations for weight loss reported no differences in mean heart rate or blood pressure when compared to placebo (37617,48792,48865,48882). Other preliminary clinical research showed that ephedrine and caffeine use by prescription did not result in increased risk of adverse cardiovascular outcomes (48806).
Endocrine ...One study in animals shows that some components of ephedra may lower blood glucose levels (48835). However, most human research suggests that ephedra and ephedrine, a component of ephedra, can raise blood glucose and insulin levels (3719,12857,48810).
Gastrointestinal ...The use of ephedra causes a 2. 2- to 3.6-fold increase in the risk of developing psychiatric, autonomic, or gastrointestinal (GI) symptoms and cardiac palpitations (9740,48878). Orally and intravenously, ephedra and ephedrine most commonly cause dry mouth, anorexia, nausea, vomiting, heartburn, abdominal discomfort, and changes in stool consistency (1276,3719,6008,6486,8647,10004,10382,37831,48817,48837). One case of ischemic colitis and symptoms of abdominal pain and bloody diarrhea associated with the use of a weight loss supplement containing ephedra has been reported (48803).
Hepatic ...Cases of hepatotoxicity such as acute hepatitis and liver failure from ephedra-containing supplements have been reported. Some cases of hepatotoxicity resolved after discontinuation of ephedra, while others required liver transplantation. In obese patients using ephedra for weight loss, it is possible that ephedra exacerbated pre-existing liver disease. Onset of liver injury seems to occur an average of 3 months after ephedra ingestion, suggesting an idiosyncratic mechanism of liver injury (1273,48747,48800,94875,94876,94877,81600,98441). Previously, it was thought that the cause of ephedra hepatotoxicity was an immune reaction or a contamination. However, since the majority of evidence suggests that hepatotoxicity is idiosyncratic, these prior postulations have since been dismissed (1273,48747,81600,98441).
Musculoskeletal ...Orally, ephedra has been reported to cause myopathies, including myalgia, rhabdomyolysis, and eosinophilia-myalgia syndrome (1270,16054,48791).
Neurologic/CNS
...The use of ephedra causes a 2.
2- to 3.6-fold increase in the risk of developing psychiatric, autonomic, or gastrointestinal (GI) symptoms and cardiac palpitations (9740,48878). Ephedra most commonly causes dizziness, restlessness, anxiety, irritability, personality changes, difficulty concentrating, insomnia, and headache (1276,3719,6008,6486,8647,10004,10382).
Ephedra can cause seizures in otherwise healthy people, as well as in people with underlying seizure disorders (10307,48870). Of 33 seizures linked to dietary supplement use that were reported to the FDA over 7 years, 27 involved ephedra (13304). Other adverse events reported with ephedra use include sudden hearing loss, stroke, transient ischemic attack, cerebral hemorrhage, and loss of consciousness (1275,1381,2729,6486,8643,9167,10005,48746,48862). In one case-control study, doses of ephedra above 32 mg daily have been associated with an increased risk for hemorrhagic stroke (9167). A case of encephalopathy syndrome with multi-organ failure and transient cortical blindness after ingestion of a performance-enhancing ephedra supplement has been reported. Symptoms were resolved after blood pressure was corrected (48788).
Ocular/Otic ...A case of encephalopathy syndrome with transient cortical blindness after ingestion of an ephedra supplement has been reported. Symptoms were resolved after blood pressure was corrected (48788). A case of sudden hearing loss following the use of ephedra has also been reported (48761).
Psychiatric
...The use of ephedra causes a 2.
2- to 3.6-fold increase in the risk of developing psychiatric, autonomic, or gastrointestinal (GI) symptoms and cardiac palpitations (9740,48878). Ephedra most commonly causes anxiety, irritability, personality changes, difficulty concentrating, and insomnia (1276,3719,6008,6486,8647,10004,10382).
Cases of ephedrine-induced psychiatric complications (6998) include mania (48855), psychosis (1276,6998,10689,48751,48841,48843), and hallucinations (48857). In some cases psychosis can be prolonged for several months after discontinuation (1276,6998,10689). A case of a suicide attempt and mood disorder associated with the use of a diet pill containing ephedra has also been reported (48752).
Long-term use of ephedra or use in high doses has been associated with dependence and tolerance (1381).
Renal ...Orally, ephedra has been reported to cause nephrolithiasis (1272,48877), diuresis, urinary retention, and dysuria (16054,48791).
General
...Orally, guarana is typically well tolerated when used in moderation.
Due to its caffeine content, use of large doses may be unsafe.
Most Common Adverse Effects:
Orally: Stomach burning and nausea.
Cardiovascular
...Orally, a case of premature ventricular contraction has been reported for a 51-year-old female who used guarana as part of a multi-ingredient herbal product (54372).
Guarana contains caffeine. Although acute administration of caffeine can increase blood pressure, regular consumption does not seem to increase either blood pressure or pulse, even in mildly hypertensive patients (1451,1452,2722). Also, epidemiological research suggests there is no association between caffeine consumption and increased incidence of hypertension. Habitual coffee consumption doesn't seem to be related to hypertension, but habitual consumption of sugared or diet cola is associated with development of hypertension (13739).
Combining ephedra with guarana can increase the risk of adverse effects. Cases of hypertension and chest pain have been reported for patients who took products containing guarana and ephedra (8644,54376). A case of cerebral infarction has also been reported for a patient consuming ephedra extract and guarana (48746). There is also a report of ischemic stroke in an athlete who consumed ephedra 40-60 mg, creatine monohydrate 6 grams, caffeine 400-600 mg, and a variety of other supplements daily for six weeks (1275).
Dermatologic ...Guarana contains caffeine. There are several case reports of urticaria after caffeine ingestion (36546,36448,36475).
Endocrine
...Guarana contains caffeine.
Some evidence shows caffeine is associated with fibrocystic breast disease, breast cancer, and endometriosis; however, this is controversial since findings are conflicting (8043). Restricting caffeine in people with fibrocystic breast conditions doesn't seem to affect breast nodularity, swelling, or pain (8996). A population analysis of the Women's Health Initiative observational study has found no association between consumption of caffeine-containing beverages and the incidence of invasive breast cancer in models adjusted for demographic, lifestyle, and reproductive factors (108806). Also, a dose-response analysis of 2 low-quality observational studies has found that high consumption of caffeine is not associated with an increased risk of breast cancer (108807).
Although the effects of guarana alone are not clear, the combination of guarana along with ephedra has been reported to cause increased blood glucose levels and decreased blood levels of potassium (54376).
Gastrointestinal ...Orally, guarana can cause a sensation of burning in the stomach and vomiting (54414,91487). These effects may be due to caffeine in guarana. Orally, caffeine can cause gastric irritation, nausea, and vomiting (11832,11838,13735). In infants, caffeine may also cause feeding intolerance and gastrointestinal irritation (6023).
Immunologic ...Guarana contains caffeine. When taken orally, caffeine can cause anaphylaxis in sensitive individuals, although true IgE-mediated caffeine allergy seems to be relatively rare (11315).
Musculoskeletal
...In a clinical trial of guarana extract, one person abandoned treatment due to symptoms of arthritis with edema.
It is not clear if this adverse effect is due to guarana (91487).
Cases of rhabdomyolysis and myoglobinuria have been reported in individuals that have taken products containing guarana in combination with ephedra and other herbal products. These adverse effects are thought to be related to the caffeine content of guarana (19154,36466).
Epidemiological evidence regarding the relationship between caffeine use and the risk for osteoporosis is contradictory. Caffeine can increase urinary excretion of calcium (2669,10202,11317). Women identified with a genetic variant of the vitamin D receptor appear to be at an increased risk for the detrimental effect of caffeine on bone mass (2669). However, moderate caffeine intake, less than 300 mg per day, does not seem to significantly increase osteoporosis risk in most postmenopausal women with normal calcium intake (2669,6025,10202,11317).
Neurologic/CNS
...Orally, guarana can cause dizziness (91483).
The caffeine in guarana can cause insomnia (especially in children), nervousness, restlessness, dizziness, tremors, delirium, and convulsions. Other symptoms include headache, anxiety, and agitation (10755,11832,11838,13735,108016).
Taking guarana with ephedra can cause insomnia, irritability, dizziness, and headache (3719). The combination of ephedra and caffeine in guarana might also increase the risk of adverse effects such as jitteriness, seizures, and temporary loss of consciousness (2729,21015).
Ocular/Otic ...Guarana contains caffeine. When taken orally, caffeine can cause ringing in the ears (11832,11838,13735).
Psychiatric ...In a clinical trial, depression was reported by one person taking guarana extract (91483).
Renal ...Guarana contains caffeine. When taken orally, caffeine can cause diuresis (11832,11838,13735).
Other ...Guarana contains caffeine. The existence or clinical importance of caffeine withdrawal is controversial. Some researchers think that if it exists, it appears to be of little clinical significance (11839). Other researchers suggest symptoms such as headache; tiredness and fatigue; decreased energy, alertness, and attentiveness; drowsiness; decreased contentedness; depressed mood; difficulty concentrating; irritability; and lack of clear-headedness are typical of caffeine withdrawal (13738). Withdrawal symptoms such as delirium, nausea, vomiting, rhinorrhea, nervousness, restlessness, anxiety, muscle tension, muscle pains, and flushed face have been described. However, these symptoms may be from nonpharmacological factors related to knowledge and expectation of effects. Clinically significant symptoms caused by caffeine withdrawal may be uncommon (2723,11839).
General
...Orally and intravenously, L-carnitine is generally well tolerated.
Most Common Adverse Effects:
All routes of administration: Abdominal cramps, abdominal pain, diarrhea, gastritis, heartburn, nausea, reduced appetite, and vomiting. A fish-like body odor has also been reported.
Serious Adverse Effects (Rare):
All routes of administration: Seizures.
Cardiovascular ...According to population research, plasma L-carnitine levels are associated with increased risk of cardiovascular disease and major cardiac events (90635). However, oral supplementation with L-carnitine does not appear to be associated with an increased risk of cardiovascular disease. In fact, a meta-analysis of clinical research shows that L-carnitine supplementation is associated with a reduction in all-cause mortality, as well as ventricular arrhythmias and the development of angina and does not increase the development of heart failure or myocardial reinfarction (59037). Also, another meta-analysis suggests that L-carnitine does not affect mortality or cardiovascular outcomes in patients with a previous myocardial infarction (90630).
Dermatologic ...Orally, L-carnitine has been reported to cause skin rash in a small number of cases (16105,91724). Two patients in a hair growth study using topical carnitine reported mild itching and increased dandruff, while a third reported strong itching with reddish bumps and a burning sensation (58390). When a specific formulation containing L-carnitine, licochalcone, and 1,2-decanediol was applied to the face, mild skin dryness and tightness was reported by 12% of volunteers, compared with 4% to 8% of those in the vehicle-only control group (26493).
Gastrointestinal ...Orally and intravenously, L-carnitine has been associated with nausea, epigastric discomfort, vomiting, abdominal cramps, heartburn, gastritis, anorexia, and diarrhea (3616,3624,59030,95069,95070,101562,107410,111870,111887,111891). Orally, diarrhea or colitis symptoms (1433,3630,16105,16107,16111,23437,58523,58554,59020,90623), nausea and abdominal pain (16105,16106,26499,58169,58392,58554,90623,90634), indigestion (26703), and constipation (58523) have been reported in various clinical trials.
Hematologic ...In one case report, L-carnitine 990 mg twice daily was started in a female presenting to hospital with valproic acid toxicity. Blood phosphorous levels subsequently fell from 2.3 mg/dL to 1.3 mg/dL over 4 days. After discontinuation of L-carnitine, blood phosphorus levels increased to 1.8 mg/dL. The authors suggested that the role of L-carnitine in improved protein metabolism may play a role in the declining levels of phosphorous in the blood and increased risk of hypophosphatemia (90628).
Neurologic/CNS ...Orally or intravenously, L-carnitine has been associated with seizures (3616). Orally, use of L-carnitine in clinical trials has resulted in headache, although this event is rare (58554,95070,111891). L-carnitine may also cause agitation (95070).
Other ...Orally or intravenously, L-carnitine has been associated with a fish-like body odor (1433,3616,58166,59854,90623). One of its metabolites, trimethylamine N-oxide, can cause the urine, breath, and sweat to have a fishy odor (12756,58664).
General
...Orally, willow bark seems to be well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, dyspepsia, heartburn, and vomiting. May cause itching and rash in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal bleeding and renal impairment. May cause serious allergic reactions, including anaphylaxis, in people who are allergic to aspirin.
Cardiovascular ...In one clinical trial, a single patient withdrew from the study investigating oral willow bark due to blood pressure instability that the authors determined was 'possibly' related to treatment (12804).
Dermatologic ...Orally, willow bark may cause itching and rash in some people due to allergy (6456,12474,12475,12804,86459).
Gastrointestinal ...Orally, willow bark extract can cause gastrointestinal adverse effects, but these appear to be less frequent than those caused by NSAIDs. Examples include diarrhea, heartburn, vomiting, and dyspepsia (12474,12475,12804,86459). In a case report of a child, severe gastrointestinal bleeding occurred following use of a specific syrup (FreddoBaby), which contained ribwort plantain, licorice, willow bark, black elder, meadowsweet, and propolis. The adverse effect was attributed to salicylate content of the syrup. This product has since been withdrawn from the market (86477).
Immunologic ...Orally, willow bark may cause serious allergic reactions, including anaphylaxis, in people who are allergic to aspirin (10392)
Neurologic/CNS ...Orally, willow bark may cause headache and dizziness (12804). In a clinical trial evaluating a combination product containing willow bark, black cohosh, sarsaparilla, poplar bark, and guaiac wood (Reumalex), severe headaches occurred (35946).
Ocular/Otic ...Orally, symptoms of allergy to willow bark have included swollen eyes (6456).
Renal ...Salicylates can inhibit prostaglandins, which can reduce renal blood flow (12805). Salicin can cause renal papillary necrosis (12806). The risk for toxicity is greater with high acute doses or chronic use (12805).
