Each tablet contains: Aesculus hippocastanum 4X • Cinchona officinalis 4X • Cocculus Indicus 4X • Conium Maculatum 4X • Gelsemium sempervirens 4X • Ruta graveolens 4X • Aconitum napellus 6X • Anacardium Orientale 6X • Hyoscyamus niger 6X • Kali Phosphoricum 6X • Thuja occidentalis 6X • Cerebrum Suis 8X • Ignatia amara 8X • Kali bichromicum 8X • Manganum phosphoricum 8X • Ambra Grisea 10X • Bothrops lanceolatus 10X • Embryo Suis 10X • Hepar Suis 10X • Magnesia Phosphorica 10X • Phosphoricum Acidum 10X • Placenta Suis 10X • Selenium Metallicum 10X • Sulfur 10X • Medorrhinum 13X • Arnica montana radix 28X. Other Ingredient: Lactose.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
This is a homeopathic preparation. Homeopathy is a system of medicine established in the 19th century by a German physician named Samuel Hahnemann. Its basic principles are that "like treats like" and "potentiation through dilution." For example, in homeopathy, diarrhea would be treated with an extreme dilution of a substance that normally causes diarrhea when taken in high doses.
Practitioners of homeopathy believe that more dilute preparations are more potent. Many homeopathic preparations are so diluted that they contain little or no active ingredient. Therefore, most homeopathic products are not expected to have any pharmacological effects, drug interactions, or other harmful effects. Any beneficial effects are controversial and cannot be explained by current scientific methods.
Dilutions of 1 to 10 are designated by an "X." So a 1X dilution = 1:10, 3X=1:1000; 6X=1:1,000,000. Dilutions of 1 to 100 are designated by a "C." So a 1C dilution = 1:100; 3C = 1:1,000,000. Dilutions of 24X or 12C or more contain zero molecules of the original active ingredient.
Homeopathic products are permitted for sale in the US due to legislation passed in 1938 sponsored by a homeopathic physician who was also a Senator. The law still requires that the FDA allow the sale of products listed in the Homeopathic Pharmacopeia of the United States. However, homeopathic preparations are not held to the same safety and effectiveness standards as conventional medicines. For more information, see the Homeopathy monograph.
Below is general information about the effectiveness of the known ingredients contained in the product Cerebrum compositum. 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
There is insufficient reliable information available about the effectiveness of gelsemium.
There is insufficient reliable information available about the effectiveness of hemlock.
There is insufficient reliable information available about the effectiveness of henbane.
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of Ignatius bean.
There is insufficient reliable information available about the effectiveness of levant berry.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Cerebrum compositum. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
UNSAFE ...when used orally or topically. Aconite root contains toxic alkaloids that are strong, fast-acting poisons that affect the heart and central nervous system, causing severe arrhythmias, reduced consciousness, and death (15499,19669,30294,30300,30301,30303,30309,30334,30335,30336,92276,104514,106706). All species of this plant are dangerous. Severe poisoning has been reported after ingestion of 0.2-2 mg of aconitine, 1 gram of the raw plant, or 6 grams of processed and cured aconite (3490,104514). Even when a processed product is used, aconite can cause toxicity including nausea, vomiting, dizziness, muscle spasms, hypothermia, paralysis of the respiratory system, and heart rhythm disorders (15499). Aconite can also be absorbed through the skin and cause significant toxicity (12).
PREGNANCY AND LACTATION: UNSAFE
when used orally or topically (15499).
POSSIBLY SAFE ...when used orally in amounts commonly found in foods. Arnica has Generally Recognized As Safe (GRAS) status for use as a food flavoring in the US (4912). However, Canadian regulations do not allow its use as a food ingredient (12). ...when used orally in homeopathic dilutions of 30C and up to 5C (19110,19111,19117,19124,19126,96769). ...when used topically on unbroken skin, short-term (12).
LIKELY UNSAFE ...when used orally or when applied topically to broken skin. Arnica is considered poisonous and has caused severe or fatal poisonings (5). Arnica can cause gastroenteritis, muscle paralysis, bleeding, arrhythmia, hypertension, shortness of breath, nausea and vomiting, multi-organ failure, and death (4,5,17,104,19101,19102,19103,19104,19105,19106,19107,19108).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally or topically; avoid using (12).
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.
UNSAFE ...when the rhizome or root are used orally. All parts of the plant contain toxic alkaloids. The adult lethal dose is 2-3 grams or 4 mL of the fluid extract (18).
CHILDREN: UNSAFE
when used orally.
The lethal dose is 500 mg (18).
PREGNANCY AND LACTATION: UNSAFE
when used orally due to toxicity (6).
UNSAFE ...when used orally (6338). All parts of hemlock including seeds, flowers, and fruits are considered poisonous (6338,6339). Death has resulted after ingestion of hemlock (6340,54711). Damage to the tubule cells of the kidneys (acute tubular necrosis), rapid breakdown of muscle tissue and release of muscle tissue byproducts into the blood (rhabdomyolysis), and subsequent kidney failure, as well as respiratory arrest, have also been reported following ingestion of hemlock (54709,54716,54718,54727). Prompt medical attention is advised after ingestion of hemlock (6341).
CHILDREN: UNSAFE
when used orally (6340).
Acute, sometimes lethal poisoning has resulted after ingestion of leaf material (6340) or when hollow stems are used as peashooters, flutes, or whistles (6338).
PREGNANCY AND LACTATION: UNSAFE
when used orally because ingestion can be lethal (6338); avoid using.
POSSIBLY SAFE ...when henbane leaf is used orally and appropriately, short-term. Henbane leaf powder has been used with apparent safety in single doses of up to 1 gram, which have been standardized to contain 500-700 mg of total alkaloids. The maximum daily dosage should not exceed 3 grams, corresponding to 1500-2100 mg of total alkaloids (2,18).
LIKELY UNSAFE ...when the leaf is used orally in doses above 3 grams daily. This maximum tolerated dose contains 1500-2100 mg of total alkaloids, which include hyoscyamine and scopolamine. These alkaloids have a narrow therapeutic range; excessive doses can cause poisoning and death (2,18). There is insufficient reliable information available about the safety of henbane seed and flower.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally because of its risk of poisoning (18).
LIKELY SAFE ...when standardized horse chestnut seed extracts are used orally and appropriately, short-term. These extracts, from which esculin, a toxic constituent, has been removed (9420), have been used with apparent safety for 2-12 weeks (281,282,283,284,285,12113,95429,95430).
UNSAFE ...when the raw seed, bark, flower, or leaf is used orally. Horse chestnut contains significant amounts of the toxin esculin, and can be lethal (17). There is insufficient reliable information available about the safety of horse chestnut when used topically, intravenously, or intramuscularly.
CHILDREN: UNSAFE
when the raw seeds, bark, flower, or leaves are used orally.
Poisoning has been reported from children drinking tea made with twigs and leaves (9,55528).
PREGNANCY AND LACTATION: UNSAFE
when the raw seed, bark, flower, or leaf are used orally.
Horse chestnut preparations can be lethal (17); avoid using. There is insufficient reliable information available about the safety of horse chestnut seed extract when used during pregnancy and lactation; avoid using.
POSSIBLY UNSAFE ...when used topically; avoid application to broken skin (6).
LIKELY UNSAFE ...when used orally due to toxic potential (6). Picrotoxin 30 mg/kg or 2-3 cocculus kernels can cause death (6,18).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally or topically (6); avoid using.
LIKELY SAFE ...when used orally and appropriately. Oral magnesium is safe when used in doses below the tolerable upper intake level (UL) of 350 mg daily (7555). ...when used parenterally and appropriately. Parenteral magnesium sulfate is an FDA-approved prescription product (96484).
POSSIBLY UNSAFE ...when used orally in excessive doses. Doses greater than the tolerable upper intake level (UL) of 350 mg daily frequently cause loose stools and diarrhea (7555).
CHILDREN: LIKELY SAFE
when used orally and appropriately.
Magnesium is safe when used in doses below the tolerable upper intake level (UL) of 65 mg daily for children 1 to 3 years, 110 mg daily for children 4 to 8 years, and 350 mg daily for children older than 8 years (7555,89396). ...when used parenterally and appropriately (96483).
CHILDREN: LIKELY UNSAFE
when used orally in excessive doses.
Tell patients not to use doses above the tolerable upper intake level (UL). Higher doses can cause diarrhea and symptomatic hypermagnesemia including hypotension, nausea, vomiting, and bradycardia (7555,8095).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately.
Magnesium is safe for those pregnant and breast-feeding when used in doses below the tolerable upper intake level (UL) of 350 mg daily (7555).
PREGNANCY AND LACTATION: POSSIBLY SAFE
when prescription magnesium sulfate is given intramuscularly and intravenously prior to delivery for up to 5 days (12592,89397,99354,99355).
However, due to potential adverse effects associated with intravenous and intramuscular magnesium, use during pregnancy is limited to patients with specific conditions such as severe pre-eclampsia or eclampsia. There is some evidence that intravenous magnesium can increase fetal mortality and adversely affect neurological and skeletal development (12590,12593,60818,99354,99355). However, a more recent analysis of clinical research shows that increased risk of fetal mortality seems to occur only in the studies where antenatal magnesium is used for tocolysis and not for fetal neuroprotection or pre-eclampsia/eclampsia (102457). Furthermore, antenatal magnesium does not seem to be associated with increased risk of necrotizing enterocolitis in preterm infants (104396). There is also concern that magnesium increases the risk of maternal adverse events. A meta-analysis of clinical research shows that magnesium sulfate might increase the risk of maternal adverse events, especially in Hispanic mothers compared to other racial and ethnic groups (60971,99319).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in excessive doses.
Tell patients to avoid exceeding the tolerable upper intake level (UL) of 350 mg daily. Taking magnesium orally in higher doses can cause diarrhea (7555). ...when prescription magnesium sulfate is given intramuscularly and intravenously prior to delivery for longer than 5 days (12592,89397,99354,99355). Maternal exposure to magnesium for longer than 5-7 days is associated with an increase in neonatal bone abnormalities such as osteopenia and fractures. The U.S. Food and Drug Administration (FDA) recommends that magnesium injection not be given for longer than 5-7 days (12590,12593,60818,99354,99355).
LIKELY SAFE ...when used orally in doses up to 100 mEq total potassium daily, not to exceed 200 mEq in a 24-hour period (95010,107989). Oral potassium chloride and potassium citrate are FDA-approved prescription products (95010,107989). Larger doses increase the risk of hyperkalemia (15). ...when administered intravenously (IV) at appropriate infusion rates (95011). Parenteral potassium is an FDA-approved prescription product (15,95011). A tolerable upper intake level (UL) for potassium has not been established; however, potassium levels should be monitored in individuals at increased risk for hyperkalemia, such as those with kidney disease, heart failure, and adrenal insufficiency (100310,107966).
CHILDREN: LIKELY SAFE
when used orally and appropriately in dietary amounts.
A tolerable upper intake level (UL) has not been established for healthy individuals (6243,100310).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in dietary amounts of 40-80 mEq daily (15).
A tolerable upper intake level (UL) has not been established for healthy individuals (100310).
LIKELY SAFE ...when used orally in amounts commonly found in foods. Rue and rue oil have Generally Recognized as Safe (GRAS) status for use in foods at concentrations that do not exceed 2 parts per million (ppm) (12,4912).
POSSIBLY SAFE ...when products containing dried rue leaves are used medicinally in appropriate doses (6,12,18,515). However, therapeutic doses can cause drowsiness, dizziness, and gastrointestinal irritation and cramps (12).
LIKELY UNSAFE ...when fresh rue and rue oil are used orally, or when large doses of the dried herb are used orally (2,12,18). Overdose is associated with severe abdominal pain, vomiting, liver damage, kidney damage, vertigo, respiratory distress, and delirium, and can be fatal (12,18). ...when fresh rue is applied topically. Rue can cause contact dermatitis and severe photodermatitis (2,6,11,19,104119,107948).
PREGNANCY: LIKELY UNSAFE
when used orally.
Rue has uterine stimulant and abortifacient effects (12,19); avoid using. Deaths have been reported in women who used rue as an abortifacient (2).
LACTATION:
There is insufficient reliable information available about the use of rue when breast-feeding; avoid use.
LIKELY SAFE ...when used orally and appropriately. Selenium appears to be safe when taken short-term in amounts below the tolerable upper intake level (UL) of 400 mcg daily (4844,7830,7831,7836,7841,9724,9797,14447,17510,17511)(17512,17513,17515,17516,97087,97943,109085); however, there is concern that taking selenium long-term might not be safe. Some evidence shows that consuming a diet containing more than the recommended dietary allowance (RDA) of selenium, which is 55 mcg daily for most adults, is associated with an increased risk for developing type 2 diabetes (99661). Some evidence also shows that taking a selenium supplement 200 mcg daily for an average of 3-8 years increases the risk of developing type 2 diabetes (97091,99661). Higher serum levels of selenium are also associated with an increased risk of developing diabetes and increased mortality (16710,99661). ...when used intravenously. Selenium, as selenious acid, is an FDA-approved drug. Sodium selenite intravenous infusions up to 1000 mcg daily have been safely used for up to 28 days (90347,92910).
POSSIBLY UNSAFE ...when used orally in high doses or long-term. Doses above 400 mcg daily can increase the risk of developing selenium toxicity (4844,7825). Additionally, some evidence shows that consuming a diet containing more than the recommended dietary allowance (RDA) of selenium, which is 55 mcg daily for most adults, is associated with an increased risk for developing type 2 diabetes (99661). There is also concern that taking a selenium supplement 200 mcg daily long-term, for an average of 3-8 years, increases the risk of developing type 2 diabetes (99661). Higher serum levels of selenium are also associated with an increased risk of developing diabetes and increased mortality (16710,99661).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately.
Selenium seems to be safe when used short-term in doses below the tolerable upper intake level (UL) of 45 mcg daily for infants up to age 6 months, 60 mcg daily for infants 7 to 12 months, 40-90 mcg daily for children 1 to 3 years, 100-150 mcg daily for children 4 to 8 years, 200-280 mcg daily for children 9 to 13 years, and 400 mcg daily for children age 14 years and older (4844,86095); however, there is some concern that long-term use might not be safe. ...when used via a nasogastric tube in premature infants (7835,9764).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately.
Selenium appears to be safe when used short-term in amounts that do not exceed the tolerable upper intake level (UL) of 400 mcg daily (4844,17507,74419,74481,74391); however, there is concern that long-term use might not be safe.
PREGNANCY: POSSIBLY UNSAFE
when used orally in excessive doses.
Doses above 400 mcg daily may cause significant toxicity (4844).
LACTATION: POSSIBLY SAFE
when used orally and appropriately.
Selenium appears to be safe when used short-term in amounts that do not exceed the tolerable upper intake level (UL) of 400 mcg daily when taken short-term (4844,74467); however, there is concern that long-term use might not be safe.
LACTATION: POSSIBLY UNSAFE
when used orally in excessive doses.
Doses above 400 mcg daily may cause significant toxicity (4844,7838). ...when used orally in HIV-positive women. Selenium supplementation in HIV-positive women not taking highly active antiretroviral therapy may increase HIV-1 levels in breast milk (90358).
POSSIBLY SAFE ...when used topically and appropriately, short-term. Topical products containing sulfur in concentrations up to 10% have been used safely in clinical research for up to 8 weeks (27846,27847,88107,88112,88123,88124,98205,98207,100735). There is insufficient reliable information available about the safety of using sulfur orally.
CHILDREN: POSSIBLY SAFE
when used topically and appropriately, short-term.
Topical products containing sulfur in concentrations up to 6% have been used safely when applied nightly in children and adolescents for up to 6 nights (27846,27847). In infants, topical products containing sulfur in concentrations up to 2% have been safely applied for 3 hours daily for up to 6 days (27847).
PREGNANCY AND LACTATION: POSSIBLY SAFE
when applied topically and appropriately, short-term.
Topical products containing sulfur in concentrations up to 6% have been safely applied nightly for up to 6 nights (27846,27847). There is insufficient reliable information available about the safety of sulfur when used orally; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Thuja that is thujone-free has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY UNSAFE ...when used orally in medicinal amounts. Large doses of thuja have been reported to cause seizures, severe vomiting, organ toxicity, and death in some cases (6002,40888). There is insufficient reliable information available about the safety of thuja when used topically.
PREGNANCY: LIKELY UNSAFE
when used orally due to abortifacient activity (12); avoid using.
LACTATION: LIKELY UNSAFE
when used orally due to toxicity (11); avoid using.
Below is general information about the interactions of the known ingredients contained in the product Cerebrum compositum. 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, combining aconite with other antiplatelet or anticoagulant drugs might increase the risk of bruising and bleeding.
 Details
Higenamine, a constituent of aconite, is thought to have antiplatelet and antithrombotic effects. In an animal model of thrombosis, higenamine inhibited platelet aggregation and reduced the size of thrombus formation (92282).
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Theoretically, combining aconite with other stimulant drugs might alter the effects of the stimulant drug or increase the risk of cardiovascular toxicity.
Details
Aconite and its constituents have stimulant effects due to agonist activity at beta-2-adrenoreceptors. In cardiac muscle, aconite appears to have a positive inotropic effect and increases heart rate and blood pressure (2634,15499,30296,92282). However, some constituents of aconite can reduce heart rate and blood pressure (15499,30343).
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Theoretically, arnica might have additive effects with anticoagulant and antiplatelet drugs. Homeopathic arnica preparations are unlikely to have this interaction.
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In vitro evidence shows that sesquiterpene lactones in arnica flowers can decrease platelet aggregation (104). However, this effect has not been reported in humans.
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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.
Details
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.
Details
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Chromium might bind levothyroxine in the intestinal tract and decrease levothyroxine absorption.
Details
Clinical research in healthy volunteers shows that taking chromium picolinate 1000 mcg with levothyroxine 1 mg decreases serum levels of levothyroxine by 17% when compared to taking levothyroxine alone (16012). Advise patients to take levothyroxine at least 30 minutes before or 3-4 hours after taking chromium.
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NSAIDs might increase chromium levels in the body.
Details
Drugs that are prostaglandin inhibitors, such as NSAIDs, seem to increase chromium absorption and retention (7135).
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Concomitant use of henbane can have additive anticholinergic effects and adverse effects with amantadine, antihistamines, atropine, belladonna alkaloids, hyoscyamine, phenothiazines, procainamide, scopolamine, and tricyclic antidepressants (2).
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Horse chestnut may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
Horse chestnut contains the constituent esculin which has been shown to have antithrombotic effects. Therefore, horse chestnut might have antiplatelet effects (19). This has not been shown in humans.
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Concomitant use of aminoglycoside antibiotics and magnesium can increase the risk for neuromuscular weakness.
Details
Both aminoglycosides and magnesium reduce presynaptic acetylcholine release, which can lead to neuromuscular blockade and possible paralysis. This is most likely to occur with high doses of magnesium given intravenously (13362).
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Use of acid reducers may reduce the laxative effect of magnesium oxide.
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A retrospective analysis shows that, in the presence of H2 receptor antagonists (H2RAs) or proton pump inhibitors (PPIs), a higher dose of magnesium oxide is needed for a laxative effect (90033). This may also occur with antacids. Under acidic conditions, magnesium oxide is converted to magnesium chloride and then to magnesium bicarbonate, which has an osmotic laxative effect. By reducing acidity, antacids may reduce the conversion of magnesium oxide to the active bicarbonate salt.
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Theoretically, magnesium may have antiplatelet effects, but the evidence is conflicting.
Details
In vitro evidence shows that magnesium sulfate inhibits platelet aggregation, even at low concentrations (20304,20305). Some preliminary clinical evidence shows that infusion of magnesium sulfate increases bleeding time by 48% and reduces platelet activity (20306). However, other clinical research shows that magnesium does not affect platelet aggregation, although inhibition of platelet-dependent thrombosis can occur (60759).
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Magnesium can decrease absorption of bisphosphonates.
Details
Cations, including magnesium, can decrease bisphosphonate absorption. Advise patients to separate doses of magnesium and these drugs by at least 2 hours (13363).
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Magnesium can have additive effects with calcium channel blockers, although evidence is conflicting.
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Magnesium inhibits calcium entry into smooth muscle cells and may therefore have additive effects with calcium channel blockers. Severe hypotension and neuromuscular blockades may occur when nifedipine is used with intravenous magnesium (3046,20264,20265,20266), although some contradictory evidence suggests that concurrent use of magnesium with nifedipine does not increase the risk of neuromuscular weakness (60831). High doses of magnesium could theoretically have additive effects with other calcium channel blockers.
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Magnesium salts may reduce absorption of digoxin.
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Gabapentin absorption can be decreased by magnesium.
Details
Clinical research shows that giving magnesium oxide orally along with gabapentin decreases the maximum plasma concentration of gabapentin by 33%, time to maximum concentration by 36%, and area under the curve by 43% (90032). Advise patients to take gabapentin at least 2 hours before, or 4 to 6 hours after, magnesium supplements.
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Magnesium might precipitate ketamine toxicity.
Details
In one case report, a 62-year-old hospice patient with terminal cancer who had been stabilized on sublingual ketamine 150 mg four times daily experienced severe ketamine toxicity lasting for 2 hours after taking a maintenance dose of ketamine following an infusion of magnesium sulfate 2 grams (105078). Since both magnesium and ketamine block the NMDA receptor, magnesium is thought to have potentiated the effects of ketamine.
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Magnesium can reduce the bioavailability of levodopa/carbidopa.
Details
Clinical research in healthy volunteers shows that taking magnesium oxide 1000 mg with levodopa 100 mg/carbidopa 10 mg reduces the area under the curve (AUC) of levodopa by 35% and of carbidopa by 81%. In vitro and animal research shows that magnesium produces an alkaline environment in the digestive tract, which might lead to degradation and reduced bioavailability of levodopa/carbidopa (100265).
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Potassium-sparing diuretics decrease excretion of magnesium, possibly increasing magnesium levels.
Details
Potassium-sparing diuretics also have magnesium-sparing properties, which can counteract the magnesium losses associated with loop and thiazide diuretics (9613,9614,9622). Theoretically, increased magnesium levels could result from concomitant use of potassium-sparing diuretics and magnesium supplements.
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Magnesium decreases absorption of quinolones.
Details
Magnesium can form insoluble complexes with quinolones and decrease their absorption (3046). Advise patients to take these drugs at least 2 hours before, or 4 to 6 hours after, magnesium supplements.
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Sevelamer may increase serum magnesium levels.
Details
In patients on hemodialysis, sevelamer use was associated with a 0.28 mg/dL increase in serum magnesium. The mechanism of this interaction remains unclear (96486).
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Parenteral magnesium alters the pharmacokinetics of skeletal muscle relaxants, increasing their effects and accelerating the onset of effect.
Details
Parenteral magnesium shortens the time to onset of skeletal muscle relaxants by about 1 minute and prolongs the duration of action by about 2 minutes. Magnesium potentiates the effects of skeletal muscle relaxants by decreasing calcium-mediated release of acetylcholine from presynaptic nerve terminals, reducing postsynaptic sensitivity to acetylcholine, and having a direct effect on the membrane potential of myocytes (3046,97492,107364). Magnesium also has vasodilatory actions and increases cardiac output, allowing a greater amount of muscle relaxant to reach the motor end plate (107364). A clinical study found that low-dose rocuronium (0.45 mg/kg), when given after administration of magnesium 30 mg/kg over 10 minutes, has an accelerated onset of effect, which matches the onset of effect seen with a full-dose rocuronium regimen (0.6 mg/kg) (96485). In another clinical study, onset times for rocuronium doses of 0.3, 0.6, and 1.2 mg/kg were 86, 76, and 50 seconds, respectively, when given alone, but were reduced to 66, 44, and 38 seconds, respectively, when the doses were given after a 15-minute infusion of magnesium sulfate 60 mg/kg (107364). Giving intraoperative intravenous magnesium sulfate, 50 mg/kg loading dose followed by 15 mg/kg/hour, reduces the onset time of rocuronium, enhances its clinical effects, reduces the dose of intraoperative opiates, and prolongs the spontaneous recovery time (112781,112782). It does not affect the activity of subsequently administered neostigmine (112782).
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Magnesium increases the systemic absorption of sulfonylureas, increasing their effects and side effects.
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Clinical research shows that administration of magnesium hydroxide with glyburide increases glyburide absorption, increases maximal insulin response by 35-fold, and increases the risk of hypoglycemia, when compared with glyburide alone (20307). A similar interaction occurs between magnesium hydroxide and glipizide (20308). The mechanism of this effect appears to be related to the elevation of gastrointestinal pH by magnesium-based antacids, increasing solubility and enhancing absorption of sulfonylureas (22364).
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Magnesium decreases absorption of tetracyclines.
Details
Magnesium can form insoluble complexes with tetracyclines in the gut and decrease their absorption and antibacterial activity (12586). Advise patients to take these drugs 1 hour before or 2 hours after magnesium supplements.
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Using ACEIs with high doses of potassium increases the risk of hyperkalemia.
Details
ACEIs block the actions of the renin-angiotensin-aldosterone system and reduce potassium excretion (95628). Concomitant use of these drugs with potassium supplements increases the risk of hyperkalemia (15,23207). However, concomitant use of these drugs with moderate dietary potassium intake (about 3775-5200 mg daily) does not increase serum potassium levels (95628).
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Using ARBs with high doses of potassium increases the risk of hyperkalemia.
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ARBs block the actions of the renin-angiotensin-aldosterone system and reduce potassium excretion (95628). Concomitant use of these drugs with potassium supplements increases the risk of hyperkalemia (15,23207). However, concomitant use of these drugs with moderate dietary potassium intake (about 3775-5200 mg daily) does not increase serum potassium levels (95628).
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Concomitant use increases the risk of hyperkalemia.
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Using potassium-sparing diuretics with potassium supplements increases the risk of hyperkalemia (15).
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Theoretically, rue might increase the risk for phototoxicity when used with photosensitizing drugs.
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Selenium may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
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Clinical research suggests that taking selenium 10 mcg/kg/day can increase bleeding times by increasing prostacyclin production, which inhibits platelet activity (14540). Other clinical research suggests that taking selenium 75 mcg daily, in combination with ascorbic acid 600 mg, alpha-tocopherol 300 mg, and beta-carotene 27 mg, reduces platelet aggregation (74406).
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Theoretically, selenium might prolong the sedating effects of barbiturates.
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Contraceptive drugs might increase levels of selenium, although the clinical significance of this effect is unclear.
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Some research suggests that oral contraceptives increase serum selenium levels in women taking oral contraceptives; however, other research shows no change in selenium levels (14544,14545,14546,101343). It is suggested that an increase could be due to increased carrier proteins, indicating a redistribution of selenium rather than a change in total body selenium (14545).
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Gold salts might interfere with selenium activity in tissues.
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Theoretically, selenium supplementation may reduce the effectiveness of immunosuppressant therapy.
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Selenium might reduce the beneficial effects of niacin on high-density lipoprotein (HDL) levels.
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A combination of niacin and simvastatin (Zocor) effectively raises HDL cholesterol levels in patients with coronary disease and low HDL levels. Clinical research shows that taking a combination of antioxidants (vitamin C, vitamin E, beta-carotene, and selenium) along with niacin and simvastatin (Zocor) attenuates this rise in HDL, specifically the HDL-2 and apolipoprotein A1 fractions, by more than 50% in patients with coronary disease (7388,11537). It is not known whether this adverse effect is due to a single antioxidant such as selenium, or to the combination. It also is not known whether it will occur in other patient populations.
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Theoretically, selenium might interfere with warfarin activity.
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Animal research suggests that selenium can increase warfarin activity. Selenium might interact with warfarin by displacing it from albumin binding sites, reducing its metabolism in the liver, or by decreasing production of vitamin K-dependent clotting factors (14541). Selenium can also prolong bleeding times in humans by increasing prostacyclin production, which inhibits platelet activity (14540).
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Thuja products can contain thujone, which might lower the seizure threshold (1304). Theoretically, this could decrease the effectiveness of anticonvulsants drugs.
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Thuja might stimulate immune function (1305). Theoretically, taking thuja might decrease the effects of immunosuppressive therapy. Immunosuppressant drugs include azathioprine (Imuran), basiliximab (Simulect), cyclosporine (Neoral, Sandimmune), daclizumab (Zenapax), muromonab-CD3 (OKT3, Orthoclone OKT3), mycophenolate (CellCept), tacrolimus (FK506, Prograf), sirolimus (Rapamune), prednisone (Deltasone, Orasone), and other corticosteroids (glucocorticoids).
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Thuja products can contains significant amounts of thujone, a neurotoxin (1304). Theoretically, patients taking drugs that lower the seizure threshold might be at greater risk of seizure if they also take thuja. Advise patients taking these drugs to avoid thuja products. Some drugs that lower the seizure threshold include anesthetics (propofol, others), antiarrhythmics (mexiletine), antibiotics (amphotericin, penicillin, cephalosporins, imipenem), antidepressants (bupropion, others), antihistamines (cyproheptadine, others), immunosuppressants (cyclosporine), narcotics (fentanyl, others), stimulants (methylphenidate), theophylline, and others.
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Below is general information about the adverse effects of the known ingredients contained in the product Cerebrum compositum. 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 and topically, aconite is generally regarded as unsafe for use.
Any benefits of therapy might not outweigh the risk of toxicity.
Most Common Adverse Effects:
All routes of administration: Serious neurologic, cardiovascular, gastrointestinal, and respiratory adverse effects have been reported.
Cardiovascular ...Orally and topically, aconite can cause hypotension, palpitations, chest tightness, pulmonary edema, arrhythmia, bradycardia, tachycardia, sustained or bidirectional ventricular tachycardia, ventricular fibrillation, and Torsade de pointes (558,559,561,562,563,3490,15499,15650,30294,30295)(30300,30305,30323,30336,92276,92277,92278,104514,106706,110473)(112901). Cardioversion has been reported to be ineffective for the reversal of aconite-induced dysrhythmia, but the use of agents such as amiodarone, lidocaine, and magnesium have been successful in some cases (2634,3490,106706,112901).
Gastrointestinal ...Orally, aconite can cause nausea, vomiting, diarrhea, and gastric pain (563,30297,30341,92277,92278). Topically, aconite can cause nausea and vomiting (92276).
Neurologic/CNS ...Orally, aconite can cause weakness, sweating, restlessness, dizziness, numbness, paresthesia, seizures, and reduced consciousness (558,559,561,562,563,3490,15499,15650,30335,30336,30341,92277,92278,104513). Topically, aconite can cause generalized paresthesia, fatigue, sweating, dizziness and tongue numbness (92276).
Ocular/Otic ...Orally, aconite has been reported to cause visual blurring and yellow-green vision with pupil dilation (30319).
Pulmonary/Respiratory ...Orally, aconite overdose can lead to respiratory failure (104513).
Renal ...Orally and topically, aconite can cause hypokalemia and metabolic and/or respiratory acidosis (558,559,561,562,563,3490,15499,15650).
Other
...Orally and topically, aconite has been reported to cause death in both adults and children (559,3490,3491,30301,30334,30341,92276,92278).
In one case report, topical application of aconite to an infant led to cardiogenic shock with multi-organ failure and death (92276). Poisoning has been reported in 15 patients after consuming a homemade liquor containing aconite. Patients presented with tongue or extremity numbness, vomiting, dizziness, or heart palpitations, and 5 died (110471). Death has also been reported in individuals who cooked aconite tubers as vegetables or for health purposes (92278).
The first symptoms of aconite poisoning after oral ingestion of the leaves or root usually occur within 10-90 minutes, although toxicity may be delayed until a second or third dose (559,15499,104513,110471). Recovery time from aconite poisoning ranges from 1.5-2 days for mild intoxication to 7-9 days for patients with cardiovascular complications; fatalities in treated patients are about 5% (15499). Treatment of aconite toxicity is typically supportive, although charcoal hemoperfusion has aided in detoxification (15499,106706).
General
...Orally, arnica is unsafe and can cause toxicity.
When used in homeopathic amounts, arnica seem to be generally well tolerated. Topically, arnica also seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Bleeding, gastroenteritis, hypertension, muscle paralysis, nausea and vomiting, shortness of breath.
Topically: Contact dermatitis and irritation.
Serious Adverse Effects (Rare):
Orally: Arrhythmia, coma, multi-organ failure, and death.
Cardiovascular ...Orally, arnica can cause tachycardia or a faster heart rate (11,17113,19101,19102). A 24-year-old female presented to the emergency department with palpitations and vomiting 24 hours after ingesting a cup of tea that reportedly contained arnica flowers picked from her local area of mountainous Southern California. The species was not specified in the article and there was no indication by the authors that any testing had been done to confirm the identity of the plant (90610).
Dermatologic ...Orally, arnica can cause irritation of mucous membranes (11,17113). Topically, arnica can cause contact itchiness, dry skin, and rash (17113). Oral lesions resulted in a woman who used a mouthwash incorrectly by not following dilution instructions. The mouthwash was 70% alcohol and contained arnica and oil of peppermint (19106).
Gastrointestinal ...Orally, arnica can cause stomach pain, nausea, vomiting, and diarrhea (11,17113,19101,19102). Homeopathic arnica has been reported to cause dry mouth (30C) and sore tongue (6C) (19107). A 24-year-old female presented to the emergency department with palpitations and vomiting 24 hours after ingesting a cup of tea that reportedly contained arnica flowers picked from her local area of mountainous Southern California. The species was not specified in the article and there was no indication by the authors that any testing had been done to confirm the identity of the plant (90610).
Musculoskeletal ...Adverse effects after ingesting arnica include muscle weakness (19101). Homeopathic arnica has been reported to result in the feeling of a "throbby" head or neck (19107).
Neurologic/CNS ...Orally, arnica may cause drowsiness, nervousness, and headache (11,17113,19101,19107).
Ocular/Otic ...In a case report, accidental intake of a large amount of a homeopathic Arnica-30 resulted in acute vision loss due to bilateral toxic optic neuropathy (19105).
Psychiatric ...Oral homeopathic arnica (6C) may cause depressed feelings, specifically a feeling of unhappiness (19107).
Pulmonary/Respiratory ...Orally, arnica can cause shortness of breath (11,17113).
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, gelsemium can cause headache, drooping of the eyelid, double vision, difficulty swallowing, dizziness, muscle weakness or rigidity, seizures, dyspnea, and bradycardia. Death due to failure of respiratory muscles can occur (18).
Neurologic/CNS ...Orally, gelsemium can cause headache, drooping of the eyelid, double vision, difficulty swallowing, dizziness, muscle weakness or rigidity, seizures, dyspnea, and bradycardia. Death due to failure of respiratory muscles can occur (18).
General ...Hemlock is generally regarded as unsafe for use. Any benefits of therapy may not outweigh the risk of toxicity. Orally, hemlock can cause burning of the mouth, throat, and abdomen, nausea, vomiting, excessive urination, salivation, drowsiness, mydriasis, muscle pain, rapid muscle swelling and stiffness, rhabdomyolysis, and tachycardia followed by bradycardia. It can also cause loss of speech, paralysis, encephalopathy, unconsciousness, rapid respiration and respiratory arrest, cardiovascular collapse, renal toxicity, and death (6340,6341,54709,54711,54712,54716,54717,54718,96877,96878).
Cardiovascular
...Orally, hemlock can cause tachycardia followed by bradycardia, cardiovascular collapse, and death (6340,6341,54712,96877).
In one case report, a 6-year old girl had prolonged coagulation tests after accidental ingestion of hemlock (96877). It can also cause hypertension (110410).
Intravenously, hemlock resulted in a brief cardiac arrest followed by return of spontaneous circulation in one case report (96876).
Gastrointestinal ...Orally, hemlock causes burning of the mouth, throat, and abdomen (6341,96877). It can also cause nausea, vomiting, and increased salivation (54712,96878,110410).
Genitourinary ...Orally, hemlock can cause excessive urination (54712).
Musculoskeletal ...Orally, hemlock can cause muscle pain, rapid muscle swelling and stiffness, and rhabdomyolysis (6340,6341,54712,110410). Plasma exchange effectively improved the signs of rhabdomyolysis in one case of hemlock poisoning (54727).
Neurologic/CNS
...Orally, hemlock can cause drowsiness, fatigue, lethargy, dizziness, numbness, loss of speech, tremors, paralysis, seizures, encephalopathy, unconsciousness, and death (6340,6341,10778,54711,54712,54716,96877,110410).
Death from hemlock toxicity is usually due to respiratory paralysis (96879,96877).
A case report describes prolonged status epilepticus in a 41-year-old, previously healthy female who mistook hemlock root for parsnip. She developed severe vomiting and drowsiness, followed by prolonged status epilepticus which was refractory to multiple drugs. Seizures and the abnormal electroencephalogram were ultimately controlled with thiopental, gradually weaning to long-term oral treatment with lacosamide and perampanel, which returned the patient to her baseline level of functioning (110411).
Ocular/Otic ...Orally, hemlock can cause blurred vision and mydriasis (54712,110410).
Pulmonary/Respiratory ...Orally, hemlock can cause rapid respiration (54712) as well as acute respiratory arrest (54709,96878). In one case report, a 45-year old woman required mechanical ventilation after accidental ingestion of hemlock (96878). Death from hemlock toxicity is usually due to respiratory paralysis (96876,96877).
Renal ...Orally, hemlock has been reported to cause myoglobinuria, acute tubular necrosis, and acute renal failure (54716,54717,54718,54728). Plasma exchange effectively improved the signs of renal failure in one case of hemlock poisoning (54727).
General ...Orally, henbane can cause anticholinergic effects including dry mouth, vision disturbances, tachycardia, difficult urination, constipation, and skin flushing (2,18). At higher doses, poisoning can occur due to the hyoscyamine and scopolamine constituents of henbane. Symptoms of toxicity include hyperpyrexia and somnolence, followed by CNS stimulation with restlessness, hallucinations, delirium, memory impairment, ataxia, and manic episodes, followed by exhaustion and coma. Henbane can cause death by asphyxiation (2,18,100917).
Cardiovascular ...Orally, henbane can cause tachycardia, especially at higher doses (2,18,100917).
Dermatologic ...Orally, henbane reduces sweating, resulting in flushing of the skin and hyperpyrexia (2,18,100917).
Gastrointestinal ...Orally, henbane causes reduced muscle activity in the bowel, leading to constipation (2,18,100917).
Genitourinary ...Orally, henbane can cause difficulty with urination (2,18,100917).
Neurologic/CNS ...Orally, high doses of henbane can cause toxicity due to its hyoscyamine and scopolamine constituents. Neurologic symptoms of henbane toxicity include somnolence, followed by CNS excitation involving restlessness, hallucinations, memory impairment, delirium, and manic episodes, followed by exhaustion and coma (2,18,100917).
Ocular/Otic ...Orally, high doses of henbane can cause toxicity due to its hyoscyamine and scopolamine constituents. Ocular symptoms of henbane toxicity include visual disturbances (2,18,100917).
Other ...Orally, high doses of henbane can cause toxicity due to its hyoscyamine and scopolamine constituents. Toxicity can result in coma and death by asphyxiation in some cases (2,18,100917). Treatment of henbane toxicity includes stomach lavage, activated charcoal, supportive therapy, and, in severe cases, the antidote physostigmine (100917).
General
...Orally, horse chestnut seed extract, from which the toxic constituent esculin has been removed, seems to be well-tolerated.
Topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally (extract): Dizziness, gastrointestinal upset, headache, and pruritus.
Orally (seed or bark): Gastrointestinal irritation and toxic nephropathy.
Cardiovascular ...Orally, there is one case report of pericardial tamponade following exudative pericardial effusion in a previously healthy 32-year-old male who consumed three boxes of horse chestnut paste over 6 weeks. The patient was treated with steroid therapy for 2 months, as well as colchicine 0.5 mg twice daily and ibuprofen 600 mg twice daily for 3 months. These cardiovascular events were considered to be possibly related to the antiplatelet activity of horse chestnut or to an immunologic response to antigens present in horse chestnut paste (91972). A case of atrial fibrillation is also reported in a previously healthy 46-year-old male after accidental ingestion of a horse chestnut seed. The patient also presented with abdominal pain, nausea, sweating, and palpitations. The arrhythmia resolved within a few hours without medical intervention (110439).
Dermatologic ...Orally, horse chestnut seed extract has been reported to cause pruritus (282,12113,55486).
Gastrointestinal ...Orally, horse chestnut seed extract has been reported to cause nausea, vomiting, diarrhea, abdominal pain, constipation, dry mouth, gastrointestinal upset, and dyspepsia (282,12113,55477,55486,55493,55520,110439).
Hepatic
...Orally, there is one case report of hepatotoxicity in a 69-year-old female who took 6-15 tablets of a specific product (Venencapsan) containing horse chestnut leaf, milfoil, celandine, sweet clover, milk thistle, and dandelion root daily for 6 weeks.
The patient's symptoms disappeared 6 weeks after discontinuing the product and reappeared following re-initiation (55518). Another case report describes a 70-year-old male presenting with acholia, choluria, and jaundice after 3 weeks of self-treatment with an unspecified dose of a specific combination product (Venenkraft) containing horse chestnut. The patient presented with elevated liver transaminase and bilirubin levels, and was diagnosed with drug-induced liver injury. Following discontinuation, laboratory values and symptoms progressively resolved (107702). In both of these case reports, it is unclear if hepatotoxicity was due to horse chestnut, another ingredient, or the combination.
Intravenously and intramuscularly, isolated cases of liver toxicity have occurred after administration of horse chestnut extract containing aescin (2,512,552).
Immunologic
...Pollen from the horse chestnut flower can cause allergic reactions in children (7775).
Horse chestnut can also cause hypersensitivity reactions, which occur more commonly in people who are allergic to latex (7853,8418).
Rectally, the horse chestnut constituent esculin has caused severe allergic contact dermatitis and proctitis in a 38-year old man (10383).
Intravenously, administration of aescin can cause anaphylaxis (18,553).
Musculoskeletal ...Orally, calf spasms have been reported in patients with CVI who took horse chestnut seed extract (282).
Neurologic/CNS ...Orally, horse chestnut seed extract has been reported to cause headache or dizziness (55486,55520).
Renal
...Orally, high doses of aescin have been reported to cause kidney toxicity (55525).
Horse chestnut seed and bark can cause toxic nephropathy (4). A case of life-threatening kidney rupture occurred in a patient who was taking horse chestnut seed extract and had been diagnosed with angiomyolipoma, a condition characterized by increased risk of kidney rupture with hemorrhage. The rupture was attributed to the anticoagulant effects of horse chestnut seed extract, which may have increased the risk of hemorrhage (55496).
Intravenously, isolated cases of kidney toxicity have occurred after administration of horse chestnut containing aescin (512).
General
...Orally, Ignatius bean is generally regarded as unsafe for use.
Any benefits of therapy may not outweigh the risk of toxicity. Ignatius bean 30-50 mg, which contains approximately 5 mg of strychnine, can cause restlessness, anxiety, heightened sense perception, enhanced reflexes, equilibrium disorders, painful back and neck stiffness, twitching, spasms of jaw and neck muscles, myoglobinuric renal failure, rhabdomyolysis, extreme muscle tension, and agitation and difficulty breathing after respiratory spasms (55854). Seizures have been reported to occur within 15 minutes of Ignatius bean ingestion (17). Taking Ignatius bean at a dose of 1-2 grams can be fatal (18). Most deaths occur within 3-6 hours of ingestion and are due to respiratory and subsequent cardiac arrest, anoxic brain damage, or multiple organ failure secondary to hyperthermia (18,505).
Long-term consumption of Ignatius bean can cause strychnine accumulation, particularly in individuals with liver damage. Chronic use can cause death after a period of weeks (18).
By inhalation, Ignatius bean has been reported to cause seizures (17).
Cardiovascular ...Orally, Ignatius bean 1-2 grams has been reported to cause fatal cardiac arrest within 3-6 hours of ingestion (55853,55855).
Endocrine ...Orally, Ignatius bean 1-2 grams has been reported to cause hyperthermia resulting in multiple organ failure within 3-6 hours of ingestion (18,505).
Musculoskeletal ...Orally, Ignatius bean 30-50 mg, which contains approximately 5 mg of strychnine, has been reported to cause rhabdomyolysis, painful back and neck stiffness, spasms of jaw and neck muscles, and extreme muscle tension (55854).
Neurologic/CNS
...Orally, Ignatius bean 30-50 mg, which contains approximately 5 mg of strychnine, has been reported to cause restlessness, anxiety, heightened sense perception, enhanced reflexes, and twitching.
It has also been reported to cause seizures within 15 minutes of ingestion (55854). Taking 1-2 grams of Ignatius bean has been reported to cause death due to anoxic brain damage (18,505).
By inhalation, Ignatius bean has been reported to cause seizures within 5 minutes (17).
Pulmonary/Respiratory ...Orally, Ignatius bean 30-50 mg, which contains approximately 5 mg of strychnine, has been reported to cause respiratory acidosis and difficulty breathing due to respiratory spasms (55854).
Renal ...Orally, Ignatius bean has been associated with myoglobinuric renal failure (55854).
Other ...Orally, Ignatius bean 1-2 grams can be fatal. Most deaths occur 3-6 hours after exposure and occur from respiratory and cardiac arrest, anoxic brain damage, or multiple organ failure due to hyperthermia (55853). Chronic use of lower doses of Ignatius bean has been reported to cause death after a period of weeks (55853).
General ...Picrotoxin is a GI irritant and central nervous system stimulant (6). Mild poisoning can lead to headache, dizziness, nausea, coordination disturbances, depression, and spasms or twitching (18). Larger amounts can cause salivation, vomiting, purging, rapid shallow breathing, drowsiness, palpitations or bradycardia, tonic-clonic spasms, stupor, loss of consciousness, and death (6). The lethal dose is stated to be 30 mg/kg (6) or 2-3 Cocculus kernels (seeds) (18).
General
...Magnesium is generally well tolerated.
Some clinical research shows no differences in adverse effects between placebo and magnesium groups.
Most Common Adverse Effects:
Orally: Diarrhea, gastrointestinal irritation, nausea, and vomiting.
Intravenously: Bradycardia, dizziness, flushing sensation, hypotension, and localized pain and irritation. In pregnancy, may cause blurry vision, dizziness, lethargy, nausea, nystagmus, and perception of warmth.
Serious Adverse Effects (Rare):
All ROAs: With toxic doses, loss of reflexes and respiratory depression can occur. High doses in pregnancy can increase risk of neonatal mortality and neurological defects.
Cardiovascular
...Intravenously, magnesium can cause bradycardia, tachycardia, and hypotension (13356,60795,60838,60872,60960,60973,60982,61001,61031).
Inhaled magnesium administered by nebulizer may also cause hypotension (113466). Magnesium sulfate may cause rapid heartbeat when administered antenatally (60915).
In one case report, a 99-year-old male who took oral magnesium oxide 3000 mg daily for chronic constipation was hospitalized with hypermagnesemia, hypotension, bradycardia, heart failure, cardiomegaly, second-degree sinoatrial block, and complete bundle branch block. The patient recovered after discontinuing the magnesium oxide (108966).
Dermatologic ...Intravenously, magnesium may cause flushing, sweating, and problems at the injection site (including burning pain) (60960,60982,111696). In a case study, two patients who received intravenous magnesium sulfate for suppression of preterm labor developed a rapid and sudden onset of an urticarial eruption (a skin eruption of itching welts). The eruption cleared when magnesium sulfate was discontinued (61045). Orally, magnesium oxide may cause allergic skin rash, but this is rare. In one case report, a patient developed a rash after taking 600 mg magnesium oxide (Maglax) (98291).
Gastrointestinal
...Orally, magnesium can cause gastrointestinal irritation, nausea, vomiting, and diarrhea (1194,4891,10661,10663,18111,60951,61016,98290).
In rare cases, taking magnesium orally might cause a bezoar, an indigestible mass of material which gets lodged in the gastrointestinal tract. In a case report, a 75-year-old female with advanced rectal cancer taking magnesium 1500 mg daily presented with nausea and anorexia from magnesium oxide bezoars in her stomach (99314). Magnesium can cause nausea, vomiting, or dry mouth when administered intravenously or by nebulization (60818,60960,60982,104400,113466). Antenatal magnesium sulfate may also cause nausea and vomiting (60915). Two case reports suggest that giving magnesium 50 grams orally for bowel preparation for colonoscopy in patients with colorectal cancer may lead to intestinal perforation and possibly death (90006).
Delayed meconium passage and obstruction have been reported rarely in neonates after intravenous magnesium sulfate was given to the mother during pregnancy (60818). In a retrospective study of 200 neonates born prematurely before 32 weeks of gestation, administration of prenatal IV magnesium sulfate, as a 4-gram loading dose and then 1-2 grams hourly, was not associated with the rate of meconium bowel obstruction when compared with neonates whose mothers had not received magnesium sulfate (108728).
Genitourinary ...Intravenously, magnesium sulfate may cause renal toxicity or acute urinary retention, although these events are rare (60818,61012). A case of slowed cervical dilation at delivery has been reported for a patient administered intravenous magnesium sulfate for eclampsia (12592). Intravenous magnesium might also cause solute diuresis. In a case report, a pregnant patient experienced polyuria and diuresis after having received intravenous magnesium sulfate in Ringer's lactate solution for preterm uterine contractions (98284).
Hematologic ...Intravenously, magnesium may cause increased blood loss at delivery when administered for eclampsia or pre-eclampsia (12592). However, research on the effect of intravenous magnesium on postpartum hemorrhage is mixed. Some research shows that it does not affect risk of postpartum hemorrhage (60982), while other research shows that intrapartum magnesium administration is associated with increased odds of postpartum hemorrhage, increased odds of uterine atony (a condition that increases the risk for postpartum hemorrhage) and increased need for red blood cell transfusions (97489).
Musculoskeletal
...Intravenously, magnesium may cause decreased skeletal muscle tone, muscle weakness, or hypocalcemic tetany (60818,60960,60973).
Although magnesium is important for normal bone structure and maintenance (272), there is concern that very high doses of magnesium may be detrimental. In a case series of 9 patients receiving long-term tocolysis for 11-97 days, resulting in cumulative magnesium sulfate doses of 168-3756 grams, a lower bone mass was noted in 4 cases receiving doses above 1000 grams. There was one case of pregnancy- and lactation-associated osteoporosis and one fracture (108731). The validity and clinical significance of this data is unclear.
Neurologic/CNS
...Intravenously, magnesium may cause slurred speech, dizziness, drowsiness, confusion, or headaches (60818,60960).
With toxic doses, loss of reflexes, neurological defects, drowsiness, confusion, and coma can occur (8095,12589,12590).
A case report describes cerebral cortical and subcortical edema consistent with posterior reversible encephalopathy syndrome (PRES), eclampsia, somnolence, seizures, absent deep tendon reflexes, hard to control hypertension, acute renal failure and hypermagnesemia (serum level 11.5 mg/dL), after treatment with intravenous magnesium sulfate for preeclampsia in a 24-year-old primigravida at 39 weeks gestation with a previously uncomplicated pregnancy. The symptoms resolved after 4 days of symptomatic treatment in an intensive care unit, and emergency cesarian delivery of a healthy infant (112785).
Ocular/Otic ...Cases of visual impairment or nystagmus have been reported following magnesium supplementation, but these events are rare (18111,60818).
Psychiatric ...A case of delirium due to hypermagnesemia has been reported for a patient receiving intravenous magnesium sulfate for pre-eclampsia (60780).
Pulmonary/Respiratory ...Intravenously, magnesium may cause respiratory depression and tachypnea when used in toxic doses (12589,61028,61180).
Other ...Hypothermia from magnesium used as a tocolytic has been reported (60818).
General
...Orally or intravenously, potassium is generally well-tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, belching, diarrhea, flatulence, nausea, and vomiting.
Serious Adverse Effects (Rare):
All ROAs: High potassium levels can cause arrhythmia, heart block, hypotension, and mental confusion.
Cardiovascular ...Orally or intravenously, high potassium levels can cause hypotension, cardiac arrhythmias, heart block, or cardiac arrest (15,16,3385,95011,95626,95630).
Gastrointestinal ...Orally or intravenously, high doses of potassium can cause, nausea, vomiting, abdominal pain, diarrhea, and flatulence (95010,95011). Bleeding duodenal ulcers have also been associated with ingestion of slow-release potassium tablets (69625,69672).
Neurologic/CNS ...Orally or intravenously, high potassium levels can cause paresthesia, generalized weakness, flaccid paralysis, listlessness, vertigo, or mental confusion (15,16,3385,95011).
General
...Orally, rue is well tolerated when taken in the amounts found in foods.
The dried herb seems to be generally well tolerated when taken in medicinal doses; however, a thorough evaluation of safety outcomes has not been conducted. Fresh rue is generally considered unsafe.
Most Common Adverse Effects:
Orally: Cramps, drowsiness, depression, dizziness, gastrointestinal irritation, and sleep disturbances with medicinal use of the dried herb.
Topically: Contact dermatitis and phototoxic skin reactions with the fresh plant.
Cardiovascular ...Orally, large doses of rue have been associated with bradycardia (2).
Dermatologic ...Topically, rue can cause contact dermatitis (2). Exposure to the fresh rue plant followed by sun exposure within 48 hours can lead to severe phototoxic reactions (2,6). Multiple case reports describe patients who developed pruritus, erythema, and severe blistering on the back of the hands and wrists, equivalent to a partial thickness burn, after contact with the fresh plant leaves and exposure to sunlight (104119,107948). One patient was successfully treated with cetirizine and oral and topical corticosteroids (107948).
Gastrointestinal ...Orally, rue can cause gastrointestinal irritation and cramps at therapeutic doses (2,12). When taken in large doses, it causes severe abdominal pain and vomiting (2,12,18).
Genitourinary ...Orally, rue can cause uterine stimulation and abortion (2).
Hepatic ...Orally, high doses of rue can cause liver damage (2,12,18).
Neurologic/CNS ...Orally, therapeutic doses of rue can cause tremor, dizziness, drowsiness, sleep disorders, and depression. High doses can cause vertigo, seizures, and delirium (2,12,18).
Pulmonary/Respiratory ...Orally, high doses of rue can cause respiratory distress (2,12,18).
Renal ...Orally, high doses of rue can cause kidney damage (2,12,18).
General
...Orally, selenium is generally well-tolerated when used in doses that do not exceed the tolerable upper intake level (UL) of 400 mcg daily.
Intravenously, selenium is generally well-tolerated.
Most Common Adverse Effects:
Orally: Gastric discomfort, headache, and rash. Excessive amounts can cause alopecia, dermatitis, fatigue, nail changes, nausea and vomiting, and weight loss.
Serious Adverse Effects (Rare):
Orally: Excessive ingestion has led to cases of multi-organ failure and death.
Dermatologic ...Excess selenium can produce selenosis in humans, affecting liver, skin, nails, and hair (74304,74326,74397,74495,90360) as well as dermatitis (74304). Results from the Nutritional Prevention of Cancer Trial conducted among individuals at high risk of nonmelanoma skin cancer demonstrate that selenium supplementation is ineffective at preventing basal cell carcinoma and that it increases the risk of squamous cell carcinoma and total nonmelanoma skin cancer (10687). Mild skin rash has been reported in patients taking up to 200 mcg of selenium daily for up to 12 months (97943).
Endocrine
...Multiple clinical studies have found an association between increased intake of selenium, either in the diet or as a supplement, and the risk for type 2 diabetes (97091,99661).
One meta-analysis shows that a selenium plasma level of 90 mcg/L or 140 mcg/L is associated with a 50% or 260% increased risk for developing type 2 diabetes, respectively, when compared with plasma levels below 90 mcg/L. Additionally, consuming selenium in amounts exceeding the recommended dietary allowance (RDA) is associated with an increased risk of developing diabetes when compared with consuming less than the RDA daily. Also, taking selenium 200 mcg daily as a supplement is associated with an 11% increased risk for diabetes when compared with a placebo supplement (99661).
Hypothyroidism, secondary to iodine deficiency, has been reported as a result of selenium intravenous administration (14563,14565). One large human clinical trial suggested a possible increased risk of type 2 diabetes mellitus in the selenium group (16707).
Gastrointestinal ...In human research, nausea, vomiting, and liver dysfunction has been reported as a result of high selenium exposure (74439,74376). Mild gastric discomfort has been reported in patients taking up to 200 mcg of selenium daily for up to 12 months (97943).
Genitourinary ...The effect of selenium supplementation on semen parameters is unclear. In human research, selenium supplementation may reduce sperm motility (9729); however, follow-up research reported no effect on sperm motility or any other semen quality parameter (74441).
Neurologic/CNS ...Chronic exposure to organic and inorganic selenium may cause neurotoxicity, particularly motor neuron degeneration, leading to an increased risk of amyotrophic lateral sclerosis (ALS) (74304). Mild headache has been reported in patients taking up to 200 mcg of selenium daily for up to 12 months (97943).
General ...Topically, sulfur is generally well tolerated when used in concentrations of up to 10%. Adverse effects include skin dryness, irritation, and pruritus (27846,88112,88120,88121,88126). Orally, sulfur has been reported to cause diarrhea and metabolic acidosis (27845).
Dermatologic ...Topically, application of sulfur preparations can cause dryness, leading to local irritation and pruritus in up to 28% of patients (27846,88112,88120,88121,88126).
Gastrointestinal ...Orally, sulfur is converted to sulfide in the gastrointestinal tract, causing intestinal irritation which can lead to diarrhea (27845).
Renal ...There is one case report of metabolic acidosis occurring in a 57-year-old woman who had consumed approximately 250 grams of flowers of sulfur, a form of sulfur prepared by sublimation, over a 6-day period (27845). Underlying conditions, including diabetes and renal failure, may have contributed to the acidosis. Sulfur is converted to sulfide by colonic bacteria and then to sulfate in various tissues, generating hydrogen ions which can lead to acidosis when clearance mechanisms are overwhelmed (27845).
General ...Orally, large doses of thuja have been reported to cause toxicity involving headache, nervous agitation, seizures, gastric irritation, vomiting, abdominal pain, and diarrhea. Thuja toxicity has also been reported to cause liver damage, renal toxicity, and death in some cases (6002,40888).
Dermatologic
...Contact dermatitis, presenting as an itchy papular squamous eruption on the hands, developed in a 46-year-old female who handled thuja plants while gardening.
It resolved when contact with thuja was avoided. The causative ingredient of thuja was identified as limonene (113415).
In one case report, a 5-year-old female presented with a papillary eccrine adenoma. In an effort to avoid excisional biopsy, an ointment containing thuja was applied to the lesion for 6 months, resulting in peripheral extension and central necrosis of the lesion, eventually necessitating complete excision (106048).
Gastrointestinal ...Orally, large doses of thuja have been reported to cause toxicity involving gastric irritation, vomiting, abdominal pain, and diarrhea (6002,40888).
Hepatic ...Orally, large doses of thuja have been reported to cause toxicity involving liver damage and death (6002,40888). In one case report, a healthy 40-year-old female taking thuja and black cohosh for 1 month presented with 3 days of severe abdominal pain and AST and ALT levels exceeding 5 times the upper limit of normal. Symptoms improved within 5 days of supplement discontinuation and levels normalized within 2 weeks (106047). It is unclear if this reaction was due to thuja, black cohosh, or other factors.
Neurologic/CNS ...Orally, large doses of thuja have been reported to cause toxicity involving nervous agitation, seizures, and death (6002,40888).
Renal ...Orally, large doses of thuja have been reported to cause toxicity involving renal toxicity and death (6002,40888).
