Each tablet contains: Hamamelis virginiana 4X • Pulsatilla 4X • Aesculus hippocastanum 6X • Carduus marianus 6X • Lycopodium clavatum 6X • Picricum Acidum 6X • Secale cornutum 6X • Carbo Vegetabilis 10X • Mercurius Praecipitatus Ruber 10X • Apis Mellifica 12X.
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 BHI Varicose. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is insufficient reliable information available about the effectiveness of clubmoss.
There is insufficient reliable information available about the effectiveness of ergot.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of pulsatilla.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product BHI Varicose. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY UNSAFE ...when used orally. Clubmoss contains toxic alkaloids, but no poisonings have been reported (18).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally; avoid using.
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.
LIKELY SAFE ...when used orally and appropriately. A specific milk thistle extract standardized to contain 70% to 80% silymarin (Legalon, Madaus GmbH) has been safely used in doses up to 420 mg daily for up to 4 years (2613,2614,2616,7355,63210,63212,63278,63280,63299,63340)(88154,97626,105792). Higher doses of up to 2100 mg daily have been safely used for up to 48 weeks (63251,96107,101150). Another specific milk thistle extract of silymarin (Livergol, Goldaru Pharmaceutical Company) has been safely used at doses of 140 mg daily for up to 6 months and doses of 420 mg daily for up to 6 weeks (95021,95029,102851,102852,105793,105794,105795,113979). Some isolated milk thistle constituents also appear to be safe. Silibinin (Siliphos, Thorne Research) has been used safely in doses up to 320 mg daily for 28 days (63218). Some combination products containing milk thistle and other ingredients also appear to be safe. A silybin-phosphatidylcholine complex (Silipide, Inverni della Beffa Research and Development Laboratories) has been safely used in doses of 480 mg daily for 7 days (7356) and 240 mg daily for 3 months (63320). Tree turmeric and milk thistle capsules (Berberol, PharmExtracta) standardized to contain 60% to 80% silybin have been safely used twice daily for up to 12 months (95019,96140,96141,96142,97624,101158).
POSSIBLY SAFE ...when used topically and appropriately, short-term. A milk thistle extract cream standardized to silymarin 0.25% (Leviaderm, Madaus GmbH) has been used safely throughout a course of radiotherapy (63239). Another milk thistle extract cream containing silymarin 1.4% has been used with apparent safety twice daily for 3 months (105791,110489). A cream containing milk thistle fruit extract 25% has been used with apparent safety twice daily for up to 12 weeks (111175). A milk thistle extract gel containing silymarin 1% has been used with apparent safety twice daily for 9 weeks (95022). There is insufficient reliable information available about the safety of intravenous formulations of milk thistle or its constituents.
PREGNANCY AND LACTATION:
While research in an animal model shows that taking milk thistle during pregnancy and lactation does not adversely impact infant development (102850), there is insufficient reliable information available about its safety during pregnancy or lactation in humans; avoid using.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
A milk thistle extract 140 mg three times daily has been used with apparent safety for up to 9 months (88154,98452). A specific product containing the milk thistle constituent silybin (Siliphos, Thorne Research Inc.) has been used with apparent safety in doses up to 320 mg daily for up to 4 weeks in children one year of age and older (63218).
LIKELY UNSAFE ...when fresh above ground parts are used orally or topically; pulsatilla is a severe local irritant (4). There is insufficient reliable information available about the safety of the use of dried pulsatilla.
PREGNANCY: LIKELY UNSAFE
when used orally.
The fresh or dried above ground parts are contraindicated due to abortifacient and teratogenic effects (2,4). ...when the fresh above ground parts are used topically. There is insufficient reliable information available about the safety of topical dried pulsatilla during pregnancy.
LACTATION: LIKELY UNSAFE
when the fresh above ground parts are used for oral or topical use (19).
There is insufficient reliable information available about the safety of dried pulsatilla during breast-feeding.
LIKELY SAFE ...when witch hazel water is used topically and appropriately (272).
POSSIBLY SAFE ...when used orally and appropriately (12). In high doses, tannins in witch hazel bark may cause liver or kidney damage (8,12). The volatile oil contains safrole, a known carcinogen, but in amounts too small for concern (4).
CHILDREN: POSSIBLY SAFE
when applied topically and appropriately (67795).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product BHI Varicose. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Evidence from in vitro research suggests that clubmoss extract can inhibit acetylcholinesterase activity (43717). Theoretically, concurrent use of clubmoss with other acetylcholinesterase (AChE) inhibitors might have additive effects and increase the risk of cholinergic side effects. AChE inhibitors and cholinergic drugs include bethanechol (Urecholine), donepezil (Aricept), echothiophate (Phospholine Iodide), edrophonium (Enlon, Reversol, Tensilon), neostigmine (Prostigmin), physostigmine (Antilirium), pyridostigmine (Mestinon, Regonol), succinylcholine (Anectine, Quelicin), and tacrine (Cognex).
|
Evidence from in vitro research suggests that clubmoss extract can inhibit acetylcholinesterase activity (43717). Theoretically, concurrent use of anticholinergic drugs and clubmoss might decrease the effectiveness of club moss or the anticholinergic agent. Some anticholinergic drugs include atropine, benztropine (Cogentin), biperiden (Akineton), procyclidine (Kemadrin), and trihexyphenidyl (Artane).
|
Evidence from in vitro research suggests that clubmoss extract can inhibit acetylcholinesterase activity (43717). Theoretically, concurrent use of clubmoss with other cholinergic drugs might have additive effects and increase the risk of cholinergic side effects. AChE inhibitors and cholinergic drugs include bethanechol (Urecholine), donepezil (Aricept), echothiophate (Phospholine Iodide), edrophonium (Enlon, Reversol, Tensilon), neostigmine (Prostigmin), physostigmine (Antilirium), pyridostigmine (Mestinon, Regonol), succinylcholine (Anectine, Quelicin), and tacrine (Cognex).
|
Ergotamine, a constituent of ergot, is a substrate of cytochrome P450 3A4 (CYP3A4) (11163). Theoretically, drugs that inhibit CYP3A4 might increase the risk of ergot toxicity. Some of these drugs include amiodarone (Cordarone), clarithromycin (Biaxin), diltiazem (Cardizem), erythromycin (E-mycin, Erythrocin), indinavir (Crixivan), ritonavir (Norvir), saquinavir (Fortovase, Invirase), and many others.
|
Concomitant use of ergot with ergot alkaloids or derivatives may increase the risk of adverse effects (11163). Some of these include bromocriptine (Parlodel), dihydroergotamine (Migranal, DHE-45), ergotamine (Cafergot), and pergolide (Permax).
|
Certain ergot alkaloids, such as dihydroergotamine, act as serotonin agonists. Theoretically, combining serotonergic drugs with ergot might increase the risk of serotonergic side effects including serotonin syndrome and cerebral vasoconstrictive disorders (8056,11163). Monitor patients for signs of serotonin syndrome and other serotonergic side effects if using ergot with serotonergic drugs.
 Details
Serotonergic drugs include the selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac), paroxetine (Paxil), and sertraline (Zoloft); tricyclic and atypical antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), and imipramine (Tofranil); triptans such as sumatriptan (Imitrex), zolmitriptan (Zomig), and rizatriptan (Maxalt); opioids such as methadone (Dolophine) and tramadol (Ultram); and many other medications.
|
Co-administration of stimulant drugs with ergot may increase the risk of vasoconstriction (11163).
Details
Some stimulant drugs include albuterol (Proventil, Ventolin), diethylpropion (Tenuate), dopamine, epinephrine, phentermine (Ionamin), pseudoephedrine (Sudafed), and many others.
|
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.
|
Taking milk thistle with antidiabetes drugs may increase the risk of hypoglycemia.
Details
Clinical research shows that milk thistle extract, alone or along with tree turmeric extract, can lower blood glucose levels and glycated hemoglobin (HbA1c) in patients with type 2 diabetes, including those already taking antidiabetes drugs (15102,63190,63314,63318,95019,96140,96141,97624,97626,113987).
|
Theoretically, milk thistle might inhibit CYP2B6.
Details
An in vitro study shows that silybin, a constituent of milk thistle, binds to and noncompetitively inhibits CYP2B6. Additionally, silybin might downregulate the expression of CYP2B6 by decreasing mRNA and protein levels (112229).
|
It is unclear if milk thistle inhibits CYP2C9; research is conflicting.
Details
In vitro research suggests that milk thistle might inhibit CYP2C9 (7089,17973,17976). Additionally, 3 case reports from the World Health Organization (WHO) adverse drug reaction database describe increased toxicity in patients taking milk thistle and cancer medications that are CYP2C9 substrates, including imatinib and capecitabine (111644). However, contradictory clinical research shows that milk thistle extract does not inhibit CYP2C9 or significantly affect levels of the CYP2C9 substrate tolbutamide (13712,95026). Differences in results could be due to differences in dosages or formulations utilized (95026).
|
It is unclear if milk thistle inhibits CYP3A4; research is conflicting.
Details
While laboratory research shows conflicting results (7318,17973,17975,17976), pharmacokinetic research shows that taking milk thistle extract 420-1350 mg daily does not significantly affect the metabolism of the CYP3A4 substrates irinotecan, midazolam, or indinavir (8234,17974,93578,95026). However, 8 case reports from the World Health Organization (WHO) adverse drug reaction database describe increased toxicity in patients taking milk thistle and cancer medications that are CYP3A4 substrates, including gefitinib, sorafenib, doxorubicin, and vincristine (111644).
|
Theoretically, milk thistle might interfere with estrogen therapy through competition for estrogen receptors.
Details
|
Theoretically, milk thistle might affect the clearance of drugs that undergo glucuronidation.
Details
Laboratory research shows that milk thistle constituents inhibit uridine diphosphoglucuronosyl transferase (UGT), the major phase 2 enzyme that is responsible for glucuronidation (7318,17973). Theoretically, this could decrease the clearance and increase levels of glucuronidated drugs. Other laboratory research suggests that a milk thistle extract of silymarin might inhibit beta-glucuronidase (7354), although the significance of this effect is unclear.
|
Theoretically, milk thistle might interfere with statin therapy by decreasing the activity of organic anion transporting polypeptide 1B1 (OATB1B1) and inhibiting breast cancer resistance protein (BCRP).
Details
Preliminary evidence suggests that a milk thistle extract of silymarin can decrease the activity of the OATP1B1, which transports HMG-CoA reductase inhibitors into the liver to their site of action, and animal research shows this increases the maximum plasma concentration of pitavastatin and pravastatin (113975). The silibinin component also inhibits BCRP, which transports statins from the liver into the bile for excretion. However, in a preliminary study in healthy males, silymarin 140 mg three times daily had no effect on the pharmacokinetics of a single 10 mg dose of rosuvastatin (16408).
|
Theoretically, milk thistle may induce cytochrome P450 3A4 (CYP3A4) enzymes and increase the metabolism of indinavir; however, results are conflicting.
Details
One pharmacokinetic study shows that taking milk thistle (Standardized Milk Thistle, General Nutrition Corp.) 175 mg three times daily in combination with multiple doses of indinavir 800 mg every 8 hours decreases the mean trough levels of indinavir by 25% (8234). However, results from the same pharmacokinetic study show that milk thistle does not affect the overall exposure to indinavir (8234). Furthermore, two other pharmacokinetic studies show that taking specific milk thistle extract (Legalon, Rottapharm Madaus; Thisilyn, Nature's Way) 160-450 mg every 8 hours in combination with multiple doses of indinavir 800 mg every 8 hours does not reduce levels of indinavir (93578).
|
Theoretically, milk thistle might increase the levels and clinical effects of ledipasvir.
Details
Animal research in rats shows that milk thistle increases the area under the curve (AUC) for ledipasvir and slows its elimination (109505).
|
Theoretically, concomitant use of milk thistle with morphine might affect serum levels of morphine and either increase or decrease its effects.
Details
Animal research shows that milk thistle reduces serum levels of morphine by up to 66% (101161). In contrast, laboratory research shows that milk thistle constituents inhibit uridine diphosphoglucuronosyl transferase (UGT), the major phase 2 enzyme that is responsible for glucuronidation (7318,17973). Theoretically, this could decrease the clearance and increase morphine levels. The effect of taking milk thistle on morphine metabolism in humans is not known.
|
Milk thistle may inhibit one form of OATP, OATP-B1, which could reduce the bioavailability and clinical effects of OATP-B1 substrates.
Details
In vitro research shows that milk thistle inhibits OATP-B1. Two case reports from the World Health Organization (WHO) adverse drug reaction database describe increased toxicity in patients taking milk thistle and cancer medications that are OATP substrates, including sorafenib and methotrexate (111644). OATPs are expressed in the small intestine and liver and are responsible for the uptake of drugs and other compounds into the body. Inhibition of OATP may reduce the bioavailability of oral drugs that are substrates of OATP.
|
Theoretically, milk thistle might increase the absorption of P-glycoprotein substrates. However, this effect does not seem to be clinically significant.
Details
In vitro research shows that milk thistle can inhibit P-glycoprotein activity (95019,111644) and 1 case report from the World Health Organization (WHO) adverse drug reaction database describes increased abdominal pain in a patient taking milk thistle and the cancer medication vincristine, a P-glycoprotein substrate, though this patient was also taking methotrexate (111644). However, a small pharmacokinetic study in healthy volunteers shows that taking milk thistle (Enzymatic Therapy Inc.) 900 mg, standardized to 80% silymarin, in 3 divided doses daily for 14 days does not affect absorption of digoxin, a P-glycoprotein substrate (35825).
|
Theoretically, milk thistle might decrease the clearance and increase levels of raloxifene.
Details
Laboratory research suggests that the milk thistle constituents silibinin and silymarin inhibit the glucuronidation of raloxifene in the intestines (93024).
|
Milk thistle might decrease the clearance of sirolimus.
Details
Pharmacokinetic research shows that a milk thistle extract of silymarin decreases the apparent clearance of sirolimus in hepatically impaired renal transplant patients (19876). It is unclear if this interaction occurs in patients without hepatic impairment.
|
Theoretically, milk thistle might decrease the levels and clinical effects of sofosbuvir.
Details
Animal research in rats shows that milk thistle reduces the metabolism of sofosbuvir, as well as the hepatic uptake of its active metabolite (109505).
|
Theoretically, the milk thistle constituent silibinin might increase tamoxifen levels and interfere with its conversion to an active metabolite.
Details
Animal research suggests that the milk thistle constituent silibinin might increase plasma levels of tamoxifen and alter its conversion to an active metabolite. The mechanism appears to involve inhibition of pre-systemic metabolism of tamoxifen by cytochrome P450 (CYP) 2C9 and CYP3A4, and inhibition of P-glycoprotein-mediated efflux of tamoxifen into the intestine for excretion (17101). Whether this interaction occurs in humans is not known.
|
Theoretically, milk thistle might increase the effects of warfarin.
Details
In one case report, a man stabilized on warfarin experienced an increase in INR from 2.64 to 4.12 after taking a combination product containing milk thistle 200 mg daily, as well as dandelion, wild yam, niacinamide, and vitamin B12. Levels returned to normal after stopping the supplement (101159). Although a direct correlation between milk thistle and the change in INR cannot be confirmed, some in vitro research suggests that milk thistle might inhibit cytochrome P450 2C9 (CYP2C9), an enzyme involved in the metabolism of various drugs, including warfarin (7089,17973,17976).
|
Below is general information about the adverse effects of the known ingredients contained in the product BHI Varicose. 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, no adverse effects have been reported; however, a thorough evaluation of safety outcomes has not been conducted.
Additionally, clubmoss contains toxic alkaloids, which could cause serious adverse effects (43721). When fir club moss (Lycopodium selago) is mistaken for clubmoss, cholinergic toxicity has been reported. This toxicity is due to huperzine A, which is not present in clubmoss (13193).
Airborne exposure to clubmoss spores might cause symptoms of asthma (43721).
Pulmonary/Respiratory ...Occupational exposure to clubmoss spores, including cases associated with facilities that use the spores to coat condoms, has been reported to cause asthma (43721).
Other ...Clubmoss (Lycopodium clavatum) might be mistaken for fir club moss (Lycopodium selago), which contains huperzine A, a constituent with strong inhibitory activity against acetylcholinesterase. In two case reports, fir club moss was mistaken for clubmoss and ingested as tea. This caused cholinergic toxicity with symptoms of sweating, nausea, dizziness, cramping, and slurred speech (13193).
General
...Orally, ergot can cause gastrointestinal symptoms such as nausea and abdominal pain.
Weakness, muscle pain of the extremities, and numbness and tingling of the fingers and toes may also occur (9). Symptoms of acute overdose include nausea, vomiting, diarrhea, extreme thirst, coldness, tingling and itching of the skin, a rapid and weak pulse, hypotension, shock, confusion, seizures, unconsciousness, and death (9).
Chronic toxicity, or ergotism, rarely occurs after a single oral dose. It usually results from cumulative doses over a short period of time (11163). Ergotism from food is rare today. It is more common from overdoses of prescription ergot alkaloids (11164). Symptoms of ergotism are related to circulatory disturbances. Numbness, coldness, and tingling of the extremities, particularly the feet and legs occur along with paleness or cyanosis. There may be no pulse in the affected area, which may develop into gangrene, especially in the toes (9,11163). A convulsive form of ergotism may also occur. Symptoms include muscle spasms in the trunk and limbs, painful involuntary flexion of the fingers and wrists, and either flexion or extension of the ankles. Neurologic adverse effects such as drowsiness, delirium, lethargy, mental changes, and visual disturbances can also occur. Sweating, fever, muscle stiffness, twitching and seizures have also been reported (9,11163).
Cardiovascular ...Orally, chronic toxicity with ergot, or ergotism, results from cumulative doses over a short period of time. Symptoms are often related to circulatory disturbances. Numbness, coldness, and tingling of the extremities, particularly the feet and legs occur along with paleness or cyanosis. There may be no pulse in the affected area, which may develop into gangrene, especially in the toes (9,11163)
Gastrointestinal ...Orally, ergot can cause gastrointestinal symptoms such as nausea, vomiting, diarrhea, and abdominal pain (9).
Musculoskeletal ...Orally, chronic toxicity from cumulative ergot doses over a short period of time can present as a convulsive form of ergotism. Symptoms include muscle spasms in the trunk and limbs, painful involuntary flexion of the fingers and wrists, and either flexion or extension of the ankles. Sweating, fever, muscle stiffness, twitching and seizures have also been reported (9,11163).
Neurologic/CNS ...Orally, ergot can cause drowsiness, delirium, lethargy, mental changes, and visual disturbances (9,11163).
Other ...Symptoms of acute ergot oral overdose include nausea, vomiting, diarrhea, extreme thirst, coldness, tingling and itching of the skin, a rapid and weak pulse, hypotension, shock, confusion, seizures, unconsciousness, and death (9).
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, milk thistle is well tolerated.
Most Common Adverse Effects:
Orally: Abdominal bloating, diarrhea, dyspepsia, flatulence, and nausea. However, these adverse effects do not typically occur at a greater frequency than with placebo.
Serious Adverse Effects (Rare):
Orally: Allergic reactions, including anaphylaxis, have been reported.
Dermatologic ...Orally, milk thistle may cause allergic reactions including urticaria, eczema, skin rash, and anaphylaxis in some people (6879,7355,8956,63210,63212,63238,63251,63315,63325,95029). Allergic reactions may be more likely to occur in patients sensitive to the Asteraceae/Compositae family (6879,8956). A case report describes a 49-year-old female who developed clinical, serologic, and immunopathologic features of bullous pemphigoid after taking milk thistle orally for 6 weeks. Symptoms resolved after treatment with prednisone and methotrexate (107376). Topically, milk thistle can cause erythema (110489).
Gastrointestinal ...Mild gastrointestinal symptoms have been reported, including nausea, vomiting, bloating, diarrhea, epigastric pain, abdominal colic or discomfort, dyspepsia, dysgeusia, flatulence, constipation, and loss of appetite (2616,6879,8956,13170,63140,63146,63160,63210,63218,63219)(63221,63244,63247,63250,63251,63320,63321,63323,63324,63325)(63327,63328,95024,95029,107374). There is one report of a 57-year-old female with sweating, nausea, colicky abdominal pain, diarrhea, vomiting, weakness, and collapse after ingesting milk thistle; symptoms subsided after 24-48 hours without medical treatment and recurred with re-challenge (63329).
Musculoskeletal ...In one clinical study three patients taking milk thistle 200 mg orally three times daily experienced tremor; the incidence of this adverse effect was similar for patients treated with fluoxetine 10 mg three times daily (63219).
General
...Orally, fresh pulsatilla is a toxic gastrointestinal irritant (4,19).
It can also cause kidney and urinary tract irritation (2).
Topically, contact with the fresh plant can cause skin irritation, mucous membrane irritation, itching, and pustule formation known as ranunculus dermatitis (2). Allergic reactions to pulsatilla volatile oil have been documented with patch tests (4).
Inhalation of pulsatilla volatile oil may cause nasal mucosal and conjunctival irritation (4).
Dermatologic ...Topically, contact with the fresh plant can cause skin irritation, mucous membrane irritation, itching, and pustule formation known as ranunculus dermatitis (2).
Gastrointestinal ...Orally, fresh pulsatilla is a toxic gastrointestinal irritant (4,19).
Genitourinary ...Orally, fresh pulsatilla can cause urinary tract irritation (2).
Immunologic ...Topically, allergic reactions to the protoanemonin-containing volatile oil of pulsatilla have been documented with patch tests (4).
Ocular/Otic ...Inhalation of the protoanemonin-containing volatile oil of pulsatilla may cause conjunctival irritation (4).
Pulmonary/Respiratory ...Inhalation of the protoanemonin-containing volatile oil of pulsatilla may cause nasal mucosal irritation (4).
Renal ...Orally, fresh pulsatilla can cause kidney irritation (2).
General
...Topically, witch hazel is generally well tolerated.
Orally, witch hazel seems to be well tolerated at appropriate doses, but high doses may be associated with more adverse effects due to the tannin content in witch hazel.
Most Common Adverse Effects:
Topically: Contact dermatitis.
Serious Adverse Effects (Rare):
Orally: Kidney and liver damage when preparations containing at least 10% tannins are used in high doses.
Dermatologic ...Topically, witch hazel can cause contact dermatitis (6,86505). A small number of people develop redness or burning (67795).
Gastrointestinal ...Witch hazel contains tannins, with the leaf containing 8% to 10% tannins and the bark containing up to 12% tannins (512,10377,93894). Orally, plants with at least 10% tannins can cause gastrointestinal disturbances (12).
Hepatic ...Witch hazel contains tannins, with the leaf containing 8% to 10% tannins and the bark containing up to 12% tannins (512,10377,93894). Orally, plants with at least 10% tannins can cause necrotic conditions of the liver (12).
Oncologic ...Witch hazel contains tannins, with the leaf containing 8% to 10% tannins and the bark containing up to 12% tannins (512,10377,93894). Some evidence suggests that tannins might cause cancer; other evidence shows tannins may prevent it (12). Regular consumption of herbs with high tannin concentrations correlates with increased incidence of esophageal or nasal cancer (12).
Renal ...Witch hazel contains tannins, with the leaf containing 8% to 10% tannins and the bark containing up to 12% tannins (512,10377,93894). Orally, plants with at least 10% tannins can cause kidney damage (12).
