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Proprietary Blend
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1 mL |
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(fruit)
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(fruit, hull, seed)
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(seed)
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(root)
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(flower, leaf, stem)
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(leaf)
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(root)
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organic Vegetable Glycerin, triple-distilled Water, Organic Plant Essence Blend (Form: organic Bergamot, organic Lavender, organic Rose), energized Trace Minerals
Below is general information about the effectiveness of the known ingredients contained in the product Plant-Based Vein Health. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of stone root.
Below is general information about the safety of the known ingredients contained in the product Plant-Based Vein Health. 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 SAFE ...when used orally and appropriately short-term. A specific butcher's broom rhizome extract (Fagorutin Ruscus Kapseln, GlaxoSmithKline Consumer Healthcare) has been used with apparent safety at a dose of 75 mg daily for up to 3 months (9932,37502). A specific combination product (Cyclo 3 Fort, Pierre Fabre Medicament) containing butcher's broom root extract, hesperidin methyl chalcone, and vitamin C has been used with apparent safety in doses providing butcher's broom root extract 150 mg twice daily for up to 3 months or 300 mg three times daily for up to 1 month (10068,37494,94779). There is insufficient reliable information available about the safety of butcher's broom when used topically.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used topically and appropriately. Gotu kola has been used safely in a cream or ointment for up to 10 weeks (11072,11073,67372,102792,105329,105335). An emulsion containing gotu kola extract 3% and other ingredients has been applied safely to the skin twice daily for up to 60 days (111571). ...when used orally and appropriately. Gotu kola extract has been used with apparent safety in doses of up to 180 mg daily for up to 12 months or 1000 mg daily for 60 days. Dried gotu kola has been used with apparent safety in doses of up to 2200 mg daily for 4 weeks (6887,11062,11063,11064,11065,11066,11067,11068,11069,11070)(11071,99756,99757,99758,105329,105332,105333). A specific gotu kola extract (Centellicum, Horphag Research Ltd) 450-675 mg daily has been used with apparent safety for up to 6 weeks (99756,99757).
PREGNANCY: POSSIBLY SAFE
when used topically and appropriately (11073,13559).
There is insufficient reliable information available about the safety gotu kola when used orally during pregnancy; avoid using.
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Grapes and grape skin extracts have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY SAFE ...when the whole fruit of the grape, or extracts of the fruit, seed, or leaf, are used orally and appropriately in medicinal amounts. Grape seed extracts have been used with apparent safety in doses up to 200 mg daily for up to 11 months (9182,53016) and in doses up to 2000 mg daily for up to 3 months (53149,53190). Specific grape fruit extracts (Stilvid, Actafarma; Cognigrape, Bionap srl) have been used with apparent safety in doses up to 250-350 mg daily for 3-12 months or 700 mg daily for 6 months (53254,53256,96198). A specific grape leaf extract (AS 195, Antistax, Boehringer Ingelheim) has been used with apparent safety in doses up to 720 mg daily for up to 3 months (2538,52985,53005,53206). A preparation of dehydrated whole grapes, equivalent to 250 grams of fresh grapes daily, has also been used with apparent safety for up to 30 days (18228). A specific grape seed extract (Enovita; Indena SpA) 150 mg twice daily, standardized to provide at least 95% oligomeric proanthocyanins, has been used with apparent safety for up to 16 weeks (108091) ...when used topically and appropriately. Creams and ointments containing grape seed extract 2% or 5% have been used topically with apparent safety for up to 3 weeks (91539,100955). There is insufficient reliable information available about the safety of other grape plant parts when used topically.
CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in foods.
Grapes and grape skin extracts have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912). However, whole grapes should be eaten with caution in children aged 5 years and under. Whole grapes can be a choking hazard for young children (96193). To reduce the risk of choking, whole grapes should be cut in half or quartered before being given to children. There is insufficient reliable information available about the safety of grape when used in medicinal amounts in children.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods.
There is insufficient reliable information available about the safety of medicinal amounts during pregnancy and breast-feeding; avoid using in amounts greater than what is commonly found in foods.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Hawthorn preparations in doses of up to 1800 mg daily seem to be safe when used for up to 16 weeks. Although hawthorn might be safe for long-term use, current studies have not evaluated safety past 16 weeks (8279,8280,8281,10144,17203,104689). There is insufficient reliable information available about the safety of hawthorn when used topically.
PREGNANCY AND LACTATION:
Insufficient reliable information available; 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.
POSSIBLY SAFE ...when used orally and appropriately. Motherwort extracts have been used with apparent safety at doses of 1200 mg daily for up to 28 days (94209) or 800 mg daily, in combination with Lactiplantibacillus plantarum, for up to 12 weeks (115049)....when administered intramuscularly, short-term. One or more intramuscular injections have been used with apparent safety in total combined doses of 40-200 mg over 48 hours or less to prevent and/or stop postpartum bleeding (94203,101890,101891,101892). Post-marketing surveillance of over 8000 females found that a specific motherwort product (Chengdu No 1 Pharma Company Ltd) has been used without significant adverse effects for a duration of 48 hours or less (104855) ...when administered by intrauterine injection, short-term. Post-marketing surveillance of over 1800 patients found that a specific motherwort product (Chengdu No 1 Pharma Company Ltd) has been used without significant adverse effects for a duration of 48 hours or less (104855).
PREGNANCY: LIKELY UNSAFE
when used orally or by injection.
Alkaloids present in motherwort have uterine stimulant effects (4,12,19).
LACTATION:
Insufficient reliable information available; avoid using.
There is insufficient reliable information available about the safety of stone root.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Plant-Based Vein Health. 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, butcher's broom might increase the effects and adverse effects of alpha-adrenergic agonists.
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Theoretically, butcher's broom might reduce the effects of alpha-adrenergic antagonists.
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Theoretically, taking gotu kola might increase the sedative effects of CNS depressants.
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Theoretically, taking gotu kola with hepatotoxic drugs might have additive adverse effects.
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Theoretically, grape extracts may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
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Ingesting grape juice with cyclosporine can reduce cyclosporine absorption.
Details
A small pharmacokinetic study in healthy young adults shows that intake of purple grape juice 200 mL along with cyclosporine can decrease the absorption of cyclosporine by up to 30% when compared with water (53177). Separate doses of grape juice and cyclosporine by at least 2 hours to avoid this interaction.
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Theoretically, grape juice might reduce the levels of CYP1A2 substrates.
Details
A small pharmacokinetic study in healthy adults shows that ingestion of 200 mL of grape juice decreases phenacetin plasma levels. This is thought to be due to induction of CYP1A2 (2539).
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It is unclear if grape juice or grape seed extract inhibits CYP2C9; research is conflicting.
Details
In vitro evidence shows that grape seed extract or grape juice might inhibit CYP2C9 enzymes (11094,53011,53089). However, a small pharmacokinetic study in healthy adults shows that drinking 8 ounces of grape juice once does not affect the clearance of flurbiprofen, a probe-drug for CYP2C9 metabolism (11094). The effects of continued grape juice consumption are unclear.
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Theoretically, grape seed extract may increase the levels of CYP2D6 substrates.
Details
In vitro evidence suggests that grape seed extract might inhibit CYP2D6 enzymes (53011). However, this interaction has not been reported in humans.
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Theoretically, grape seed extract might increase the levels of CYP2E1 substrates.
Details
In vitro and animal research suggests that grape seed proanthocyanidin extract inhibits CYP2E1 enzymes (52949). However, this interaction has not been reported in humans.
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It is unclear if grape seed extract inhibits or induces CYP3A4; research is conflicting.
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Theoretically, long-term intake of grape seed extract might decrease the effects of midazolam.
Details
Animal research shows that subchronic ingestions of grape seed extract can increase the elimination of intravenous midazolam by increasing hepatic CYP3A4 activity. Single doses of grape seed extract do not appear to affect midazolam elimination (53011).
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Grape juice might decrease phenacetin absorption.
Details
A small pharmacokinetic study in healthy adults shows that ingestion of 200 mL of grape juice decreases phenacetin plasma levels. This is thought to be due to induction of cytochrome P450 1A2 (CYP1A2) (2539).
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Theoretically, hawthorn may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
In vitro and animal research shows that hawthorn can inhibit platelet aggregation (95528,95529,95530,95531). However, its effect in humans is unclear. One observational study shows that patients taking hawthorn shortly before undergoing coronary artery bypass graft (CABG) surgery or valve replacement surgery have a 10% incidence of postoperative bleeding, compared with 1% in those who never consumed hawthorn extract (95527). However, clinical research shows that taking a specific preparation of dried hawthorn leaves and flowers (Crataesor, Soria Natural Lab) 800 mg three times daily for 15 days does not affect platelet aggregation or levels of thromboxane B2, the metabolite of thromboxane A2, in healthy humans (54664).
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Theoretically, concomitant use might cause additive effects on blood pressure and heart rate.
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Theoretically, concomitant use might cause additive coronary vasodilation and hypotensive effects.
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Theoretically, hawthorn might potentiate the effects and adverse effects of digoxin.
Details
Hawthorn appears to improve cardiac output (12595); however, hawthorn does not appear to affect digoxin pharmacokinetics (19249). Case reports suggest that at least one species of hawthorn root extract (Crataegus mexicana) may produce adverse effects similar to digoxin and can cross-react with digoxin assays, leading to falsely elevated plasma digoxin levels (113112,113113).
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Theoretically, concomitant use might cause additive coronary vasodilatory effects.
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Theoretically, concomitant use might result in additive vasodilation and hypotension.
Details
Hawthorn might inhibit PDE-5 and cause vasodilation (12595).
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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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Theoretically, taking motherwort concomitantly with other CNS depressants may increase the risk of sedation.
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Below is general information about the adverse effects of the known ingredients contained in the product Plant-Based Vein Health. 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, butcher's broom seems to be well tolerated, short-term.
Most Common Adverse Effects:
Orally: Diarrhea, dyspepsia, gastritis, heartburn, nausea, and vomiting.
Topically: Contact dermatitis in sensitive individuals.
Dermatologic ...Topically, butcher's broom may cause contact dermatitis (37487,94780). A 30-year-old female developed an erythematous, papular, pruritic rash on both legs after applying a cream containing butcher's broom root extract (Fabroven, Pierre Fabre Iberica) to varicose veins for 2 months. The rash spread to the entire body, and the patient had positive patch tests to ethanol extracts of butcher's broom (37487). In another report, a 34-year-old female developed pruritic eczematous lesions in the perianal area after using an antihemorrhoidal cream containing a butcher's broom extract (Proctolog, Desma Pharmaceutical). Several months later, the patient developed a generalized eczematous rash after applying another cream containing butcher's broom extract to the legs. The patient had positive patch tests to ruscogenins, which are constituents of butcher's broom (94780).
Gastrointestinal ...Orally, butcher's broom may cause nausea, vomiting, diarrhea, dyspepsia, heartburn, and gastritis (10068,37494,37498,94778). A 39-year-old female with poorly-controlled diabetes reported severe vomiting and diarrhea after taking butcher's broom for 5 days and was ultimately hospitalized with dehydration, hyperkalemia, acidosis, and sinus tachycardia (94778).
General
...Orally and topically, gotu kola seems to be well tolerated.
Most Common Adverse Effects:
Orally: Gastric irritation and nausea.
Topically: Eczema.
Serious Adverse Effects (Rare):
Orally: Hepatotoxicity.
Dermatologic ...Topically, gotu kola may cause eczema (10277,10278). Also, gotu kola can cause allergic contact dermatitis, characterized by erythema, itching, papules, and a burning sensation (4,6887,9789,52875,52887,52896,52902). One specific gotu kola product (Blasteostimulina,Almirall, S. A.) has been reported to cause allergic contact dermatitis. However, not all patients with reactions to this product are sensitive to gotu kola; some patients are sensitive to neomycin, another ingredient in the product (52875). Madecassol ointment (Rona Laboratories Limited) is another gotu kola product that has resulted in allergic contact dermatitis. Controlled testing suggests that this product can cause this adverse effect in about 8% of patients (9789). Centellase cream has also caused allergic contact dermatitis in at least two cases (52887,52888).
Gastrointestinal ...In some patients, gotu kola can extract cause gastrointestinal upset and nausea (780,6887,52894).
Hepatic
...There is concern that gotu kola may cause liver toxicity in some patients.
There are at least four case reports of hepatotoxicity associated with gotu kola; however, hepatotoxic contaminants cannot be ruled out, as laboratory analysis was not conducted on the products used. Additionally, the doses of gotu kola used in these cases were not reported (13182,92506). In a clinical trial where liver function was monitored, taking gotu kola 120 mg daily for 6 months was not associated with changes in liver function (11065).
In one case of hepatotoxicity, a 61-year-old female developed elevated liver transaminase and total bilirubin levels after taking gotu kola tablets for 30 days. Liver biopsy showed granulomatous acute hepatitis. Months later, the patient took gotu kola again and developed elevated liver transaminases after 2 weeks. In another case, a 52-year-old female developed symptoms of hepatitis and increased liver transaminases after taking gotu kola for 3 weeks. Biopsy indicated chronic hepatitis and granulomas, areas of necrosis, and cirrhotic transformation. Liver function normalized after discontinuation of gotu kola. In a third case, a 49-year-old female developed symptoms of hepatitis after taking gotu kola for 2 months. Biopsy revealed granulomatous hepatitis. Liver function normalized after discontinuation of gotu kola (13182). In a fourth case, a 15-year-old female taking an unknown dose of gotu kola and lymecycline for 6 weeks for acne experienced acute liver failure with abdominal pain and vomiting, as well as elevated liver transaminases, bilirubin, international normalized ratio (INR), and prothrombin. Liver function returned to normal after both products were discontinued (92506).
Immunologic ...Topically, gotu kola can cause allergic contact dermatitis, characterized by erythema, itching, papules, and a burning sensation (4,6887,9789,52875,52887,52896,52902). One specific gotu kola product (Blasteostimulina, Almirall, S. A.) has been reported to cause allergic contact dermatitis in some patients. However, not all patients who react to this product are sensitive to gotu kola; some are sensitive to neomycin, another ingredient in the product (52875). Madecassol ointment (Rona Laboratories Limited) is another gotu kola product that has resulted in allergic contact dermatitis. Controlled testing suggests that this product can cause this adverse effect in about 8% of patients (9789). Centellase cream has also caused allergic contact dermatitis in at least two cases (52887,52888).
Psychiatric ...A case of night eating syndrome has been reported for a 41-year-old female who had been taking a gotu kola tincture (dose not specified) for 2 years. Symptoms resolved after gotu kola use was discontinued (52878).
General
...Orally, the whole fruit, as well as the seed, fruit, and leaf extracts, seem to be well tolerated.
Topically, grape seed extracts seem to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, diarrhea, dry mouth, dyspepsia, headache, joint pain, and nausea.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis to grape skin has been reported.
Dermatologic ...Orally, mild hair thinning has been reported in a patient taking a specific grape leaf extract AS195 KG) (2538). Urticaria (hives) has also been reported with this same extract (53206). Cases of contact dermatitis have been reported in grape workers, including those working in California vineyards (53270,53272,53275).
Gastrointestinal ...Orally, abdominal pain and nausea have been reported with use of grape seed extract, but these effects typically occur at rates similar to placebo (9182,13162). In a case report of a 57-year-old man, intermittent nausea, vomiting, and diarrhea occurred over a 10-day period and improved once grape seed extract was stopped (96764). Gastrointestinal adverse effects have also been reported with use of a different grape seed extract (Entelon, Hanlim Pharm). However, the specific types of gastrointestinal effects were not described (100954). A specific grape leaf extract AS195 (Antistax, Boehringer Ingelheim Pharma GmbH & Co. KG) has reportedly caused flatulence, mild constipation, gastrointestinal discomfort, diarrhea, dyspepsia, dry mouth, and retching (2538,52985,53206). Diarrhea, gastrointestinal distress, indigestion, and aversion to taste have been reported with use of Concord grape juice (52972,53166,53175,53181,53199). Loose stools have been reported in a clinical trial of grape pomace (99270). Bowel obstruction caused by intact grapes and grape seeds has been described in case reports (53241,53284,53278). Excessive consumption of grapes, dried grapes, raisins, or sultanas might cause diarrhea due to laxative effects (4201).
Hematologic ...Orally, one case of leg hematoma following a minor trauma was reported in a person using grape leaf extract (2538). Also, one case of bruising was reported in a person drinking Concord grape juice daily for 2 weeks (52972).
Immunologic ...Orally, there is one report of an anaphylactic reaction to oral grape skin extract, which included urticaria and angioedema (4073).
Musculoskeletal ...Orally, musculoskeletal disorders, including back pain, have been reported with use of a specific grape leaf extract AS195 KG) (2538,53206). Joint pain and lumbago have been reported with use of grape seed extract, but these effects occur at rates similar to placebo (91541).
Neurologic/CNS ...Orally, headache has been reported with use of grape seed extract, but this effect occurs at rates similar to placebo (9182,91541). A specific grape leaf extract AS195 (Antistax, Boehringer Ingelheim Pharma GmbH & Co. KG) has reportedly caused dizziness, tiredness, headache, and sleep problems (2538,53206). As a class, nervous system adverse effects have been reported with use of a specific grape seed extract (Entelon, Hanlim Pharm). However, the specific types of adverse neurologic effects were not described (100954).
Ocular/Otic ...Orally, ocular adverse effects have been reported with use of a specific grape seed extract (Entelon, Hanlim Pharm). However, the specific types of ocular adverse effects were not described (100954).
Pulmonary/Respiratory ...Orally, nasopharyngitis and oropharyngeal pain have been reported with use of a specific grape leaf extract AS195 KG) (53206). Sore throat, cough, allergic rhinitis, and nasopharyngitis have been reported with use of grape seed extract, but these effects occur at rates similar to placebo (9182,91541). One case report describes a 16-year-old female who developed increased levels of immunoglobulin E (IgE) following skin-prick exposure to grape vine pollen, as well as positive test responses following bronchial and conjunctival provocation (53301). Reduced forced vital capacity has been described in California grape workers (53080,53081). Occupational eosinophilic lung was diagnosed in a grape grower with a history of asthma. Respiratory exposure to sulfites in grape was implicated as the cause of the adverse reaction (53285).
Other
...Orally, grape products can cause adverse effects due to contamination with pesticides or mycotoxins.
Some evidence has shown that pesticides used in vineyards may remain on grape surfaces post-harvesting. For example, the fungicide folpet sprayed on grapevines has been shown to remain on the grape surface. Although there was minimal penetration of the epicuticular wax, it showed high resistance to washing (52935). Carbaryl has been identified in over 58% of juice samples collected in Canada. This pesticide reportedly occurred more frequently in grape than in other juices. However, estimates of short-term intake were below proposed acute reference doses (53003).
Ochratoxin A is a mycotoxin that is suspected to be nephrotoxic, teratogenic, hepatotoxic and carcinogenic and has been identified in grape juice, frozen grape pulps, and red and white wine sold in Rio de Janeiro, Brazil. However, the highest levels identified in grape products were lower than the established virtually safe dose of 5 ng/kg of body weight daily (53010,53004). Ochratoxin A has also been identified in red, but not white, grape juice marketed in Switzerland, Canada, and the U.S. (53292,53020).
General
...Orally, hawthorn seems to be well tolerated when used appropriately.
Topically, no adverse effects have been reported, although a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Multiorgan hypersensitivity reactions resulting in acute renal failure have been reported rarely.
Cardiovascular
...Orally, tachycardia (with facial pains) of uncertain relationship to hawthorn was reported in a multicenter clinical trial (54640).
Palpitations (19244) were reported in three patients in a large surveillance trial of 3,664 patients with cardiac failure (54692) and in 11 patients with congestive heart failure (CHF) in a literature review of 5,577 patients (19247). Circulation failure has been reported in two patients with CHF in a literature review of 5,577 patients (19247). Incidences of hospitalization, hospitalization due to CHF, worsening of CHF, angina, and atrial fibrillation have also been reported with the use of hawthorn extract WS 1442 (Crataegutt forte), although it is unclear if these events are related to hawthorn supplementation or existing CHF (19222). In clinical trials, chest pain (8281), short-term increases in blood pressure (19240), and other non-specific heart problems (17203) have also been reported following the use of various hawthorn preparations (e.g. WS 1442, Korodin).
Orally, severe bradycardia, bradypnea, and Mobitz type 1 second degree heart block have been reported in a 16-year-old female who consumed Hawthorn root extract. Blood tests indicated plasma digoxin levels in the therapeutic range, despite no history of digoxin use. Medical treatment for digoxin cardiotoxicity did not improve symptoms. Symptoms gradually normalized over 3 days after discontinuation of the product (113112). Similarly, a 40-year-old female presented with bradycardia and elevated plasma digoxin levels after taking hawthorn root extract 196 mg daily for 2 days with no history of digoxin use. Symptoms resolved within 24 hours (113113).
Dermatologic ...Orally, erythematous rash has been reported in patients with CHF in a literature review of 5,577 patients (19247). Non-specific rashes and itching (19222,19243) as well as toxiderma from the fruits of hawthorn (54670) have also been reported.
Gastrointestinal ...Orally, rare abdominal discomfort of uncertain relationship to hawthorn has been reported in a large clinical trial, surveillance study, case reports, and a literature review (19247,54640,54692,113112). Digestive intolerance (19241), diarrhea (19243,113112), flatulence (8281), gastroenteritis (8281), increased bowel movements (19243), obstipation (8281), mild and rare nausea (10144,19247,19244), vomiting (113112), nutritional and metabolic problems (17203), and other non-specific gastrointestinal effects (19222), have also been reported. Furthermore, gastrointestinal hemorrhage has been reported in two patients with CHF in a literature review of 5,577 patients (19247).
Musculoskeletal ...In clinical trials, arthritis (8281), back pain (8281), weakness (19243), and other non-specific musculoskeletal effects (19222) have been reported following the use of various hawthorn preparations g. WS 1442, CKBM-A01). Additionally, in a case report, myalgia has been reported following use of hawthorn root extract (113113).
Neurologic/CNS ...Orally, headache and dizziness/vertigo were reported in 2 patients in a large surveillance trial of 3,664 patients with cardiac failure (54692), in 15 patients with CHF as reported in a literature review of 5,577 patients (19247), in a varying number of clinical trial participants (8281,19222,19244), and in case reports (113112,113113). Incidences of fainting (19222), fever (17203), and infrequent, mild and transient sleepiness have also been reported (19221,54692).
Psychiatric ...Orally, agitation was reported in a large surveillance trial of 3,664 patients with cardiac failure (54692).
Pulmonary/Respiratory ...Orally, bronchitis has been reported following the use of hawthorn extract WS 1442 (8281), and bradypnea has been reported following the use of hawthorn root extract (113112).
Renal ...A case of multiorgan hypersensitivity reaction and acute renal failure following the consumption of C. orientalis has been reported (54654).
Other ...Flu-like syndrome (8281) and other non-specific infections have been reported following the use of the hawthorn extract WS 1442 (17203,19222). Hawthorn has also been reported to cause nosebleeds (8281,10144).
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 or via intramuscular or intrauterine injection, motherwort appears to be generally well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, stomach irritation.
Topically: Contact dermatitis, photosensitivity.
Intramuscular / Intrauterine: Abdominal pain, erythema, eyelid edema, fever, nausea, pruritus, rash.
Dermatologic ...Motherwort leaves can cause contact dermatitis, and the oil may cause photosensitivity reactions (4). Intramuscularly and via intrauterine injection, mild erythema, rash, and pruritus have been reported (101892,104855).
Gastrointestinal ...Orally, use of motherwort in amounts greater than 3 grams can cause diarrhea and stomach irritation (12). Intramuscularly and via intrauterine injection, abdominal pain and nausea have been reported (104855).
Genitourinary ...Orally, use of motherwort in amounts greater than 3 grams can cause uterine bleeding (12).
Immunologic ...Motherwort can also cause allergic reactions in sensitive individuals (4). Intramuscularly and via intrauterine injection, transient fever and chills lasting less than 24 hours have been reported (104855).
Ocular/Otic ...Intramuscularly and via intrauterine injection, transient eyelid edema lasting less than 24 hours has been reported (104855).
General ...There is limited reliable information available about the adverse effects of stone root.
Gastrointestinal ...Orally, large amounts of stone root can cause intestinal tract irritation and colic-like pain dizziness, and nausea (18).
Genitourinary ...Orally, large amounts of stone root can cause painful urination (18).
