Baryta Carbonica 3 CH • Berberis vulgaris 3 CH • Conium Maculatum 3 CH • Picricum Acidum 3 CH • Pulsatilla 3 CH • Sabal serrulata 3 CH • Thlaspi Bursa-Pastoris 3 DH • Thuja occidentalis 3 CH. Other Ingredients: Ethanol.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
In 2004, Canada began regulating natural medicines as a category of products separate from foods or drugs. These products are officially recognized as "Natural Health Products." These products include vitamins, minerals, herbal preparations, homeopathic products, probiotics, fatty acids, amino acids, and other naturally derived supplements.
In order to be marketed in Canada, natural health products must be licensed. In order to be licensed in Canada, manufacturers must submit applications to Health Canada including information about uses, formulation, dosing, safety, and efficacy.
Products can be licensed based on several criteria. Some products are licensed based on historical or traditional uses. For example, if an herbal product has a history of traditional use, then that product may be acceptable for licensure. In this case, no reliable scientific evidence is required for approval.
For products with non-traditional uses, some level of scientific evidence may be required to support claimed uses. However, a high level of evidence is not necessarily required. Acceptable sources of evidence include at least one well-designed, randomized, controlled trial; well-designed, non-randomized trials; cohort and case control studies; or expert opinion reports.
Finished products licensed by Health Canada must be manufactured according to Good Manufacturing Practices (GMPs) as outlined by Health Canada.
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 Sabal Serrulata Complex (Drops). 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
There is insufficient reliable information available about the effectiveness of hemlock.
There is insufficient reliable information available about the effectiveness of pulsatilla.
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 Sabal Serrulata Complex (Drops). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when the fruit is consumed orally in food amounts (13527). There is insufficient reliable information available about the safety of European barberry when used orally in medicinal amounts or when used topically.
CHILDREN: LIKELY UNSAFE
when used orally in newborns.
The berberine constituent of European barberry can cause kernicterus in newborns, particularly preterm neonates with hyperbilirubinemia (2589). There is insufficient reliable information available about the safety of European barberry when used orally in older children.
PREGNANCY: LIKELY UNSAFE
when used orally.
Berberine is thought to cross the placenta and may cause harm to the fetus. Kernicterus has developed in newborn infants exposed to berberine (2589).
LACTATION: LIKELY UNSAFE
when used orally.
Berberine and other harmful constituents can be transferred to the infant through breast milk (2589).
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.
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 used orally and appropriately. Saw palmetto has been safely used in clinical studies lasting up to 3 years (2735,6750,6752,6764,6772,6773,11354,14274,15550,17202,17306,17684,73315,73383,73384,73385,73389,89441,96410,96412,110540).
POSSIBLY SAFE ...when used rectally and appropriately. Saw palmetto has been used safely in clinical research at a dose of 640 mg once daily for 30 days (73387). However, the long-term safety of saw palmetto administered rectally is not known.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally.
Saw palmetto has hormonal activity (6766); avoid using.
POSSIBLY SAFE ...when preparations of the above ground parts are used orally and appropriately (4,12). Doses of 1280 mg daily have been used safely for up to 7 days in a clinical trial (102404). ...when used topically (4).
POSSIBLY UNSAFE ...when large amounts of shepherd's purse are ingested, it can cause heart palpitations (12).
PREGNANCY: LIKELY UNSAFE
when used orally or topically, due to possible uterine stimulation, menstrual flow stimulation, and miscarriage (12).
LACTATION:
Insufficient reliable information available; avoid excessive use (4).
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 Sabal Serrulata Complex (Drops). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, taking European barberry with anticholinergic drugs might cause additive effects.
 Details
In vitro evidence suggests that European barberry might have anticholinergic properties (13527).
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Theoretically, European barberry may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
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Theoretically, taking European barberry with antidiabetes drugs might increase the risk of hypoglycemia.
Details
Preliminary clinical evidence suggests that European barberry juice reduces fasting glucose levels in patients with type 2 diabetes who are also taking antidiabetes drugs (98575). Additionally, some animal studies show that berberine, a constituent of European barberry, has antiglycemic potential (33622,33667). Monitor blood glucose levels closely.
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Theoretically, taking European barberry with antihypertensive drugs might increase the risk of hypotension.
Details
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Theoretically, taking European barberry with cholinergic drugs might decrease the effects of cholinergic drugs.
Details
In vitro evidence suggests that European barberry might have anticholinergic properties (13527).
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Theoretically, concomitant use with drugs that have sedative properties may cause additive effects.
Details
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Theoretically, concomitant use with cyclosporine may cause additive effects.
Details
Berberine, a constituent of European barberry, can reduce the metabolism and increase serum levels of cyclosporine. This effect is attributed to the ability of berberine to inhibit cytochrome P450 3A4 (CYP3A4), which metabolizes cyclosporine (13524). Theoretically, European barberry might have a similar effect.
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Theoretically, European barberry might increase the levels and clinical effects of CYP3A4 substrates.
Details
There is very preliminary evidence suggesting that berberine, a constituent of European barberry, might inhibit the CYP3A4 enzyme (13524). Theoretically, European barberry might have a similar effect.
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Saw palmetto might increase the risk of bleeding with anticoagulant or antiplatelet drugs.
Details
Saw palmetto is reported to prolong bleeding time (8659). Theoretically, it might increase the risk of bleeding when used concomitantly with anticoagulant or antiplatelet drugs.
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Saw palmetto might reduce the effectiveness of contraceptive drugs.
Details
Saw palmetto might have antiestrogenic effects (6766). Theoretically, it might interfere with contraceptive drugs taken concomitantly.
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Saw palmetto might reduce the effectiveness of estrogens.
Details
Saw palmetto might have antiestrogenic effects (6766). Theoretically, it might interfere with estrogens taken concomitantly.
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Theoretically, concomitant use with drugs with sedative properties may cause additive effects and side effects (4).
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Theoretically, concomitant use may interfere with thyroid dysfunction therapy (4).
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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 Sabal Serrulata Complex (Drops). 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 ...European barberry is generally well tolerated when consumed in amounts commonly found in food. A thorough evaluation of safety outcomes has not been conducted for the use of larger, medicinal amounts. Topically, European barberry seems to be well tolerated.
Hepatic ...Orally, a case of hepatitis-associated aplastic anemia is reported in an adult male after consuming European barberry 15 drops and nannari root 15 drops twice a day for 2 weeks. The patient presented with lethargy, loss of appetite, and jaundice that progressed to high-grade fevers, chills, rigors, severe pancytopenia, and abnormal liver function tests. Liver biopsy was suggestive of drug-induced liver injury. The patient was hospitalized for multiple infections and symptomatic thrombocytopenia. Despite receiving supportive care, blood transfusions, and corticosteroids, the patient died 7 weeks after diagnosis (110021). The exact reason for this adverse effect is not clear.
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, 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
...Orally, saw palmetto is well tolerated and adverse effects are mild, infrequent, and reversible.
Most Common Adverse Effects:
Orally: Abdominal pain, constipation, decreased libido, diarrhea, dizziness, fatigue, headache, nausea, rhinitis, vomiting.
Cardiovascular ...Occasionally, cases of hypertension, postural hypotension, tachycardia, angina pectoris, arrhythmia, extrasystole, angiopathy, myocardial infarction, and congestive heart failure have been reported in patients using saw palmetto orally (6424,6484,6752,6772,17684,73388,89441). One case of severe bradycardia and second degree heart block was reported in a 64 year-old male taking an unknown amount of saw palmetto for a few weeks (96413).
Dermatologic ...A case report describes a 61-year-old male who developed a fixed drug eruption with localized blisters and erosions three days after starting oral saw palmetto. The lesions resolved when saw palmetto was stopped, but recurred when it was reintroduced six months later. Topical corticosteroid treatment was necessary and the patient was left with some residual hyperpigmented patches (104805). A combination of saw palmetto and beta-sitosterol has been associated with a single report of worsening acne (15550).
Endocrine ...Two case reports involving one 11-year-old female undergoing treatment for telogen effluvium and another 10-year-old female undergoing treatment for hirsutism, describe hot flashes and the onset of menarche associated with use of saw palmetto. One of these patients was consuming saw palmetto in a food supplement; the other was taking a supplement containing saw palmetto 320 mg daily (73361,96414). In both cases, the hot flashes resolved following treatment discontinuation. In one case, a rechallenge with saw palmetto caused a recurrence of hot flashes.
Gastrointestinal ...Gastrointestinal complaints such as nausea, vomiting, constipation, diarrhea, gastralgia, and halitosis are the most frequently reported adverse effects associated with saw palmetto (6484,6752,60442,73315,73320,73348,73354,73383,73385,73388,89441). Less often, cases of duodenal ulcer, dyspepsia, or heartburn have been reported (6772,73329,73354). Meteorism (intestinal gas accumulation) has also been reported with saw palmetto, although causality was unclear (60442).
Genitourinary ...Some clinicians are concerned that saw palmetto might cause erectile dysfunction, ejaculatory disturbance, or altered libido because of its potential effects on 5-alpha-reductase. Some preliminary clinical studies have reported sexual dysfunction, particularly ejaculatory dysfunction, erectile dysfunction, and reduced libido, in patients taking saw palmetto (5093,17202,17684,73383,89441). However, most of these patients were previously diagnosed with prostate disorders, so causality is unclear. Additionally, several clinical studies indicate that the occurrence of impotence in males taking saw palmetto is similar to placebo and tamsulosin (Flomax), and significantly less than finasteride (Proscar) (2732,6424,17306,107481). Rarely, cases of testicular pain, vesical tenesmus, and urinary tract infections have been reported in patients using saw palmetto extract orally (73388).
Hematologic ...Saw palmetto might have antiplatelet effects and potentially increase the risk of bleeding in some patients. There is one report of excessive intraoperative bleeding in a patient who took saw palmetto prior to surgery. Bleeding time normalized when saw palmetto was discontinued (8659). Also, one case of cerebral hemorrhage has been reported, but details are not available to determine causality (6772,73348). A case of retroperitoneal hematoma after bilateral inguinal hernia repair is reported in a male patient taking saw palmetto. The patient was discharged after a 3-day hospitalization in stable condition (112177).
Hepatic ...A case report describes a patient who developed acute hepatitis and pancreatitis while taking saw palmetto. Symptoms resolved when saw palmetto was discontinued, and reemerged upon re-challenge (14457). Other cases of acute hepatitis and pancreatitis, with elevated alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin have been reported in patients using saw palmetto orally (14457,73350,73351).
Musculoskeletal ...Orally, saw palmetto may cause fatigue, weakness, muscle pain, and back pain, although these adverse events are rare (6424,73388,89441). A case of saw palmetto-related rhabdomyolysis was reported in an 82-year-old male presenting with kidney dysfunction, increased C-reactive protein levels, and elevated serum creatine kinase (73358).
Neurologic/CNS ...Orally, saw palmetto can cause headaches, dizziness, insomnia, and fatigue (6750,6752,6772,11354,60442,73348,73385,73388,89441).
Ocular/Otic ...A case of intraoperative floppy-iris syndrome (IFIS) has been reported in a patient using saw palmetto orally (73340). However, no statistically significant association between saw palmetto and IFIS was found in a case series of 660 patients undergoing cataract surgery (73347).
Pulmonary/Respiratory ...Rhinitis is one of the more commonly reported adverse effects of saw palmetto (73348). One patient taking saw palmetto extract 160 mg twice daily reported "breathlessness" (73388). Two cases of respiratory depression have been reported in patients using saw palmetto extract (Permixon) 320 mg (6772).
General ...Orally, shepherd's purse seems to be well tolerated when used in small amounts, short-term. Adverse effects traditionally thought to be associated with shepherd's purse have included sedation, hypertension, hypotension, abnormal thyroid function, abnormal menstruation (4), and palpitations (12).
Cardiovascular ...Orally, some adverse effects traditionally thought to be associated with shepherd's purse have included hypertension, hypotension, (4), and palpitations (12).
Endocrine ...Orally, some adverse effects traditionally thought to be associated with shepherd's purse have included abnormal thyroid function (4).
Genitourinary ...Orally, some adverse effects traditionally thought to be associated with shepherd's purse have included abnormal menstruation (4).
Neurologic/CNS ...Orally, some adverse effects traditionally thought to be associated with shepherd's purse have included sedation (4).
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).
