Hypophysinum L.A. 10X • Surreninum 10X • Arnica montana 6X • Erigeron canadensis 6X • Hydrastis canadensis 6X • Achilliea millefolium 6X • Sabina 8X • Secale cornutum 8X. Other Ingredients: Ethanol, Purified Water.
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 HPTP. 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 Canadian fleabane.
There is insufficient reliable information available about the effectiveness of ergot.
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of savin tops.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product HPTP. 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 in amounts commonly found in foods. Arnica has Generally Recognized As Safe (GRAS) status for use as a food flavoring in the US (4912). However, Canadian regulations do not allow its use as a food ingredient (12). ...when used orally in homeopathic dilutions of 30C and up to 5C (19110,19111,19117,19124,19126,96769). ...when used topically on unbroken skin, short-term (12).
LIKELY UNSAFE ...when used orally or when applied topically to broken skin. Arnica is considered poisonous and has caused severe or fatal poisonings (5). Arnica can cause gastroenteritis, muscle paralysis, bleeding, arrhythmia, hypertension, shortness of breath, nausea and vomiting, multi-organ failure, and death (4,5,17,104,19101,19102,19103,19104,19105,19106,19107,19108).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally or topically; avoid using (12).
POSSIBLY SAFE ...when used orally and appropriately (12). There is insufficient reliable information available about the safety of Canadian fleabane when used topically.
PREGNANCY AND LACTATION:
Insufficient reliable information is available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately as a single dose (260,261). There is insufficient reliable information available about the safety of goldenseal when used as more than a single dose.
CHILDREN: LIKELY UNSAFE
when used orally in newborns.
The berberine constituent of goldenseal can cause kernicterus in newborns, particularly preterm neonates with hyperbilirubinemia (2589).
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 goldenseal (2589).
LACTATION:
LIKELY UNSAFE when used orally.
Berberine and other harmful constituents can be transferred to the infant through breast milk (2589). Use during lactation can cause kernicterus in the newborn and several resulting fatalities have been reported (2589).
POSSIBLY UNSAFE ...when used topically. The essential oil from savin tops can cause severe irritation of skin and mucous membranes (18).
UNSAFE ...when used orally. Fatal poisonings have occurred with as little as 6 drops of the essential oil (18).
PREGNANCY AND LACTATION: UNSAFE
when used orally or topically.
Savin tops are contraindicated in pregnancy because they can induce abortion, and fatal poisoning has occurred with as little as 6 drops of the essential oil (18,19).
LIKELY SAFE ...when used orally in amounts commonly found in foods. Yarrow products that are thujone-free have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912); however, products containing thujone might not be safe. Thujone is a chemical that stimulates the central nervous system and is poisonous in large doses.
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (2,12,100346). Yarrow whole plant extract has been used with apparent safety at a dose of 250-500 mg daily for 12 months (100346). ...when used intravaginally as a cream containing yarrow extract 2% daily for 7 days (105360). There is insufficient reliable information available about the safety of yarrow when applied topically.
PREGNANCY: LIKELY UNSAFE
when used orally; yarrow is believed to be an abortifacient and affect the menstrual cycle (12).
LACTATION:
Insufficient reliable information available; avoid use.
Below is general information about the interactions of the known ingredients contained in the product HPTP. 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, arnica might have additive effects with anticoagulant and antiplatelet drugs. Homeopathic arnica preparations are unlikely to have this interaction.
Details
In vitro evidence shows that sesquiterpene lactones in arnica flowers can decrease platelet aggregation (104). However, this effect has not been reported in humans.
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Theoretically, Canadian fleabane might cause additive effects and side effects when used with anticoagulant or antiplatelet drugs. Canadian fleabane has been shown to inhibit platelet aggregation in vitro (99708,99709).
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Some anticoagulant/antiplatelet drugs include aspirin, clopidogrel (Plavix), dalteparin (Fragmin), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin), and others.
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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.
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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).
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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.
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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.
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Theoretically, goldenseal might increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.
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Theoretically, goldenseal might increase the risk of hypoglycemia when used with antidiabetes drugs.
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Theoretically, goldenseal might increase the risk of hypotension when taken with antihypertensive drugs.
Details
Goldenseal contains berberine. Animal research shows that berberine can have hypotensive effects (33692,34308). Also, an analysis of clinical research shows that taking berberine in combination with amlodipine can lower systolic and diastolic blood pressure when compared with amlodipine alone (91956). However, this effect has not been reported with goldenseal.
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Theoretically, goldenseal might increase the sedative effects of CNS depressants.
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Theoretically, goldenseal might increase serum levels of drugs metabolized by CYP2C9.
Details
In vitro research shows that goldenseal root extract can modestly inhibit CYP2C9. This effect may be due to its alkaloid constituents, hydrastine and berberine (21117). However, this effect has not been reported in humans.
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Goldenseal might increase serum levels of drugs metabolized by CYP2D6.
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Theoretically, goldenseal might increase serum levels of drugs metabolized by CYP2E1.
Details
In vitro research shows that goldenseal root extract can inhibit the activity of CYP2E1 (94140). However, this effect has not been reported in humans.
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Goldenseal might increase serum levels of drugs metabolized by CYP3A4.
Details
Most clinical and in vitro research shows that goldenseal inhibits CYP3A4 enzyme activity and increases serum levels of CYP3A4 substrates, such as midazolam (6450,13536,21117,91740,111725). However, in one small clinical study, goldenseal did not affect the levels of indinavir, a CYP3A4 substrate, in healthy volunteers (10690,93578). This is likely due to the fact that indinavir has a high oral bioavailability, making it an inadequate probe for CYP3A4 interactions (13536,91740) and/or that it is primarily metabolized by hepatic CYP3A, while goldenseal has more potential to inhibit intestinal CYP3A enzyme activity (111725). Both goldenseal extract and its isolated constituents berberine and hydrastine inhibit CYP3A, with hydrastine possibly having more inhibitory potential than berberine (111725).
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Theoretically, goldenseal might increase serum levels of dextromethorphan.
Details
Goldenseal contains berberine. A small clinical study shows that berberine can inhibit cytochrome P450 2D6 (CYP2D6) activity and reduce the metabolism of dextromethorphan (34279).
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Goldenseal might increase serum levels of digoxin, although this effect is unlikely to be clinically significant.
Details
Clinical research shows that goldenseal modestly increases digoxin peak levels by about 14% in healthy volunteers. However, goldenseal does not seem to affect other pharmacokinetic parameters such as area under the curve (AUC) (15132). This suggests that goldenseal does not cause a clinically significant interaction with digoxin. Digoxin is a P-glycoprotein substrate. Some evidence suggests that goldenseal constituents might affect P-glycoprotein; however, it is unclear whether these constituents inhibit or induce P-glycoprotein.
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Theoretically, goldenseal might decrease the conversion of losartan to its active form.
Details
Goldenseal contains berberine. A small clinical study shows that berberine inhibits cytochrome P450 2C9 (CYP2C9) activity and reduces the metabolism of losartan (34279). However, this effect has not been reported with goldenseal.
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Theoretically, goldenseal might reduce blood levels of metformin.
Details
In vitro research shows that goldenseal extract decreases the bioavailability of metformin, likely by interfering with transport, intestinal permeability, or other processes involved in metformin absorption. It is unclear which, if any, of metformin's transporters are inhibited by goldenseal. Goldenseal does not appear to alter the clearance or half-life of metformin (105764).
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Theoretically, goldenseal might reduce the therapeutic effects of oseltamivir by decreasing its conversion to its active form.
Details
In vitro evidence suggests that goldenseal reduces the formation of the active compound from the prodrug oseltamivir (105765). The mechanism of action and clinical relevance is unclear.
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Theoretically, goldenseal might increase or decrease serum levels of P-glycoprotein (P-gp) substrates.
Details
There is conflicting evidence about the effect of goldenseal on P-gp. In vitro research suggests that berberine, a constituent of goldenseal, modestly inhibits P-gp efflux. Other evidence suggests that berberine induces P-gp. In healthy volunteers, goldenseal modestly increases peak levels of the P-gp substrate digoxin by about 14%. However, it does not seem to affect other pharmacokinetic parameters such as area under the curve (AUC) (15132). This suggests that goldenseal is not a potent inhibitor of P-gp-mediated drug efflux. Until more is known, goldenseal should be used cautiously with P-gp substrates.
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Theoretically, goldenseal might increase the sedative effects of pentobarbital.
Details
Animal research shows that berberine, a constituent of goldenseal, can prolong pentobarbital-induced sleeping time (13519). However, this effect has not been reported with goldenseal.
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Theoretically, goldenseal might increase serum levels of tacrolimus.
Details
Goldenseal contains berberine. In a 16-year-old patient with idiopathic nephrotic syndrome who was being treated with tacrolimus 6.5 mg twice daily, intake of berberine 200 mg three times daily increased the blood concentration of tacrolimus from 8 to 22 ng/mL. Following a reduction of tacrolimus dosing to 3 mg daily, blood levels of tacrolimus decreased to 12 ng/mL (91954).
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Theoretically, taking yarrow with lithium might increase the levels and adverse effects of lithium.
Details
Animal research shows that yarrow has diuretic activity (106018). Theoretically, due to these potential diuretic effects, yarrow might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.
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Below is general information about the adverse effects of the known ingredients contained in the product HPTP. 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, arnica is unsafe and can cause toxicity.
When used in homeopathic amounts, arnica seem to be generally well tolerated. Topically, arnica also seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Bleeding, gastroenteritis, hypertension, muscle paralysis, nausea and vomiting, shortness of breath.
Topically: Contact dermatitis and irritation.
Serious Adverse Effects (Rare):
Orally: Arrhythmia, coma, multi-organ failure, and death.
Cardiovascular ...Orally, arnica can cause tachycardia or a faster heart rate (11,17113,19101,19102). A 24-year-old female presented to the emergency department with palpitations and vomiting 24 hours after ingesting a cup of tea that reportedly contained arnica flowers picked from her local area of mountainous Southern California. The species was not specified in the article and there was no indication by the authors that any testing had been done to confirm the identity of the plant (90610).
Dermatologic ...Orally, arnica can cause irritation of mucous membranes (11,17113). Topically, arnica can cause contact itchiness, dry skin, and rash (17113). Oral lesions resulted in a woman who used a mouthwash incorrectly by not following dilution instructions. The mouthwash was 70% alcohol and contained arnica and oil of peppermint (19106).
Gastrointestinal ...Orally, arnica can cause stomach pain, nausea, vomiting, and diarrhea (11,17113,19101,19102). Homeopathic arnica has been reported to cause dry mouth (30C) and sore tongue (6C) (19107). A 24-year-old female presented to the emergency department with palpitations and vomiting 24 hours after ingesting a cup of tea that reportedly contained arnica flowers picked from her local area of mountainous Southern California. The species was not specified in the article and there was no indication by the authors that any testing had been done to confirm the identity of the plant (90610).
Musculoskeletal ...Adverse effects after ingesting arnica include muscle weakness (19101). Homeopathic arnica has been reported to result in the feeling of a "throbby" head or neck (19107).
Neurologic/CNS ...Orally, arnica may cause drowsiness, nervousness, and headache (11,17113,19101,19107).
Ocular/Otic ...In a case report, accidental intake of a large amount of a homeopathic Arnica-30 resulted in acute vision loss due to bilateral toxic optic neuropathy (19105).
Psychiatric ...Oral homeopathic arnica (6C) may cause depressed feelings, specifically a feeling of unhappiness (19107).
Pulmonary/Respiratory ...Orally, arnica can cause shortness of breath (11,17113).
General ...Orally, Canadian fleabane seems to be well tolerated. It can cause an allergic reaction in individuals sensitive to the Asteraceae/Compositae family (19).
Immunologic ...Canadian fleabane can cause an allergic reaction in individuals sensitive to the Asteraceae/Compositae family (19). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.
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
...There is limited reliable information available about the safety of goldenseal when used in more than a single dose.
Berberine, a constituent of goldenseal, is generally well tolerated when used orally.
Most Common Adverse Effects:
Orally: Berberine, a constituent of goldenseal, can cause abdominal distension, abdominal pain, bitter taste, constipation, diarrhea, flatulence, headache, nausea, and vomiting.
Dermatologic ...Orally, berberine, a constituent of goldenseal, may cause rash. However, this appears to be rare (34285). A case of photosensitivity characterized by pruritic, erythematous rash on sun-exposed skin has been reported in a 32-year-old female taking a combination product containing goldenseal, ginseng, bee pollen, and other ingredients. The rash resolved following discontinuation of the supplement and treatment with corticosteroids (33954). It is not clear if this adverse effect is due to goldenseal, other ingredients, or the combination.
Endocrine ...A case of severe, reversible hypernatremia has been reported in an 11-year-old female with new-onset type 1 diabetes and diabetic ketoacidosis who took a goldenseal supplement (52592).
Gastrointestinal ...Orally, berberine, a constituent of goldenseal, may cause diarrhea, constipation, flatulence, vomiting, abdominal pain, abdominal distention, and bitter taste (33648,33689,34245,34247,34285,91953). Theoretically, these effects may occur in patients taking goldenseal. However, this hasn't been reported in clinical research or case reports.
Neurologic/CNS ...Orally, berberine, a constituent of goldenseal, may cause headache when taken in a dose of 5 mg/kg daily (33648). Theoretically, this may occur with goldenseal, but this hasn't been reported in clinical research or case reports.
General
...Savin tops are generally regarded as unsafe for use.
Any benefits of therapy may not outweigh the risk of toxicity. Orally, symptoms of savin tops poisoning include nausea, nervousness, cardiac rhythm disorders, spasm, kidney damage, hematuria, central paralysis, unconsciousness, and death (18). Ingestion can also cause irritation of mucous membranes resulting in gastroenteritis, hepatitis, pneumonitis, and nephritis (19).
Topically, savin tops oil can cause skin irritation, blisters, and necrosis (18).
Cardiovascular ...Orally, savin tops can cause toxicity. Cardiovascular symptoms of savin tops toxicity include cardiac rhythm disturbances (18).
Dermatologic ...Topically, the volatile oil from savin tops can cause skin irritation, blisters, and necrosis. It can also cause severe irritation to mucous membranes (18,19).
Gastrointestinal ...Orally, savin tops can cause toxicity. Gastrointestinal symptoms of savin tops toxicity include nausea and gastroenteritis (18,19).
Hepatic ...Orally, savin tops can cause toxicity. Hepatic symptoms of savin tops toxicity include hepatitis (19).
Neurologic/CNS ...Orally, savin tops can cause toxicity. Neurologic symptoms of savin tops toxicity include nervousness, spasm, central paralysis, unconsciouness, and death (18).
Pulmonary/Respiratory ...Orally, savin tops can cause toxicity. Pulmonary symptoms of savin tops toxicity include pneumonitis (19).
Renal ...Orally, savin tops can cause toxicity. Renal symptoms of savin tops toxicity include kidney damage, hematuria, and nephritis (18,19).
General
...Orally and intravaginally, yarrow seems to be well tolerated.
Most Common Adverse Effects:
Topically: Dermatitis.
Dermatologic
...Topically, yarrow can cause atopic or allergic dermatitis or urticaria due to its sesquiterpene lactone content (52558,68385,77007).
Yarrow has also been reported to cause phototoxic and photo-allergic dermatitis and airborne contact dermatitis (68385).
Intravaginally, aggravated facial acne was reported by 1 of 40 patients in a clinical trial (105360).
Endocrine ...Intravaginally, an early menses was reported by 1 of 40 patients in a clinical trial (105360).
Genitourinary ...Intravaginally, aggravated vaginal pruritus and dryness were reported by 1 of 40 patients in a clinical trial (105360).
Immunologic ...Topically, yarrow can cause atopic or allergic dermatitis or urticaria due to its sesquiterpene lactone content (52558,68385,77007,96911). It has also been reported to cause phototoxic and photo-allergic dermatitis and airborne contact dermatitis (68385). In one 44-year-old female, handling yarrow flowers resulted in rhinitis and asthma (96911).