Aconitum napellus 6 X • Arnica montana 8 X • Belladonna 8 X • Eupatorium perfoliatum 10 X • Gelsemium sempervirens 12 X • Mercurius Solubilis 10 X • Rhus toxicodendron 8 X. Other Ingredients: Glyceryl Behenate, Lactose Monohydrate, Microcrystalline Cellulose, Sorbitol, Xylitol.
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 Febriplex. 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
There is insufficient reliable information available about the effectiveness of gelsemium.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Febriplex. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
UNSAFE ...when used orally or topically. Aconite root contains toxic alkaloids that are strong, fast-acting poisons that affect the heart and central nervous system, causing severe arrhythmias, reduced consciousness, and death (15499,19669,30294,30300,30301,30303,30309,30334,30335,30336,92276,104514,106706). All species of this plant are dangerous. Severe poisoning has been reported after ingestion of 0.2-2 mg of aconitine, 1 gram of the raw plant, or 6 grams of processed and cured aconite (3490,104514). Even when a processed product is used, aconite can cause toxicity including nausea, vomiting, dizziness, muscle spasms, hypothermia, paralysis of the respiratory system, and heart rhythm disorders (15499). Aconite can also be absorbed through the skin and cause significant toxicity (12).
PREGNANCY AND LACTATION: UNSAFE
when used orally or topically (15499).
POSSIBLY SAFE ...when used orally in amounts commonly found in foods. Arnica has Generally Recognized As Safe (GRAS) status for use as a food flavoring in the US (4912). However, Canadian regulations do not allow its use as a food ingredient (12). ...when used orally in homeopathic dilutions of 30C and up to 5C (19110,19111,19117,19124,19126,96769). ...when used topically on unbroken skin, short-term (12).
LIKELY UNSAFE ...when used orally or when applied topically to broken skin. Arnica is considered poisonous and has caused severe or fatal poisonings (5). Arnica can cause gastroenteritis, muscle paralysis, bleeding, arrhythmia, hypertension, shortness of breath, nausea and vomiting, multi-organ failure, and death (4,5,17,104,19101,19102,19103,19104,19105,19106,19107,19108).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally or topically; avoid using (12).
POSSIBLY UNSAFE ...when used rectally. It is not known whether significant amounts of the toxic alkaloids are absorbed from the rectum (106909). ...when used topically. It is not known whether significant amounts of the toxic alkaloids are absorbed through the skin (106909).
LIKELY UNSAFE ...when used orally. Belladonna contains toxic alkaloids and has been linked to reports of serious adverse effects (12,553,34144).
CHILDREN: LIKELY UNSAFE
when used orally.
Fatalities in children may occur at doses of belladonna providing atropine 0.2 mg/kg (34168). Two belladonna berries, which contain 2 mg atropine per fruit, may be lethal for a small child (34144). Severe adverse effects and fatalities have been reported in infants treated with topical homeopathic teething products containing belladonna (17493,34142,34146,93537).
PREGNANCY: LIKELY UNSAFE
when used orally.
Belladonna contains toxic alkaloids and has been linked to reports of serious adverse effects (12,553,34144).
LACTATION: LIKELY UNSAFE
when used orally.
Belladonna can reduce milk production and is secreted into breast milk (15).
POSSIBLY UNSAFE ...when used orally. Boneset can cause severe diarrhea and vomiting. Hepatotoxic pyrrolizidine alkaloids (PAs) are common in this genus of plants; however, the alkaloids in boneset have not been adequately characterized to determine their toxic potential (12842,102557).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally.
Hepatotoxic PAs are common in this genus of plants; however, the alkaloids in boneset have not been adequately characterized to determine their toxic potential (12842,102557). Hepatotoxic PAs might be teratogenic; avoid using.
UNSAFE ...when the rhizome or root are used orally. All parts of the plant contain toxic alkaloids. The adult lethal dose is 2-3 grams or 4 mL of the fluid extract (18).
CHILDREN: UNSAFE
when used orally.
The lethal dose is 500 mg (18).
PREGNANCY AND LACTATION: UNSAFE
when used orally due to toxicity (6).
LIKELY UNSAFE ...when used orally or topically (6). Poison ivy is highly irritant and allergenic (68970).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally or topically (6); avoid using.
Below is general information about the interactions of the known ingredients contained in the product Febriplex. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, combining aconite with other antiplatelet or anticoagulant drugs might increase the risk of bruising and bleeding.
 Details
Higenamine, a constituent of aconite, is thought to have antiplatelet and antithrombotic effects. In an animal model of thrombosis, higenamine inhibited platelet aggregation and reduced the size of thrombus formation (92282).
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Theoretically, combining aconite with other stimulant drugs might alter the effects of the stimulant drug or increase the risk of cardiovascular toxicity.
Details
Aconite and its constituents have stimulant effects due to agonist activity at beta-2-adrenoreceptors. In cardiac muscle, aconite appears to have a positive inotropic effect and increases heart rate and blood pressure (2634,15499,30296,92282). However, some constituents of aconite can reduce heart rate and blood pressure (15499,30343).
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Theoretically, arnica might have additive effects with anticoagulant and antiplatelet drugs. Homeopathic arnica preparations are unlikely to have this interaction.
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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Belladonna may increase the risk of adverse effects when used concomitantly with anticholinergic drugs.
Details
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Theoretically, belladonna might reduce the effects of cisapride.
Details
Belladonna contains atropine. In vivo evidence suggests that atropine can prevent cisapride from increasing motility in the gastrointestinal tract (25191).
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Boneset belongs to the genus Eupatorium, and many species of this genus contain hepatotoxic pyrrolizidine alkaloids (PAs). Hepatotoxic PAs are substrates of cytochrome P450 3A4 (CYP3A4) (12841,12860). Theoretically, drugs that induce CYP3A4 might increase the conversion of PAs to toxic metabolites. Some drugs that induce CYP3A4 include carbamazepine (Tegretol), phenobarbital, phenytoin (Dilantin), rifampin, rifabutin (Mycobutin), and others.
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Below is general information about the adverse effects of the known ingredients contained in the product Febriplex. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally and topically, aconite is generally regarded as unsafe for use.
Any benefits of therapy might not outweigh the risk of toxicity.
Most Common Adverse Effects:
All routes of administration: Serious neurologic, cardiovascular, gastrointestinal, and respiratory adverse effects have been reported.
Cardiovascular ...Orally and topically, aconite can cause hypotension, palpitations, chest tightness, pulmonary edema, arrhythmia, bradycardia, tachycardia, sustained or bidirectional ventricular tachycardia, ventricular fibrillation, and Torsade de pointes (558,559,561,562,563,3490,15499,15650,30294,30295)(30300,30305,30323,30336,92276,92277,92278,104514,106706,110473)(112901). Cardioversion has been reported to be ineffective for the reversal of aconite-induced dysrhythmia, but the use of agents such as amiodarone, lidocaine, and magnesium have been successful in some cases (2634,3490,106706,112901).
Gastrointestinal ...Orally, aconite can cause nausea, vomiting, diarrhea, and gastric pain (563,30297,30341,92277,92278). Topically, aconite can cause nausea and vomiting (92276).
Neurologic/CNS ...Orally, aconite can cause weakness, sweating, restlessness, dizziness, numbness, paresthesia, seizures, and reduced consciousness (558,559,561,562,563,3490,15499,15650,30335,30336,30341,92277,92278,104513). Topically, aconite can cause generalized paresthesia, fatigue, sweating, dizziness and tongue numbness (92276).
Ocular/Otic ...Orally, aconite has been reported to cause visual blurring and yellow-green vision with pupil dilation (30319).
Pulmonary/Respiratory ...Orally, aconite overdose can lead to respiratory failure (104513).
Renal ...Orally and topically, aconite can cause hypokalemia and metabolic and/or respiratory acidosis (558,559,561,562,563,3490,15499,15650).
Other
...Orally and topically, aconite has been reported to cause death in both adults and children (559,3490,3491,30301,30334,30341,92276,92278).
In one case report, topical application of aconite to an infant led to cardiogenic shock with multi-organ failure and death (92276). Poisoning has been reported in 15 patients after consuming a homemade liquor containing aconite. Patients presented with tongue or extremity numbness, vomiting, dizziness, or heart palpitations, and 5 died (110471). Death has also been reported in individuals who cooked aconite tubers as vegetables or for health purposes (92278).
The first symptoms of aconite poisoning after oral ingestion of the leaves or root usually occur within 10-90 minutes, although toxicity may be delayed until a second or third dose (559,15499,104513,110471). Recovery time from aconite poisoning ranges from 1.5-2 days for mild intoxication to 7-9 days for patients with cardiovascular complications; fatalities in treated patients are about 5% (15499). Treatment of aconite toxicity is typically supportive, although charcoal hemoperfusion has aided in detoxification (15499,106706).
General
...Orally, arnica is unsafe and can cause toxicity.
When used in homeopathic amounts, arnica seem to be generally well tolerated. Topically, arnica also seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Bleeding, gastroenteritis, hypertension, muscle paralysis, nausea and vomiting, shortness of breath.
Topically: Contact dermatitis and irritation.
Serious Adverse Effects (Rare):
Orally: Arrhythmia, coma, multi-organ failure, and death.
Cardiovascular ...Orally, arnica can cause tachycardia or a faster heart rate (11,17113,19101,19102). A 24-year-old female presented to the emergency department with palpitations and vomiting 24 hours after ingesting a cup of tea that reportedly contained arnica flowers picked from her local area of mountainous Southern California. The species was not specified in the article and there was no indication by the authors that any testing had been done to confirm the identity of the plant (90610).
Dermatologic ...Orally, arnica can cause irritation of mucous membranes (11,17113). Topically, arnica can cause contact itchiness, dry skin, and rash (17113). Oral lesions resulted in a woman who used a mouthwash incorrectly by not following dilution instructions. The mouthwash was 70% alcohol and contained arnica and oil of peppermint (19106).
Gastrointestinal ...Orally, arnica can cause stomach pain, nausea, vomiting, and diarrhea (11,17113,19101,19102). Homeopathic arnica has been reported to cause dry mouth (30C) and sore tongue (6C) (19107). A 24-year-old female presented to the emergency department with palpitations and vomiting 24 hours after ingesting a cup of tea that reportedly contained arnica flowers picked from her local area of mountainous Southern California. The species was not specified in the article and there was no indication by the authors that any testing had been done to confirm the identity of the plant (90610).
Musculoskeletal ...Adverse effects after ingesting arnica include muscle weakness (19101). Homeopathic arnica has been reported to result in the feeling of a "throbby" head or neck (19107).
Neurologic/CNS ...Orally, arnica may cause drowsiness, nervousness, and headache (11,17113,19101,19107).
Ocular/Otic ...In a case report, accidental intake of a large amount of a homeopathic Arnica-30 resulted in acute vision loss due to bilateral toxic optic neuropathy (19105).
Psychiatric ...Oral homeopathic arnica (6C) may cause depressed feelings, specifically a feeling of unhappiness (19107).
Pulmonary/Respiratory ...Orally, arnica can cause shortness of breath (11,17113).
General
...Orally, belladonna can cause anticholinergic side effects even at low doses, and is considered poisonous.
Most Common Adverse Effects:
Orally: Anticholinergic side effects, including blurred vision, constipation, delirium, dilated pupils, dizziness, dry mouth, fever, headache, hypertension, muscle rigidity and tremor, psychosis, respiratory failure, and slurred speech.
Cardiovascular ...Orally, belladonna can cause anticholinergic side effects such as hypertension, hypotension, tachycardia, and ventricular premature beats (553,34168,34180).
Dermatologic
...Orally, belladonna can cause anticholinergic side effects such as dry, red skin and decreased perspiration (553,34146,34152).
One case of rash and another case of hives have been reported in patients taking belladonna with phenobarbital and ergotamine orally; it is unclear if the adverse effects were due to belladonna or the other ingredients (34154).
Topically, belladonna plaster (Cuxon Gerrard) can cause contact dermatitis (34152).
Gastrointestinal ...Orally, belladonna can cause anticholinergic side effects such as dry mouth and constipation (553,34162,34163,34176,34180,34181).
Genitourinary ...Orally, belladonna can cause anticholinergic side effects such as urinary retention (553,34145,34150,34163).
Neurologic/CNS ...Orally, belladonna can cause anticholinergic side effects such as memory and attention impairment, headache, and confusion (553,34163,34180).
Ocular/Otic ...Orally and topically, belladonna can cause anticholinergic side effects such as dilation of pupils and blurred vision (553,34157,34168,34169,34180). A case report describes anisocoria (unequal pupil sizes) in a 70-year-old female who used homeopathic pink eye relief drops (Similasan) containing belladonna, eyebright, and hepar sulphuris (calcium sulfide) in one eye for 3 days. The pupil dilation lasted more than 2 weeks and did not respond to bright light or pilocarpine (106907). Another report describes a case of acute angle closure glaucoma, requiring referral to an ophthalmologist, in a 55-year-old female who used these eye drops for 2 days (106906).
General ...Orally, boneset is reported to cause nausea and severe diarrhea and vomiting (12842). Additionally, other plants in the Eupatorium genus contain the hepatotoxic pyrrolizidine alkaloids (PAs). However, the alkaloids in boneset have not been adequately characterized to determine their toxic potential (12842,102557). Liver toxicity and liver damage may be possible in high doses.
Gastrointestinal ...Orally, boneset has been reported to cause nausea and severe diarrhea and vomiting (12842).
Hepatic ...Other plants in the Eupatorium genus contain hepatotoxic pyrrolizidine alkaloids (PAs). However, the alkaloids in boneset have not been adequately characterized to determine their toxic potential (12842,102557). Liver toxicity and liver damage may be possible in high doses.
General ...Orally, gelsemium can cause headache, drooping of the eyelid, double vision, difficulty swallowing, dizziness, muscle weakness or rigidity, seizures, dyspnea, and bradycardia. Death due to failure of respiratory muscles can occur (18).
Neurologic/CNS ...Orally, gelsemium can cause headache, drooping of the eyelid, double vision, difficulty swallowing, dizziness, muscle weakness or rigidity, seizures, dyspnea, and bradycardia. Death due to failure of respiratory muscles can occur (18).
General
...When used orally or topically, poison ivy may be unsafe.
Most Common Adverse Effects:
Orally: Diarrhea, dizziness, fever, intestinal colic, nausea, vomiting, severe mucous membrane irritation.
Topically: Contact dermatitis, herpes-like blisters, reddening, swelling.
Inhaled: Fever.
Serious Adverse Effects (Rare):
Orally: Fever, hematuria, nephritis, stupor, unconsciousness.
Topically: Erythema multiforme, black spot poison ivy dermatitis. Eye contact can cause severe conjunctivitis, corneal inflammations, or loss of sight.
Inhaled: Lung infection, respiratory distress syndrome, throat swelling.
Dermatologic ...Topically, poison ivy can cause contact dermatitis, reddening, swelling, and herpes-like blisters (18). These reactions occur at the area of contact, usually within a few hours, but are sometimes delayed for several days (68970). Sometimes papules and vesicles develop and can spread beyond the area of initial contact, but are generally self-limiting and eventually form crusts. (3839,68955,68960,68977,69007,69008,69038,69042). In a few cases, small white papules known as milia have developed on an area of poison ivy exposure after the typical skin reaction has subsided (94222). Occasionally, poison ivy causes more severe dermatologic reactions such as erythema multiforme (3839,68983,69032,112851). Black spot poison ivy dermatitis also occurs in rare cases, with black lacquer-like lesions on the skin that cannot be washed off, followed by the typical pruritic papules (112850). The black lesions are concentrated urushiol oleoresin that has darkened with exposure to oxygen and moisture (68960,68997,69027,69034). They eventually peel off and the skin heals normally (68960,112850).
Gastrointestinal ...Orally, poison ivy can cause severe mucous membrane irritation, nausea, vomiting, and diarrhea (18).
Genitourinary ...Orally, poison ivy can cause hematuria (18).
Immunologic ...Cross-allergenicity with poison ivy exists with cashew, mango, and ginkgo biloba (106574).
Neurologic/CNS ...Orally, poison ivy can cause dizziness, fever, stupor, and unconsciousness (18).
Ocular/Otic ...Topically, eye contact with urushiol from poison ivy can cause severe conjunctivitis, corneal inflammation, and potentially loss of sight (18).
Pulmonary/Respiratory ...Inhaled, urushiol in the smoke from burning of poison ivy can result in life-threatening throat swelling, fever, and secondary lung infections (6). Respiratory distress syndrome after smoke inhalation from burning poison ivy has also been reported (69036). Two fatal cases of acute respiratory distress and anaphylaxis after inhaling burned poison ivy are reported in patients with known allergies to poison ivy (112420).
Renal ...Orally, poison ivy can cause nephritis (18).
