Each vial contains: Astragalus membranaceus 10:1 extract (DHE: 1000 mg) 100 mg • Echinacea angustifolia 5:1 extract (DHE: 400 mg, 4% echinacosides) 20 mg • Echinacea purpurea 6:1 extract (DHE: 900 mg, 4% chicoric and caffeoyltartaric acids) 150 mg • Lentinus edodes 8:1 extract (DHE: 500 mg) 62.5 mg. Other Ingredients: Glycerin, Natural Orange Flavor, Sorbitol, 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.
Below is general information about the effectiveness of the known ingredients contained in the product Adrien Gagnon Echinacee Preparation 2500 mg. 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
Below is general information about the safety of the known ingredients contained in the product Adrien Gagnon Echinacee Preparation 2500 mg. 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. Doses of astragalus up to 60 grams daily for up to 4 months have been used without reported adverse effects (32920,33038,95909). ...when used intravenously. Infusion of doses up to 80 grams daily for up to 4 months under the supervision of a medical professional have been used with apparent safety (32811,32812,32828,95909). There is insufficient reliable information available about the safety of astragalus when used topically.
PREGNANCY AND LACTATION:
There is insufficient reliable information in humans.
However, astragaloside, a constituent of astragalus, has maternal and fetal toxic effects in animals (32881). Avoid using.
LIKELY SAFE ...when used orally and appropriately, short-term. Various liquid extracts of Echinacea purpurea have been used safely for up to 10 days, including EchinaGuard (Madaus AG) 20 drops every 2 hours for 1 day, then three times daily (10320), or Echinilin (Inovobiologic Inc.) 40 mL in divided doses for 1 day, then 15 mL in divided doses daily thereafter (12355,20062). Other liquid extracts have been used safely for relatively longer periods, including Echinaforce (A. Vogel Bioforce AG) 2.4 grams daily for 4 months or 1.6 grams daily for 6 months (7087,18225), and Echinacin (Madaus AG) 5 mL twice daily for 10 days, or 4 mL twice daily for 8 weeks (3282,10802). Specific solid dosage forms of echinacea that have been used safely for up to 10 days include Echinacea purpurea above-ground parts (EchinaFresh, Enzymatic Therapy) 300 mg daily (11970), and mixtures of Echinacea purpurea and Echinacea angustifolia herb in divided doses of 6 grams to 10.5 grams for 1 day then 3 grams to 5.1 grams daily (10800,17519,20059). A specific Echinacea angustifolia extract (ExtractumPharma ZRT) has also been used with apparent safety at a dose of 40 mg once or twice daily for up to 7 days (20064,103233). An Echinacea purpurea product (Natures Resource) has been used safely at a dose of 1.8 grams daily for 8 weeks (17521), and echinacea (Puritan's Pride) has been used safely at 8 grams daily for 28 days (20066).
POSSIBLY SAFE ...when used topically, short-term. A specific cream (Linola Plus Cream, Dr. August Wolff GmbH & Co.) containing echinacea extract (WO 3260) has been applied to the skin safely 2-3 times daily for up to 12 weeks (97499). There is insufficient reliable evidence about the safety of echinacea when used parenterally.
CHILDREN: POSSIBLY SAFE
when used orally, short-term.
Some clinical research shows that an extract of the above-ground parts of Echinacea purpurea (EC31J2, Echinacin Saft, Madaus AG) in a dose of 3.75 mL twice daily (for ages 2 years to 5 years) or 7.5 mL twice daily (for ages 6 years to 11 years) is safe when used for up to 10 days (4989). However, about 7% of children experienced a rash after taking echinacea, which might have been caused by an allergic reaction (4989). There is concern that allergic reactions could be severe in some children. The Medicines and Healthcare Products Regulatory Agency in the United Kingdom recommends against the use of oral echinacea products in children under 12 years of age due to this risk of allergic reaction (18207). In contrast, another clinical study in children 4-12 years old shows that a specific Echinacea purpurea product (Echinaforce Junior, A. Vogel) does not cause allergic or urticarial reactions more frequently than vitamin C (105719).
PREGNANCY: POSSIBLY SAFE
when used orally, short-term.
There is preliminary evidence that mothers can safely use echinacea in the form of E. purpurea or E. angustifolia solid dosage forms, 250-1000 mg daily, or tinctures, up to 30 drops daily, for 5 days to 7 days during the first trimester without adversely affecting the fetus (7056,13418,15123). There is insufficient reliable information available about the safety of echinacea when used for longer than 7 days.
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when consumed in typical food amounts (6).
POSSIBLY SAFE .... ..when the shiitake mushroom extract AHCC is used orally and appropriately. AHCC 4.5-6 grams daily has been used with apparent safety in clinical trials lasting up to 6 months (22926,30419). Population research identified no safety concerns with the use of AHCC 3 grams daily for up to 9 years (30353,94830).
POSSIBLY UNSAFE ...when shiitake mushroom powder is used orally in medicinal amounts. Ingestion of shiitake mushroom powder 4 grams daily for 10 weeks can cause eosinophilia (1149). ...when uncooked shiitake mushroom is ingested. The lentinan component, which is broken down by heat, can cause toxic reactions, including shiitake dermatitis (94354).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid consuming greater than food amounts.
Below is general information about the interactions of the known ingredients contained in the product Adrien Gagnon Echinacee Preparation 2500 mg. 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 astragalus with antidiabetes drugs might increase the risk of hypoglycemia.
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Theoretically, astragalus might interfere with cyclophosphamide therapy.
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Theoretically, astragalus might interfere with immunosuppressive therapy.
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Theoretically, astragalus might increase levels and adverse effects of lithium.
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Animal research suggests that astragalus has diuretic properties (15103). Theoretically, due to this diuretic effect, astragalus might reduce excretion and increase levels of lithium.
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Echinacea can increase plasma levels of caffeine by inhibiting its metabolism.
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Echinacea seems to increase plasma concentrations of caffeine by around 30% (12155). This is likely due to inhibition of cytochrome P450 1A2 (CYP1A2) by echinacea.
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Echinacea might inhibit the metabolism of CYP1A2 and increase plasma levels of some drugs.
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Echinacea appears to inhibit CYP1A2 enzymes in humans. Additionally, echinacea seems to increase plasma concentrations of caffeine, a CYP1A2 substrate, by around 30% (12155). Theoretically, echinacea might increase levels of other drugs metabolized by CYP1A2.
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Echinacea may induce hepatic CYP3A4 and inhibit intestinal CYP3A4. This may increase or decrease levels of drugs metabolized by CYP3A4.
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Several clinical trials have shown that taking echinacea for up to one month does not significantly affect the metabolism of various CYP3A4 substrates, including midazolam, docetaxel, etravirine, lopinavir-ritonavir, and darunavir-ritonavir (13712,48618,88164,88165). However, other clinical research shows that echinacea may increase the clearance of midazolam, suggesting that echinacea might induce CYP3A4 (48618). The discrepancy is thought to be due to differing effects of echinacea on intestinal versus hepatic CYP3A4 enzymes. Echinacea appears to induce hepatic CYP3A4 but inhibit intestinal CYP3A4 (12155). In some cases, these effects might cancel each other out, but in others, drug levels may be increased or decreased depending on the level of effect at hepatic and intestinal sites. The effect of echinacea on CYP3A4 activity may differ depending on the CYP3A4 substrate (6450,11026,88162,88167).
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Theoretically, echinacea may interfere with the metabolism of darunavir; however, a small clinical study found no effect.
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Darunavir is metabolized by cytochrome P450 3A4 (CYP3A4) and is administered with the CYP3A4 inhibitor ritonavir to increase its plasma concentrations. Echinacea has variable effects on CYP3A4, but administration of an E. purpurea root extract (Arkocapsulas Echinacea, Arkopharma) 500 mg four times daily for 14 days did not affect darunavir/ritonavir pharmacokinetics in 15 HIV-infected patients (88163,93578).
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Theoretically, echinacea may interfere with the metabolism of docetaxel; however, a small clinical study found no effect.
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Docetaxel is metabolized by cytochrome P450 3A4 (CYP3A4). Echinacea has variable effects on CYP3A4, but taking E. purpurea whole plant extract (Echinaforce, A. Vogel Biopharma AG) 20 drops three times daily for 2 weeks did not alter the pharmacokinetics of docetaxel in one clinical study (88164).
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Echinacea may increase levels of etoposide.
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In one report, concomitant use of etoposide and echinacea was associated with more severe thrombocytopenia than the use of etoposide alone, suggesting inhibition of etoposide metabolism (20082). Etoposide is a cytochrome P450 3A4 (CYP3A4) substrate. Echinacea has variable effects on CYP3A4, but some studies have reported inhibition of the enzyme (6450,11026,12155,88162,88167).
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Theoretically, echinacea may interfere with the metabolism of etravirine; however, a small clinical study found no effect.
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Echinacea has immunostimulant activity which may interfere with immunosuppressant therapy.
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Theoretically, echinacea may interfere with the metabolism of lopinavir; however, a small clinical study found no effect.
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Lopinavir is metabolized by cytochrome P450 3A4 (CYP3A4) and is administered with the CYP3A4 inhibitor ritonavir to increase its plasma concentrations. Echinacea has variable effects on CYP3A4, but taking E. purpurea (Echinamide, Natural Factors Nutritional Products, Inc.) 500 mg three times daily for 14 days did not alter the pharmacokinetics of lopinavir/ritonavir in healthy volunteers (48618,93578).
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Theoretically, echinacea may increase the metabolism of intravenous midazolam.
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Echinacea induces hepatic CYP3A4 and might decrease plasma levels of midazolam by about 20%, reducing the effectiveness of intravenous midazolam (12155). Echinacea also appears to inhibit intestinal CYP3A4, which could theoretically increase the bioavailability of oral midazolam. This may cancel out the decrease in availability caused by induction of hepatic CYP3A4, such that overall plasma levels after oral administration of midazolam are not affected by echinacea.
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Echinacea seems to increase the clearance of warfarin, although the effect may not be clinically significant.
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Preliminary clinical research in healthy male volunteers suggests that taking echinacea increases the clearance of the active S-isomer of warfarin after a single dose of warfarin, but there was not a clinically significant effect on the INR (20083).
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Theoretically, shiitake mushroom might increase levels of drugs metabolized by CYP2D6.
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Theoretically, taking shiitake mushroom might decrease the effects of immunosuppressive therapy.
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Below is general information about the adverse effects of the known ingredients contained in the product Adrien Gagnon Echinacee Preparation 2500 mg. 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 intravenously, astragalus root seems to be well tolerated.
Topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: A case report raises concerns about liver and kidney cysts with astragalus use.
Cardiovascular ...Orally, astragalus has reportedly been associated with lacunar angina in one clinical trial. However, this may not have been caused by astragalus (17355). In addition, rapid intravenous administration of astragalus has resulted in temporary palpitations (32812).
Dermatologic ...Intravenously, astragalus may cause rash, eczema, and pruritus (33034).
Gastrointestinal ...Orally, astragalus has reportedly been associated with enterocolitis and nausea in one clinical trial. However, these effects may not have been caused by astragalus (17355).
Genitourinary ...Orally, astragalus has reportedly been associated with vulvitis in one clinical trial. However, this effect may not have been caused by astragalus (17355).
Hepatic ...A case of high serum CA19-9 levels and small liver and kidney cysts has been reported for a 38-year-old woman who drank astragalus tea daily for one month. Levels returned to normal after one month, and cysts disappeared after ten months. Both symptoms returned following a resumption of astragalus use. The authors state that astragalus was the likely cause given the temporal relationship (90658).
Neurologic/CNS ...Rapid intravenous administration of astragalus has resulted in temporary dizziness (32812).
Pulmonary/Respiratory ...Orally, astragalus has reportedly been associated with rhinosinusitis and pharyngitis in one clinical trial. However, these effects may not have been caused by astragalus (17355).
Renal ...A case of high serum CA19-9 levels and small liver and kidney cysts has been reported for a 38-year-old woman who drank astragalus tea daily for one month. Levels returned to normal after one month, and cysts disappeared after ten months. Both symptoms returned following a resumption of astragalus use. The authors state that astragalus was the likely cause given the temporal relationship (90658).
General
...Orally, echinacea is well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, constipation, diarrhea, heartburn, nausea and vomiting, rashes, and stomach upset.
Serious Adverse Effects (Rare):
Orally: Severe allergic reactions and hepatitis have been reported.
Dermatologic ...Itching, urticaria, tingling, and allergic rashes have been reported with various echinacea preparations (8225,12355,17519,20059,20077,101592,111530,111540). In a study of children aged 2-11 years, rash occurred in about 7% of children treated with an extract of the above-ground parts of E. purpurea (EC31J2, Echinacin Saft, Madaus AG), compared with about 3% of those treated with placebo (4989,95652). There is concern that allergic reactions could be severe in some children. The Medicines and Healthcare Products Regulatory Agency in the United Kingdom (UK) recommends against the use of oral echinacea products in children under 12 years of age due to this risk of allergic reaction (18207). However, another study in children 4-12 years old shows that a specific E. purpurea product (Echinaforce Junior, A. Vogel) did not cause allergic or urticarial reactions more frequently than vitamin C (105719).
Gastrointestinal ...Gastrointestinal adverse effects include nausea and vomiting, abdominal pain, stomach upset, heartburn, diarrhea, and constipation (10802,11970,12355,13419,17519,20059,48680,105719,106626). An unpleasant taste, dry mouth, and burning, tingling or numbness of the tongue also occur (11970,12355,17519,20059,20070,20077).
Hematologic ...A 51-year-old female presented with leukopenia after taking echinacea 450 mg three times daily for 2 months, along with ginkgo biloba, multivitamins, and calcium. Her leukocyte count recovered upon stopping these supplements, but dropped again when she restarted echinacea alone about a year later. The problem resolved when echinacea was stopped permanently (48533). A 32-year-old male presented with severe thrombotic thrombocytopenic purpura (TTP) about 2 weeks after using an extract of E. pallida to treat a cold. He required admission to an intensive care unit and extensive plasmapheresis. The authors speculate that immunostimulant effects of echinacea induced or exacerbated the TTP (48572).
Hepatic
...Although uncommon, cases of echinacea-induced hepatitis have been reported.
One case report describes acute cholestatic autoimmune hepatitis in a 45-year-old male who had been taking an echinacea root extract 1500 mg daily for about 2 weeks. He presented with significantly elevated liver function tests (LFTs), elevated immunoglobulin G (IgG) levels, and a positive test for anti-smooth muscle antibodies, indicating an autoimmune process. Elevated LFTs and IgG levels returned to normal within one month of stopping echinacea (17518). Another case report describes acute cholestatic hepatitis in a 44-year-old male who had taken echinacea root tablets 600 mg daily for 5 days to treat flu-like symptoms. He presented with elevated LFTs, prothrombin time, and international normalized ratio (INR). His condition gradually improved after stopping echinacea, and his LFTs normalized within 3 months (91528).
Seven cases of hepatitis associated with echinacea use were reported to the Australian Adverse Drug Reactions Advisory Committee between 1979 and 2000, but specific details are lacking (8225).
One case report describes acute liver failure in a 2 year-old child who had been given about 100 mg of echinacea daily for 2 weeks. The patient presented with jaundice, diarrhea, lethargy, anorexia, and significantly elevated LFTs. A liver biopsy showed hepatocyte swelling, spotty necrosis, and inflammatory infiltrate with eosinophils. A full recovery was made over a 2-week period (88166).
Immunologic
...Allergic reactions, including urticaria, runny nose, dyspnea, bronchospasm, acute asthma, angioedema, and anaphylaxis, have been reported with various echinacea preparations (638,1358,8225).
Atopic individuals and those sensitive to other members of the Asteraceae family (ragweed, chrysanthemums, marigolds, daisies) seem to be at higher risk for these reactions (1358,8225).
A case report describes a 36-year-old female who presented with muscle weakness, electrolyte abnormalities, renal tubular acidosis, fatigue, and dry mouth and eyes after taking echinacea, kava, and St. John's Wort for 2 weeks., She also had a positive antinuclear antibody (ANA) test, with elevated anti-dsDNA antibodies SSA and SSB. Sjogren syndrome was diagnosed; the authors hypothesize that it may have been triggered by the immunostimulant effects of echinacea (10319). A 55-year-old male with a history of pemphigus vulgaris in remission for about a year experienced a flare of the disease after taking an echinacea supplement for one week. After stopping echinacea, medical treatment resulted in partial control of the disease (12171). Another case report describes a 58-year-old male who presented with marked eosinophilia and elevated immunoglobulin E (IgE) levels while taking an echinacea supplement. He required prednisone therapy until he stopped taking echinacea 3 years later, at which time his eosinophils and IgE normalized (48623). A 41-year-old male experienced four episodes of erythema nodosum, each occurring after he had taken echinacea for early symptoms of influenza. After stopping echinacea, he had no further exacerbations of erythema nodosum, suggesting that it had been triggered by the immunostimulant effects of echinacea (7057).
Musculoskeletal ...Reports of arthralgia and myalgia have been associated with echinacea (13418).
Neurologic/CNS ...Headache has been reported in people taking various echinacea preparations orally (3282,11970,17519,20059,20064). Dizziness has also been reported (3282,8225,11970). In one study using an alcoholic extract of the above-ground parts of E. purpurea (EC31J0, Echinacin, Madaus AG), somnolence and a tendency to aggressiveness were reported (3282).
General
...Orally, shiitake mushroom is generally well tolerated when cooked and consumed as a food.
Most Common Adverse Effects:
Orally: Abdominal discomfort, bloating, diarrhea, nausea, and vomiting.
Serious Adverse Effects (Rare):
Orally: Consumption of raw shiitake mushroom can cause shiitake dermatitis, a skin eruption resembling whiplash marks which can be accompanied by systemic symptoms. Large pieces that have been inadequately chewed can cause intestinal blockage, occasionally requiring surgery.
Dermatologic
...Orally, shiitake mushrooms can cause shiitake dermatitis, a skin eruption that resembles whiplash marks, usually found on the trunk and limbs.
This dermatitis is thought to be a toxic response to lentinan or other compounds found normally in uncooked or inadequately cooked shiitake mushroom. The rash can be made worse by scratching. Symptom onset is usually within hours to days and can persist for 3-4 weeks before resolving on its own. There is some evidence that treatment with steroids alone or with antihistamines might reduce the duration of the rash by a small amount in some people (1148,1152,74782,74806,94236,94237,94238,94240,94241,94243) (94244,94246,94247,94248,94249,94252,94253,94254,94255,94256)(94257,94259,94261,94262,108302,111909,111912,111913). The dermatitis may include small purple spots from broken capillaries, skin plaques, burning, blanching, and pustules (94256,108302). Rarely the rash may look like measles rather than whiplash (94256). Histologically, there may be evidence of dermal and epidermal edema, lymphocyte infiltration, and skin thickening (94256,94257). Other symptoms associated with the dermatitis include fever, aching, malaise, eosinophilia, diarrhea, prickling in the hands, trouble swallowing, conjunctivitis, and pustules with small ulcers in the mouth (94240,94246,94247,94249,94256,94257,108302). It is likely that the dermatitis and other symptoms are due to a delayed type hypersensitivity reaction (94244,94255). Cooking shiitake mushroom generally prevents shiitake dermatitis, although some cases have occurred in people who have consumed cooked sources (94242,94244). It appears that to inactivate lentinan, cooking temperatures of at least 130°C are needed (94243).
Less common is a photosensitivity reaction associated with oral ingestion, which involves rash and pruritus after sun exposure (1148,94241).
Orally, the shiitake mushroom extract AHCC has been reported to cause mild itching (30375).
Gastrointestinal
...Orally, shiitake mushrooms can cause abdominal discomfort, including bloating, nausea, pain, vomiting, and diarrhea (1149,30365,30375,30419,94241).
Gastrointestinal symptoms, such as diarrhea, problems swallowing, or mouth ulcers have been associated with shiitake dermatitis (94241,94256). Consumption of large pieces of shiitake mushroom with inadequate chewing can cause abdominal obstruction that has resulted in death in one case and surgical intervention in two others. In another case, parenteral nutrition was used exclusively until the shiitake mushroom pieces were passed (1147,94260,103160,108303,108304).
Topically, an oral rinse containing shiitake mushroom extract has been associated with teeth sensitivity, teeth staining, and burning in the mouth (94250).
Hematologic ...Ingestion of shiitake mushroom powder 4 grams daily for 10 weeks caused eosinophilia in 5 of 10 healthy humans (1149). Eosinophilia, and leukocytosis or leukopenia have been reported with shiitake dermatitis (94254,94256,94257).
Immunologic ...Allergic contact dermatitis can occur by contact with shiitake hyphae (filaments) (1153,74785,111913). It appears to be more common in growers or others that handle shiitake mushrooms extensively (94241,94259). Contact or inhalation also results in other symptoms of allergy, such as asthma, rhinitis, conjunctivitis, and pneumonia (94241,94249,94258,94259).
Musculoskeletal ...Orally, the shiitake mushroom extract AHCC has been reported to cause foot cramps and difficulty moving hand joints (30365,30416).
Neurologic/CNS
...In patients experiencing shiitake dermatitis, other symptoms may include prickling in the hands (94256).
Malaise has also been reported following oral intake or contact (1151,94240).
Orally, the shiitake mushroom extract AHCC has been reported to cause mild and transient headache (30365).
Ocular/Otic ...Conjunctivitis has been reported rarely in mushroom growers and handlers, or following oral intake in patients with shiitake dermatitis (94241,94256,94259).
Pulmonary/Respiratory ...In mushroom workers, hypersensitivity pneumonitis due to shiitake spore inhalation has occurred. Symptoms include difficulty breathing, chest pain, a dry cough, asthma, and rhinitis (1150,1151,74776,74813,94239,94241,94258,94259).
