5-methyl-2-propan-2-yl-cyclohexan-1-0 • Artemisia annua • Bupleurum Chinense • Forsythia Suspensa • Lonicera Japonica • Platycodon Grandiflorus • Prunus Armeniaca , pueraria lobata • Scutellaria baicalensis . Other Ingredients: Confectioner's Sugar.
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 Ganmao Zhike Chongji. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is insufficient reliable information available about the effectiveness of apricot.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Ganmao Zhike Chongji. 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 apricot fruit or juice is consumed as food. There is insufficient reliable information available about the safety of apricot fruit, juice, or leaves when used orally for medicinal purposes.
PREGNANCY AND LACTATION: LIKELY SAFE
when apricot fruit or juice is consumed as food.
There is insufficient reliable information available about the safety of apricot fruit, juice, or leaves when used orally for medicinal purposes; avoid use.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Oral Baikal skullcap 0.5-3.52 grams daily has been used with apparent safety for up to 8 weeks (92776,101738,101739,110023). However, a high quality assessment of safety has not been conducted. A specific product (Limbrel, Primus Pharmaceuticals) containing flavocoxid, a mixture of Baikal skullcap flavonoid extract and catechu extract, has been associated with an increased risk for liver and lung injury. In 2017, the US Food and Drug Administration (FDA) formally requested the recall of all non-expired lots of this product (106042). It is unclear if these effects were due to Baikal skullcap, catechu, or the combination. There is insufficient reliable information available about the safety of Baikal skullcap when used intravenously or topically.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts. Bupleurum has been used with apparent safety as part of a multi-ingredient decoction (sho-saiko-to) for up to 5 years (37391,37410). It has also been used with apparent safety as part of another multi-ingredient decoction (chima qingwen) at doses of up to 40 grams bupleurum daily for up to 5 days (100167).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately. Kudzu appears to be safe for up to 4 months (10386,11386,92257). ...when used intravaginally and appropriately. Kudzu 5% to 6% gel has been used with apparent safety for up to 12 weeks (96740,105521,110702).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Sweet Annie 300 mg daily has been used with apparent safety in studies lasting up to 9 months (11055,94520,94521). Sweet Annie tea, prepared from dried leaves and twigs and consumed in divided doses daily, has been used with apparent safety for up to 7 days (11055,11058). While rare, there is some concern that Sweet Annie might cause liver damage (16895,103254,103255).
POSSIBLY SAFE ...when used sublingually and appropriately, short-term. Sweet Annie up to 2400 biological units daily as sublingual immunotherapy has been used with apparent safety in studies lasting up to 16 months (106441,112392,112393,112394). There is insufficient reliable information available about the safety of Sweet Annie when used topically.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Ganmao Zhike Chongji. 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, Baikal skullcap might potentiate the sedative effects of alcohol.
Details
In vitro and animal research suggests that Baikal skullcap binds to GABA-A receptors and causes sedation. Theoretically, Baikal skullcap might potentiate the sedative effects of alcohol (6290,6291,33477). Preliminary clinical research has not identified clinically relevant sedation after use of Baikal skullcap; however, a thorough evaluation of safety outcomes has not been conducted.
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Theoretically, Baikal skullcap might increase the risk of bleeding when used concomitantly with anticoagulant and antiplatelet drugs.
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Preliminary clinical research suggests that taking capsules containing a combination of astragalus, goldthread, and Baikal skullcap daily for 4 weeks inhibits platelet aggregation; the effect seems to be similar to that of aspirin 50 mg daily (33075). It is unclear if this effect is due to Baikal skullcap, other ingredients, or the combination.
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Theoretically, concomitant use of Baikal skullcap with antidiabetes drugs might enhance blood glucose lowering effects.
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Baicalein, a constituent of Baikal skullcap, has alpha-glucosidase inhibitory activity in vitro (6292). Animal research also suggests that Baikal skullcap enhances the antidiabetic effects of metformin (33408). However, in a small human study, taking Baikal skullcap extract did not enhance the antidiabetic effects of metformin, although it did modestly lower glucose levels during an oral glucose tolerance test (OGTT) (101738). Until more is known, use cautiously.
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Theoretically, concomitant use of Baikal skullcap with antihypertensive drugs might have additive effects and increase the risk of hypotension.
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Animal research suggests that baicalein, a constituent of Baikal skullcap, might lower blood pressure (33374).
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Theoretically, concomitant use of Baikal skullcap and antithyroid drugs may result in additive activity and increase the risk of hypothyroidism.
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In an animal hyperthyroid model, Baikal skullcap improved levels of triiodothyronine (T3), thyroxine (T4), and thyroid stimulating hormone (TSH) (101736). The clinical significance of this effect is unclear.
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Theoretically, Baikal skullcap might cause additive therapeutic and adverse effects when used concomitantly with drugs with sedative properties.
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In vitro and animal research suggests that Baikal skullcap binds to GABA-A receptors and causes sedation. Theoretically, Baikal skullcap might cause additive therapeutic and adverse effects when used concomitantly with drugs with sedative properties (6290,6291,33477). Preliminary clinical research has not identified clinically relevant sedation after use of Baikal skullcap; however, a thorough evaluation of safety outcomes has not been conducted.
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Theoretically, Baikal skullcap may increase levels of drugs metabolized by CYP1A2 enzymes.
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Theoretically, Baikal skullcap might increase levels of drugs metabolized by CYP2C19 enzymes.
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In vitro evidence suggest that wogonin, a constituent of Baikal skullcap, modestly inhibits the activity of CYP2C19 enzymes (33484). This effect has not been reported in humans.
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Theoretically, concomitant use of large amounts of Baikal skullcap might interfere with hormone replacement therapy, due to competition for estrogen receptors.
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In vitro evidence suggests that Baikal skullcap has estrogenic activity (16061).
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Theoretically, Baikal skullcap might reduce lithium excretion and increase serum levels of lithium.
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Baikal skullcap is thought to have diuretic properties, which may reduce lithium excretion (5541). The dose of lithium might need to be decreased.
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Theoretically, Baikal skullcap might alter the levels and clinical effects of OATP substrates.
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Some pharmacokinetic research shows that baicalin, a constituent of Baikal skullcap, can decrease plasma levels of rosuvastatin. The mechanism is thought to involve stimulation of the activity of the organic anion-transporting polypeptide 1B1 (OATP1B1), which transports rosuvastatin into the liver. This decreases plasma levels of the drug, but increases levels at the site of action in the liver. The degree to which rosuvastatin levels are affected depends on the OATP1B1 haplotype of the individual (16395). Baikal skullcap might also affect other OATP1B1 substrates (16396,16397,16398).
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Theoretically, Baikal skullcap might increase levels of drugs transported by P-glycoprotein.
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Theoretically, bupleurum might increase the risk of bleeding when taken with anticoagulant or antiplatelet drugs.
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Theoretically, bupleurum might decrease the effects of antidiabetes drugs.
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Theoretically, bupleurum might decrease the effects of immunosuppressants.
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Theoretically, taking forsythia with anticoagulant or antiplatelet drugs might increase the risk of bleeding due to decreased platelet aggregation. Forsythia might reduce platelet aggregation by inhibiting platelet activating factor (12619). Some of these drugs include aspirin, clopidogrel (Plavix), dalteparin (Fragmin), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin), and others.
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Theoretically, taking forsythia with azithromycin might increase the risk of adverse effects. Animal research in rats shows that taking a single dose of forsythia with azithromycin decreases the clearance and increases the area under the curve of both forsythiaside, a constituent of forsythia, and azithromycin. The mechanism of this interaction is not well understood (106675).
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Theoretically, kudzu may increase the risk of bleeding if used with antiplatelet or anticoagulant drugs.
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Theoretically, taking kudzu with antidiabetes drugs might increase the risk of hypoglycemia.
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Theoretically, taking kudzu with caffeine might increase levels of caffeine.
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In healthy males injected with the kudzu constituent puerarin, caffeine clearance and metabolism is inhibited (23583). This effect has been attributed to inhibition of cytochrome P450 1A2 (CYP1A2) enzyme, which is involved in caffeine metabolism. It is unclear if taking kudzu orally would have this same effect.
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Theoretically, kudzu might alter the effects of estrogen therapy.
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Theoretically, concomitant use might have additive hepatotoxic effects.
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Theoretically, taking kudzu with methotrexate might increase the risk of methotrexate toxicity.
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Preclinical research suggests that kudzu extract greatly reduces the elimination and increases the toxicity of methotrexate. Kudzu might inhibit organic anion transporters (OATs) that are responsible for hepatobiliary and renal excretion of anions, similar to the interaction between methotrexate and non-steroidal anti-inflammatory drugs (NSAIDs) (13296).
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Theoretically, kudzu might interfere with tamoxifen activity.
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Sweet Annie may alter plasma levels and clinical effects of drugs metabolized by CYP2B6.
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In vitro research shows that the Sweet Annie constituent artemisinin induces CYP2B6, possibly increasing CYP2B6 activity by 1.6-fold (92501,109316). However, Sweet Annie extract seems to inhibit the activity of CYP2B6 in vitro, suggesting that other constituents of Sweet Annie play a role in its effects on the overall activity of this enzyme (109316). More information is needed to determine whether taking Sweet Annie extract affects the metabolism of CYP2B6 substrates.
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Sweet Annie may alter plasma levels and clinical effects of drugs metabolized by CYP3A4.
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In vitro research shows that the Sweet Annie constituent artemisinin induces CYP3A4, possibly increasing CYP3A4 activity by 1.9-fold (92501). However, Sweet Annie extract seems to inhibit the activity of CYP3A4 in vitro, suggesting that other constituents of Sweet Annie play a role in its effects on the overall activity of this enzyme (109316). More information is needed to determine whether taking Sweet Annie extract affects the metabolism of CYP3A4 substrates.
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Theoretically, concomitant use might have additive adverse hepatotoxic effects.
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Below is general information about the adverse effects of the known ingredients contained in the product Ganmao Zhike Chongji. 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 ...No adverse effects have been reported; however, a thorough evaluation of safety outcomes has not been conducted.
General
...Orally, Baikal skullcap seems to be well-tolerated.
There is currently a limited amount of information on the adverse effects of intravenous and topical Baikal skullcap.
Most Common Adverse Effects:
Orally: Abdominal pain, constipation, diarrhea, erythema, nausea, pruritus, and vomiting.
Intravenously: Skin reactions.
Topically: Dermatitis.
Serious Adverse Effects (Rare):
Orally: Hepatotoxicity and hypersensitivity pneumonitis have been reported with a specific combination product (Limbrel, Primus Pharmaceuticals) containing extracts of Baikal skullcap and catechu.
Cardiovascular ...Orally, in a small clinical study evaluating the safety of baicalein, a constituent of Baikal skullcap, in healthy adults, elevated triglyceride levels occurred in 1 of 10 patients who received 400 mg every 8 hours and 2 of 10 patients treated with 600 mg every 8 hours, compared with 0 of 10 patients who received 200 mg every 8 hours and 0 of 6 patients who received placebo. Triglyceride elevations were considered mild and resolved after discontinuation (110023).
Dermatologic
...Orally, taking Baikal skullcap may cause erythema and pruritus (105867).
Intravenously, Baikal skullcap as part of a Tanreqing injection has been associated with reports of skin reactions in some pediatric patients (96281).
Topically, several cases of allergic contact dermatitis have been reported after applying sunscreen containing Baikal skullcap extract (105869,105870). Allergic contact dermatitis has also been reported after applying a facial cream (Resveratrol BE, Skinceuticals) containing Baikal skullcap root extract 0.5% and resveratrol 1%. Patch testing identified a positive reaction to both ingredients (110024). Baikal skullcap-induced dermatitis appears to respond to treatment with a topical corticosteroid and calcineurin inhibitor (105870).
Gastrointestinal ...Orally, use of Baikal skullcap has been associated with epigastric pain, abdominal pain, constipation, diarrhea, nausea, and vomiting (101738,105867).
Hepatic
...A specific combination product (Limbrel, Primus Pharmaceuticals) containing flavocoxid, a mixture of Baikal skullcap flavonoid extract and catechu extract, has been linked to several reports of acute liver damage.
There have been at least five published reports of liver damage associated with this product. In all cases, the patients were females aged 54-68 years taking doses of 250-500 mg twice daily for 1-3 months. Signs and symptoms included jaundice, pruritus, abdominal pain, fever, rash, and elevated serum bilirubin and liver transaminase levels. All patients fully recovered and levels normalized within 3 months after discontinuation (18009,96282). In addition to these published case reports, approximately 30 liver-related adverse events have been reported to the manufacturer of this product (18009). The mechanism of hepatotoxicity is unclear (18009,18010); it is estimated that the incidence of hepatotoxicity with this product is around 1 in 10,000, although the actual incidence is unknown (18010). In 2017, the US Food and Drug Administration (FDA) formally requested the recall of all non-expired lots of this product due to the risk for liver and lung injury (106042). It is unclear if these effects were due to Baikal skullcap, catechu, or the combination.
Hepatotoxicity has also been reported in two patients taking a specific dietary supplement (Move Free Advanced, Reckitt Benckiser) containing Baikal skullcap, black catechu, glucosamine, chondroitin, and hyaluronic acid (33460) and in a patient taking Baikal skullcap, elderflower, horseradish, and white willow (101737). The investigators determined that the hepatotoxicity was likely caused by Baikal skullcap in these cases (33460,101737). Additionally, cases of liver injury are reported in 4 of 37 patients taking various Kampo formulations containing Baikal skullcap and other herbs daily. Patients presented with elevated liver function tests 7 to 38 days after consumption (112179). It is unclear if this adverse effect is from Baikal skullcap, other ingredients, or the combination.
In a small study evaluating the safety of baicalein, a constituent of Baikal skullcap, in healthy adults, liver transaminase elevations occurred in 2 of 10 patients who received 400 mg every 8 hours for 6 days, compared with 0 of 6 patients who received placebo. No patients receiving either 200 mg or 600 mg every 8 hours experienced liver transaminase elevations. The elevations were considered mild and resolved after discontinuation (110023).
Pulmonary/Respiratory ...A specific combination product (Limbrel, Primus Pharmaceuticals) containing flavocoxid, a mixture of Baikal skullcap flavonoid extract and catechu extract, has been linked to several reports of hypersensitivity pneumonitis. Symptoms include fever, chills, headache, cough, chronic bronchitis, shortness of breath, weight loss, and fatigue. In 2017, the US Food and Drug Administration (FDA) formally requested the recall of all non-expired lots of this product due to the risk for liver and lung injury (106042). It is unclear if these effects were due to Baikal skullcap, catechu, or the combination.
Renal ...Orally, in a small clinical study evaluating the safety of baicalein, a constituent of Baikal skullcap, in healthy adults, proteinuria of undefined severity occurred in 1 of 10 patients who received 200 mg every 8 hours for 6 days, 3 of 10 patients who received 400 mg every 8 hours for 6 days, and 5 of 10 patients who received 600 mg every 8 hours for 6 days, compared with 1 of 6 patients who received placebo. The proteinuria was considered mild and resolved after discontinuation (110023).
General ...Orally, bupleurum seems to be well tolerated. However, most research has evaluated bupleurum in combination with other ingredients; the adverse effects of bupleurum when used alone are unclear.
Gastrointestinal ...Orally, a specific bupleurum-containing combination product (sho-saiko-to) has been reported to cause nausea, anorexia, and abdominal fullness (37391). It is unclear if these adverse effects are due to bupleurum, other ingredients, or the combination.
Hepatic ...Orally, a specific bupleurum-containing combination product (sho-saiko-to) has been associated with at least 24 reported cases of hepatotoxicity (92575). It is unclear if these adverse effects are due to bupleurum, other ingredients, or the combination.
Neurologic/CNS ...Orally, a specific bupleurum-containing combination product (sho-saiko-to) has been reported to cause fatigue and paresthesia (37391). It is unclear if these adverse effects are due to bupleurum, other ingredients, or the combination.
Pulmonary/Respiratory ...Orally, combination products containing bupleurum have been reported to cause eosinophilic pneumonia (354), pulmonary edema (361), and multiple cases of pneumonitis (355,356,357,37404). A specific combination product (sho-saiko-to), used in combination with interferon-alpha in patients with chronic active hepatitis, has also been associated with multiple cases of pneumonitis (358,359,360). It is unclear if these adverse effects are due to bupleurum, other ingredients, or the combination.
General ...Adverse effects of forsythia have not been reported. However, a thorough evaluation of safety outcomes has not been conducted.
General
...Orally and intravaginally, kudzu seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Elevated liver transaminases.
Cardiovascular ...Orally, side effects of kudzu reported in clinical trials have included palpitations and chest discomfort; however, these effects did not occur more frequently than with placebo (57924,57927).
Dermatologic ...Orally, a side effect of kudzu reported in one clinical trial has included urticaria; however, this effect did not occur more frequently than with placebo (57924). There is one case report of allergic reaction following use of a combination herbal product (Kakkonto) containing kudzu involving a maculopapular eruption starting on the thighs and spreading over the entire body (13111,57886).
Gastrointestinal ...Orally, some side effects of kudzu reported in clinical trials have included nausea, dyspepsia, and bloating; however, these effects did not occur more frequently than with placebo (57927,57942).
Genitourinary ...Intravaginally, irritation of the vulva has been reported with kudzu gel. These cases were generally mild and transient (110702).
Hematologic ...Intravenously, the kudzu derivative, puerarin, has caused intravascular hemolysis (13298,15025,57947).
Hepatic ...Orally, there are several cases reports of liver injury following use of kudzu involving elevated aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels (88777,92260).
Neurologic/CNS ...Orally, a side effect of kudzu reported in one clinical trial has included dizziness; however, this effect did not occur more frequently than with placebo (57924).
Other ...Orally, a side effect of kudzu reported in one clinical trial has included mastodynia; however, this effect did not occur more frequently than with placebo (57942).
General
...Orally, Sweet Annie is generally well-tolerated.
Most Common Adverse Effects:
Orally: Nausea and vomiting.
Serious Adverse Effects (Rare):
Orally: Hepatotoxicity.
Gastrointestinal ...Orally, Sweet Annie might cause gastrointestinal upset including nausea and vomiting in some patients (11058,112393).
Hepatic
...Orally, Sweet Annie might cause hepatic adverse effects (16895,103254,103255).
In one case, a 52-year-old patient developed hepatitis after taking the Sweet Annie constituent artemisinin 200 mg three times daily for 10 days. The patient developed abdominal pain and dark urine and was found to have elevated liver enzymes consistent with hepatitis. Symptoms resolved within 2 weeks of discontinuing use. Although it is possible this supplement caused liver disease in this patient, it is not certain. In clinical trials evaluating artemisinin, elevated liver enzymes have only been reported in around 0.9% of patients. However, the dose of artemisinin in this case was substantially higher than a typical dose (16895). A case of severe acute cholestatic hepatitis has also been reported in a 51-year-old male who drank Sweet Annie tea daily, prepared using 1.25 grams of Sweet Annie powder, for malaria prophylaxis during a 4-week trip to Ethiopia. Three weeks after his return, he presented with malaise, abdominal discomfort, jaundice, elevated liver enzymes, and markers of cholestasis. The patient was treated with corticosteroids and ursodeoxycholic acid and ultimately recovered (103255).
A series of cases linking the use of a supercritical carbon dioxide extract of Sweet Annie to hepatoxicity has also been reported. Of the 29 reports of adverse hepatic reactions to this extract, 19 patients noted symptoms within 12 weeks of starting the extract, 16 patients experienced jaundice, and 9 patients required hospitalization. Other common symptoms of hepatotoxicity included abdominal pain, vomiting, nausea, fever, headache, anorexia, malaise, fatigue, and lethargy. All but one case involved doses below or up to the extract's recommended dose of 300 mg daily. Upon discontinuation, symptoms resolved completely or were improved in nearly all cases (103254).
Immunologic ...One case of a mild allergic reaction to Sweet Annie tea has been reported. The reaction was characterized by a rash and cough that resolved quickly and did not require treatment (11059). When low doses are taken sublingually by individuals allergic to Sweet Annie, numbness of the tongue and throat itching have been reported (109315,112392,112393,112394).