Each pill contains: Angelica sinensis 2:1 extract (DHE: 25.5 mg) 12.75 mg • Chaenomeles Speciosa 2:1 extract (DHE: 25.5 mg) 12.75 mg • Codonopsis Pilosula 10:1 extract (DHE: 25.5 mg) 2.55 mg • Ligusticum chuanxiong 2:1 extract (DHE: 10.2 mg) 5.1 mg • Ligustrum lucidum 25.5 mg • Lycium barbarum 10:1 (DHE: 25.5 mg) 2.55 mg • Morus Alba 10:1 extract (DHE: 25.5 mg) 2.55 mg • Notopterygium incisum 10:1 extract (DHE: 7.7 mg) 0.77 mg • Polygonum Multiflorum 25.5 mg • Rehmannia glutinosa 10:1 extract (DHE: 25.5 mg) 2.55 mg • Salvia Miltiorrhiza 10:1 extract (DHE: 25.5 mg) 2.55 mg • Sesamum indicum 10:1 extract (DHE: 38.3 mg) 3.83 mg. Other Ingredients: Honey, Licorice Root.
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 Ban Tu Wan. 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 glossy privet.
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 Ban Tu Wan. 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. Traditionally, aqueous extract of codonopsis 6-9 grams daily has been used with apparent safety (12).
POSSIBLY UNSAFE ...when used orally in large amounts. Large doses of codonopsis (30-60 grams) have been associated with adverse effects including chest pain, arrhythmia, visual impairment, dizziness, and other conditions (12).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately (12,94396,96441,96444). There is insufficient reliable information available about the safety of danshen when used by intravenous injection.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately. Dong quai has been used with apparent safety in a dose of 4.5 grams daily for 24 weeks, or in combination with other ingredients in doses of up to 150 mg daily for up to 6 months (19552,35797). ...when used intravenously as a 25% solution, in a dose of 200-250 mL daily for up to 20 days (48438,48442,48443,48483).
POSSIBLY UNSAFE ...when used orally in large amounts, long-term. Theoretically, long-term use of large amounts of dong quai could be harmful. Dong quai contains several constituents such as bergapten, safrole, and isosafrole that are considered carcinogenic (7162). There is insufficient reliable information available about the safety of dong quai when used topically.
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Dong quai has uterine stimulant and relaxant effects (8142); theoretically, it could adversely affect pregnancy. Observational research has found that intake of An-Tai-Yin, an herbal combination product containing dong quai and parsley, during the first trimester is associated with an increased risk of congenital malformations of the musculoskeletal system, connective tissue, and eyes (15129).
LACTATION:
Insufficient reliable information available; avoid use.
POSSIBLY UNSAFE ...when used orally. Fo-ti has been linked to several cases of liver damage (7626,7627,14327,14347,14482,16459,17192,50711,50727,50729) (92892,92895,112231).
CHILDREN: POSSIBLY UNSAFE
when used orally.
Fo-ti has been linked to several cases of liver damage in adults and at least one case in a 5-year-old child (14339,92895).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Fo-ti contains anthraquinone constituents, which can exert a stimulant laxative effect. Bulk-forming or emollient laxatives are preferred in pregnancy (272). Fo-ti has also been linked to several cases of liver damage (7626,7627,14327). There is insufficient reliable information available about the safety of fo-ti when used topically during pregnancy.
LACTATION: POSSIBLY UNSAFE
when used orally.
Anthraquinone constituents can cross into breast milk and might cause loose stools in some breast-fed infants (272). Fo-ti has also been linked to several cases of liver damage (7626,7627,14327). There is insufficient reliable information available about the safety of fo-ti when used topically during lactation.
POSSIBLY SAFE ...when used orally and appropriately (12).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when goji fruit preparations are used orally and appropriately, short-term. Goji berry whole fruit, boiled or steamed, has been used with apparent safety at a dose of 15 grams daily for 16 weeks (105489). Other goji berry products have also been used with apparent safety in clinical research, including a specific goji fruit juice (GoChi, FreeLife International) 120 mL daily for 30 days (52532), a goji fruit polysaccharide 300 mg daily for 3 months (92117), and a specific milk-based formulation of goji berry (Lacto-Wolfberry, Nestlé Research Center) for 3 months (52539). There has been some concern about the atropine content of goji; however, most analyses show that levels of atropine in goji berries from China and Thailand are far below potentially toxic levels (52524,94667). There is insufficient reliable information available about the safety of oral use of other parts of the goji plant.
PREGNANCY AND LACTATION:
Insufficient reliable information available.
Some animal research shows that goji fruit may stimulate the uterus (12). However, this has not been reported in humans. Until more is known, avoid using during pregnancy or lactation.
POSSIBLY SAFE ...when used orally and appropriately, short term. Rehmannia root extract 4 grams daily or rehmannia leaf extract 800 mg daily has been used with apparent safety for 8 weeks in clinical studies (93660,93662).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in food. Sesame has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when sesame oil is used orally and appropriately, short-term. Sesame oil has been used with apparent safety in doses up to 35 grams daily for up to 12 weeks (96179,96180,108354). The sesame constituent sesamin has been used with apparent safety at doses of 200 mg daily for 6 weeks (103230) and 10 mg daily for 12 weeks (99863). Sesame oil 150 mL has also been administered via nasogastric tube with apparent safety as a single dose (27645). ...when sesame oil is used in a nasal spray, short-term. A specific nasal spray (Nozoil) containing sesame oil has been used with apparent safety for up to 20 days (27658,27659,27660). ...when sesame oil is applied topically (96178,103227,103228). There is insufficient reliable information available about the safety of other forms of sesame when used in medicinal amounts.
CHILDREN: POSSIBLY SAFE
when sesame oil is used orally and appropriately in medicinal amounts, short-term.
Sesame oil 5 mL has been used safely at bedtime for up to 3 days (27647).
PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of sesame when used in medicinal amounts during pregnancy and lactation.
POSSIBLY SAFE ...when used orally and appropriately. White mulberry powdered leaf or leaf extract has been used with apparent safety at doses of up to 4.6 grams three times daily for up to 12 weeks (16494,17051,100627,103870,105796,110480). There is insufficient reliable information available about the safety of white mulberry berries.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Ban Tu Wan. 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 codonopsis root with abiraterone might reduce the levels and therapeutic effects of abiraterone.
Details
Animal research in rats shows that intragastric administration of codonopsis root along with abiraterone every 2 days for 2 weeks seems to increase the clearance of abiraterone and reduce the overall exposure and time to maximum concentration (105912). This interaction has not been reported in humans.
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Theoretically, codonopsis liquor might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.
Details
A small clinical study in adults with coronary heart disease shows that consuming Codonopsis pilosula liquor for 4 weeks inhibits platelet aggregation but does not affect tissue-type plasminogen activator (t-PA) or plasminogen activator inhibitor (PAI) (43888).
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Theoretically, codonopsis might increase the risk of hypoglycemia when taken with antidiabetes drugs.
Details
Laboratory and animal research suggest that codonopsis has antidiabetic effects (110743).
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Theoretically, taking danshen in combination with amlodipine may decrease the clinical effects of amlodipine.
Details
In animal research, taking danshen orally in combination with amlodipine reduced blood levels of amlodipine by about 52%. This may have been due to induction of cytochrome P450 3A4 (CYP3A4) by danshen, which has been demonstrated in vitro (101977). So far, this interaction has not been reported in humans.
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Theoretically, danshen may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
Danshen has been reported to have antithrombotic effects (6048,96440). Animal research also suggests that taking a danshen combination formula with clopidogrel exhibits a synergistic increase in antiplatelet aggregation and prolongation of coagulation time when compared with either taken alone (112399).
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Theoretically, taking danshen with antihypertensive drugs might increase the risk of hypotension.
Details
Animal research suggests that danshen can produce dose-dependent hypotensive effects. Furthermore, concomitant use with captopril appears to potentiate this effect (47071).
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Theoretically, danshen may increase the levels of aspirin and the risk of bleeding.
Details
Research in healthy adult males shows that taking a combination of danshen and kudzu with aspirin increases plasma aspirin area under the curve by approximately 3.4-fold (105517). Animal research also shows that taking a combination of danshen and kudzu (danshen-gegen formula) with aspirin increases maximal blood levels of aspirin and salicylic acid by approximately 4-fold and 3.7-fold, respectively, without impacting blood loss (94399). Taking danshen increases the antiplatelet activity of aspirin and might increase the side effects of aspirin (105517).
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Theoretically, danshen may increase the risk of bleeding if taken with clopidogrel.
Details
Clopidogrel is an antiplatelet prodrug that is metabolized by carboxyl esterase 1 (CES1) to an inactive metabolite. Animal research shows that a danshen combination formula decreases the activity of CES1, decreasing levels of the inactive metabolite in the blood and possibly increasing levels of the active metabolite (94389). Animal research also suggests that taking a danshen combination formula with clopidogrel exhibits a synergistic increase in antiplatelet aggregation and prolongation of coagulation time when compared with either taken alone (112399).
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Theoretically, danshen may increase the levels and clinical effects of drugs metabolized by CYP1A2.
Details
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Theoretically, danshen may increase the levels and clinical effects of drugs metabolized by CYP2C9.
Details
In vitro research shows that various constituents of danshen inhibit the activity of CYP2C9 (94393). So far, this interaction has not been reported in humans.
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Theoretically, danshen may increase the levels and clinical effects of drugs metabolized by CYP2E1.
Details
In vitro research shows that various constituents of danshen inhibit the activity of CYP2E1 (94393). So far, this interaction has not been reported in humans.
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Danshen might alter the levels and clinical effects of drugs metabolized by CYP3A4.
Details
Preliminary clinical research in healthy males shows that the administration of danshen for 10-14 days induces intestinal CYP3A4 and increases the clearance of midazolam, a CYP3A4 substrate. The maximum concentration of midazolam was decreased by 31% to 67%, and drug levels were decreased by 27% to 80% (17404,94390). However, a single dose of danshen has the opposite effect, increasing maximum concentrations of midazolam by 87% (94390).
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Theoretically, using danshen with digoxin might increase the risk of adverse effects.
Details
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Danshen might increase the levels and clinical effects of fexofenadine.
Details
Pharmacokinetic research in healthy volunteers shows that taking danshen extract 1 gram three times daily for 10 days prior to receiving fexofenadine 60 mg increases peak levels of fexofenadine, a p-glycoprotein substrate, by 27.4% and area under the curve (AUC) by 37.2% (94391).
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Theoretically, danshen might affect the levels and clinical effects of drugs requiring glucuronidation.
Details
In vitro research shows that danshen induces the expression of glucuronosyltransferases. However, it also inhibits the activity of glucuronosyltransferases, including various members of the 1A and 2B families. The extent of inhibition of a specific glucuronosyltransferase seems to be dependent on whether or not the danshen is processed via 'sweating'. This type of processing may affect the levels of constituents in danshen that alter glucuronosyltransferase activity (109375). So far, this interaction has not been reported in humans.
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Danshen might alter the levels and clinical effects of midazolam.
Details
Preliminary clinical research in healthy males shows that the administration of danshen for 10-14 days induces intestinal CYP3A4 and increases midazolam clearance. The maximum concentration was decreased by 31% to 67%, and drug levels were decreased by 27% to 80% (17404,94390). However, a single dose of danshen has the opposite effect, increasing maximum concentrations of midazolam by 87% (94390).
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Danshen might alter the levels of drugs cleared by p-glycoprotein.
Details
Pharmacokinetic research in healthy volunteers suggests that danshen might affect p-glycoprotein activity. Taking danshen extract 1 gram three times daily for 10 days prior to receiving fexofenadine 60 mg increases peak levels of fexofenadine, a p-glycoprotein substrate, by 27.4% and area under the curve (AUC) by 37.2% (94391).
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Theoretically, danshen might increase the levels and clinical effects of rosuvastatin.
Details
Animal research shows that a single dose of danshen increases levels of rosuvastatin at least 2-fold, possibly by increasing absorption and/or decreasing elimination (94395). So far, this interaction has not been reported in humans.
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Theoretically, danshen may increase the risk of bleeding if used with warfarin.
Details
There have been several case reports of increased international normalized ratio (INR) after concomitant use of danshen and warfarin. Elevations in INR have occurred as early as 3-5 days after start of danshen (611,612,2237,5883,5884). However, a clinical trial in adults taking warfarin with stable INR found that the addition of compound danshen dripping pills, containing danshen extract, Panax notoginseng, and borneol, 270 mg three times daily for 4 weeks did not alter INR levels or the average required warfarin dose when compared to baseline (96438). These findings are consistent with animal research, which found no change in warfarin pharmacokinetics with the use of danshen (94388,94397,94399). Other research in healthy adult males also shows that taking a combination of danshen and kudzu with warfarin does not increases plasma warfarin area under the curve, but may reduce plasma soluble thrombomodulin levels (105517). However, other research shows that danshen might increase the rate of absorption and decrease the elimination rate of warfarin (5884,6048,94398). Also, research in healthy adult males shows that taking a combination of danshen and kudzu with warfarin increases plasma area under the curve of danshensu, a constituent of danshen, by approximately 29.5-fold (105517). Danshen should be used cautiously in patients taking warfarin.
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Theoretically, dong quai may increase the risk of bleeding when used with anticoagulant or antiplatelet drugs; however, research is conflicting.
Details
Animal studies suggest that dong quai has antithrombin activity and inhibits platelet aggregation due to its coumarin components (6048,10057,96137). Additionally, some case reports in humans suggest that dong quai can increase the anticoagulant effects of warfarin (3526,6048,23310,48439). However, clinical research in healthy adults shows that taking 1 gram of dong quai root daily for 3 weeks does not significantly inhibit platelet aggregation or cause bleeding (96137). Until more is known, use dong quai with caution in patients taking antiplatelet/anticoagulant drugs.
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Theoretically, dong quai may reduce the effects of estrogens.
Details
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Dong quai may increase the risk of bleeding when used with warfarin.
Details
Case reports suggest that concomitant use of dong quai with warfarin can increase the anticoagulant effects of warfarin and increase the risk of bleeding (3526,6048,23310,48439). In one case, after 4 weeks of taking dong quai 565 mg once or twice daily, the international normalized ratio (INR) increased to 4.9. The INR normalized 4 weeks after discontinuation of dong quai (3526).
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Theoretically, fo-ti might increase the risk of hypoglycemia when taken with antidiabetes drugs.
Details
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Theoretically, taking large amounts of fo-ti might interfere with contraceptive drugs due to competition for estrogen receptors.
Details
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Theoretically, fo-ti might increase or decrease the levels and clinical effects of drugs metabolized by CYP1A2.
Details
In vitro research suggests that fo-ti might inhibit CYP1A2 (12479,112351). Additionally, in vitro research suggests that the degree of CYP1A2 inhibition depends on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, in an animal study, an aqueous extract of fo-ti inhibited CYP1A2 while an alcoholic extract of fo-ti induced CYP1A2 (92898). Induction or inhibition of CYP1A2 by fo-ti has not been reported in humans.
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Theoretically, fo-ti might increase the levels and clinical effects of drugs metabolized by CYP2B6.
Details
Animal research suggests that fo-ti might inhibit CYP2B6 (92898). One in vitro study suggests that the degree of CYP2B6 inhibition may depend on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, this interaction has not been reported in humans.
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Theoretically, fo-ti may increase the levels and clinical effects of drugs metabolized by CYP2C19.
Details
Animal and in vitro research suggests that fo-ti may inhibit CYP2C19 (12479,92898,112351). An in vitro study suggests that the degree of CYP2C19 inhibition may depend on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, this interaction has not been reported in humans.
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Theoretically, fo-ti might increase the levels and clinical effects of drugs metabolized by CYP2C8.
Details
In vitro research suggests that fo-ti might inhibit CYP2C8 (112351). However, this interaction has not been reported in humans.
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Theoretically, fo-ti may increase the levels and clinical effects of drugs metabolized by CYP2C9.
Details
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Theoretically, fo-ti may increase the levels and clinical effects of drugs metabolized by CYP2D6.
Details
Animal research suggests that fo-ti might inhibit CYP2D6 (92898). Additionally, an in vitro study suggests that the degree of CYP2D6 inhibition may depend on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, this interaction has not been reported in humans.
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Theoretically, fo-ti might increase the levels and clinical effects of drugs metabolized by CYP3A4.
Details
In vitro research suggests that fo-ti might inhibit CYP3A4 (12479,112351). One in vitro study suggests that the degree of CYP3A4 inhibition may depend on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, this evidence conflicts with animal research suggesting that fo-ti does not inhibit CYP3A4 (92898). This interaction has not been reported in humans.
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Theoretically, fo-ti, particularly raw fo-ti root, might increase the risk of hypokalemia and cardiotoxicity when taken with digoxin.
Details
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Theoretically, fo-ti, particularly raw fo-ti root, might increase the risk of hypokalemia when taken with diuretic drugs.
Details
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Theoretically, taking large amounts of fo-ti might interfere with hormone replacement therapy through competition for estrogen receptors.
Details
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Theoretically, fo-ti might increase the risk of liver damage when taken with hepatotoxic drugs.
Details
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Theoretically, fo-ti, particularly raw fo-ti root, might increase the risk of fluid and electrolyte depletion when taken with stimulant laxatives.
Details
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Theoretically, fo-ti might increase or decrease the levels and clinical effects of sulindac.
Details
Animal research suggests that the type of fo-ti extract might affect the levels of sulindac differently; the raw plant may increase levels, but processed parts may decrease levels (112351). Induction or inhibition of CYP1A2 by fo-ti has not been reported in humans.
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Theoretically, fo-ti might increase the effects and adverse effects of warfarin.
Details
Fo-ti may have stimulant laxative effects and cause diarrhea, especially when the raw or unprocessed fo-ti root is used (5,12,16459,50733,99855). Diarrhea can increase the effects of warfarin, increase international normalized ratio (INR), and increase the risk of bleeding. Also, fo-ti has been linked to cases of acute liver failure which can decrease clotting factor production and increase the effects of warfarin. In one case, a patient who had been stable on warfarin presented with acute hepatitis and an INR elevated to 14.98. The patient had been taking fo-ti for 90 days prior to admission. Discontinuation of warfarin and fo-ti lead to a decrease in the INR and full recovery (17192).
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Glossy privet is thought to have diuretic properties. Theoretically, due to these potential diuretic effects, glossy privet might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.
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Theoretically, concomitant use of goji fruit polysaccharides or goji root bark with antidiabetes drugs might have additive effects.
Details
Animal and in vitro research show that goji root bark and fruit polysaccharides might have hypoglycemic effects (7126,92118,94667). However, clinical research has only shown that taking goji fruit polysaccharides with or without antidiabetes drugs modestly reduces postprandial glucose when compared with control, with no reports of hypoglycemia (92117).
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Theoretically, concomitant use of goji root bark, but not goji fruit, with antihypertensive drugs might have additive effects.
Details
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Theoretically, goji berry might inhibit CYP2C19 and reduce metabolism of CYP2C19 substrates.
Details
In vitro research shows that goji berry tincture and juice inhibit CYP2C19 enzymes (105486). Concomitant use with goji may decrease metabolism and increase levels of CYP2C19 substrates. However, this has not been reported in humans.
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Theoretically, goji berry might inhibit CYP2C9 and reduce metabolism of CYP2C9 substrates.
Details
In vitro research shows that goji berry tincture and juice inhibit CYP2C9 enzymes (105486). Additionally, multiple case reports suggest that goji berry concentrated tea and juice inhibit the metabolism of warfarin, a CYP2C9 substrate (7158,105462). Concomitant use with goji may decrease metabolism and increase levels of CYP2C9 substrates.
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Theoretically, goji berry might inhibit CYP2D6 and reduce metabolism of CYP2D6 substrates.
Details
In vitro research shows that goji berry juice inhibits CYP2D6 enzymes (105486). Concomitant use with goji may decrease metabolism and increase levels of CYP2D6 substrates. However, this has not been reported in humans.
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Theoretically, goji berry might inhibit CYP3A4 and reduce metabolism of CYP3A4 substrates.
Details
In vitro research shows that goji berry juice inhibits CYP3A4 enzymes (105486). Concomitant use with goji may decrease metabolism and increase levels of CYP3A4 substrates. However, this has not been reported in humans.
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Theoretically, goji berry might increase the levels and clinical effects of flecainide.
Details
In one case report, a 75-year-old patient stable on flecainide and warfarin presented to the emergency room with fainting and pleomorphic arrhythmia caused by flecainide toxicity. Flecainide toxicity was attributed to drinking 1-2 glasses of concentrated goji tea daily for 2 weeks. Theoretically, goji may have inhibited the cytochrome P450 2D6 (CYP2D6) metabolism of flecainide (105462).
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Goji can increase the effects of warfarin and possibly increase the risk of bleeding.
Details
There are at least 5 case reports of increased international normalized ratio (INR) in patients stabilized on warfarin who began drinking goji juice, concentrated goji tea, or goji wine (7158,16529,23896,105462,105487). Goji may inhibit the metabolism of warfarin by cytochrome P450 2C9 (CYP2C9) (7158).
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Theoretically, rehmannia might increase the risk of hypoglycemia when taken with antidiabetes drugs.
Details
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Theoretically, rehmannia might increase the risk of hypotension when taken with antihypertensive drugs.
Details
Animal research shows that rehmannia may have hypotensive effects. Laboratory research shows that formulations of dried and processed rehmannia root inhibit angiotensin-converting enzyme (ACE) (104272).
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Taking sesame oil with antidiabetes drugs might increase the risk of hypoglycemia.
Details
Clinical studies show that sesame oil can decrease plasma glucose and glycated hemoglobin (HbA1c) levels. Some clinical research in patients taking glibenclamide shows that using sesame oil or a blend of sesame oil and rice bran oil in place of other oil for cooking reduces plasma glucose more than glibenclamide alone (27654,28139,96177,108350,108352,108355). Monitor blood glucose levels closely. Dose adjustments might be necessary.
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Taking sesame oil with antihypertensive drugs might increase the risk of hypotension.
Details
Clinical research shows that replacing other cooking oil with sesame oil can lower systolic blood pressure (SBP) and diastolic blood pressure (DBP) in patients with or without hypertension. There is also some evidence that sesame oil has additive effects in patients also taking atenolol, nifedipine, and/or hydrochlorothiazide (27652,27654,27655,96179,108355,108357). In patients using nifedipine, using a blend of sesame oil and rice bran oil for cooking reduces both SBP and DBP more than nifedipine alone (96180).
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Theoretically, sesame might increase the levels and clinical effects of CYP2C9 substrates.
Details
In vitro, sesame inhibits CYP2C9 (11028). However, this interaction has not been reported in humans.
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Theoretically, sesame might alter the transport of P-glycoprotein substrates.
Details
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Theoretically, sesame might interfere with tamoxifen.
Details
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Theoretically, white mulberry leaf might increase the risk of hypoglycemia when taken with antidiabetes drugs.
Details
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Theoretically, white mulberry leaf might slow the elimination and increase the adverse effects of drugs which are OCT2 substrates.
Details
Animal research shows that coadministration of white mulberry leaf extract with metformin, an OCT2 substrate, slows the renal elimination of metformin via inhibition of OCT2 activity (103869). OCT2 is expressed in the kidneys and is responsible for transporting cationic drugs into tubular epithelial cells in order to be excreted in the urine.
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Below is general information about the adverse effects of the known ingredients contained in the product Ban Tu Wan. 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, codonopsis seems to be well tolerated when used appropriately; however, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Allergic reactions such as anaphylaxis.
Cardiovascular ...Orally, very large doses of codonopsis (30-60 grams) may cause chest pain or arrhythmia (12).
Gastrointestinal ...Orally, very large doses of codonopsis (30-60 grams) may cause throat pain and loss of voice (12).
Immunologic ...Orally, codonopsis can cause allergic reactions including anaphylaxis and urticaria. In one case report, an 18-year-old male developed anaphylaxis after ingesting codonopsis roots. In an oral re-challenge test, he developed anaphylaxis and urticaria again 30 minutes after consuming 20 grams of codonopsis root. Although codonopsis is in the same family as mugwort, the patient did not appear to be sensitized to mugwort pollen (100060).
Neurologic/CNS ...Orally, very large doses of codonopsis (30-60 grams) may cause vision problems, dizziness, loss of balance, leg spasms, and confusion (12).
General
...Orally, danshen seems to be well tolerated.
There is limited reliable information available about the adverse effects of danshen when used intravenously.
Most Common Adverse Effects:
Orally or intravenously: Upset stomach, pruritus, and reduced appetite.
Cardiovascular ...Orally, in clinical trials, side effects of danshen preparations include palpitations; however, it is not known if these effects were due to danshen or other drugs (109370).
Dermatologic ...Orally or intravenously, danshen can cause pruritus (12,96440).
Gastrointestinal ...Orally or intravenously, danshen can cause upset stomach and reduced appetite (12). In clinical trials, side effects of danshen preparations include loose stools; however, it is not known if these effects were due to danshen or other drugs (109370).
Hematologic ...Orally or intravenously, side effects of danshen preparations reported in clinical trials include thrombocytopenia; however, it is not known if this effect was due to danshen or other drugs (15538).
Neurologic/CNS ...Orally or intravenously, in clinical trials, side effects of danshen preparations include drowsiness, dizziness, or headache; however, it is not known if these effects were due to danshen or other drugs (15538,109370).
General
...Orally, dong quai is generally well-tolerated.
Most Common Adverse Effects:
Orally: Burping and flatulence.
Intravenously: Headache.
Cardiovascular ...Orally, dong quai might cause hypertension; according to one case report, a parent and breastfed infant experienced hypertension (195/85 mmHg and 115/69 mmHg, respectively) after the parent consumed a soup containing dong quai root (48428).
Dermatologic ...Dong quai contains psoralens that may cause photosensitivity and photodermatitis (10054,10057,48461).
Endocrine ...In a case report, a male developed gynecomastia after ingesting dong quai tablets (48504).
Gastrointestinal ...Orally, burping and gas may occur with dong quai (738).
Hematologic ...In one case report, a 55-year-old female with protein S deficiency and systemic lupus erythematosus (SLE) had temporary vision loss in the left eye from hemiretinal vein thrombosis three days after taking a phytoestrogen preparation containing dong quai 100 mg, black cohosh 250 mg, wild Mexican yam 276 mg, and red clover 250 mg (13155). It is unclear if dong quai contributed to this event.
Neurologic/CNS ...Dong quai given orally or by injection may be associated with headache (738,48438).
Oncologic ...Dong quai contains constituents that are carcinogenic; however, whether these constituents are present in concentrations large enough to cause cancer with long-term or high-dose use is unknown (7162).
Pulmonary/Respiratory ...A pharmacist experienced allergic asthma and rhinitis after occupational exposure to dong quai and other herbs (48435).
General
...Orally, fo-ti may be unsafe.
Most Common Adverse Effects:
Orally: Abdominal pain, diarrhea, nausea, and vomiting with use of unprocessed fo-ti.
Serious Adverse Effects (Rare):
Orally: Hepatotoxicity with processed or unprocessed fo-ti.
Dermatologic ...Orally, one case of a fine maculopapular rash was reported in a patient taking the herbal product known as Shen-Min, which contains fo-ti. Symptoms resolved within three weeks after discontinuing the product (14482). It is unclear if the rash was due to fo-ti or other ingredients in the herbal product.
Gastrointestinal ...Orally, unprocessed fo-ti may cause diarrhea, abdominal pain, nausea, and vomiting (12,50733).
Hematologic ...Orally, one case of mild eosinophilia was reported in a patient taking the herbal product known as Shen-Min, which contains fo-ti. Symptoms resolved within three weeks after discontinuing the product (14482). It is unclear if this reaction was due to fo-ti or other ingredients in the herbal product. A case of agranulocytosis was reported in a 65-year-old female taking fo-ti 30 grams/day for 17 days. The patient recovered gradually following a 15-day hospitalization, which included treatment with intravenous steroids and granulocyte colony-stimulating factor (112231).
Hepatic
...Orally, cases of liver damage due to both processed and unprocessed fo-ti have been well documented in the medical literature.
(7626,7627,14327,14339,14347,14482,16459,17192,50711,50726)(50727,50729,92892,92895,112231).
In a systematic review, around 450 cases of hepatitis associated with fo-ti were identified. These cases occurred in patients 5-78 years of age. Liver damage occurred at a wide range of doses, formulations, and durations of intake. The type of liver injury ranged from hepatocellular, to cholestatic, or mixed. Outcomes ranged from full recovery to cirrhosis, liver transplantation, and/or death. The evidence suggests that when the daily fo-ti dose is less than 12 grams, the median time to occurrence of liver damage is 60 days. When the daily fo-ti dose is more than 12 grams, the median time to liver damage is 30 days (92895). Presenting signs and symptoms may include jaundice, abdominal pain, nausea, fatigue, loss of appetite, dark urine, myalgias, and elevations in liver function tests (LFTs), ferritin, transferrin, prothrombin time, and INR (17192,92892). Other manifestations may include fever, skin rash, thrombocytopenia, pancytopenia, and arthralgias. Symptoms and increased LFTs usually seem to resolve within a month after discontinuing fo-ti (7626,7627,14339,14347,14482,16459). In one case series, liver enzymes began to normalize 48 hours after discontinuation of fo-ti and treatment with S-adenosylmethionine, compound glycyrrhizin injection, polyene phosphatidylcholine, and reduced glutathione. All patients were eventually discharged home in stable condition (92892). Rechallenge with fo-ti should not be attempted. A patient who had recovered from hepatitis associated with fo-ti use presented with myalgias and markedly elevated LFTs after a single dose of the herb (17192).
It is thought that this idiosyncratic reaction leading to liver damage is at least partially related to genetic polymorphisms. Cytochrome P450 1A2 (CYP1A2) is the predominant enzyme involved in biotransformation of emodin, a constituent of fo-ti thought to play a role in liver damage. In one genetic study, the frequency of CYP1A2*1C mutation in fo-ti induced drug-induced liver injury patients was 46.5%, which is significantly higher than the 27.9% frequency of liver injury reported in healthy patients without the mutation. Patients with a CYP1A2*1C mutation may have decreased activity of the CYP1A2 enzyme, which could inhibit the metabolism of fo-ti, causing an accumulation of toxic substances (92897).
General
...Orally, goji fruit seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Allergic reactions including anaphylaxis.
Dermatologic ...A case of photosensitivity secondary to consumption of goji berries has been reported. The patient presented with a pruriginous eruption that had lasted for 2 weeks. The patient had been taking goji berries for 5 months and cat's claw for 3 months. Upon testing, it was revealed that the patient tested positive to goji berries in a photoprovocation test, but not to cat's claw (40263).
Hepatic ...Orally, consumption of goji berries has been associated with a single case report of autoimmune hepatitis (52541). A case of acute hepatitis has also been reported in a female who consumed 2 ounces of a specific combination product (Euforia, Nuverus International) containing goji berry, pomegranate, curcumin, green tea, noni, acai berry, aloe vera, blueberry, resveratrol, mangosteen, and black seed, daily for one month. It is unclear whether the liver injury was caused by goji berry, other ingredients, or the combination (90125).
Immunologic ...Several cases of allergic reactions secondary to consumption of goji berries have been reported. Symptoms included facial angioedema with dyspnea, pharyngeal itching, itching in the mouth, ears, and axilla, labial angioedema, and perioral skin rash (92116). Anaphylaxis has also been reported (52538).
General ...Orally, rehmannia seems to be well tolerated.
General
...Orally, topically, or intranasally, sesame seems to be well tolerated.
Most Common Adverse Effects:
All routes of administration: Allergic reactions.
Dermatologic ...In a small clinical study, one patient using a cream containing sesame oil as well as aqueous extracts of guggul and Allium ampeloprasum complained of rash at the application site (105751). It is unclear if this reaction was due to sesame, other ingredients, or other factors.
Gastrointestinal ...There was a single case of diarrhea associated with oral sesame in a clinical trial (108356).
Immunologic
...Multiple cases of allergic response to sesame seed occurring after occupational, topical, intramuscular, or oral exposure have been reported (28157,28158,28159,28160,28161,28162,28163,28166,28167,28183)(28184,28185,28186,28188,108348).
One study found that up to 0.5% of the United States population reports having a sesame allergy, and 0.23% of the population meets criteria for an IgE-mediated allergic reaction to sesame (100501). Allergic symptoms may be dermatologic, such as angioedema (28160,28167,108348), cheilitis (28207), dermatitis (28157,28166,28182,28185,28186), edema (28159), erythema (28167), pruritis (28167,108348), purpura (28188), flushing (108348), and urticaria (28159,28160,28162,108348); musculoskeletal (28188); respiratory, such as asthma (28159,28162), rhinitis (28162), wheezing (28167), and general breathing difficulties (108348); gastrointestinal, such as vomiting (28159,108348); and others such as conjunctivitis (28159), anaphylactic shock (28157,28159,28160,28167,28177,28178,28179,28180,28204,108348), and hemodynamic modifications (28169). In Canada, sesame accounted for 4% of pediatric food-induced anaphylaxis reactions presenting to emergency departments over a 10-year period. The majority of cases were mild to moderate in severity and occurred within 2 hours of exposure; however, about 3% occurred 2-8 hours after exposure. Epinephrine was the most common treatment, followed by antihistamines, inhaled beta-agonists, and corticosteroids (108348).
Approximately one-third of patients with IgE-mediated sesame allergy have reported previous use of epinephrine due to this allergy (100501). There is evidence that IgE-mediated sesame allergy is influenced by both genetic and environmental factors; there was a high correlation of the allergy between family members, especially siblings (28175).
Allergens believed to be responsible for sesame seed hypersensitivity include beta-globulin (28213); sesamol, sesamolin, and sesamin (28182,28207); storage proteins including ses i 1 and ses i 2 (2S albumins) (28132,28187,28211,28212,28216,28217), ses i 3 (a 7S vicilin-type globulin) (28187,28214), ses i 4 (28158), ses i 5 (28158), ses i 6 (an 11S globulin) (28132,28215), and ses i 7 (28215). Typically allergens in sesame seeds that cause reactions after oral intake have molecular weights ranging from 8-62 kDa (28208,28210).
Pulmonary/Respiratory ...In clinical trials involving a sesame oil nasal spray, minor adverse effects included adverse smell, oil dripping from the nose, and nasal blockage (27659).
General
...Orally, white mulberry leaf seems to be well tolerated.
Most Common Adverse Effects:
Orally: Transient bloating, constipation, flatulence, and loose stools.
Gastrointestinal ...Orally, white mulberry leaf powder 4. 6 grams three times daily for 4 weeks was associated with bloating and flatulence in 50% of patients, loose stools in 25% of patients, and constipation in 21% of patients in one clinical study. However, reports of these adverse effects decreased over the course of the 12-week study, suggesting that for some patients the adverse effects may be transient in nature (103870).