| Ingredients | Amount Per Serving |
|---|---|
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Proprietary Extract Blend
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1140 mg |
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(Xanthium sibiricum )
(fruit)
(Cang er zi)
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(Magnolia biondii )
(flower)
(Xin yi hua)
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(Forsythia suspensa )
(fruit)
(Lian qiao)
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Saposhnikovia divaricata root extract
(Saposhnikovia divaricata )
(root)
(Fang feng)
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(Angelica dahurica )
(root)
(Bai zhi)
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Anemarrhena asphodeloides extract
(Anemarrhena asphodeloides )
(rhizome)
(Zhi mu)
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(Glycyrrhiza uralensis )
(root)
(Gan cao)
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(Schizonepeta tenuifolia )
(herb)
(Jing jie)
|
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(Chrysanthemum indicum )
(flower)
(Ye ju hua)
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(Schisandra chinensis )
(fruit)
(Wu wei zi)
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Platycodon grandiflorum extract
(Platycodon grandiflorum )
(root)
(Jie geng)
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Microcrystalline Cellulose, Hypromellose, Polyethylene Glycol, Magnesium Stearate
Below is general information about the effectiveness of the known ingredients contained in the product Bi Yan Pian. 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
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 Siberian cocklebur.
Below is general information about the safety of the known ingredients contained in the product Bi Yan Pian. 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 used orally in amounts commonly found in foods. Angelica archangelica has Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of Angelica archangelica when used orally or topically for medicinal purposes.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately, short-term. A specific extract of chrysanthemum (GreenCross Wellbeing Corporation) has been used with apparent safety at a dose of 250 mg daily for up to 12 weeks (106308). There is insufficient reliable information available about the safety of chrysanthemum when used topically.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Licorice has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when licorice products that do not contain glycyrrhizin (deglycyrrhizinated licorice) are used orally and appropriately for medicinal purposes. Licorice flavonoid oil 300 mg daily for 16 weeks, and deglycyrrhizinated licorice products in doses of up to 4.5 grams daily for up to 16 weeks, have been used with apparent safety (6196,11312,11313,17727,100984,102960). ...when licorice products containing glycyrrhizin are used orally in low doses, short-term. Licorice extract 272 mg, containing glycyrrhizin 24.3 mg, has been used daily with apparent safety for 6 months (102961). A licorice extract 1000 mg, containing monoammonium glycyrrhizinate 240 mg, has been used daily with apparent safety for 12 weeks (110320). In addition, a syrup providing licorice extract 750 mg has been used twice daily with apparent safety for 5 days (104558). ...when applied topically. A gel containing 2% licorice root extract has been applied to the skin with apparent safety for up to 2 weeks. (59732). A mouth rinse containing 5% licorice extract has been used with apparent safety four times daily for up to one week (104564).
POSSIBLY UNSAFE ...when licorice products containing glycyrrhizin are used orally in large amounts for several weeks, or in smaller amounts for longer periods of time. The European Scientific Committee on Food recommends that a safe average daily intake of glycyrrhizin should not exceed 10 mg (108577). In otherwise healthy people, consuming glycyrrhizin daily for several weeks or longer can cause severe adverse effects including pseudohyperaldosteronism, hypertensive crisis, hypokalemia, cardiac arrhythmias, and cardiac arrest. Doses of 20 grams or more of licorice products, containing at least 400 mg glycyrrhizin, are more likely to cause these effects; however, smaller amounts have also caused hypokalemia and associated symptoms when taken for months to years (781,3252,15590,15592,15594,15596,15597,15599,15600,16058)(59731,59740,59752,59785,59786,59787,59792,59795,59805,59811)(59816,59818,59820,59822,59826,59828,59849,59850,59851,59867)(59882,59885,59888,59889,59895,59900,59906,97213,110305). In patients with hypertension, cardiovascular or kidney conditions, or a high salt intake, as little as 5 grams of licorice product or 100 mg glycyrrhizin daily can cause severe adverse effects (15589,15593,15598,15600,59726).
PREGNANCY: UNSAFE
when used orally.
Licorice has abortifacient, estrogenic, and steroid effects. It can also cause uterine stimulation. Heavy consumption of licorice, equivalent to 500 mg of glycyrrhizin per week (about 250 grams of licorice per week), during pregnancy seems to increase the risk of delivery before gestational age of 38 weeks (7619,10618). Furthermore, high intake of glycyrrhizin, at least 500 mg per week, during pregnancy is associated with increased salivary cortisol levels in the child by the age of 8 years. This suggests that high intake of licorice during pregnancy may increase hypothalamic-pituitary-adrenocortical axis activity in the child (26434); avoid using.
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately, short-term. A specific product containing magnolia extract and phellodendron extract (Relora, Next Pharmaceuticals, Inc.) has been used with apparent safety in clinical trials at a dose of 250 mg two to three times daily for up to 6 weeks (14349,34246,94904). ...when used topically in a toothpaste for up to 6 months (92464).
PREGNANCY: UNSAFE
when the magnolia flower bud is used orally due to reports of uterine stimulant activity (11953).
There is insufficient reliable information available about the safety of using magnolia bark during pregnancy; avoid using.
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately. Schisandra extract up to 1 gram daily has been used for up to 12 weeks with apparent safety (12,96632,105562,105563).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Some evidence suggests schisandra fruit is a uterine stimulant (11).
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY UNSAFE ...when used orally in excessive amounts. Schizonepeta contains pulegone, a known hepatotoxin (12620,12626).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY UNSAFE ...when the seeds and seedlings of Siberian cocklebur are used orally. Fatalities have been reported (27827,27828). There is insufficient reliable information available about the safety of Siberian cocklebur fruit when used orally for medicinal purposes in adults.
CHILDREN: POSSIBLY UNSAFE
when the fruit of Siberian cocklebur is used orally.
A case report describes fatal poisoning in a 20-month old child given Siberian cocklebur fruit over a 2-month period (27815).
CHILDREN: LIKELY UNSAFE
when the seeds and seedlings of Siberian cocklebur are used orally.
Fatalities and liver failure necessitating liver transplant have been reported (27827,27828,99948).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when the seeds and seedlings of Siberian cocklebur are used orally (27827,27828).
Below is general information about the interactions of the known ingredients contained in the product Bi Yan Pian. 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 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, licorice might reduce the effects of antihypertensive drugs.
 Details
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Theoretically, licorice might reduce the effects of cisplatin.
Details
In animal research, licorice diminished the therapeutic efficacy of cisplatin (59763).
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Theoretically, concomitant use of licorice and corticosteroids might increase the side effects of corticosteroids.
Details
Case reports suggest that concomitant use of licorice and oral corticosteroids, such as hydrocortisone, can potentiate the duration of activity and increase blood levels of corticosteroids (3252,12672,20040,20042,48429,59756). Additionally, in one case report, a patient with neurogenic orthostatic hypertension stabilized on fludrocortisone 0.1 mg twice daily developed pseudohyperaldosteronism after recent consumption of large amounts of black licorice (108568).
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Theoretically, licorice might increase levels of drugs metabolized by CYP2B6.
Details
In vitro research shows that licorice extract and glabridin, a licorice constituent, inhibit CYP2B6 isoenzymes (10300,94822). Licorice extract from the species G. uralensis seems to inhibit CYP2B6 isoenzymes to a greater degree than G. glabra extract in vitro (94822). Theoretically, these species of licorice might increase levels of drugs metabolized by CYP2B6; however, these interactions have not yet been reported in humans.
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Theoretically, licorice might increase levels of drugs metabolized by CYP2C19.
Details
In vitro, licorice extracts from the species G. glabra and G. uralensis inhibit CYP2C19 isoenzymes in vitro (94822). Theoretically, these species of licorice might increase levels of drugs metabolized by CYP2C19; however, this interaction has not yet been reported in humans.
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Theoretically, licorice might increase levels of drugs metabolized by CYP2C8.
Details
In vitro, licorice extract from the species G. glabra and G. uralensis inhibits CYP2C8 isoenzymes (94822). Theoretically, these species of licorice might increase levels of drugs metabolized by CYP2C8; however, this interaction has not yet been reported in humans.
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Theoretically, licorice might increase or decrease levels of drugs metabolized by CYP2C9.
Details
There is conflicting evidence about the effect of licorice on CYP2C9 enzyme activity. In vitro research shows that extracts from the licorice species G. glabra and G. uralensis moderately inhibit CYP2C9 isoenzymes (10300,94822). However, evidence from an animal model shows that licorice extract from the species G. uralensis can induce hepatic CYP2C9 activity (14441). Until more is known, licorice should be used cautiously in people taking CYP2C9 substrates.
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Theoretically, licorice might increase or decrease levels of drugs metabolized by CYP3A4.
Details
Pharmacokinetic research shows that the licorice constituent glycyrrhizin, taken in a dosage of 150 mg orally twice daily for 14 days, modestly decreases the area under the concentration-time curve of midazolam by about 20%. Midazolam is a substrate of CYP3A4, suggesting that glycyrrhizin modestly induces CYP3A4 activity (59808). Animal research also shows that licorice extract from the species G. uralensis induces CYP3A4 activity (14441). However, licorice extract from G. glabra species appear to inhibit CYP3A4-induced metabolism of testosterone in vitro. It is thought that the G. glabra inhibits CYP3A4 due to its constituent glabridin, which is a moderate CYP3A4 inhibitor in vitro and not present in other licorice species (10300,94822). Until more is known, licorice should be used cautiously in people taking CYP3A4 substrates.
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Theoretically, concomitant use of licorice with digoxin might increase the risk of cardiac toxicity.
Details
Overuse or misuse of licorice with cardiac glycoside therapy might increase the risk of cardiac toxicity due to potassium loss (10393).
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Theoretically, concomitant use of licorice with diuretic drugs might increase the risk of hypokalemia.
Details
Overuse of licorice might compound diuretic-induced potassium loss (10393,20045,20046,59812). In one case report, a 72-year-old male with a past medical history of hypertension, type 2 diabetes, hyperlipidemia, arrhythmia, stroke, and hepatic dysfunction was hospitalized with severe hypokalemia and uncontrolled hypertension due to pseudohyperaldosteronism. This was thought to be provoked by concomitant daily consumption of a product containing 225 mg of glycyrrhizin, a constituent of licorice, and hydrochlorothiazide 12.5 mg for 1 month (108577).
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Theoretically, licorice might increase or decrease the effects of estrogen therapy.
Details
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Theoretically, loop diuretics might increase the mineralocorticoid effects of licorice.
Details
Theoretically, loop diuretics might enhance the mineralocorticoid effects of licorice by inhibiting the enzyme that converts cortisol to cortisone; however, bumetanide (Bumex) does not appear to have this effect (3255).
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Theoretically, licorice might increase levels of methotrexate.
Details
Animal research suggests that intravenous administration of glycyrrhizin, a licorice constituent, and high-dose methotrexate may delay methotrexate excretion and increase systemic exposure, leading to transient elevations in liver enzymes and total bilirubin (108570). This interaction has not yet been reported in humans.
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Theoretically, licorice might decrease levels of midazolam.
Details
In humans, the licorice constituent glycyrrhizin appears to moderately induce the metabolism of midazolam (59808). This is likely due to induction of cytochrome P450 3A4 by licorice. Until more is known, licorice should be used cautiously in people taking midazolam.
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Theoretically, licorice might decrease the absorption of P-glycoprotein substrates.
Details
In vitro research shows that licorice can increase P-glycoprotein activity (104561).
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Theoretically, licorice might decrease plasma levels and clinical effects of paclitaxel.
Details
Multiple doses of licorice taken concomitantly with paclitaxel might reduce the effectiveness of paclitaxel. Animal research shows that licorice 3 grams/kg given orally for 14 days before intravenous administration of paclitaxel decreases the exposure to paclitaxel and increases its clearance. Theoretically, this occurs because licorice induces cytochrome P450 3A4 enzymes, which metabolize paclitaxel. Notably, a single dose of licorice did not affect exposure or clearance of paclitaxel (102959).
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Theoretically, licorice might decrease plasma levels and clinical effects of warfarin.
Details
Licorice seems to increase metabolism and decrease levels of warfarin in animal models. This is likely due to induction of cytochrome P450 2C9 (CYP2C9) metabolism by licorice (14441). Advise patients taking warfarin to avoid taking licorice.
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Theoretically, magnolia might have additive effects and increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.
Details
In vitro research shows that the chemicals magnolol and honokiol, isolated from magnolia bark, inhibit platelet aggregation that is experimentally induced by collagen and arachidonic acid. However, they do not inhibit platelet aggregation that is induced by adenosine diphosphate, platelet-activating factor, or thrombin (18273). This interaction has not been reported in humans.
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Theoretically, concomitant use of large doses of magnolia bark and CNS depressants might have additive effects.
Details
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Theoretically, schisandra might increase the levels and clinical effects of cyclophosphamide.
Details
In vitro research shows that schisandra increases the concentration of cyclophosphamide, likely through inhibition of cytochrome P450 3A4. After multiple doses of the schisandra constituents schisandrin A and schisantherin A, the maximum concentration of cyclophosphamide was increased by 7% and 75%, respectively, while the overall exposure to cyclophosphamide was increased by 29% and 301%, respectively (109636).
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Schisandra can increase the levels and clinical effects of cyclosporine.
Details
A small observational study in children with aplastic anemia found that taking schisandra with cyclosporine increased cyclosporine trough levels by 93% without increasing the risk of adverse events. However, the dose of cyclosporine was reduced in 9% of children to maintain appropriate cyclosporine blood concentrations (109637).
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Theoretically, schisandra might increase the levels and clinical effects of CYP2C19 substrates.
Details
In vitro research shows that schisandra inhibits CYP2C19, and animal research shows that schisandra increases the concentration of voriconazole, a CYP2C19 substrate (105566). Theoretically, schisandra may also inhibit the metabolism of other CYP2C19 substrates. This effect has not been reported in humans.
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Theoretically, schisandra might decrease the levels and clinical effects of CYP2C9 substrates.
Details
In vitro and animal research suggests that schisandra induces CYP2C9 enzymes (14441). This effect has not been reported in humans.
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Schisandra can increase the levels and clinical effects of drugs metabolized by CYP3A4.
Details
Most clinical and laboratory research shows that schisandra, administered either as a single dose or up to twice daily for 14 days, inhibits CYP3A4 and increases the concentration of CYP3A4 substrates such as cyclophosphamide, midazolam, tacrolimus, and talinolol (13220,17414,23717,91386,91388,91387,96631,105564,109636,109638,109639,109640,109641). Although one in vitro and animal study shows that schisandra may induce CYP3A4 metabolism (14441), this effect appears to be overpowered by schisandra's CYP3A4 inhibitory activity and has not been reported in humans.
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Schisandra can increase the levels and clinical effects of midazolam.
Details
A small pharmacokinetic study in healthy adults shows that taking schisandra extract (Hezheng Pharmaceutical Co.) containing deoxyschizandrin 33.75 mg twice daily for 8 days and a single dose of midazolam 15 mg on day 8 increases the overall exposure to midazolam by about 119%, increases the peak plasma level of midazolam by 86%, and decreases midazolam clearance by about 52%. This effect has been attributed to inhibition of CYP3A4 by schisandra (91388).
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Schisandra might increase the levels and clinical effects of P-glycoprotein substrates.
Details
In vitro research shows that schisandra extracts and constituents such as schisandrin B inhibit P-glycoprotein mediated efflux in intestinal cells and in P-glycoprotein over-expressing cell lines (17414,105643,105644). Additionally, a small clinical study shows that schisandra increases the peak concentration and overall exposure to talinolol, a P-glycoprotein probe substrate (91386). Theoretically, schisandra might inhibit the efflux of other P-glycoprotein substrates.
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Schisandra can increase the levels and clinical effects of sirolimus.
Details
A small pharmacokinetic study in healthy volunteers shows that taking 3 capsules of schisandra (Hezheng Pharmaceutical Company) containing a total of 33.75 mg deoxyschizandrin twice daily for 13 days and then taking a single dose of sirolimus 2 mg increases the overall exposure and peak level of sirolimus by two-fold. This effect is thought to be due to inhibition of cytochrome P450 3A4 by schisandra, as well as possible inhibition of the P-glycoprotein drug transporter (105643).
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Schisandra can increase the levels and clinical effects of tacrolimus.
Details
Clinical research in healthy volunteers and transplant patients shows that taking schisandra with tacrolimus increases tacrolimus peak levels by 183% to 268%, increases overall exposure to tacrolimus by 126% to 343%, and decreases tacrolimus clearance by 48% to 73%. This effect is thought to be due to inhibition of CYP3A4 by schisandra, and possibly also inhibition of the P-glycoprotein drug transporter. It may also be related to the inhibition of CYP3A5 in people who are CYP3A5 expressors. Small clinical studies show that schisandra increases tacrolimus levels in both expressors and non-expressors of CYP3A5 (15570,17414,91387,96631,105623,109639,109641). However, some clinical and observational research shows that schisandra increases tacrolimus levels to a greater degree in CYP3A5 expressors when compared with CYP3A5 non-expressors (109638,109640). Animal research suggests that the greatest increase in tacrolimus levels occurs when schisandra is taken either concomitantly or up to 2 hours before tacrolimus (105564).
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Schisandra can increase the levels and clinical effects of talinolol.
Details
A small pharmacokinetic study in healthy volunteers shows that taking schisandra extract 300 mg twice daily for 14 days with a single dose of talinolol 100 mg on day 14 increases the peak talinolol level by 51% and the overall exposure to talinolol by 47%. This effect is thought to be due to the possible inhibition of cytochrome P450 3A4 and P-glycoprotein by schisandra (91386).
tly.
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Theoretically, schisandra might increase the levels and clinical effects of voriconazole.
Details
Animal research shows that oral schisandra given daily for 1 or 14 days increases levels of intravenously administered voriconazole, a cytochrome P450 (CYP) 2C19 substrate. This effect is thought to be due to inhibition of CYP2C19 by schisandra (105566). However, this interaction has not been reported in humans.
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Theoretically, schisandra might decrease the levels and clinical effects of warfarin.
Details
Animal research suggests that oral schisandra extract, given daily for 6 days, reduces levels of intravenously administered warfarin. This effect might be due to the induction of cytochrome P450 (CYP) 2C9 metabolism by schisandra (14441). However, this interaction has not been reported in humans.
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Animal research suggests that schizonepetin, a monoterpene constituent of schizonepeta, inhibits cytochrome P450 (CYP) 1A2 (94787). Theoretically, schizonepeta might increase the effects and side effects of CYP1A2 substrates.
Details
Some substrates of CYP1A2 include clozapine (Clozaril), cyclobenzaprine (Flexeril), fluvoxamine (Luvox), haloperidol (Haldol), imipramine (Tofranil), mexiletine (Mexitil), olanzapine (Zyprexa), pentazocine (Talwin), propranolol (Inderal), tacrine (Cognex), theophylline, zileuton (Zyflo), zolmitriptan (Zomig), and others.
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Animal research suggests that schizonepetin, a monoterpene constituent of schizonepeta, inhibits cytochrome P450 (CYP) 2D6 (94787). Theoretically, schizonepeta might increase the effects and side effects of CYP2D6 substrates.
Details
Some substrates of CYP2D6 include amitriptyline (Elavil), codeine, desipramine (Norpramin), flecainide (Tambocor), haloperidol (Haldol), imipramine (Tofranil), metoprolol (Lopressor, Toprol XL), ondansetron (Zofran), paroxetine (Paxil), risperidone (Risperdal), tramadol (Ultram), venlafaxine (Effexor), and others.
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Animal research suggests that schizonepetin, a monoterpene constituent of schizonepeta, inhibits cytochrome P450 (CYP) 2E1 (94787). Theoretically, schizonepeta might increase the effects and side effects of CYP2E1 substrates.
Details
Some substrates of CYP2E1 include acetaminophen, chlorzoxazone (Parafon Forte), ethanol, theophylline, and anesthetics such as enflurane (Ethrane), halothane (Fluothane), isoflurane (Forane), and methoxyflurane (Penthrane).
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Animal research suggests that schizonepetin, a monoterpene constituent of schizonepeta, induces cytochrome P450 (CYP) 3A4 (94787). Theoretically, schizonepeta might decrease the effects of CYP3A4 substrates.
Details
Some substrates of CYP3A4 include lovastatin (Mevacor), ketoconazole (Nizoral), itraconazole (Sporanox), fexofenadine (Allegra), triazolam (Halcion), and numerous others.
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Siberian cocklebur seedlings and seeds have caused severe hypoglycemia in humans. Hypoglycemia occurs soon after consumption and worsens with time in most cases (27828,99948). Do not use Siberian cocklebur in people taking medications that also lower blood glucose.
Details
Some antidiabetes drugs include glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, pioglitazone (Actos), rosiglitazone (Avandia), and others.
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Siberian cocklebur can adversely affect the liver. It has been linked to many cases of hepatotoxicity and some cases of liver failure (27827,27828,99948). Theoretically, concomitant use with other potentially hepatotoxic drugs might increase the risk of developing liver damage. Some of these drugs include acarbose (Precose, Prandase), amiodarone (Cordarone), atorvastatin (Lipitor), azathioprine (Imuran), carbamazepine (Tegretol), cerivastatin (Baycol), diclofenac (Voltaren), felbamate (Felbatol), fenofibrate (TriCor), fluvastatin (Lescol), gemfibrozil (Lopid), isoniazid, itraconazole, (Sporanox), ketoconazole (Nizoral), leflunomide (Arava), lovastatin (Mevacor), methotrexate (Rheumatrex), nevirapine (Viramune), niacin, nitrofurantoin (Macrodantin), pioglitazone (Actos), pravastatin (Pravachol), pyrazinamide, rifampin (Rifadin), ritonavir (Norvir), rosiglitazone (Avandia), simvastatin (Zocor), tacrine (Cognex), tamoxifen, terbinafine (Lamisil), valproic acid, and zileuton (Zyflo).
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Siberian cocklebur can adversely affect the kidney (27828,99948). Theoretically, combining Siberian cocklebur with potentially nephrotoxic drugs might have additive harmful effects on kidney function.
Details
Some potentially nephrotoxic drugs include cyclosporine (Neoral, Sandimmune); aminoglycosides including amikacin (Amikin), gentamicin (Garamycin, Gentak, others), and tobramycin (Nebcin, others); nonsteroidal anti-inflammatory drugs (NSAIDs) including ibuprofen (Advil, Motrin, Nuprin, others), indomethacin (Indocin), naproxen (Aleve, Anaprox, Naprelan, Naprosyn), piroxicam (Feldene); and numerous others.
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Below is general information about the adverse effects of the known ingredients contained in the product Bi Yan Pian. 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, Angelica archangelica is generally well tolerated in food amounts.
There is limited information available about the adverse effects of Angelica archangelica when used as medicine.
Most Common Adverse Effects:
Orally: Constipation, photosensitivity.
Dermatologic ...Orally or topically, Angelica archangelica might cause photosensitivity reactions (13406). Patients who take Angelica archangelica orally or apply it topically should be advised to avoid prolonged exposure to the sun. Some constituents of the leaves have a strong irritant effect on the skin and mucous membranes, referred to as "angelica dermatitis" (18).
Gastrointestinal ...Orally, Angelica archangelica has been reported to cause constipation in one out of 21 patients taking a specific Angelica archangelica leaf extract (SagaPro, SagaMedica) (92461).
General
...There is currently a limited amount of information on the adverse effects of chrysanthemum.
A thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Topically: Allergic reactions, contact dermatitis, eczema, urticaria.
Serious Adverse Effects (Rare):
Topically: Asthma.
Immunologic ...Topically and via occupational exposure, chrysanthemum can cause allergic reactions. Chrysanthemum allergy symptoms can include urticaria, contact dermatitis, eczema, actinic reticuloid photosensitivity dermatitis, pollinosis, rhinoconjunctivitis, and asthma (5552,5554,5556,5557,6958,42842,42845,42849,42859,42867,42893,42872,42873,42874)(42879,42880,42881,42882,42883,42887,42888). There are numerous case reports and studies showing that allergies to Chrysanthemum are very common, with an estimated 60% of Europeans being allergic (19149,42847,42856,42854).
General ...Adverse effects of forsythia have not been reported. However, a thorough evaluation of safety outcomes has not been conducted.
General
...Orally, licorice is generally well tolerated when used in amounts commonly found in foods.
It seems to be well tolerated when licorice products that do not contain glycyrrhizin (deglycyrrhizinated licorice) are used orally and appropriately for medicinal purposes or when used topically, short-term.
Most Common Adverse Effects:
Orally: Headache, nausea, and vomiting.
Topically: Contact dermatitis.
Intravenously: Diarrhea, itching, nausea, and rash.
Serious Adverse Effects (Rare):
Orally: Case reports have raised concerns about acute renal failure, cardiac arrest, cardiac arrhythmias, hypertension, hypokalemia, muscle weakness, paralysis, pseudohyperaldosteronism, and seizure associated with long-term use or large amounts of licorice containing glycyrrhizin.
Cardiovascular
...Orally, excessive licorice ingestion can lead to pseudohyperaldosteronism, which can precipitate cardiovascular complications such as hypertension and hypertensive crisis, ventricular fibrillation or tachycardia, sinus pause, and cardiac arrest.
These effects are due to the licorice constituent glycyrrhizin and usually occur when 20-30 grams or more of licorice product is consumed daily for several weeks (781,15590,15592,15594,15596,15597,15599,15600,16835,97213) (104563,108574,108576,110305,112234). In one case report, an 89-year-old female taking an herbal medicine containing licorice experienced a fatal arrhythmia secondary to licorice-induced hypokalemia. The patient presented to the hospital with recurrent syncope, weakness, and fatigue for 5 days after taking an herbal medicine containing licorice for 2 months. Upon admission to the hospital, the patient developed seizures, QT prolongation, and ventricular arrhythmia requiring multiple defibrillations. Laboratory tests confirmed hypokalemia and pseudohyperaldosteronism (112234).
However, people with cardiovascular or kidney conditions may be more sensitive, so these adverse events may occur with doses as low as 5 grams of licorice product or glycyrrhizin 100 mg daily (15589,15593,15598,15600,59726). A case report in a 54-year-old male suggests that malnutrition might increase the risk of severe adverse effects with excessive licorice consumption. This patient presented to the emergency room with cardiac arrest and ventricular fibrillation after excessive daily consumption of licorice for about 3 weeks. This caused pseudohyperaldosteronism and then hypokalemia, leading to cardiovascular manifestations. In spite of resuscitative treatment, the patient progressed to kidney failure, refused dialysis, and died shortly thereafter (103791).
Dermatologic
...There have been reports of contact allergy, resulting in an itchy reddish eruption, occurring in patients that applied cosmetic products containing oil-soluble licorice extracts (59912).
There have also been at least 3 cases of allergic contact dermatitis reported with the topical application of glycyrrhizin-containing products to damaged skin. In one case report, a 31-year-old female with acne presented with a 2-year history of pruritic erythematous-scaly plaques located predominantly on the face and neck after the use of a cosmetic product containing licorice root extract 1%. The patient had a positive skin patch test to licorice root extract, leading the clinicians to hypothesize that the use of benzoyl peroxide, a strong irritant, might have sensitized the patient to licorice (108578). Burning sensation, itching, redness, and scaling were reported rarely in patients applying a combination of licorice, calendula, and snail secretion filtrate to the face. The specific role of licorice is unclear (110322).
In rare cases, the glycyrrhizin constituent of licorice has caused rash and itching when administered intravenously (59712).
Endocrine
...Orally, excessive licorice ingestion can cause a syndrome of apparent mineralocorticoid excess, or pseudohyperaldosteronism, with sodium and water retention, increased urinary potassium loss, hypokalemia, and metabolic alkalosis due to its glycyrrhizin content (781,10619,15591,15592,15593,15594,15595,15596,15597,15598)(15600,16057,16835,25659,25660,25673,25719,26439,59818,59822)(59832,59864,91722,104563,108568,108574,110305,112234).
These metabolic abnormalities can lead to hypertension, edema, EKG changes, fatigue, syncope, arrhythmias, cardiac arrest, headache, lethargy, muscle weakness, dropped head syndrome (DHS), rhabdomyolysis, myoglobinuria, paralysis, encephalopathy, respiratory impairment, hyperparathyroidism, and acute kidney failure (10393,10619,15589,15590,15593,15594,15596,15597,15599)(15600,16057,16835,25660,25673,25719,26439,31562,59709,59716)(59720,59740,59787,59820,59826,59882,59889,59900,91722,97214,100522) (104563,108576,108577). These effects are most likely to occur when 20-30 grams of licorice products containing glycyrrhizin 400 mg or more is consumed daily for several weeks (781,15590,15592,15594,15596,15597,15599,15600,16835,108574). However, some people may be more sensitive, especially those with hypertension, diabetes, heart problems, or kidney problems (15589,15593,15598,15600,59726,108576,108577) and even low or moderate consumption of licorice may cause hypertensive crisis or hypertension in normotensive individuals (1372,97213). The use of certain medications with licorice may also increase the risk of these adverse effects (108568,108577). One case report determined that the use of large doses of licorice in an elderly female stabilized on fludrocortisone precipitated hypokalemia and hypertension, requiring inpatient treatment (108568). Another case report describes severe hypokalemia necessitating intensive care treatment due to co-ingestion of an oral glycyrrhizin-specific product and hydrochlorothiazide for 1 month (108577). Glycyrrhetinic acid has a long half-life, a large volume of distribution, and extensive enterohepatic recirculation. Therefore, it may take 1-2 weeks before hypokalemia resolves (781,15595,15596,15597,15600). Normalization of the renin-aldosterone axis and blood pressure can take up to several months (781,15595,108568). Treatment typically includes the discontinuation of licorice, oral and intravenous potassium supplementation, and short-term use of aldosterone antagonists, such as spironolactone (108574,108577).
Chewing tobacco flavored with licorice has also been associated with toxicity. Chewing licorice-flavored tobacco, drinking licorice tea, or ingesting large amounts of black licorice flavored jelly beans or lozenges has been associated with hypertension and suppressed renin and aldosterone levels (12671,12837,97214,97215,97217,108574). One case report suggests that taking a combination product containing about 100 mg of licorice and other ingredients (Jintan, Morishita Jintan Co.) for many decades may be associated with hypoaldosteronism, even up to 5 months after discontinuation of the product (100522). In another case report, licorice ingestion led to hyperprolactinemia in a female (59901). Licorice-associated hypercalcemia has also been noted in a case report (59766).
Gastrointestinal ...Nausea and vomiting have been reported rarely following oral use of deglycyrrhizinated licorice (25694,59871). Intravenously, the glycyrrhizin constituent of licorice has rarely caused gastric discomfort, diarrhea, or nausea (59712,59915).
Immunologic ...There have been reports of contact allergy, resulting in an itchy reddish eruption, occurring in patients that applied cosmetic products containing oil-soluble licorice extracts (59912). There have also been at least 3 cases of allergic contact dermatitis reported with the topical application of glycyrrhizin-containing products to damaged skin. In one case report, a 31-year-old female with acne presented with a 2-year history of pruritic erythematous-scaly plaques located predominantly on the face and neck after the use of a cosmetic product containing licorice root extract 1%. The patient had a positive skin patch test to licorice root extract, leading the clinicians to hypothesize that the use of benzoyl peroxide, a strong irritant, might have sensitized the patient to licorice (108578).
Musculoskeletal ...In a case report, excessive glycyrrhizin-containing licorice consumption led to water retention and was thought to trigger neuropathy and carpal tunnel syndrome (59791).
Neurologic/CNS ...Orally, licorice containing larger amounts of glycyrrhizin may cause headaches. A healthy woman taking glycyrrhizin 380 mg daily for 2 weeks experienced a headache (59892). Intravenously, the glycyrrhizin constituent of licorice has rarely caused headaches or fatigue (59721). In a case report, licorice candy ingestion was associated with posterior reversible encephalopathy syndrome accompanied by a tonic-clonic seizure (97218).
Ocular/Otic ...Orally, consuming glycyrrhizin-containing licorice 114-909 grams has been associated with transient visual loss (59714).
Pulmonary/Respiratory ...Orally, large amounts of licorice might lead to pulmonary edema. In one case report, a 64-year old male consumed 1020 grams of black licorice (Hershey Twizzlers) containing glycyrrhizin 3.6 grams over 3 days, which resulted in pulmonary edema secondary to pseudohyperaldosteronism (31561). Intravenously, the glycyrrhizin constituent of licorice has caused cold or flu-like symptoms, although these events are not common (59712,59721).
General
...Orally, magnolia seems to be well tolerated.
Most Common Adverse Effects:
Topically: Contact dermatitis.
Dermatologic ...Topically, magnolia bark has been associated with reports of allergic contact dermatitis (92463,92468,95030,110709). In several cases, the use of anti-aging facial creams containing magnolia bark extract was associated with allergic contact dermatitis of the face (92463,92468,95030). In one case, the use of a vaginal gel containing magnolia bark extract was associated with allergic contact dermatitis of the vulva (110709). Symptoms typically resolve with the use of topical corticosteroids and discontinuation of magnolia bark extract (95030,110709). Patch testing suggests that the magnolia bark extract constituents magnolol and honokiol are responsible for this adverse effect (110709).
Endocrine ...In a clinical trial of an oral combination product containing extracts of magnolia and phellodendron, one patient reported thyroid dysfunction (14349). However, it's not known if this side effect is related to magnolia or some other factor.
Gastrointestinal ...In a clinical trial of an oral combination product containing extracts of magnolia and phellodendron, one patient reported heartburn (14349). However, it's not known if this side effect is related to magnolia or some other factor.
Neurologic/CNS ...In a clinical trial of an oral combination product containing extracts of magnolia and phellodendron, one patient reported shaking hands and perilabial numbness. Another patient reported fatigue and headache (14349). However, it's not known if these side effects are related to magnolia or some other factor.
Psychiatric ...In a clinical trial of an oral combination product containing extracts of magnolia and phellodendron, one patient reported sexual dysfunction (14349). However, it's not known if this side effect is related to magnolia or some other factor.
General
...Orally, schisandra seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Decreased appetite, heartburn, stomach upset, and urticaria.
Dermatologic ...Orally, schisandra can cause urticaria in some patients (11).
Gastrointestinal ...Orally, schisandra can cause heartburn, decreased appetite, and stomach upset (11).
General
...There is currently a limited amount of information available about the adverse effects of schizonepeta.
Orally, a specific combination product (Zemaphyte, Phytopharm Plc) containing schizonepeta and numerous other ingredients has been reported to cause nausea, vomiting, colic, dyspepsia, dizziness, headache, and hair loss (12627,12630). However, it is unclear if these effects are due to schizonepeta or the other ingredients.
High doses of schizonepeta may be hepatotoxic due to its pulegone constituent (12620,12626).
Gastrointestinal ...Orally, a specific combination product (Zemaphyte, Phytopharm Plc) containing schizonepeta and numerous other ingredients has been reported to cause nausea, vomiting, colic, and dyspepsia (12627,12630). However, it is unclear if these effects are due to schizonepeta or the other ingredients.
Hepatic ...Schizonepeta contains pulegone, a hepatotoxin. When taken orally in high doses, schizonepeta may be hepatotoxic due to this constituent (12620,12626).
Neurologic/CNS ...Orally, a specific combination product (Zemaphyte, Phytopharm Plc) containing schizonepeta and numerous other ingredients has been reported to cause dizziness and headache (12627,12630). However, it is unclear if these effects are due to schizonepeta or the other ingredients.
General ...Siberian cocklebur is generally regarded as unsafe for use. Any benefits of therapy might not outweigh the risk of toxicity. Orally, Siberian cocklebur seeds and seedlings can cause various adverse effects. Initial effects include abdominal pain, nausea, vomiting, hypoglycemia, elevated liver function tests, increased risk of bleeding, drowsiness, dizziness, dyspnea, sweating, fever, and palpitations (27827,27828,99948). In some cases, symptoms have progressed to metabolic acidosis, worsening changes in blood sugar, arrhythmia, seizures, convulsions, coma, pancreatitis, hepatic failure, renal failure, myocardial and muscle injury, and death due to multi-organ failure (27827,27828,99948). Fatal hepatic failure due to the Siberian cocklebur fruit has also been reported in a 20-month old child (27815).
Cardiovascular ...Orally, Siberian cocklebur seed can cause both tachycardia and bradycardia (27828,99948). Palpitations can occur in as little as 3 hours after ingestion, with arrhythmia occurring a few hours later (27828). Elevated heart enzymes can also occur soon after intake (27828). White blood cell infiltration in the myocardium has been reported in autopsy findings from patients who died after consuming Siberian cocklebur (27828).
Endocrine ...Orally, Siberian cocklebur seedlings and seeds can cause hypoglycemia. This occurs soon after consumption. Later, metabolic acidosis, hyperglycemia, and/or worsening hypoglycemia might occur. In some individuals, these changes can cause seizures (27828,99948).
Gastrointestinal ...Orally, Siberian cocklebur seedlings and seeds can cause abdominal pain, nausea, and vomiting. Gastrointestinal symptoms occur within a few hours after consumption (27827,27828,99948). In one case, pancreatitis occurred approximately 2 days after intake of the seeds in a 15-year-old girl (99948).
Hematologic ...Orally, Siberian cocklebur seedlings and seeds can increase the risk of bleeding, mainly due to hepatotoxic effects (27828).
Hepatic
...Orally, Siberian cocklebur seedlings and seeds can cause liver damage, including increased bilirubin levels and increases in liver enzyme levels by as much as 6 times the normal value.
These symptoms can progress to include jaundice, hepatomegaly, and edema, resulting in liver failure and death in some patients (27827,27828,99948). In one case, grade 3 encephalopathy and liver failure necessitated a liver transplant in a 15-year-old girl who had consumed approximately 80 Siberian cocklebur seeds (27815,99948).
The Siberian cocklebur fruit has also been reported to cause fatal hepatic failure in a 20-month old child who consumed Siberian cocklebur fruit over a 2-month period (27815)
Musculoskeletal ...Orally, Siberian cocklebur seedlings and seeds can cause rhabdomyolysis (27828). White blood cell infiltration in the muscles has been reported in autopsy findings from patients who died after consuming Siberian cocklebur (27828).
Neurologic/CNS ...Orally, Siberian cocklebur seedlings and seeds can cause altered mental status, malaise, dizziness, sweating, fever, seizures, convulsions, unconsciousness, and coma (27827,27828,99948). Malaise, dizziness, and sweating onset are rapid (27828). Fever onset is usually after the onset of vomiting (27827). Unconsciousness can follow vomiting within minutes or hours, with coma occurring later in some individuals (27827,27828). Microvascular hemorrhage in the brain has been reported in autopsy findings for patients who died after consuming Siberian cocklebur (27828).
Pulmonary/Respiratory ...Orally, Siberian cocklebur seedlings and seeds can cause dyspnea and irregular breathing. White blood cell infiltration in the lungs has been reported in autopsy findings from patients who died after consuming Siberian cocklebur (27828).
Renal ...Orally, Siberian cocklebur seedlings and seeds have resulted in cases of renal injury with increased levels of creatinine and blood urea nitrogen. This can result in decreased urine output. In some individuals, renal symptoms return to normal. However, renal failure can occur and renal proximal tubular necrosis has been reported in autopsy findings for patients who died after consuming Siberian cocklebur (27828,99948).
Other
...Orally, Siberian cocklebur can cause death associated with multi-organ failure.
In some cases, death occurred less than 12 hours following intake. In one outbreak of illness related to consumption of Siberian cocklebur seedlings, death occurred in 25% of those affected. In another group of individuals with Siberian cocklebur seed poisoning, death occurred in three of nine of those affected. Death is more likely to occur in young children, especially those less than 15 years of age (27827,27828).
The quantity of Siberian cocklebur associated with death is not clear. In one illness outbreak, deaths were mainly in children and the seedlings were consumed in large quantities due to a food shortage (27827). In another, children died after consuming an unknown quantity of seeds while working on a farm (27828).
