Each tablet contains: Angelica root (Bai Zhi; Angelica Dahurica) 75 mg • Magnolia bud (Xin Ye Hua; Magnolia Flos) 75 mg • Anemarrhena root (Zhi Mu; Anemarrhena Radix) 75 mg • Centipede Plant (Shi Hu Sui; Centepeda Herba) 75 mg • Patchouli Plant (Huo Xiang; Agastach Pogostemi Herba) 75 mg • Liquidambar fruit (Lu Lu Tong; Liquidambar Fructus) 75 mg • Cocklebur fruit (Cang Er Zi; Xanthium Fructus) 75 mg • Sicklepod seed (Ju Ming; Cassia Torre Semen) 37.5 mg • Mint leaf (Bo He; Mentha Herba) 37.5 mg • Siler root (Fang Feng; Ledebouriella Radix) 37.5 mg • Hairy Sage ( Jing Jie ; Schizonepeta Herba) 37.5 mg • Mulberry root bark (Sang Bai Pi; Mori Radices Cortex) 37.5 mg • Tree Peony root bark (Mu Dan Pi; Moutan Radicis Cortex) 37.5 mg.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
Below is general information about the effectiveness of the known ingredients contained in the product Dr. Shen's Allergy. 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
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.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Dr. Shen's Allergy. 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 in medicinal amounts, short-term. An ashitaba extract has been used with apparent safety in doses of 500 mg twice daily for 12 weeks (100594). There is insufficient reliable information available about the safety of ashitaba when used long-term.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally in food amounts. The fruit is commonly used in foods (96981,96982). ...when the leaf is used orally in medicinal amounts, short-term. Black mulberry leaf powder has been used with apparent safety at a dose of 250 mg daily for up to 60 days (103280).
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 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. Noni juice has been used in doses of up to 200 mL daily with apparent safely in small clinical studies for up to 3 months (11944,17169,65173). However, there have been several case reports of increased liver enzymes and hepatotoxicity in people taking some noni products (13107,14341,14468,17170,17171,17172). In three reports, hepatotoxicity was linked to a specific brand of noni juice (Tahitian Noni Juice, Tahitian Noni International) (14341,17171). It is unclear if potential contaminants or hypersensitivity reactions may be the cause of these events. More evidence is needed to determine if noni increases the risk for hepatotoxicity. There is insufficient reliable information available about the safety of noni fruit extract when used orally or the safety of noni when used topically.
PREGNANCY AND LACTATION:
While animal research is conflicting on the teratogenic effects of noni (65205,65206), there is insufficient reliable information available about the safety of noni in humans; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Patchouli oil has Generally Recognized As Safe (GRAS) status for use as a food additive in the US (4912). There is insufficient reliable information available about the safety of patchouli oil when used orally in medicinal amounts or when used topically or by inhalation.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately, short term. Total glucosides of peony has been used with apparent safety in doses of up to 1800 mg daily for up to 12 months (92786,97949,97950,98466,100992,110432,112861,112862). Peony root extract has been used with apparent safety at a dose of 2250 mg daily for up to 3 months (97216). There is insufficient reliable information available about the safety of peony when used orally, topically, or rectally, long-term.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Total glucosides of peony has been used with apparent safety in children 1.5-4 years of age at doses up to 180 mg/kg daily or 1.2 grams daily for up to 12 months (92785). Peony root extract 40 mg/kg daily has also been used with apparent safety in children 1-14 years of age for 4 weeks (106851).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Preliminary research suggests that peony can cause uterine contractions (13400). However, other preliminary research suggests a combination of peony and angelica with or without motherwort, banksias rose, and ligustica, might be safe (11015,48433). Until more is known, avoid use.
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when peppermint oil is used orally, topically, or rectally in medicinal doses. Peppermint oil has been safely used in multiple clinical trials (3801,3804,6190,6740,6741,10075,12009,13413,14467,17681)(17682,68522,96344,96360,96361,96362,96363,96364,96365,99493).
POSSIBLY SAFE ...when peppermint leaf is used orally and appropriately, short-term. There is some clinical research showing that peppermint leaf can be used safely for up to 8 weeks (12724,13413). The long-term safety of peppermint leaf in medicinal doses is unknown. ...when peppermint oil is used by inhalation as aromatherapy (7107). There is insufficient reliable information available about the safety of using intranasal peppermint oil.
CHILDREN: POSSIBLY SAFE
when used orally for medicinal purposes.
Enteric-coated peppermint oil capsules have been used with apparent safety under medical supervision in children 8 years of age and older (4469).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (96361).
There is insufficient information available about the safety of using peppermint in medicinal amounts during pregnancy or lactation; 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).
LIKELY SAFE ...when used orally in amounts commonly found in foods. Storax has Generally Recognized As Safe (GRAS) status for use in foods as a flavoring agent in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts. There are no published reports of toxicity from oral use in medicinal amounts (6). ...when used topically on small areas of skin (18).
POSSIBLY UNSAFE ...when used orally in large amounts. ...when applied to large open wounds. Systemic absorption can cause poisoning including kidney damage (e.g., albuminuria and hemorrhagic nephritis) (18).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Dr. Shen's Allergy. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
In vitro research shows that ashitaba extract inhibits cytochrome P450 (CYP) 1A1 (100593). Theoretically, concomitant use of ashitaba with CYP1A1 substrates might decrease the clearance of these substrates and increase the risk for adverse effects. However, this interaction has yet to be reported in humans. Until more is known, use with caution.
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In vitro research shows that ashitaba extract inhibits cytochrome P450 (CYP) 1A2 (100593). Theoretically, concomitant use of ashitaba with CYP1A2 substrates might decrease the clearance of these substrates and increase the risk for adverse effects. However, this interaction has yet to be reported in humans. Until more is known, use with caution.
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Theoretically, black mulberry leaf might increase the risk of hypoglycemia when taken with antidiabetes drugs.
Details
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Theoretically, black mulberry might inhibit the metabolism of midazolam.
Details
In vitro research shows that black mulberry juice can inhibit midazolam 1'-hydroxylation, a reaction that is catalyzed by cytochrome P450 3A4 (36010). This effect has not been reported in humans.
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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, 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, combining noni and ACE inhibitors might increase the risk of hyperkalemia.
Details
Noni juice contains significant amounts of potassium, about 6 mEq/100 mL juice (1298). This may increase the risk for hyperkalemia when used in conjunction with ACE inhibitors, which can also increase potassium levels.
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Theoretically, combining noni and ARBs might increase the risk of hyperkalemia.
Details
Noni juice contains significant amounts of potassium, about 6 mEq/100 mL juice (1298). This may increase the risk for hyperkalemia when used in conjunction with ARBs, which can also increase potassium levels.
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Theoretically, noni may increase the risk of hypotension when used in combination with antihypertensive drugs.
Details
Preliminary clinical research suggests that drinking noni juice can reduce blood pressure in individuals with hypertension (65231).
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Theoretically, taking noni with hepatotoxic drugs might increase the risk of liver damage.
Details
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Theoretically, taking noni fruit juice concomitantly with phenytoin may lower phenytoin levels and increase the risk of seizures.
Details
In one case report, an adult taking phenytoin for partial seizures experienced low serum phenytoin levels while taking noni juice 90-200 mL daily. Serum phenytoin levels increased after decreasing noni juice consumption; similarly, serum phenytoin levels decreased after increasing noni juice consumption. Some researchers believe noni juice may induce cytochrome P450 2C9 enzymes, which would decrease phenytoin levels, but this has not been well studied. Patients may need additional monitoring when starting or stopping noni juice supplementation (106057).
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Theoretically, combing noni and a potassium-sparing diuretic might increase the risk of hyperkalemia.
Details
Noni juice contains significant amounts of potassium, about 6 mEq/100 mL juice (1298). This may increase the risk for hyperkalemia when used in conjunction with potassium-sparing diuretics, which can also increase potassium levels.
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Taking noni fruit with ranitidine might increase the levels and clinical effects of ranitidine.
Details
Clinical evidence shows that taking an aqueous extract of noni fruit 30 minutes prior to taking a single oral dose of ranitidine can increase the rate of absorption and plasma concentration of ranitidine (23387).
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Theoretically, taking noni juice concomitantly with warfarin might decrease the effectiveness of warfarin.
Details
In one case, a 41-year-old patient stabilized on warfarin had a decreased international normalized ratio (INR) following consumption of a specific commercial noni juice product (Noni juice 4 Everything). While the patient was still taking noni juice, an increase in warfarin dose did not produce an increase in INR (14434). However, it should be noted that this particular product contained extracts and derivatives from more than 115 components, many of which contained vitamin K. Furthermore, vitamin K was listed as a separate ingredient of the product, suggesting that the product was possibly fortified with vitamin K. It has not been verified that noni fruit alone contains a significant amount of vitamin K or interacts with warfarin.
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Theoretically, combining peony with anticoagulant or antiplatelet drugs might increase the risk of bleeding.
Details
In vitro research suggests that peony might have antiplatelet, anticoagulant, and antithrombotic effects (92787).
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Theoretically, peony might increase the levels and clinical effects of clozapine.
Details
In vitro research shows that peony suppresses the metabolism of clozapine via weak-to-moderate inhibitory effects on cytochromes P450 (CYP) 1A2 and CYP3A4 (92790). This effect has not been reported in humans.
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Theoretically, peony might interfere with contraceptive drugs due to competition for estrogen receptors.
Details
In vitro and animal research shows that peony extract has estrogenic activity (100990). Concomitant use might also increase the risk for estrogen-related adverse effects.
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Theoretically, use of peony may increase the levels and clinical effects of drugs metabolized by CYP1A2.
Details
In vitro research shows that peony suppresses the metabolism of clozapine via weak-to-moderate inhibitory effects on CYP1A2 and CYP3A4 (92790). This effect has not been reported in humans.
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Theoretically, use of peony may increase the levels and clinical effects of drugs metabolized by CYP3A4.
Details
In vitro research shows that peony suppresses the metabolism of clozapine via weak-to-moderate inhibitory effects on CYP1A2 and CYP3A4 (92790). This effect has not been reported in humans.
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Theoretically, concomitant use of large amounts of peony might interfere with hormone replacement therapy and/or increase the risk for estrogen-related adverse effects.
Details
In vitro and animal research shows that peony extract has estrogenic activity (100990). Theoretically, peony might compete for estrogen receptors and/or cause additive estrogenic effects.
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Theoretically, peony might reduce the levels and clinical effects of phenytoin.
Details
Animal research shows that taking peony root reduces levels of phenytoin (8657). Some researchers suggest that peony root might affect cytochrome P450 (CYP) 2C9, which metabolizes phenytoin. However, preliminary research in humans shows that peony root does not alter levels of losartan (Cozaar), which is also metabolized by CYP2C9 (11480).
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Theoretically, peppermint oil might increase the levels and adverse effects of cyclosporine.
Details
In animal research, peppermint oil inhibits cyclosporine metabolism and increases cyclosporine levels. Inhibition of cytochrome P450 3A4 (CYP3A4) may be partially responsible for this interaction (11784). An interaction between peppermint oil and cyclosporine has not been reported in humans.
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Theoretically, peppermint might increase the levels of CYP1A2 substrates.
Details
In vitro and animal research shows that peppermint oil and peppermint leaf inhibit CYP1A2 (12479,12734). However, in clinical research, peppermint tea did not significantly affect the metabolism of caffeine, a CYP1A2 substrate. It is possible that the 6-day duration of treatment may have been too short to identify a difference (96359).
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Theoretically, peppermint might increase the levels of CYP2C19 substrates.
Details
In vitro research shows that peppermint oil inhibits CYP2C19 (12479). So far, this interaction has not been reported in humans.
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Theoretically, peppermint might increase the levels of CYP2C9 substrates.
Details
In vitro research shows that peppermint oil inhibits CYP2C9 (12479). So far, this interaction has not been reported in humans.
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Theoretically, peppermint might increase the levels of CYP3A4 substrates.
Details
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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.
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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 Dr. Shen's Allergy. 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 ...No adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
General
...Orally, black mulberry leaf extracts and black mulberry molasses seem to be generally well tolerated.
However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Topically: Contact dermatitis in sensitive individuals.
Dermatologic ...Topically, black mulberry leaf may cause contact dermatitis. A case of lichenoid contact dermatitis was reported in a 68-year-old male who came into contact with black mulberry leaves while picking black mulberries (105799).
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, 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 and topically, noni seems to be generally well tolerated; however, high quality studies of adverse effects have not been conducted.
Most Common Adverse Effects:
Orally: Abdominal discomfort, nausea.
Serious Adverse Effects (Rare)::
Orally: Hepatotoxicity, including liver failure. However, studies have not conclusively identified whether noni, or contaminants in noni products, were responsible for this toxicity.
Gastrointestinal ...Orally, dehydrated noni fruit has been reported to cause nausea and abdominal discomfort (65173).
Hepatic
...Noni has been associated with several cases of hepatotoxicity in previously healthy patients ranging in age from 14 to 62 years (13107,14341,14468,17170,17171,17172).
In two cases, the patients had used a tea or other herbal products containing noni (13107,17172); five had consumed noni juice, specifically Tahitian Noni Juice (Tahitian Noni International) (14341,16648,17171); and two cases involved energy drinks containing several herbal ingredients including noni (17170,90125). Symptoms of liver dysfunction and elevated liver function tests (LFTs) were seen between 2 weeks and 4 months after starting noni. The LFTs started to improve within 2 days of stopping noni and generally normalized within 1 month (13107,14468,17171). Biopsy findings included acute hepatitis, inflammation, hepatocyte necrosis, and hepatocellular cholestasis (14341,17170). One patient, who had a history of prior mild acetaminophen toxicity, had rapidly progressive liver failure after noni ingestion and required transplantation (14341).
Potential product contamination was not ruled out in these case reports. Some researchers theorize that anthraquinones contained in noni could potentially cause hepatotoxicity. Other products containing anthraquinones, such as senna, have been linked to cases of hepatotoxicity. However, analyses of a noni juice product associated with reports of liver damage (Tahitian Noni Juice, Tahitian Noni International) have not detected anthraquinone content (14444). Another analysis of noni fruit puree from which the seeds and skin had been removed had no detectable anthraquinones (92201). However, products containing seed or leaf material had detectable amounts of anthraquinones (92201). The part of the noni plant used might affect hepatotoxicity risk. More evidence is needed to determine if noni causes hepatotoxicity.
General ...No adverse effects have been reported (104776). However, a thorough evaluation of safety outcomes has not been conducted.
General
...Orally, peony seems to be well tolerated when used alone and as part of Chinese herbal formulas.
Most Common Adverse Effects:
Orally: Abdominal distension, anorexia, diarrhea, gastrointestinal discomfort, nausea.
Topically: Dermatitis.
Dermatologic ...Topically, peony has been reported to cause contact dermatitis (13555).
Endocrine ...Orally, a specific traditional Chinese medicine preparation called DDT has been reported to lower follicle-stimulating hormone (FSH) levels and increase estradiol levels. It is not known if this effect is due to peony or the other ingredients (48404). Another specific traditional Chinese medicine preparation, Toki-shakuyaku-san, has been reported to increase plasma progesterone levels in some patients. It is not known if this effect is due to peony or the other ingredients (15294).
Gastrointestinal ...Orally, peony and total glucosides of peony (TGP) have been reported to cause gastrointestinal discomfort, including abdominal distension, anorexia, diarrhea, and nausea, in some patients (13538,92785,97949,98466,100992). In one clinical study, diarrhea was reported in 5% of patients taking TGP 600 mg three times daily for 24 weeks versus 1% of patients taking placebo (100992).
Hematologic ...Orally, there is one case report of easy gum bleeding, epistaxis, and skin bruising with an international normalized ratio (INR) above 6 in a 61-year-old male who was previously stable on warfarin therapy. This patient had switched from one brand of quilinggao, a popular Chinese herbal product, to another brand 5 days prior. This product contained Fritillaria spp. (beimu), Paeonia rubra, Chinese peony (chishao), Lonicera japonica (jinyinhua), and Poncirus trifoliata (jishi). The patient's INR decreased to 1.9 after temporary withdrawal of warfarin therapy. Upon re-initiation of quilinggao, his INR increased to 5.2. It is not known if the increased INR is due to peony or the other ingredients (68343).
General
...Orally, topically, or rectally, peppermint oil is generally well tolerated.
Inhaled,
peppermint oil seems to be well tolerated. Intranasally, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted. Orally, peppermint leaf seems to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, anal burning, belching, diarrhea, dry mouth, heartburn, nausea, and vomiting.
Topically: Burning, dermatitis, irritation, and redness.
Dermatologic
...Topically, peppermint oil can cause skin irritation, burning, erythema, and contact dermatitis (3802,11781,31528,43338,68473,68457,68509,96361,96362).
Also, a case of severe mucosal injury has been reported for a patient who misused an undiluted over the counter mouthwash that contained peppermint and arnica oil in 70% alcohol (19106).
In large amounts, peppermint oil may cause chemical burns when used topically or orally. A case of multiple burns in the oral cavity and pharynx, along with edema of the lips, tongue, uvula, and soft palate, has been reported for a 49-year-old female who ingested 40 drops of pure peppermint oil. Following treatment with intravenous steroids and antibiotics, the patient's symptoms resolved over the course of 2 weeks (68432). Also, a case of chemical burns on the skin and skin necrosis has been reported for a 35-year-old male who spilled undiluted peppermint oil on a previous skin graft (68572). Oral peppermint oil has also been associated with burning mouth syndrome and chronic mouth ulceration in people with contact sensitivity to peppermint (6743). Also, excessive consumption of mint candies containing peppermint oil has been linked to cases of stomatitis (13114).
Gastrointestinal ...Orally, peppermint oil can cause heartburn, nausea and vomiting, anal or perianal burning, abdominal pain, belching, dry mouth, diarrhea, and increased appetite (3803,6740,6741,6742,10075,11779,11789,17682,68497,68514)(68532,68544,96344,96360,102602,104219,107955). Enteric-coated capsules might help to reduce the incidence of heartburn (3802,4469,6740,11777). However, in one clinical study, a specific enteric-coated formulation of peppermint oil (Pepogest; Nature's Way) taken as 180 mg three times daily was associated with a higher rate of adverse effects when compared with placebo (48% versus 31%, respectively). Specifically, of the patients consuming this product, 11% experienced belching and 26% experienced heartburn, compared to 2% and 12%, respectively, in the placebo group (107955). A meta-analysis of eight small clinical studies in patients with irritable bowel syndrome shows that taking enteric-coated formulations of peppermint oil increases the risk of gastroesophageal reflux symptoms by 67% when compared with a control group (109980). Enteric-coated capsules can also cause anal burning in people with reduced bowel transit time (11782,11789).
Genitourinary ...Orally, a sensitive urethra has been reported rarely (102602).
Hepatic ...One case of hepatocellular liver injury has been reported following the oral use of peppermint. Symptoms included elevated liver enzymes, fatigue, jaundice, dark urine, and signs of hypersensitivity. Details on the dosage and type of peppermint consumed were unavailable (96358).
Immunologic ...One case of IgE-mediated anaphylaxis, characterized by sudden onset of lip and tongue swelling, tightness of throat, and shortness of breath, has been reported in a 69-year-old male who consumed peppermint candy (89479). An allergic reaction after use of peppermint oil in combination with caraway oil has been reported in a patient with a history of bronchial asthma (96344). It is not clear if this reaction occurred in response to the peppermint or caraway components.
Neurologic/CNS ...Orally, headache has been reported rarely (102602).
Ocular/Otic ...Orally, peppermint has been reported to cause blurry vision (3803).
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).
General
...There is currently a limited amount of information on the adverse effects of sortax.
A thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Diarrhea.
Topically: Allergic reactions, skin sensitization.
Serious Adverse Effects (Rare):
Topically: Nephrotoxicity.
Dermatologic ...Topically, storax can cause skin sensitization and contact allergies (9,18).
Gastrointestinal ...Orally, storax can cause diarrhea (18).
Renal ...When applied to large, open wounds, systemic absorption of storax can cause kidney damage g., albuminuria and hemorrhagic nephritis) (18).