Ginseng • Deer Horn • Carthamus • millettia • Notoginseng • Common Peony • Common Peony root • Prepared Rehmannia root • Chinese Angelica root • Atractylodes • Goji • Scute • Cyperus • Motherwort • Cnidium • De-glued Antler powder • Ejiao Glue • Corydalis .
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 Female Regularity. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is insufficient reliable information available about the effectiveness of adrue.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of cnidium.
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
Below is general information about the safety of the known ingredients contained in the product Female Regularity. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is insufficient reliable information available about the safety of adrue.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
There is insufficient reliable information available about the safety of atractylodes.
PREGNANCY: POSSIBLY UNSAFE
when used orally.
In animals, atractylodes has caused reproductive toxicity, including fetal death, as well as changes in gestation, growth, and skeletal formation (94304).
LACTATION:
There is insufficient reliable information available about the safety of atractylodes when used during breast-feeding.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Oral Baikal skullcap 0.5-3.52 grams daily has been used with apparent safety for up to 8 weeks (92776,101738,101739,110023). However, a high quality assessment of safety has not been conducted. A specific product (Limbrel, Primus Pharmaceuticals) containing flavocoxid, a mixture of Baikal skullcap flavonoid extract and catechu extract, has been associated with an increased risk for liver and lung injury. In 2017, the US Food and Drug Administration (FDA) formally requested the recall of all non-expired lots of this product (106042). It is unclear if these effects were due to Baikal skullcap, catechu, or the combination. There is insufficient reliable information available about the safety of Baikal skullcap when used intravenously or topically.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
There is insufficient reliable information available about the safety of cnidium.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally, short-term. A specific supplement (Motilitone, Dong-A ST) containing Corydalis yanhusuo extract in combination with Pharbitis seed extract has been used with apparent safety in a dose of 90 mg daily for up to 4 weeks in clinical research (97158,97159,97160). There is insufficient reliable information available about the safety of Corydalis yanhusuo when used orally as a single ingredient.
CHILDREN: LIKELY UNSAFE
when used orally in newborns.
The berberine constituent of Corydalis yanhusuo can cause kernicterus in newborns, particularly preterm neonates with hyperbilirubinemia (2589).
PREGNANCY: LIKELY UNSAFE
when used orally.
Corydalis yanhusuo might promote menstrual flow and stimulate uterine contractions (12). The berberine constituent of Corydalis yanhusuo is thought to cross the placenta and may cause harm to the fetus. Kernicterus has developed in newborn infants exposed to berberine (2589).
LACTATION: LIKELY UNSAFE
when used orally.
The berberine constituent of Corydalis yanhusuo and other harmful constituents can be transferred to the infant through breast milk (2589).
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 goji fruit preparations are used orally and appropriately, short-term. Goji berry whole fruit, boiled or steamed, has been used with apparent safety at a dose of 15 grams daily for 16 weeks (105489). Other goji berry products have also been used with apparent safety in clinical research, including a specific goji fruit juice (GoChi, FreeLife International) 120 mL daily for 30 days (52532), a goji fruit polysaccharide 300 mg daily for 3 months (92117), and a specific milk-based formulation of goji berry (Lacto-Wolfberry, Nestlé Research Center) for 3 months (52539). There has been some concern about the atropine content of goji; however, most analyses show that levels of atropine in goji berries from China and Thailand are far below potentially toxic levels (52524,94667). There is insufficient reliable information available about the safety of oral use of other parts of the goji plant.
PREGNANCY AND LACTATION:
Insufficient reliable information available.
Some animal research shows that goji fruit may stimulate the uterus (12). However, this has not been reported in humans. Until more is known, avoid using during pregnancy or lactation.
POSSIBLY SAFE ...when used orally and appropriately. A motherwort extract in soybean oil has been used with apparent safety at doses of 1200 mg daily for up to 28 days (94209) ...when administered intramuscularly, short-term. One or more intramuscular injections have been used with apparent safety in total combined doses of 40-200 mg over 48 hours or less to prevent and/or stop postpartum bleeding (94203,101890,101891,101892). Post-marketing surveillance of over 8000 females found that a specific motherwort product (Chengdu No 1 Pharma Company Ltd) has been used without significant adverse effects for a duration of 48 hours or less (104855) ...when administered by intrauterine injection, short-term. Post-marketing surveillance of over 1800 patients found that a specific motherwort product (Chengdu No 1 Pharma Company Ltd) has been used without significant adverse effects for a duration of 48 hours or less (104855).
PREGNANCY: LIKELY UNSAFE
when used orally or by injection.
Alkaloids present in motherwort have uterine stimulant effects (4,12,19).
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Panax notoginseng has been used with apparent safety in doses of 100-400 mg 1-3 times daily for up to 6 weeks (17183,94321,94326,94378,94384,109674). ...when given as an injection, under medical supervision. Panax notoginseng extract has been used with apparent safety in doses of 400-800 mg daily for up to 10 weeks (94324,94326,94373,98976,109523). There is insufficient reliable information available about the safety of Panax notoginseng when administered rectally.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally (5559).
Ginsenoside Rb1, an active constituent of Panax notoginseng, has teratogenic effects in animal models (10447).
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.
POSSIBLY SAFE ...when used orally and appropriately, short term. Rehmannia root extract 4 grams daily or rehmannia leaf extract 800 mg daily has been used with apparent safety for 8 weeks in clinical studies (93660,93662).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when safflower oil is used orally as part of the diet (6,13146,72238).
POSSIBLY SAFE ...when safflower oil is used topically for up to 8 weeks (95938). ...when safflower oil is administered intravenously in recommended doses by a health care professional. A specific safflower oil emulsion (Liposyn) 10% to 20% has been used intravenously for up to 2 weeks (72300,72301). ...when safflower yellow, a component of safflower flower, is administered intravenously and appropriately. Safflower yellow has been used with apparent safety in doses up to 150 mg daily for up to 5 weeks (94038,94041,102381).
CHILDREN: POSSIBLY SAFE
when safflower oil is administered intravenously in recommended doses by a healthcare professional.
A specific safflower oil emulsion (Liposyn) 20% has been used intravenously in infants and children for up to 2 weeks (72284,72295). ...when safflower oil is used orally in medicinal amounts. Safflower oil 2.5 mL daily has been taken safely for 8 weeks (94042). There is insufficient reliable information available about the safety of safflower flower in children.
PREGNANCY: LIKELY SAFE
when safflower oil is used orally as part of the diet (6,13146,72238).
PREGNANCY: POSSIBLY SAFE
when safflower oil is administered intravenously in recommended doses by a healthcare professional (20529).
PREGNANCY: LIKELY UNSAFE
when safflower flower is used due to its abortifacient, menstrual stimulant, and uterine stimulant effects (11,12).
LACTATION: LIKELY SAFE
when safflower oil is used orally as part of the diet (6,13146,72238).
There is insufficient reliable information available about the safety of safflower flower during lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Female Regularity. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Animal research suggests that taking adrue in combination with sodium thiopental increases total sleep time three-fold compared to the effects of sodium thiopental alone (57157). Theoretically, concomitant use of adrue and barbiturates might increase the risk of drowsiness and motor reflex depression. Some barbiturates include amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), pentobarbital (Nembutal), phenobarbital (Luminal), secobarbital (Seconal), and others.
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Animal research suggests that taking adrue in combination with diazepam increases total sleep time four-fold compared to the effects of diazepam alone (57157). Theoretically, concomitant use adrue and benzodiazepines might increase the risk of drowsiness and motor reflex depression. Some benzodiazepines include clonazepam (Klonopin), diazepam (Valium), lorazepam (Ativan), and others.
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Animal research suggests that taking adrue in combination with sodium thiopental or diazepam increases total sleep time up to four-fold compared to the effects of the drugs alone (57157). Theoretically, concomitant use of adrue with CNS depressants might cause additive sedation. Some CNS depressants include benzodiazepines, such as diazepam (Valium), alprazolam (Xanax), triazolam (Halcion), and estazolam (ProSom); barbiturates, such as mephobarbital (Mebaral), phenobarbital (Luminal Sodium), and pentobarbital sodium (Nembutal); zolpidem (Ambien); and others.
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Theoretically, atractylodes might increase the risk of bleeding when used concomitantly with anticoagulant and antiplatelet drugs.
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Laboratory research suggests that atractylenolides II and III, constituents of atractylodes, reduce platelet activation (94299). So far, this has not been shown in humans.
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Theoretically, atractylodes may have an additive effect when used with other aromatase inhibitors.
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Laboratory research suggests that atractylodes and its constituents exhibit aromatase inhibitor effects (94302).
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Theoretically, atractylodes might decrease the levels of CYP1A2 substrates.
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In animals, atractylodes administered at high doses has been shown to induce CYP1A2 activity (112828). This effect has not been shown in humans.
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Theoretically, atractylodes might increase the levels of CYP3A4 substrates.
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In animals, atractylodes administered at high doses has been shown to inhibit CYP3A1 activity, which is a homolog to the human CYP3A4 enzyme (112828). This effect has not been shown in humans.
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Theoretically, taking atractylodes may prolong the therapeutic and adverse effects of hexobarbital.
Details
In animals, atractylodes has been shown to prolong the effects of hexobarbital (94303). These effects have not been shown in humans.
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Theoretically, Baikal skullcap might potentiate the sedative effects of alcohol.
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In vitro and animal research suggests that Baikal skullcap binds to GABA-A receptors and causes sedation. Theoretically, Baikal skullcap might potentiate the sedative effects of alcohol (6290,6291,33477). Preliminary clinical research has not identified clinically relevant sedation after use of Baikal skullcap; however, a thorough evaluation of safety outcomes has not been conducted.
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Theoretically, Baikal skullcap might increase the risk of bleeding when used concomitantly with anticoagulant and antiplatelet drugs.
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Preliminary clinical research suggests that taking capsules containing a combination of astragalus, goldthread, and Baikal skullcap daily for 4 weeks inhibits platelet aggregation; the effect seems to be similar to that of aspirin 50 mg daily (33075). It is unclear if this effect is due to Baikal skullcap, other ingredients, or the combination.
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Theoretically, concomitant use of Baikal skullcap with antidiabetes drugs might enhance blood glucose lowering effects.
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Baicalein, a constituent of Baikal skullcap, has alpha-glucosidase inhibitory activity in vitro (6292). Animal research also suggests that Baikal skullcap enhances the antidiabetic effects of metformin (33408). However, in a small human study, taking Baikal skullcap extract did not enhance the antidiabetic effects of metformin, although it did modestly lower glucose levels during an oral glucose tolerance test (OGTT) (101738). Until more is known, use cautiously.
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Theoretically, concomitant use of Baikal skullcap with antihypertensive drugs might have additive effects and increase the risk of hypotension.
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Animal research suggests that baicalein, a constituent of Baikal skullcap, might lower blood pressure (33374).
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Theoretically, concomitant use of Baikal skullcap and antithyroid drugs may result in additive activity and increase the risk of hypothyroidism.
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In an animal hyperthyroid model, Baikal skullcap improved levels of triiodothyronine (T3), thyroxine (T4), and thyroid stimulating hormone (TSH) (101736). The clinical significance of this effect is unclear.
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Theoretically, Baikal skullcap might cause additive therapeutic and adverse effects when used concomitantly with drugs with sedative properties.
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In vitro and animal research suggests that Baikal skullcap binds to GABA-A receptors and causes sedation. Theoretically, Baikal skullcap might cause additive therapeutic and adverse effects when used concomitantly with drugs with sedative properties (6290,6291,33477). Preliminary clinical research has not identified clinically relevant sedation after use of Baikal skullcap; however, a thorough evaluation of safety outcomes has not been conducted.
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Theoretically, Baikal skullcap may increase levels of drugs metabolized by CYP1A2 enzymes.
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Theoretically, Baikal skullcap might increase levels of drugs metabolized by CYP2C19 enzymes.
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In vitro evidence suggest that wogonin, a constituent of Baikal skullcap, modestly inhibits the activity of CYP2C19 enzymes (33484). This effect has not been reported in humans.
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Theoretically, concomitant use of large amounts of Baikal skullcap might interfere with hormone replacement therapy, due to competition for estrogen receptors.
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In vitro evidence suggests that Baikal skullcap has estrogenic activity (16061).
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Theoretically, Baikal skullcap might reduce lithium excretion and increase serum levels of lithium.
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Baikal skullcap is thought to have diuretic properties, which may reduce lithium excretion (5541). The dose of lithium might need to be decreased.
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Theoretically, Baikal skullcap might alter the levels and clinical effects of OATP substrates.
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Some pharmacokinetic research shows that baicalin, a constituent of Baikal skullcap, can decrease plasma levels of rosuvastatin. The mechanism is thought to involve stimulation of the activity of the organic anion-transporting polypeptide 1B1 (OATP1B1), which transports rosuvastatin into the liver. This decreases plasma levels of the drug, but increases levels at the site of action in the liver. The degree to which rosuvastatin levels are affected depends on the OATP1B1 haplotype of the individual (16395). Baikal skullcap might also affect other OATP1B1 substrates (16396,16397,16398).
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Theoretically, Baikal skullcap might increase levels of drugs transported by P-glycoprotein.
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Laboratory research shows that osthol, a constituent of cnidium, inhibits blood clotting and the activity of platelets (103851). Theoretically, cnidium might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.
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Some anticoagulant or antiplatelet drugs include aspirin, clopidogrel (Plavix), dalteparin (Fragmin), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin), and others.
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In laboratory research, cnidium has been shown to have sedative and hypnotic effects, possibly related to constituent coumarins (103851). Theoretically, cnidium may potentiate the effects of barbiturates, other sedatives, and anxiolytics.
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Theoretically, Corydalis yanhusuo might increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.
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Theoretically, Corydalis yanhusuo may increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Theoretically, Corydalis yanhusuo might have additive effects with antihypertensive drugs.
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Corydalis yanhusuo contains berberine. Animal research suggests that berberine can have hypotensive effects (33692,34308). Also, a clinical study suggests that taking berberine in combination with amlodipine can lower systolic and diastolic blood pressure when compared with amlodipine alone (91956). Theoretically, Corydalis yanhusuo might also reduce blood pressure.
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Theoretically, Corydalis yanhusuo might increase the sedative effects of CNS depressants.
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Theoretically, Corydalis yanhusuo might increase blood levels of cyclosporine.
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Corydalis yanhusuo contains berberine. Preliminary clinical research shows that berberine can reduce metabolism of cyclosporine and increase serum levels, likely through inhibition of cytochrome P450 3A4 (CYP3A4), which metabolizes cyclosporine (13524). Theoretically, Corydalis yanhusuo might also reduce the metabolism of cyclosporine.
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Theoretically, Corydalis yanhusuo might increase serum levels of drugs metabolized by CYP2C9.
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Corydalis yanhusuo contains berberine. Preliminary clinical research shows that berberine can inhibit CYP2C9 (34279). Theoretically, Corydalis yanhusuo might also inhibit CYP2C9.
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Theoretically, Corydalis yanhusuo might increase serum levels of drugs metabolized by CYP2D6.
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Theoretically, Corydalis yanhusuo might increase serum levels of drugs metabolized by CYP3A4.
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Theoretically, Corydalis yanhusuo may increase serum levels of dextromethorphan.
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Corydalis yanhusuo contains berberine. Preliminary clinical research shows that berberine can inhibit cytochrome P450 2D6 (CYP2D6) activity and reduce the metabolism of dextromethorphan (34279). Theoretically, Corydalis yanhusuo may also inhibit the metabolism of dextromethorphan.
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Theoretically, Corydalis yanhusuo might reduce the therapeutic effects of losartan by decreasing its conversion to its active form.
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Corydalis yanhusuo contains berberine. Preliminary clinical research suggests that berberine can inhibit cytochrome P450 2C9 (CYP2C9) activity and reduce metabolism of losartan (34279). Theoretically, Corydalis yanhusuo might also inhibit the metabolism of losartan.
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Theoretically, Corydalis yanhusuo might increase the therapeutic and adverse effects of metformin.
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Corydalis yanhusuo contains berberine. In vitro and animal studies show that berberine can increase the systemic exposure and half-life of metformin, potentially increasing metformin's effects and side effects. This interaction seems to be most apparent when berberine is administered 2 hours prior to metformin. Taking berberine and metformin at the same time does not appear to increase systemic exposure to metformin (103195). It is unclear if Corydalis yanhusuo might have this same effect.
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Theoretically, Corydalis yanhusuo might reduce metabolism of midazolam, which might increase the risk of severe adverse effects.
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Corydalis yanhusuo contains berberine. Preliminary clinical research shows that berberine can inhibit cytochrome P450 3A4 (CYP3A4) activity and reduce metabolism of midazolam (34279). Theoretically, Corydalis yanhusuo might also inhibit the metabolism of midazolam.
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Theoretically, Corydalis yanhusuo might increase the sedative effect of pentobarbital.
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Corydalis yanhusuo contains berberine. Animal research shows that berberine can prolong pentobarbital-induced sleeping time (13519). Theoretically, Corydalis yanhusuo might increase the sedative effects of pentobarbital.
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Theoretically, Corydalis yanhusuo might increase blood levels of tacrolimus.
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Corydalis yanhusuo contains berberine. In a 16-year-old patient with idiopathic nephrotic syndrome who was being treated with tacrolimus 6.5 mg twice daily, intake of berberine 200 mg three times daily increased the blood concentration of tacrolimus from 8 to 22 ng/mL. Following a reduction of the tacrolimus dose to 3 mg daily, blood levels of tacrolimus decreased to 12 ng/mL (91954). It is unclear if Corydalis yanhusuo might have this same effect.
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Theoretically, dong quai may increase the risk of bleeding when used with anticoagulant or antiplatelet drugs; however, research is conflicting.
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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.
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Dong quai may increase the risk of bleeding when used with warfarin.
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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, concomitant use of goji fruit polysaccharides or goji root bark with antidiabetes drugs might have additive effects.
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Animal and in vitro research show that goji root bark and fruit polysaccharides might have hypoglycemic effects (7126,92118,94667). However, clinical research has only shown that taking goji fruit polysaccharides with or without antidiabetes drugs modestly reduces postprandial glucose when compared with control, with no reports of hypoglycemia (92117).
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Theoretically, concomitant use of goji root bark, but not goji fruit, with antihypertensive drugs might have additive effects.
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Theoretically, goji berry might inhibit CYP2C19 and reduce metabolism of CYP2C19 substrates.
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In vitro research shows that goji berry tincture and juice inhibit CYP2C19 enzymes (105486). Concomitant use with goji may decrease metabolism and increase levels of CYP2C19 substrates. However, this has not been reported in humans.
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Theoretically, goji berry might inhibit CYP2C9 and reduce metabolism of CYP2C9 substrates.
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In vitro research shows that goji berry tincture and juice inhibit CYP2C9 enzymes (105486). Additionally, multiple case reports suggest that goji berry concentrated tea and juice inhibit the metabolism of warfarin, a CYP2C9 substrate (7158,105462). Concomitant use with goji may decrease metabolism and increase levels of CYP2C9 substrates.
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Theoretically, goji berry might inhibit CYP2D6 and reduce metabolism of CYP2D6 substrates.
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In vitro research shows that goji berry juice inhibits CYP2D6 enzymes (105486). Concomitant use with goji may decrease metabolism and increase levels of CYP2D6 substrates. However, this has not been reported in humans.
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Theoretically, goji berry might inhibit CYP3A4 and reduce metabolism of CYP3A4 substrates.
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In vitro research shows that goji berry juice inhibits CYP3A4 enzymes (105486). Concomitant use with goji may decrease metabolism and increase levels of CYP3A4 substrates. However, this has not been reported in humans.
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Theoretically, goji berry might increase the levels and clinical effects of flecainide.
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In one case report, a 75-year-old patient stable on flecainide and warfarin presented to the emergency room with fainting and pleomorphic arrhythmia caused by flecainide toxicity. Flecainide toxicity was attributed to drinking 1-2 glasses of concentrated goji tea daily for 2 weeks. Theoretically, goji may have inhibited the cytochrome P450 2D6 (CYP2D6) metabolism of flecainide (105462).
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Goji can increase the effects of warfarin and possibly increase the risk of bleeding.
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There are at least 5 case reports of increased international normalized ratio (INR) in patients stabilized on warfarin who began drinking goji juice, concentrated goji tea, or goji wine (7158,16529,23896,105462,105487). Goji may inhibit the metabolism of warfarin by cytochrome P450 2C9 (CYP2C9) (7158).
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Theoretically, taking motherwort concomitantly with other CNS depressants may increase the risk of sedation.
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Theoretically, taking Panax notoginseng concomitantly with aspirin may increase the risk of adverse effects from both products.
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Theoretically, taking Panax notoginseng may decrease the levels and clinical effects of caffeine.
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Animal research shows that administering Panax notoginseng intravenously for 7 days before intraperitoneal injection of caffeine can decrease maximal blood levels of caffeine by 37%. This interaction is attributed to the ability of Panax notoginseng to increase the activity of cytochrome P450 1A2 (CYP1A2) enzymes (94319).
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Theoretically, taking Panax notoginseng might reduce the levels and clinical effects of CYP1A2 substrates.
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Animal research shows that administering Panax notoginseng intravenously for 7 days before intraperitoneal injection of caffeine can decrease maximal blood levels of caffeine by 37%. This interaction was attributed to the ability of Panax notoginseng to increase the activity of CYP1A2 (94319).
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Theoretically, taking Panax notoginseng concomitantly with warfarin may increase the risk of bleeding.
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Animal research shows that taking Panax notoginseng concomitantly with warfarin increases plasma warfarin levels, prothrombin time, and international normalized ratio when compared with control. In vitro research also suggests that Panax notoginseng may downregulate expression of cytochrome P450 3A4 enzymes, which may affect warfarin metabolism (109676).
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Theoretically, combining peony with anticoagulant or antiplatelet drugs might increase the risk of bleeding.
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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.
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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.
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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.
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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.
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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.
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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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In vitro, purple nut sedge dose-dependently inhibits acetylcholinesterase (AChE) (27563). Theoretically, concurrent use of anticholinergic drugs and purple nut sedge might decrease the effectiveness of purple nut sedge or the anticholinergic agent.
Details
Some anticholinergic drugs include atropine, benztropine (Cogentin), biperiden (Akineton), procyclidine (Kemadrin), and trihexyphenidyl (Artane).
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In vitro, purple nut sedge inhibits platelet aggregation (27551). Theoretically, purple nut sedge might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.
Details
Some anticoagulant or antiplatelet drugs include aspirin, clopidogrel (Plavix), dalteparin (Fragmin), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin), and others.
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Evidence from animal research suggests that purple nut sedge can reduce blood glucose levels (27554). Theoretically, purple nut sedge might have additive effects with antidiabetes drugs and increase the risk of hypoglycemia. Monitor blood glucose levels closely. Dose adjustments might be necessary.
Details
Some antidiabetes drugs include glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, pioglitazone (Actos), rosiglitazone (Avandia), and others.
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In vitro, purple nut sedge dose-dependently inhibits acetylcholinesterase (AChE) (27563). Theoretically, concurrent use of purple nut sedge with cholinergic drugs might have additive effects and increase the risk of cholinergic side effects.
Details
Cholinergic drugs include bethanechol (Urecholine), donepezil (Aricept), echothiophate (Phospholine Iodide), edrophonium (Enlon, Reversol, Tensilon), neostigmine (Prostigmin), physostigmine (Antilirium), pyridostigmine (Mestinon, Regonol), succinylcholine (Anectine, Quelicin), and tacrine (Cognex).
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Theoretically, rehmannia might increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Theoretically, rehmannia might increase the risk of hypotension when taken with antihypertensive drugs.
Details
Animal research shows that rehmannia may have hypotensive effects. Laboratory research shows that formulations of dried and processed rehmannia root inhibit angiotensin-converting enzyme (ACE) (104272).
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High doses of safflower oil might increase the risk of bleeding when taken with anticoagulant or antiplatelet drugs.
Details
Small clinical studies show that taking safflower oil, approximately 55 grams daily for 2-3 weeks, decreases platelet aggregation (72241,72303). However, taking lower doses of safflower oil, such as 5 grams daily for 4 weeks, does not seem to affect platelet function (66267). In one case report, a 74-year-old male stabilized on warfarin developed urinary tract bleeding and an elevated INR after taking a safflower extract 20 grams daily for 14 days (95939).
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Theoretically, safflower oil might alter the effects of antidiabetes drugs.
Details
Some clinical research shows that taking safflower oil 10 grams daily for 3 weeks can increase fasting blood glucose in patients with type 2 diabetes (13146). However, clinical research in patients with metabolic syndrome with or without impaired glucose tolerance shows that taking safflower oil 8 grams daily for 12 weeks reduces fasting glucose levels by around 8 mg/dL (108889). Some clinical research also shows that taking safflower oil 8 grams daily for 16 weeks does not affect fasting glucose levels in patients with type 2 diabetes (94039).
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Theoretically, safflower oil might increase the risk of bleeding when taken with warfarin.
Details
In one case report, a 74-year-old male stabilized on warfarin developed urinary tract bleeding and an elevated INR after taking a safflower extract 20 grams daily for 14 days (95939).
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Below is general information about the adverse effects of the known ingredients contained in the product Female Regularity. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General ...No adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
General
...There is currently a limited amount of information on the adverse effects of atractylodes.
A thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Allergic reaction, dry mouth, nausea.
Gastrointestinal ...Orally, atractylenolide I, an isolated constituent of atractylodes, can cause bad taste, nausea, and dry mouth (15706).
Immunologic ...Atractylodes can cause an allergic reaction in people sensitive to the Asteraceae/Compositae family (12450). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.
General
...Orally, Baikal skullcap seems to be well-tolerated.
There is currently a limited amount of information on the adverse effects of intravenous and topical Baikal skullcap.
Most Common Adverse Effects:
Orally: Abdominal pain, constipation, diarrhea, erythema, nausea, pruritus, and vomiting.
Intravenously: Skin reactions.
Topically: Dermatitis.
Serious Adverse Effects (Rare):
Orally: Hepatotoxicity and hypersensitivity pneumonitis have been reported with a specific combination product (Limbrel, Primus Pharmaceuticals) containing extracts of Baikal skullcap and catechu.
Cardiovascular ...Orally, in a small clinical study evaluating the safety of baicalein, a constituent of Baikal skullcap, in healthy adults, elevated triglyceride levels occurred in 1 of 10 patients who received 400 mg every 8 hours and 2 of 10 patients treated with 600 mg every 8 hours, compared with 0 of 10 patients who received 200 mg every 8 hours and 0 of 6 patients who received placebo. Triglyceride elevations were considered mild and resolved after discontinuation (110023).
Dermatologic
...Orally, taking Baikal skullcap may cause erythema and pruritus (105867).
Intravenously, Baikal skullcap as part of a Tanreqing injection has been associated with reports of skin reactions in some pediatric patients (96281).
Topically, several cases of allergic contact dermatitis have been reported after applying sunscreen containing Baikal skullcap extract (105869,105870). Allergic contact dermatitis has also been reported after applying a facial cream (Resveratrol BE, Skinceuticals) containing Baikal skullcap root extract 0.5% and resveratrol 1%. Patch testing identified a positive reaction to both ingredients (110024). Baikal skullcap-induced dermatitis appears to respond to treatment with a topical corticosteroid and calcineurin inhibitor (105870).
Gastrointestinal ...Orally, use of Baikal skullcap has been associated with epigastric pain, abdominal pain, constipation, diarrhea, nausea, and vomiting (101738,105867).
Hepatic
...A specific combination product (Limbrel, Primus Pharmaceuticals) containing flavocoxid, a mixture of Baikal skullcap flavonoid extract and catechu extract, has been linked to several reports of acute liver damage.
There have been at least five published reports of liver damage associated with this product. In all cases, the patients were females aged 54-68 years taking doses of 250-500 mg twice daily for 1-3 months. Signs and symptoms included jaundice, pruritus, abdominal pain, fever, rash, and elevated serum bilirubin and liver transaminase levels. All patients fully recovered and levels normalized within 3 months after discontinuation (18009,96282). In addition to these published case reports, approximately 30 liver-related adverse events have been reported to the manufacturer of this product (18009). The mechanism of hepatotoxicity is unclear (18009,18010); it is estimated that the incidence of hepatotoxicity with this product is around 1 in 10,000, although the actual incidence is unknown (18010). In 2017, the US Food and Drug Administration (FDA) formally requested the recall of all non-expired lots of this product due to the risk for liver and lung injury (106042). It is unclear if these effects were due to Baikal skullcap, catechu, or the combination.
Hepatotoxicity has also been reported in two patients taking a specific dietary supplement (Move Free Advanced, Reckitt Benckiser) containing Baikal skullcap, black catechu, glucosamine, chondroitin, and hyaluronic acid (33460) and in a patient taking Baikal skullcap, elderflower, horseradish, and white willow (101737). The investigators determined that the hepatotoxicity was likely caused by Baikal skullcap in these cases (33460,101737). Additionally, cases of liver injury are reported in 4 of 37 patients taking various Kampo formulations containing Baikal skullcap and other herbs daily. Patients presented with elevated liver function tests 7 to 38 days after consumption (112179). It is unclear if this adverse effect is from Baikal skullcap, other ingredients, or the combination.
In a small study evaluating the safety of baicalein, a constituent of Baikal skullcap, in healthy adults, liver transaminase elevations occurred in 2 of 10 patients who received 400 mg every 8 hours for 6 days, compared with 0 of 6 patients who received placebo. No patients receiving either 200 mg or 600 mg every 8 hours experienced liver transaminase elevations. The elevations were considered mild and resolved after discontinuation (110023).
Pulmonary/Respiratory ...A specific combination product (Limbrel, Primus Pharmaceuticals) containing flavocoxid, a mixture of Baikal skullcap flavonoid extract and catechu extract, has been linked to several reports of hypersensitivity pneumonitis. Symptoms include fever, chills, headache, cough, chronic bronchitis, shortness of breath, weight loss, and fatigue. In 2017, the US Food and Drug Administration (FDA) formally requested the recall of all non-expired lots of this product due to the risk for liver and lung injury (106042). It is unclear if these effects were due to Baikal skullcap, catechu, or the combination.
Renal ...Orally, in a small clinical study evaluating the safety of baicalein, a constituent of Baikal skullcap, in healthy adults, proteinuria of undefined severity occurred in 1 of 10 patients who received 200 mg every 8 hours for 6 days, 3 of 10 patients who received 400 mg every 8 hours for 6 days, and 5 of 10 patients who received 600 mg every 8 hours for 6 days, compared with 1 of 6 patients who received placebo. The proteinuria was considered mild and resolved after discontinuation (110023).
General ...Orally, cnidium has been reported to cause mild symptoms of bitter mouth, drowsiness, and stomach discomfort (103851).
Gastrointestinal ...Orally, cnidium has been reported to cause bitter mouth and stomach discomfort (103851).
Neurologic/CNS ...Orally, cnidium has been reported to cause drowsiness (103851).
General
...Orally, Corydalis yanhusuo is generally well tolerated.
Serious Adverse Effects (Rare):
Orally: Clonic spasms and muscle tremors with high doses.
Musculoskeletal ...Orally, clonic spasms and muscle tremors may occur with overdoses of Corydalis yanhusuo (18).
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, goji fruit seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Allergic reactions including anaphylaxis.
Dermatologic ...A case of photosensitivity secondary to consumption of goji berries has been reported. The patient presented with a pruriginous eruption that had lasted for 2 weeks. The patient had been taking goji berries for 5 months and cat's claw for 3 months. Upon testing, it was revealed that the patient tested positive to goji berries in a photoprovocation test, but not to cat's claw (40263).
Hepatic ...Orally, consumption of goji berries has been associated with a single case report of autoimmune hepatitis (52541). A case of acute hepatitis has also been reported in a female who consumed 2 ounces of a specific combination product (Euforia, Nuverus International) containing goji berry, pomegranate, curcumin, green tea, noni, acai berry, aloe vera, blueberry, resveratrol, mangosteen, and black seed, daily for one month. It is unclear whether the liver injury was caused by goji berry, other ingredients, or the combination (90125).
Immunologic ...Several cases of allergic reactions secondary to consumption of goji berries have been reported. Symptoms included facial angioedema with dyspnea, pharyngeal itching, itching in the mouth, ears, and axilla, labial angioedema, and perioral skin rash (92116). Anaphylaxis has also been reported (52538).
General
...Orally or via intramuscular or intrauterine injection, motherwort appears to be generally well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, stomach irritation.
Topically: Contact dermatitis, photosensitivity.
Intramuscular / Intrauterine: Abdominal pain, erythema, eyelid edema, fever, nausea, pruritus, rash.
Dermatologic ...Motherwort leaves can cause contact dermatitis, and the oil may cause photosensitivity reactions (4). Intramuscularly and via intrauterine injection, mild erythema, rash, and pruritus have been reported (101892,104855).
Gastrointestinal ...Orally, use of motherwort in amounts greater than 3 grams can cause diarrhea and stomach irritation (12). Intramuscularly and via intrauterine injection, abdominal pain and nausea have been reported (104855).
Genitourinary ...Orally, use of motherwort in amounts greater than 3 grams can cause uterine bleeding (12).
Immunologic ...Motherwort can also cause allergic reactions in sensitive individuals (4). Intramuscularly and via intrauterine injection, transient fever and chills lasting less than 24 hours have been reported (104855).
Ocular/Otic ...Intramuscularly and via intrauterine injection, transient eyelid edema lasting less than 24 hours has been reported (104855).
General
...Panax notoginseng seems to be generally well tolerated when used orally or intravenously.
Most Common Adverse Effects:
Orally: Dry mouth, flushed skin, insomnia, nausea, nervousness, rash, vomiting.
Intravenously: Headache, itching, rash.
Serious Adverse Effects (Rare):
Intravenously: Fever, pustular drug eruption.
Dermatologic ...Orally, Panax notoginseng can cause flushed skin (5558). When given orally or intravenously, rash has been reported (94321,94324,94326,94378,98976). There is a case of interstitial granulomatous drug reaction in a 73-year-old male who had been using oral Panax notoginseng extract for 2 months. The condition repeated after 5 days of intravenous use at a later time. The skin condition gradually cleared after use of the product was discontinued (94316). In a retrospective review of hospital records of 30,884 patients, a specific Xueshuantong injection (XSTI) containing Panax notoginseng saponins was associated with a 4% incidence of skin reactions, including redness, itching, and maculopapules (98976).
Gastrointestinal ...Orally and intravenously, Panax notoginseng can cause dry mouth, nausea, and vomiting (5558,94321,98976). In one case report, a patient developed a large submucosal hematoma extending from the hypopharynx to lower esophagus after taking one oral dose of an unknown quantity of Panax notoginseng and hirudin (109671). It is unclear if this event was due to Panax notoginseng, hirudin, or other factors.
Immunologic ...Intravenously, Panax notoginseng saponins have been associated with five cases of pustular drug eruption due to acute generalized exanthematous pustulosis. The skin eruption was associated with fever and an increased neutrophil count in some cases. Symptoms were deemed to be probably or likely due to the Panax notoginseng product (94327). In a retrospective review of hospital records of 30,884 patients, a specific Xueshuantong injection (XSTI) containing Panax notoginseng saponins was associated with a fever frequency of 0.2%, edema frequency of 0.1%, and anaphylactic reactions in 0.03% (98976).
Neurologic/CNS ...Orally, Panax notoginseng can cause nervousness and insomnia (5558). Intravenously, Panax notoginseng has been reported to cause headache (94326,94378). In a retrospective review of hospital records of 30,884 patients, a specific Xueshuantong injection (XSTI) containing Panax notoginseng saponins was associated with a headache frequency of 0.3% and paresthesia frequency of 0.1% (98976).
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 ...There is currently a limited amount of information available about the adverse effects of purple nut sedge. Orally, purple nut sedge tuber seems to be generally well tolerated. In clinical research, purple nut sedge tuber 450 mg taken orally daily as a part of a combination product for 8 weeks did not cause adverse effects (89900). Topically, purple nut sedge essential oil seems to be well-tolerated, except for a complaint of bad odor (99457).
General ...Orally, rehmannia seems to be well tolerated.
General
...Orally and intravenously, safflower oil seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Liver failure.
Dermatologic ...Intravenously, safflower yellow, a constituent of safflower flower, can cause skin rash (94038,94041). In one case, adjusting the rate of the drip improved the rash (94041).
Hepatic ...Orally, safflower oil has been associated with liver failure. There are at least 7 case reports of acute liver failure requiring liver transplant that are probably associated with over-use of safflower oil, usually for weight loss purposes. However, it is not clear what dose or duration of safflower use led to liver failure in these cases (99138).
Immunologic ...Safflower can cause an allergic reaction in individuals sensitive to the Asteraceae/Compositae family. Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.