Goldenseal

Before using goldenseal, talk to your healthcare provider. You may not be able to use goldenseal if you have certain medical conditions.

Goldenseal is considered likely unsafe to use during pregnancy. It is not known whether this medicine will harm an unborn baby, but newborn babies exposed to goldenseal have developed brain damage. Do not use this product without medical advice if you are pregnant.

Goldenseal is considered likely unsafe to use if you are nursing a baby.

Goldenseal should not be given to a newborn baby because it may cause brain damage. Do not give any herbal/health supplement to a child without medical advice.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although not all side effects are known, goldenseal is thought to be possibly safe when taken as a single dose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although not all side effects are known, goldenseal is thought to be possibly safe when taken as a single dose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Consult your pharmacist.

How to use Goldenseal Powder

Consult your pharmacist.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

Goldenseal is a perennial herb found in the rich woods of the Ohio River valley and other locations in the northeastern United States. The single, green-white flower, which has no petals, appears in the spring on a hairy stem above a basal leaf and two palmate, wrinkled leaves. The flower develops into a red-seeded berry. The plant grows from horizontal, bright yellow rhizomes, which have a twisted, knotty appearance. 1

The isoquinoline alkaloids hydrastine (4%), berberine (up to 6%), canadine, and palmatine are present in goldenseal root and are viewed as the principle bioactive components. 6 , 7 Considerable variation in alkaloid content has been noted among various commercial products available, with some not meeting the USP standards for berberine and hydrastine. 6 , 8 , 9 Some preparations contain alkaloids associated with other herbal substances. 8 , 10 Other minor alkaloids, such as canadaline and canadinic acid, 11 , 12 have been isolated. Quinic acid esters were elucidated. 13 Traces of calcium, magnesium, potassium, and zinc have been described. 14 Quantitation of the alkaloids has been accomplished in a variety of ways, including spectrophotometry, thin-layer chromatography, ion-pair dye colorimetry, high-performance liquid chromatography, capillary electrophoresis, and capillary electrophoresis-mass spectrometry. 9 , 10 , 15 , 16 , 17 , 18 , 19 , 20 , 21

Despite the widespread use of goldenseal, controlled clinical trials are lacking. The alkaloids are poorly absorbed when taken orally; in vitro and animal studies must be interpreted with care. 22

Goldenseal alkaloids have shown modest antimicrobial activity in vitro against Staphylococcus aureus , Klebsiella and Candida species, Helicobacter pylori , and Mycobacterium tuberculosis . 13 , 23 , 24 , 25 , 26 Berberine sulfate (400 mg single dose) significantly reduced the mean stool volume after 8 hours and stopped diarrhea caused by enterotoxigenic Escherichia coli in more patients after 24 hours than the control patients. 27 Activity of berberine against diarrhea caused by cholera has been demonstrated to be minimal in comparison with tetracycline. 27 , 28

Animal experiments have shown goldenseal and berberine to exhibit effects on the cardiovascular system, although the mechanisms remain poorly understood. Positive inotropic, negative chronotropic, vasodilatory, and hypotensive effects have been described. 29 , 30 , 31 The sodium-sparing diuretic effect of goldenseal resulted in a case report of reversible hypernatremia in a child. 31 Goldenseal decreased low-density lipoproteins in hyperlipidemic rats. 32 , 33 Berberine improved the lipid profile and exerted a hypoglycemic action in a small trial of patients with type 2 diabetes. 34

Goldenseal has traditionally been used for eye ailments. 35 Berberine has been evaluated against sulfacetamide in ocular trachoma infections with comparable effects. 29 A phototoxic reaction leading to decreased lens epithelial cell viability between berberine alkaloid and ultraviolet A (UVA) light has been described; therefore, exercise caution until further data are available. 35 , 36

Immunostimulation has been described for berberine. 29 , 37 Berberine has been reported to inhibit uptake of glucose by cancer cells 38 and to inhibit tumor promotion by phorbol esters in a mouse skin carcinogenesis model. 39 Berberine showed weak activity in an antioxidant model. 40 , 41 Although hydrastine is closely related to the convulsant isoquinoline alkaloid bicuculline, it had no activity in a gamma-aminobutyric acid–receptor binding assay at high concentrations. 42

One study investigated the inhibitory activity of Hydrastis alkaloids on isolated rabbit aorta stimulated by epinephrine, finding a weak synergistic effect for berberine, canadine, and canadaline, but no activity with hydrastine. 43 In isolated guinea pig ileum preparations, the same group found that berberine, canadine, and canadaline evoked contractions, while hydrastine was inactive. 44 A third study found a relaxant effect of berberine on rabbit prostate strips stimulated by norepinephrine or phenylephrine 45 ; however, an adrenergic mechanism was considered unlikely. Adrenergic effects on guinea pig trachea have been described. 46