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Safety

The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.

Allergies

Soy may act as a food allergen similar to milk, eggs, peanuts, fish, and wheat. Symptoms of an allergic reaction range from a runny nose to a sudden drop in blood pressure.

Side Effects and Warnings

Soy has been a dietary staple in many countries for more than 5,000 years and it does not appear to cause long-term toxicity. Aside from allergic reactions, limited side effects have been reported in infants, children, and adults.

Soy protein taken by mouth has been associated with stomach and intestinal difficulties, such as bloating, nausea, and constipation. Changes in stool quality have been reported. More serious intestinal side effects have been uncommonly reported in infants fed soy protein formula, including vomiting, diarrhea, growth failure, and damage/bleeding of the intestine walls. People who experience intestinal irritation (colitis) from cow's milk may also react to soy formula.

Based on human case reports and animal research, soy may affect thyroid hormone levels in infants. There have been rare reports of goiters (enlarged neck due to increased thyroid size). Hormone levels became normal again after stopping soy. Infants fed soy or cow's milk formula may also have higher rates of atopic eczema than infants who are breastfed.

Acute migraine headache has been reported with the use of a soy isoflavone product. Based on animal research, damage to the pancreas may theoretically occur from regularly eating raw soybeans or soy flour/protein powder made from raw, unroasted, or unfermented beans.

The use of soy is often discouraged in patients with hormone-sensitive cancers, such as breast, ovarian, or uterine cancer, due to concerns about possible estrogen-like effects (which theoretically may stimulate tumor growth). Other hormone-sensitive conditions, such as endometriosis, may also theoretically be worsened. In laboratory studies, it is not clear if isoflavones stimulate or block the effects of estrogen or both (acting as a "receptor agonist/antagonist"). Until additional research is available, patients with these conditions should be cautious and speak with a qualified healthcare practitioner before starting use.

It is not known if soy or soy isoflavones share the same side effects as estrogens, such as increased risk of blood clots. Early studies suggest that soy isoflavones, unlike estrogens, do not cause the lining of the uterus (endometrium) to build up.

There has been a case report of vitamin D deficiency rickets in an infant nursed with soybean milk (not specifically designed for infants). Patients should consult their qualified healthcare practitioners for current breastfeeding recommendations and use formulas with adequate nutritional value.

Pregnancy and Breastfeeding

Soy as a part of the regular diet is traditionally considered to be safe during pregnancy and breastfeeding, although scientific research is limited in these areas. The effects of high doses of soy or soy isoflavones in humans are not clear, and therefore are not recommended.

Recent study demonstrates that isoflavones, which may have estrogen-like properties, are transferred through breast milk from mothers to infants. High doses of isoflavones given to pregnant animals have resulted in tumors and reproductive changes in offspring, although this has not been tested in humans.

In one human study, male infants born to women who ingested soymilk or soy products during pregnancy experienced more frequent hypospadias (a birth defect in which the urethral meatus, the opening from which urine passes, is abnormally positioned on the underside of the penis). However, other human and animal studies have examined males or females fed soy formula as infants, and have not found abnormalities in infant growth, head circumference, height, weight, occurrence of puberty, menstruation, or reproductive ability.

Research in children during the first year of life has found that the substitution of soy formula for cow's milk may be associated with significantly lower bone mineral density. Parents considering the use of soy formula should speak with qualified healthcare practitioners to make sure the appropriate vitamins and minerals are provided in the formula.

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