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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

Avoid with known allergy/hypersensitivity to products that contain vitamin E. Skin reactions such as contact dermatitis and eczema have been reported with topical vitamin E preparations, such as ointments or vitamin E-containing deodorants.

Side Effects and Warnings

For short periods of time, vitamin E supplementation is generally considered safe at doses up to the recommended tolerable upper intake level (UL). However, vitamin E is possibly unsafe when used orally at doses exceeding the tolerable upper intake level. The recommended dietary allowance (RDA) obtained through food consumption is considered to be safe and beneficial.

The European Food Safety Authority (EFSA) has set the tolerable upper intake level (UL) for adults at 300 milligrams daily, regardless of pregnancy or lactation status. The UL for children ranges from 100 milligrams daily for ages 1-3 years to 260 milligrams daily for ages 15-17 years.

Evidence suggests that regular use of high-dose vitamin E may increase the risk of death from all causes by a small amount. These conclusions have been criticized by some experts. Nonetheless, this is the best available scientific evidence currently. Chronic use of vitamin E should be used cautiously, and high-dose vitamin E should be avoided. Acute overdose of vitamin E is very uncommon.

In rare cases, vitamin E supplementation has been associated with dizziness, fatigue, headache, weakness, blurred vision, abdominal pain, diarrhea, nausea, or flu-like symptoms (particularly when used in high doses). The risk of necrotizing enterocolitis may be increased with large doses of vitamin E.

Use cautiously in patients with cardiovascular conditions. Vitamin E may increase risk of all-cause mortality and incidence of heart failure with doses #8805;400 IU daily for over one year.

Vitamin E should be used cautiously for long periods of time (>10 years) due to a possible increased risk of hemorrhagic stroke.

Use cautiously in patients with skin conditions. Skin reactions, such as contact dermatitis and eczema, have been reported with topical vitamin E preparations, such as ointments or vitamin E-containing deodorants. Pruritus (itching) has been reported following oral supplementation of vitamin E.

Use cautiously in patients with kidney impairment. In rare cases, vitamin E supplementation has been associated with gonadal dysfunction and diminished kidney function.

Use cautiously in patients with Alzheimer's disease or cognitive decline. In patients with Alzheimer's disease or cognitive decline, vitamin E has been associated with an increase in falls and syncope (fainting).

Oral vitamin E should be used cautiously in patients with retinitis pigmentosa, as is does not appear to slow visual decline and may be associated with more rapid loss of visual acuity, although the validity of this finding has been questioned.

Use cautiously in patients who smoke. Vitamin E supplementation may transiently increase tuberculosis risk in males who smoke heavily and have high dietary vitamin C intake.

Vitamin E should be used cautiously in preterm infants, due to reports of an increased risk of sepsis. Premature infants should be under strict medical supervision. Decisions regarding vitamin supplementation should be made with the infant's physician.

Although this has not been well studied in humans, an increased risk of bleeding when used with warfarin (Coumadin®) has been noted. However, other studies have not observed a greater incidence of bleeding. Bleeding has been observed in patients given high repeated doses of intravenous all-rac-alpha-tocopherol (synthetic vitamin E). Avoid in patients with bleeding disorders or those taking drugs that may increase the risk of bleeding. Dosing adjustments may be necessary. Reported adverse effects attributed to vitamin E supplementation included minor bleeding and epistaxis (nosebleed).

Avoid doses greater than the RDA in pregnant women, due to a possible increased risk of congenital heart defects in offspring.

Avoid with known allergy/hypersensitivity to products that contain vitamin E.

Pregnancy and Breastfeeding

Many prenatal vitamins contain small amounts of vitamin E. Natural forms of vitamin E may be preferable to synthetic forms. Vitamin E is in the U.S. Food and Drug Administration (FDA) Pregnancy Category A at doses advocated by the FDA. Doses above the RDA level are in FDA Pregnancy Category C.

Use beyond the recommended dietary allowance (RDA) level in otherwise healthy pregnant women is generally not recommended. There is otherwise insufficient evidence regarding the safety of higher doses of oral, topical, or injected vitamin E during pregnancy and breastfeeding, and therefore it is not recommended.

A combination of vitamins C and E may increase the risk of gestational hypertension (high blood pressure during pregnancy) and low-birthweight infants. Vitamin E use during pregnancy may increase the risk of congenital heart defects.

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