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.
People who are sensitive to beta-carotene, vitamin A, or any other ingredients in beta-carotene products should avoid supplemental use.
Side Effects and Warnings
Supplemental beta-carotene in children should be limited to specific medical indications. There is insufficient reliable information available about the safety of large doses of beta-carotene in pregnant or breastfeeding women.
Supplemental beta-carotene may increase the risk of lung cancer, prostate cancer, intracerebral hemorrhage, and cardiovascular and total mortality in people who smoke cigarettes or have a history of high-level exposure to asbestos. Beta-carotene from foods does not seem to have this effect.
In people who smoke, beta-carotene may increase cardiovascular mortality. In men who smoke and have had a prior myocardial infarction (MI or heart attack), the risk of fatal coronary heart disease increases by as much as 43% with low doses of beta-carotene. There is some evidence that beta-carotene in combination with selenium, vitamin C, and vitamin E might lower high-density lipoprotein 2 (HDL2) cholesterol levels. HDL levels are protective so this is considered to be a negative effect. Dizziness, reversible yellowing of palms, hands, or soles of feet and to a lesser extent the face (called carotenoderma) can occur with high doses of beta-carotene. Loose stools, diarrhea, unusual bleeding or bruising, and joint pain have been reported.
Pregnancy and Breastfeeding
U.S. Food and Drug Administration (FDA) Pregnancy Risk Factor C.
Insufficient data are available on larger oral doses of beta-carotene in pregnant and breastfeeding woman.