The official Amberen website states that numerous studies have not shown any side effects associated with the product. Amberen has been on the market for 8 years, as of 2015, and has undergone numerous clinical and safety studies.
Amberen is a non-hormonal dietary supplement that claims to help alleviate symptoms of menopause and perimenopause. It is the only product on the market that helps regulate production of female hormones by renewing the body's natural hormonal system, states the Amberen website. It is not considered a drug, so no doctor's prescription is required. Amberen has reportedly been clinically tested and shown to help relieve sleeplessness, hot flashes, night sweats, fatigue, irritability, mood swings, menopause headaches, irritability, anxiety, sadness and body aches.
Amberen has been tested in three randomized, double-blind clinical trials and observed in a three-year clinical study, according to the Amberen website. The main ingredients of Amberen include Enerlit, CytoCalcium, CytoMagnesium, CytoZinc, Monosodium L-Glutamate and Tocopherol Acetate. Amberen is not FDA approved, as it is a dietary supplement. Dietary supplements can be sold without prior FDA approval, but manufacturers must ensure that the products are safe, explains the FDA. Manufacturers must also ensure that marketing of products is not false or misleading, and that the products comply with all other FDA and Federal Food, Drug and Cosmetic Act regulations.