"Bioidentical" hormones have the same structure as hormones your body makes, such as estradiol and progesterone. Several FDA-approved products are bioidentical. Custom-compounded "BHRT" is not FDA-approved, and major medical groups find no good evidence that it is safer or works better than approved hormone therapy.
The Endocrine Society defines bioidentical hormones as substances with exactly the same chemical and molecular structure as hormones made in the human body. In menopause care, this usually means:
Some other hormone products are not bioidentical. For example, some estrogens come from other sources, and many progestins are made to act like progesterone without being the same molecule. Both bioidentical and non-bioidentical products can be FDA-approved.
FDA-approved bioidentical hormones are made by drug companies under FDA oversight. They have been tested for safety and effectiveness, each dose is checked for quality, and they come with a label that lists risks. The Endocrine Society notes that hormones with structures identical to the body's own can be obtained as FDA-approved preparations, with strict manufacturing oversight.
Compounded bioidentical hormones (cBHT) are mixed by a compounding pharmacy from a clinician's prescription. ACOG notes that compounding pharmacies must be licensed but do not have to show the safety, effectiveness and quality control FDA requires of drug makers. The Menopause Society adds that custom-compounded hormones are not tested for safety and effectiveness, and may not contain the prescribed amount of hormone, which can be dangerous.
Because compounded products don't go through FDA review, they also don't come with the standard FDA label and its warnings. NASEM recommended that patients be told clearly when a preparation is not FDA-approved.
In 2018, FDA asked the National Academies of Sciences, Engineering, and Medicine to review the evidence on compounded bioidentical hormones. The report, delivered in July 2020, found:
It recommended limiting compounded hormones to people with a documented allergy to an ingredient in FDA-approved products, and said patient preference alone should not decide their use.
There is no good evidence that they are. The Menopause Society says custom-compounded hormones are not safer or more effective than approved bioidentical hormones. NASEM found insufficient data to show compounded hormones are as safe as or safer than FDA-approved hormone therapy.
A hormone with the same structure as your body's hormone still acts like that hormone. That means bioidentical estrogen carries the same kinds of risks as other estrogen, such as blood clots and stroke, and the need for a progestogen if you have a uterus. Our guide Is HRT safe? explains those risks in more detail.
No. The Endocrine Society says claims that simple saliva tests can customize hormone doses are not supported by scientific data. Hormone levels in perimenopause can also change a lot from day to day. Treatment is usually guided by your symptoms, your health history and how you respond, not by a saliva test.
The Menopause Society notes that hormone therapy is FDA-approved as a first-line treatment for bothersome hot flashes. According to MedlinePlus, estrogen may be used to treat hot flashes, to treat vaginal dryness, itching or burning, and to help prevent osteoporosis after menopause. These are the same goals whether the product is bioidentical or not. Results vary, and not everyone is a candidate.
Are FDA-approved bioidentical hormones available? Yes. The Menopause Society says many well-tested, FDA-approved products meet the definition of bioidentical, and they come in a range of doses.
Is compounded BHRT FDA-approved? No. Compounded hormones are not FDA-approved and FDA does not check them for safety, effectiveness or quality before they are used.
Is "bioidentical" the same as "natural"? Not exactly. Bioidentical describes the molecule's shape. ACOG notes that bioidentical hormones come from plant sources and include both FDA-approved products and compounded mixes. "Natural" does not mean risk-free.
Do bioidentical hormones have fewer side effects? There is no good evidence that compounded bioidentical hormones have fewer side effects. Any estrogen or progesterone can cause side effects and carries risks.
Can I get custom doses with FDA-approved products? FDA-approved hormones come in many strengths and forms, such as pills, patches, gels and sprays, so clinicians can adjust the dose for each person (The Menopause Society).
Ask about FDA-approved hormone options for your symptoms. Book a visit or call (210) 903-1030. In-clinic in San Antonio • Telehealth for women located in Texas Yaso Wellness Health Clinic, 1907 Goliad Rd, San Antonio, TX 78223
Education only, not medical advice. Not everyone is a candidate for hormone therapy. In an emergency, call 911.
Leticia Vargas, MD, OB/GYN, sees patients at Yaso Wellness Health Clinic in San Antonio. About Dr. Vargas
Education only, not medical advice or a diagnosis. In an emergency, call 911.
