
- Means
- Same molecular structure as your own hormones
- FDA-approved examples
- Estradiol, oral micronized progesterone
- Compounded versions
- Not FDA-approved
- Safer by default?
- No evidence
What 'bioidentical' does and doesn't tell you
The word is often used as if it meant 'natural' or 'safer.' It doesn't. Bioidentical hormones are made in a lab, usually from plant starting materials, and a hormone that's identical to yours carries the same kinds of benefits and risks as the hormone itself.
What matters more is the product: the dose, the route (pill, patch, gel, cream, vaginal insert), whether it's FDA-approved, and whether it's paired with what you need, such as a progestogen if you have a uterus.
FDA-approved bioidentical options
Many bioidentical hormones are available as FDA-approved prescriptions you can fill at a regular pharmacy. Examples The Menopause Society lists include:
- Estradiol as pills, skin patches, gels, sprays and vaginal products.
- Oral micronized progesterone.
- A combined oral estradiol and progesterone capsule.
- Transdermal testosterone (approved for men).
- Vaginal prasterone (DHEA) for painful sex after menopause.
Compounded bioidentical hormones
Compounded bioidentical hormone therapy (often shortened to cBHT) is mixed by a pharmacy to a custom formula. It is not FDA-approved, and its safety and effectiveness haven't been tested in randomized trials. A 2020 report from the National Academies found no well-designed evidence that compounded products are safer or work better than approved ones, called their widespread use a public health concern, and recommended limiting them to people with an allergy to an ingredient in an approved product or a need for a dose form that isn't commercially available.
Specific worries include inconsistent dosing, lack of the standard warnings that come with approved products, and, with implanted pellets, hormone levels that run well above normal for long periods. The Menopause Society also says saliva hormone tests, sometimes used to 'customize' compounded doses, haven't been proven accurate or reliable.
How HealifyMD approaches it
Hormone therapy at HealifyMD starts with an individual risk discussion with a licensed clinician, covering blood clots, stroke and breast cancer. Some products in the plan are compounded, and the treatment pages say so. You can ask your clinician whether an FDA-approved bioidentical product would meet your needs instead.
Whatever form you use, the basics of safe hormone therapy are the same: the lowest dose that controls your symptoms, a progestogen if you have a uterus and take systemic estrogen, prompt reporting of unexpected bleeding, and a regular review of whether the treatment still makes sense for you.
Bioidentical hormones: common questions
Are bioidentical hormones natural?
They're usually made in a lab from plant-derived starting materials. 'Bioidentical' means the molecule matches your own hormone, not that the product is unprocessed.
Are bioidentical hormones safer than other hormone therapy?
There's no good evidence that bioidentical hormones are safer simply because of their structure. Risks depend on the hormone, dose, route and your health history.
Can I get bioidentical hormones that are FDA-approved?
Yes. Estradiol in several forms and oral micronized progesterone are FDA-approved bioidentical options.
Is compounded progesterone cream enough to protect the uterus?
Ask your clinician. The endometrial protection seen in research comes from studied progestogens such as oral micronized progesterone, and compounded creams haven't been tested the same way.
Do I need saliva testing to get the right dose?
No. Hormone levels swing through the day, and The Menopause Society notes that symptom response, not a saliva number, is the reliable guide to dosing.
What are hormone pellets?
They're compounded hormone implants placed under the skin. They can't be removed easily and may produce hormone levels above the normal range.
Sources
We cite government agencies, professional societies and peer-reviewed research. See our editorial policy.
- Practice Pearl: Compounded Bioidentical Hormone Therapy (2020)The Menopause Society
- Prescribers should restrict the use of non-FDA-approved compounded bioidentical hormonesNational Academies of Sciences, Engineering, and Medicine
- NASEM study on the clinical utility of compounded bioidentical hormone therapyU.S. Food and Drug Administration
- Hormone TherapyThe Menopause Society
- What is hormone testing?The Menopause Society