Bioidentical Hormones (BHRT): What They Are, FDA-Approved vs Compounded
Medically reviewed by Sabeen Munib M.D.Bioidentical hormones have the same chemical structure as the estrogen, progesterone and testosterone your body makes. Many are FDA-approved, such as estradiol patches and gels and oral progesterone; others are compounded by a pharmacy to a custom dose and are not FDA-approved. Both are real hormones with the same kinds of risks, and neither is safer or more natural than the other.
What are bioidentical hormones?
A bioidentical hormone is made in a lab, usually from plant sources such as soy or yam, so that its structure matches the hormone made in your body exactly. The main ones used in hormone therapy are:
- Estradiol, the main estrogen your ovaries make before menopause
- Progesterone, which protects the lining of the uterus when you take estrogen
- Testosterone, used for men with confirmed low testosterone and, in selected cases, for women
Bioidentical is a description of the molecule, not a medical category. It does not tell you whether a product was made to a tested strength or reviewed by the FDA. That is the difference that matters, and it is where most of the confusion comes from.
Bioidentical vs FDA-approved vs compounded: what is the difference?
It helps to think of three groups rather than two.
FDA-approved bioidentical hormones
Many standard prescriptions are already bioidentical. They are made to a fixed strength, tested batch by batch, and come with full safety information on the label.
- Estradiol patches, gels, sprays and pills
- Vaginal estradiol creams, tablets and rings for dryness and bladder symptoms
- Oral micronized progesterone capsules, taken at bedtime
- A capsule that combines estradiol and progesterone
- Testosterone gels and injections for men
Compounded bioidentical hormones
Compounded hormones are mixed by a pharmacy for one patient, often as a cream, to a dose the prescriber chooses. They can include combinations or hormones that are not sold in any FDA-approved product, such as estriol.
- They are not FDA-approved, so their strength and purity are not checked the way approved products are
- The dose absorbed through the skin can vary from batch to batch and person to person
- They do not come with the same printed safety information, even though the risks are the same kinds as approved hormones
- They make the most sense when an approved product does not fit, for example if you react to an ingredient or need a dose or form that is not made commercially
Non-bioidentical hormones
Some approved hormones are not identical to human hormones, such as conjugated estrogens and synthetic progestins used in some pills and combination patches. They are still effective and widely used. Being non-bioidentical does not make them wrong for you, and it depends on your symptoms and history.
Are bioidentical hormones safer than regular HRT?
No. Bioidentical and compounded hormones are not safer or more effective than other hormone therapy. Your body responds to estradiol the same way whether it comes from a patch or a compounded cream. What changes your risk is the hormone, the dose, how it is given and your own health history.
The risks to know about apply to all estrogen and progesterone therapy:
- Blood clots and stroke, more so with estrogen pills than with patches or gels
- A higher risk of breast cancer with long-term combined estrogen and progestogen
- Cancer of the uterine lining if you take estrogen without enough progesterone and still have a uterus
That last point is the main concern with some creams. Progesterone absorbed through the skin from a cream may not be enough to protect the uterus, so if you have a uterus and use estrogen, the progesterone part of your plan needs to be one that is known to work.
Do I need saliva or hormone level testing for BHRT?
Saliva testing is not recommended. Saliva hormone levels change through the day and do not match what is happening in your blood or tissues, so they cannot be used to set a dose.
For menopause, the dose is guided by how you feel, not by a target number. Blood work still has a place:
- To rule out other causes of your symptoms, such as thyroid problems or anemia
- To confirm low testosterone in men on two morning blood tests before treatment
- To check levels when testosterone is prescribed, so they stay in a normal range
- Occasionally, to check estradiol if symptoms are not responding to a dose
What about hormone pellets?
Pellets are small implants placed under the skin that release hormone over several months. Some facts to know if you are considering them:
- Estradiol pellets are compounded and not FDA-approved in the United States
- The only FDA-approved testosterone pellet is labeled for men
- Once placed, the dose cannot be lowered or removed if you have side effects, and levels can run higher than with other forms
If you are using pellets now or thinking about them, bring your questions and your most recent labs to your visit.
Who are bioidentical hormones for?
Hormone therapy, bioidentical or not, is mainly used for:
- Hot flashes, night sweats and broken sleep in perimenopause and menopause
- Vaginal dryness, painful sex and bladder symptoms after menopause
- Protecting bone in women at risk of bone loss
- Early menopause, before about 45
- Men with low testosterone confirmed by blood work
It may not be right if you have had breast or uterine cancer, a blood clot, stroke or heart attack, liver disease, or unexplained vaginal bleeding. For most healthy women, the benefits usually outweigh the risks when hormone therapy starts before 60 or within 10 years of the last period.
Read how hormone replacement works at The Pur Health
How Dr. Munib approaches bioidentical hormones
Dr. Munib prescribes both FDA-approved hormones, many of which are bioidentical, and compounded topical hormone creams mixed by a pharmacy. The choice depends on your symptoms, your history, whether you have a uterus and what you have tried before.
- Your first visit covers your symptoms, periods, sleep and mood, and your personal and family history of clots, stroke, heart disease and breast cancer
- Blood work may be ordered to rule out other causes
- She explains the trade-offs of each form, including what is and is not FDA-approved, so you can decide together
- Follow-up visits check how you feel and any side effects, and the dose is adjusted from there
The care is the same whichever you choose: the same history review, labs and follow-up.
See all hormone care at The Pur Health
If you want to talk through bioidentical hormones, book a visit with Dr. Munib at 114 Pacifica, Suite 280, Irvine. We are in-network with most PPO plans, HSA and FSA cards are accepted, and no referral is needed. Cash visits are $190 for new patients and $150 for returning patients.