Is Biote Safe? What the Evidence Says About Hormone Pellets

Is Biote safe? The short answer

Biote is a company that trains clinicians to deliver hormone therapy as pellets: small cylinders of estradiol or testosterone placed under the skin of the upper buttock, which slowly dissolve over three to six months, according to Biote’s FAQ. The hormones themselves are well studied. The open questions are about the delivery method and the compounding.

So whether Biote is safe for you depends on three things: whether hormone therapy is safe for you at all, how high the pellet pushes your hormone levels, and how closely your clinic monitors you. The evidence so far points to real trade-offs:

• Pellets are compounded and are not FDA-approved.
• They can produce hormone levels well above the normal female range, especially for testosterone.
• Once inserted, the dose can’t be lowered, and the pellet isn’t designed to be removed.
• Long-term outcome studies, the kind that answer questions about breast cancer, heart disease and the uterus, have not been done.

Are Biote pellets FDA-approved?

No. Biote pellets are prepared by compounding pharmacies. Biote says the pharmacies it works with test their ingredients carefully. Even so, as the FDA explains, compounded drugs are not FDA-approved, which means the agency does not review them for safety, effectiveness or quality before they are used. There is also no FDA-approved testosterone product for women in the US, as ACOG notes.

“Bioidentical” doesn’t settle the question either. It means the hormone has the same structure as the one your body makes, and many FDA-approved estradiol and progesterone products are bioidentical too. A 2020 National Academies report found little evidence that compounded bioidentical hormones are safer or more effective than approved products. Our comparison of Biote and compounded hormone creams covers the differences between compounded forms.

What does research show about pellet safety?

Hormone levels can go well above normal

The clearest study is a 2021 review of medical records from 539 postmenopausal women, 384 on pellets and 155 on FDA-approved hormone therapy. Compared with the FDA-approved group, the pellet group had:

• More side effects overall: 57.6% versus 14.8%.
• More abnormal uterine bleeding among women with a uterus: 55.3% versus 15.2%.
• More hysterectomies: 20.3% versus 6.3%.
• Much higher average peak levels: estradiol of about 238 versus 93 pg/mL, and testosterone of about 194 versus 16 ng/dL. Four pellet users had estradiol above 1,000 pg/mL, and nine had testosterone above 400 ng/dL.

This was a records study from one health system, not a randomized trial, so it can’t prove pellets caused every difference. But it fits other evidence. A 2025 review of 38 studies found testosterone pellets produce early peaks above the female range with wide person-to-person variation, and concluded that their safety “cannot be confirmed” without better trials. For comparison, ACOG advises keeping testosterone in women within 20 to 80 ng/dL.

By the numbers

Pellets vs FDA-approved hormone therapy

57.6%of pellet users had side effects, vs 14.8% on FDA-approved therapySource: Records review 2021

55.3%of pellet users with a uterus had abnormal bleeding, vs 15.2%Source: Records review 2021

20.3%of pellet users had a hysterectomy, vs 6.3%Source: Records review 2021

The dose can’t be adjusted or reversed

With a pill, patch or cream, a dose that is too high can be lowered the next day. With a pellet, it keeps releasing hormone until it dissolves. ACOG recommends preparations other than pellets for testosterone because of “the lack of safety data and inability to remove the pellet.” This is also the most common complaint in Biote reviews.

Estradiol pellets depend on careful dosing

A 2025 review of estradiol pellets found that after a peak in the first week, levels stay fairly steady for four to six months and pellets relieve hot flashes and help bone density. It linked the main safety concerns, including bleeding, tachyphylaxis (needing pellets sooner as symptoms return despite high levels) and above-normal levels, to excessive dosing, re-inserting pellets too early, and not protecting the uterine lining with a progestogen. It also noted that protocols aren’t standardized.

Side effects

Common effects include acne, oily skin and unwanted hair growth from testosterone; breast tenderness, fluid retention and spotting from estrogen; and soreness, bruising, infection or pellet extrusion at the insertion site. Some androgen effects, such as voice changes, may not reverse. See our full guide to hormone pellet side effects.

What do The Menopause Society, ACOG and the Endocrine Society say?

Major medical groups agree that FDA-approved hormone therapy should come first, and they raise specific concerns about compounded pellets.

Sources: Menopause Society 2022, ACOG 2023, Endocrine Society, Davis 2019.

What are the outcomes of Biote and other pellet therapy?

Pellet studies do report benefits: fewer hot flashes, better sexual function, mood and energy, and higher bone density. The limits are in how those studies were done. The 2025 review found only one randomized controlled trial of testosterone pellets; the rest were observational, often unblinded, used varied doses and sometimes had conflicts of interest. ACOG noted that a 10-year cohort reporting lower breast cancer rates in testosterone pellet users was limited by mixing premenopausal and postmenopausal women, adding anastrozole to many pellets, losing most participants to follow-up, and comparing against a historical control group. The Endocrine Society notes that no clinical outcomes trials of compounded hormones have been completed.

Who should avoid hormone pellets?

Pellets are a form of hormone therapy, so the usual cautions apply, and the fixed dose makes some situations riskier. Talk to a clinician before considering pellets if you have:

• A history of breast, uterine or another hormone-sensitive cancer.
• A past blood clot, stroke, heart attack or known heart disease.
• Liver disease or unexplained vaginal bleeding.
• A uterus and no plan for a progestogen to protect the lining.
• Strong sensitivity to acne, hair growth or other androgen effects.
• No experience with hormone therapy yet. Many clinicians prefer to find a dose that works with an adjustable form first.

Your age, time since menopause and personal history all shape the balance of benefits and risks, as the National Institute on Aging explains. A licensed clinician should review these with you.

Is Biote worth it?

Some women value not having a daily routine and are happy with pellets, particularly once they have a stable dose. Others find that the cost, the insertion visits and the fixed dose outweigh the convenience. Pellets, insertion fees and labs are usually paid out of pocket; our guide to what Biote costs breaks down typical spending. Many FDA-approved estradiol and progesterone products are covered by insurance, and you can change or stop them quickly. If you are considering testosterone for libido, our guide to Biote HER-T and testosterone for women covers that evidence.

Amie HRT+ is another option for menopause symptoms: a compounded cream combining estradiol and progesterone, at a strength chosen by a licensed clinician after an online review. Like Biote pellets, it is compounded and not FDA-approved. The practical difference is adjustability: there’s no procedure, and if the strength needs to change, the clinician adjusts the next prescription. A clinician decides whether it is right for you.

Questions to ask a Biote clinic

• Which hormones will be in my pellet, at what dose, and why?
• What hormone levels are you aiming for, and which lab test will you use to check testosterone?
• When will you recheck my levels and symptoms after insertion?
• What is the plan if my levels are too high or I have side effects before the pellet dissolves?
• If I have a uterus, how will my uterine lining be protected?
• Which pharmacy compounds the pellets?
• Would an FDA-approved patch, gel, pill or cream work for me instead?