Menopausal hormone therapy (HRT) is prescription estrogen, alone or with a progestogen, given as pills, patches, gels, sprays or vaginal products around menopause.
- Boxed warning change
- Announced Nov 10, 2025: heart disease, breast cancer and probable dementia to come out of the box [1]
- Still boxed
- Endometrial cancer, on systemic estrogen-alone products [1]
- Label timing advice
- Start systemic HRT within 10 years of menopause onset or before age 60 [1]
- First new labels
- 6 products approved Feb 12, 2026; 29 companies submitted changes [2]
- Generic estradiol
- $19.87 to $24.83 per 90 tablets with a coupon, checked Oct 16, 2026 [3]
What changed on the HRT label
Estrogen products have carried a boxed warning that listed heart disease, breast cancer and probable dementia. In November 2025, HHS announced that FDA would take those three items out of the box. It was not a blanket removal. The endometrial cancer boxed warning stays on systemic estrogen-alone products [1].
FDA asked the makers of these drugs to submit new wording, and 29 companies did. On February 12, 2026, FDA approved the first set of changes for 6 products, covering systemic combination products, systemic estrogen-alone, systemic progestogen-alone and vaginal estrogen [2]. The new labeling recommends starting systemic HRT within 10 years of menopause onset or before age 60, and leaves timing and duration to the prescriber and patient [1].
Your box may still show older wording
We could not confirm which 6 products were in the first batch, or whether every estrogen label has been updated since. Read the leaflet that comes with your prescription and ask the pharmacist if it differs from what you read here.
FDA also noted how few people use these drugs. About 41 million US women were aged 45 to 64 in 2020, but only about 2 million women aged 46 to 65 received a hormone therapy prescription [2].
Who hormone therapy is for
The Menopause Society defines menopause as the final menstrual period, confirmed after 12 months in a row without one. Natural menopause happens at an average age of 52. Perimenopause starts when cycles and symptoms begin to change and lasts until 1 year after menopause [4].
The society's 2022 position statement says the benefits of hormone therapy outweigh the risks for most healthy women with symptoms who are under 60 or within 10 years of menopause [5]. If you are still in perimenopause, ask your prescriber how the label's timing advice applies to you, since it counts from menopause onset.
HRT costs at a glance
| Product | Price | Checked | Source |
|---|---|---|---|
| Generic estradiol tablets, 90 tablets | $19.87 (0.5 mg) to $24.83 (2 mg) with coupon | Oct 16, 2026 | GoodRx [3] |
| Generic estradiol patches, 4 patches | $22.66 to $34.41 by strength with coupon | Oct 16, 2026 | GoodRx [3] |
| Generic estradiol vaginal cream 0.01%, 42.5 g | $36.74 with coupon (retail average $310.37) | Oct 17, 2026 | GoodRx [6] |
| Telehealth menopause visit (Midi Health, self-pay) | $250 first visit, $150 return visit | Oct 17, 2026 | Midi Health [7] |
| Compounded hormone pellets | About $300 to $500 per insertion (clinic estimate) | 2026 | Highland Longevity [8] |
The visit often costs more than the hormone. See HRT cost without insurance for every form, hidden fees and insurance rules, and hormone pellet cost for implant pricing.
Where to get a prescription
- In person. Start with HRT clinics near you, which links our city guides and state medical board lookups.
- A menopause specialist. The Menopause Society runs a practitioner directory [9]. Our guide on how to find a menopause specialist explains how to use it.
- Online. Telehealth clinics such as Midi Health and Evernow prescribe estradiol and progesterone. Evernow's membership starts at $35 a month [10]. Compare them on our online HRT page.
Bioidentical, compounded and pellet hormones
Some clinics sell compounded hormone creams, troches or pellets as "bioidentical." Compounded products are not FDA-approved, and FDA does not review them for safety, effectiveness or quality [15]. A 2020 National Academies review found insufficient evidence for the clinical utility of compounded bioidentical hormone therapy and said its use should be limited to people allergic to an ingredient in an approved product or who need a dosage form that is not available [11]. The Menopause Society lists safety concerns that include overdosing or underdosing, impurities and a lack of sterility [5].
Read more in bioidentical hormones: cost and clinics.
Weight changes and GLP-1 drugs
Falling estrogen shifts fat toward the abdomen, according to a review in Climacteric [12]. Some telehealth menopause clinics now prescribe GLP-1 drugs alongside HRT. Our guide to menopause weight gain covers what the research shows and what the drugs cost.
How to choose an HRT option
- Ask whether the product is FDA-approved or compounded. Approved generics such as estradiol tablets and patches cost under $35 per fill with a coupon [3].
- Ask for the total price: visits, labs, membership fees and the drug itself.
- Check the prescriber's license on your state medical board site, which the Federation of State Medical Boards links for every state [13].
- Check the company's record. We track FDA letters on our FDA warning letter page and rate providers on our reviews page.
- Check your insurance. Coverage depends on the plan, and Medicare Part D can cover the hormones at a cost set by formulary tier [14].
Safety note
Systemic estrogen-alone products still carry a boxed warning for endometrial cancer [1]. Read the boxed warning on your own product's label and ask your prescriber which symptoms should prompt a call. Call 911 in an emergency.
Every hormone therapy guide on this site
- HRT cost without insurance
- HRT clinics near you
- How to find a menopause specialist
- Online HRT for menopause: providers compared
- Bioidentical hormones: cost and clinics
- Hormone pellet cost
- Menopause weight gain: HRT to GLP-1s
- Reviews: Midi Health, Evernow, Alloy, Winona, Gennev, Hers menopause, Biote
- For men: testosterone replacement therapy
In this section
Costs and prices
- Cost guideHormone pellet cost: estradiol and testosterone pellets
- Cost guideHRT cost without insurance
Finding care
By city
Hormone therapy
Questions people ask
Is HRT safe now that FDA changed the boxed warning?
FDA did not declare HRT risk-free. In November 2025 it moved to take heart disease, breast cancer and probable dementia out of the boxed warning, but systemic estrogen-alone products keep the endometrial cancer boxed warning [1]. The new labels recommend starting systemic HRT within 10 years of menopause onset or before age 60 [1].
When did the HRT label change take effect?
How much does HRT cost?
Can I start HRT during perimenopause?
Who should consider menopause hormone therapy?
The Menopause Society's 2022 position statement says benefits outweigh risks for most healthy women with symptoms who are under 60 or within 10 years of menopause [5]. A prescriber decides based on your history.
Are bioidentical hormones safer than regular HRT?
Not on the evidence. Compounded bioidentical hormones are not FDA-approved, and a 2020 National Academies review found insufficient evidence for their clinical utility [11].
Sources
15 cited
- Fact sheet: FDA initiates removal of black box warnings from menopausal hormone replacement therapy products. U.S. Department of Health and Human Services, Nov 10, 2025.
- FDA approves labeling changes for menopausal hormone therapy products. U.S. Food and Drug Administration, Feb 12, 2026.
- Estradiol prices and coupons. GoodRx, Oct 16, 2026.
- Menopause glossary. The Menopause Society, Oct 17, 2026.
- The 2022 hormone therapy position statement of The North American Menopause Society (press release). The Menopause Society (then NAMS), Jul 7, 2022.
- Estrace (estradiol vaginal cream) prices. GoodRx, Oct 17, 2026.
- Pricing and insurance. Midi Health, Oct 17, 2026.
- Cost of hormone pellets. Highland Longevity (clinic marketing page), 2026.
- Find a menopause practitioner. The Menopause Society, Oct 17, 2026.
- How it works. Evernow, Oct 17, 2026.
- Prescribers should restrict the use of non-FDA-approved compounded bioidentical hormones except for specific medical circumstances. National Academies of Sciences, Engineering, and Medicine, Jul 1, 2020.
- Menopause not to blame for weight gain. Monash University (reporting a Climacteric review), Oct 17, 2012.
- Contact a state medical board. Federation of State Medical Boards, Oct 17, 2026.
- Is HRT covered by insurance?. Healthline, Aug 1, 2025.
- Compounding and the FDA: questions and answers. U.S. Food and Drug Administration, 2025-09-16 (accessed 2026-10-17).
This page is general information, not medical advice. Talk with a licensed clinician about your own care.