Hormone Therapy for Menopause: Benefits, Risks, and Who It's For

Key takeaways

• Hormone therapy is the most effective treatment for hot flashes and night sweats. It also treats vaginal dryness and helps prevent bone loss.
• For most healthy women under 60, or within 10 years of menopause, who have bothersome symptoms, The Menopause Society concludes that the benefits generally outweigh the risks.
• The FDA has begun removing boxed warnings about heart disease, breast cancer, and dementia from hormone therapy labels. Those risks are still described in the labels, and the boxed warning for endometrial cancer remains on estrogen-only products.
• Risk depends on your age, time since menopause, health history, the type and dose of hormone, the route, and whether you have a uterus.
• The research in this article comes from FDA-approved products. Compounded hormones are not FDA-approved, and the findings can't be assumed to apply to them.
• Hormone therapy is not recommended to prevent heart disease, dementia, or other chronic diseases.

About the research in this article. The studies and FDA label changes described here involve FDA-approved hormone products, including Premarin (conjugated estrogens), Prempro (conjugated estrogens with medroxyprogesterone acetate), and other approved estradiol and progestogen pills, patches, gels, and vaginal products. Compounded hormone preparations are not FDA-approved, and the FDA does not review compounded drugs for safety, effectiveness, or quality before they are marketed. [14] The results described below cannot be assumed to apply to compounded versions.

What is hormone therapy for menopause?

Hormone therapy for menopause replaces some of the estrogen the ovaries stop making around menopause. You will see it called menopausal hormone therapy (MHT) or hormone replacement therapy (HRT). The terms mean the same thing.

There are three main types:

• Estrogen-only therapy. Usually for women who have had a hysterectomy. It comes as pills, skin patches, gels, sprays, or a vaginal ring. [1]
• Estrogen plus a progestogen. For women who still have a uterus. Estrogen alone can thicken the uterine lining and raise the risk of endometrial (uterine) cancer, so a progestogen is added to protect it. [1]
• Low-dose vaginal estrogen. A cream, tablet, insert, or ring used locally for vaginal dryness, irritation, and painful sex. It acts mainly on vaginal and urinary tissue rather than the whole body. [1]

The first two are called systemic therapy, because the hormones circulate through the body. The distinction matters: systemic therapy and low-dose vaginal estrogen have quite different benefits and risks.

Hormone therapy is used for symptoms that begin during the menopause transition and can continue after it. If you are still having periods and aren't sure whether your symptoms are hormonal, our guide to perimenopause symptoms covers the early signs and what to get checked.

FDA-approved vs. compounded hormones

You will often see the word "bioidentical." It means a hormone has the same chemical structure as one your body makes. Several FDA-approved products already meet that definition, including estradiol patches, gels, and pills, and micronized progesterone. [2]

Compounded hormones are different. A compounding pharmacy mixes them for an individual patient, and they are not FDA-approved. [14] A 2020 review by the National Academies of Sciences, Engineering, and Medicine found insufficient evidence that compounded bioidentical hormones are safer or more effective than FDA-approved products. It recommended limiting them to specific situations, such as an allergy to an ingredient in an approved product or a need for a dose or form that isn't commercially available. [12] The Menopause Society has also raised concerns about inconsistent dosing, purity, and limited safety data for compounded hormones. [2]

If a clinician recommends a compounded product, it is reasonable to ask why an FDA-approved option isn't the better fit for you and what is known about the specific preparation.

What hormone therapy can help with

The Menopause Society's 2022 position statement, the main U.S. clinical guidance on this topic, describes hormone therapy as the most effective treatment for hot flashes and night sweats (vasomotor symptoms). It is also effective for genitourinary symptoms of menopause, such as vaginal dryness, and for preventing bone loss and fracture. [2] The FDA-approved uses of these products line up with this. [1]

What it is not for: the Women's Health Initiative (WHI), the largest set of randomized hormone therapy trials, does not support using hormone therapy to prevent heart disease, dementia, or other chronic diseases. [3] It is also not a weight-loss treatment.

Why the advice on HRT changed

In 2002, early results from the WHI linked one specific regimen, oral Prempro (conjugated estrogens plus medroxyprogesterone acetate), to higher rates of breast cancer, heart disease, stroke, and blood clots. In 2003 the FDA added a boxed warning, its strongest label warning, to all estrogen products, and hormone therapy use dropped sharply.

Two things later became clearer. First, the average WHI participant was in her 60s and more than a decade past menopause, which is older than most women who start therapy for symptoms. Later analyses found that risks were lower, and in some cases absent, in women who started in their 50s. [3] Second, the warnings were applied to every dose, formulation, and route, including low-dose vaginal products, even though they were based mainly on oral conjugated estrogen regimens. [4]

What the FDA changed in 2025 and 2026

On November 10, 2025, HHS and the FDA announced they would ask manufacturers to remove references to cardiovascular disease, breast cancer, and probable dementia from the boxed warnings on hormone therapy products. [5] [7] Twenty-nine companies submitted proposed label changes, and in February 2026 the FDA approved a first batch of six updated labels covering combined therapy, estrogen-only therapy, progestogen-only therapy, and vaginal estrogen. [6] Because the rollout is happening in batches, some products may still carry the older warning.

The new labels also recommend starting systemic hormone therapy within 10 years of menopause or before age 60, and they leave decisions about timing and duration to you and your prescriber. [5]

What did not change:

• The boxed warning for endometrial cancer stays on systemic estrogen-only products, because estrogen without a progestogen raises that risk in women with a uterus. [5]
• The risks of cardiovascular disease and breast cancer are still described in the Warnings and Precautions section of the labels. [1]

In short, the change puts risk in proportion. It does not declare hormone therapy risk-free, and some women's health groups cautioned that labels should still reflect evidence-based risks. [13] The label changes apply to FDA-approved products.

The risks, in context

Hormone therapy is neither simply "safe" nor "dangerous." Here are the main risks and what affects them.

Blood clots and stroke

Oral estrogen increases the risk of blood clots in the veins, and the route makes a real difference. In a large UK study of licensed prescription HRT that compared more than 80,000 women who had blood clots with women who did not, oral HRT was linked to about 58% higher odds of a clot. Transdermal estrogen (patch, gel, or spray) showed no significant increase. [8] The study was observational, so it can't prove cause and effect, but it matches The Menopause Society's view that transdermal routes and lower doses may reduce clot and stroke risk. [2]

Breast cancer

A large analysis of worldwide observational studies of prescription hormone therapy found that most types of systemic therapy were associated with higher breast cancer risk, and that risk rose with longer use. [9] The risk was higher with estrogen plus a progestogen than with estrogen alone. If the associations are largely causal, the authors estimated that five years of use starting at age 50 would lead to about one extra breast cancer for every 50 women using estrogen plus a daily progestogen, and about one for every 200 women using estrogen alone. Vaginal estrogen was not associated with excess risk in that analysis. [9]

These estimates come from observational data and are debated. The randomized WHI trials found something different for estrogen alone: in women who had had a hysterectomy, Premarin (conjugated estrogens) alone did not increase breast cancer risk. [3] Your own baseline risk matters, and it is worth discussing with a clinician.

Endometrial cancer

Systemic estrogen alone raises the risk of endometrial cancer in women with a uterus. Adding a progestogen addresses this, which is why combined therapy is standard for women who have not had a hysterectomy. [1] [5]

Why timing matters

Much of the risk debate comes down to age and time since menopause. The Menopause Society concludes that for women under 60, or within 10 years of menopause, without contraindications, the balance of benefits and risks is generally favorable. For women who start more than 10 years after menopause or after age 60, it is less favorable, because the absolute risks of heart disease, stroke, blood clots, and dementia are higher. [2] Women already using hormone therapy don't need to stop automatically at a certain age. Continuing can be reasonable after a review with a clinician. [2]

Who may not be a good candidate

Systemic hormone therapy is usually not recommended if you have: [10]

• A history of breast cancer or endometrial cancer
• A history of stroke or heart attack
• A history of blood clots in the veins or lungs
• Liver disease

Other factors call for a more careful discussion and may affect which type, dose, or route makes sense. These include heart disease risk factors, high triglycerides, gallbladder disease, and a strong family history of breast cancer. [11] Unexplained vaginal bleeding should always be evaluated before you start treatment.

Low-dose vaginal estrogen is a different conversation. The Menopause Society notes it may be an option even for some breast and endometrial cancer survivors whose symptoms haven't responded to nonhormonal treatment, decided together with their oncologist. [2] For women who can't or prefer not to use hormones, the FDA has also approved nonhormonal medicines for hot flashes. [1]

Pill, patch, or gel? Formulations and routes

Option	How it is used	What to know
Oral estrogen	Daily pill	Well studied and convenient. Linked to higher blood clot risk than transdermal routes. [8]
Transdermal estrogen	Patch, gel, or spray on the skin	Not linked to higher clot risk in large observational studies. Often preferred for women with some cardiovascular risk factors. [2] [8]
Progestogen	Pill, or combined with estrogen in some patches	Needed with systemic estrogen if you have a uterus. [1]
Vaginal estrogen	Cream, tablet, insert, or ring	Treats vaginal and urinary symptoms with minimal effect on the rest of the body. Does not treat hot flashes. [1]

Questions to ask your clinician

• Based on my age, health history, and time since menopause, how do my benefits and risks compare?
• Do I need a progestogen? Which type?
• Would a patch or gel suit me better than a pill?
• Would vaginal estrogen alone address my symptoms?
• Is the product you're recommending FDA-approved or compounded, and why that one?
• How will we decide how long to continue, and when will we review it?
• What nonhormonal options are available if hormone therapy isn't right for me?

The bottom line

Hormone therapy is the most effective treatment for menopause symptoms such as hot flashes and night sweats. For many healthy women who start within 10 years of menopause or before 60, current guidance finds that the benefits outweigh the risks. It still carries real risks, which vary with the type of hormone, route, dose, timing, and your personal history. The right decision is an individual one, made with a clinician who knows your history.

If you'd like to talk through whether hormone therapy might be appropriate for you, Stone's clinician-guided menopause care starts with a review of your symptoms and health history, including whether hormone therapy is a good fit at all. You can also send our team a question.

This article is for educational purposes only and is not medical advice. Hormone therapy is a prescription treatment. Talk with a licensed clinician about whether it is appropriate for you.