Hormone therapy (HRT) for menopause: benefits, risks and 2025-2026 label changes
Hormone therapy replaces some of the estrogen the ovaries stop making, and it is the most effective treatment for hot flashes and night sweats. For most healthy women who start it before 60, or within 10 years of menopause, major guidelines say the benefits usually outweigh the risks.
See a doctor promptly if you have any vaginal bleeding after menopause, a new breast lump, leg pain or swelling, chest pain, sudden shortness of breath, or signs of stroke while using hormone therapy.
What it is
Menopausal hormone therapy (often called HRT) uses estrogen to replace what the ovaries no longer make. Women who still have a uterus are usually also given a progestogen. This is because estrogen alone can thicken the womb lining and raise the risk of womb cancer.3
Systemic hormone therapy reaches the whole body. It comes as pills, skin patches, gels, sprays and rings. Low-dose vaginal estrogen is a separate, local treatment for vaginal and urinary symptoms; see vaginal estrogen.3
What the research shows
A Cochrane review pooled 24 trials with 3,329 women. Oral estrogen, with or without a progestogen, cut how often hot flashes happened by about 75% compared with a placebo. It also made them less severe.1
The Menopause Society (then called NAMS) reviewed the wider evidence in 2022. It said hormone therapy is the most effective treatment for hot flashes and for genitourinary syndrome of menopause. It also prevents bone loss and fractures.2
Timing matters. For healthy women under 60, or within 10 years of their last period, benefits generally outweigh risks. For women who start later, the balance looks less favorable. This is because the absolute risks of heart disease, stroke, blood clots and dementia are higher at older ages.2
The UK guideline body NICE updated its menopause guideline in November 2024. One updated area was the evidence on how HRT affects long-term health.8 Its draft said HRT is unlikely to change overall life expectancy.9
Safety and who should be careful
The main risks named by Mayo Clinic are heart disease, stroke, blood clots, breast cancer, gallbladder disease and womb cancer. Risk depends on your age and health history. It also depends on the type and dose of hormone, how it is taken and how long you use it.3
A history of breast or other cancers, heart disease, stroke, blood clots or liver disease needs a careful talk with a doctor first.3 Skin patches, gels and lower doses may carry a lower risk of blood clots and stroke than pills.2
The Menopause Society has raised concerns about custom-mixed (compounded) "bioidentical" hormones. These products are less tightly regulated, doses can vary, and they lack safety and efficacy data.2
A doctor or pharmacist can check for interactions with other medicines you take.
Recent US label changes (2025-2026)
On November 10, 2025, US health officials and the FDA announced plans to change the "boxed warning" on hormone therapy. This is the most prominent warning a US medicine label can carry.6
The FDA asked makers to remove boxed-warning wording about heart disease, breast cancer and probable dementia. The boxed warning about womb cancer stays on systemic estrogen-only products. Information on heart disease and breast cancer remains elsewhere in the label.5
The FDA also asked for new wording about who may benefit. It says systemic therapy can be considered for moderate to severe hot flashes in women under 60, or within 10 years of menopause.5
On February 12, 2026, the FDA approved the first six updated labels. It said it had asked 29 companies for changes.4 The six included pills, a gel, a vaginal ring and a combined capsule.7 Labels on other products may update over time.
These changes apply to US labels. They do not change the risks themselves, and other countries have their own rules.
How it is available
Systemic hormone therapy is a prescription medicine in the US, UK, EU and most other countries. Which products are offered, and what they cost, varies widely by country.
Decisions about starting, changing or stopping hormone therapy should be made with a doctor, based on your symptoms, age and health history.2
What it is used for: evidence rated
| Option | Evidence | What the research shows |
|---|---|---|
| Hot flashes | Trials show about a 75% drop in hot flash frequency compared with placebo.1 | |
| Night sweats | The same trials found big drops in night sweats as well as daytime flashes.1 | |
| Vaginal dryness | Guidelines call hormone therapy the most effective treatment for genitourinary syndrome of menopause; local vaginal estrogen is often preferred when only vaginal symptoms are present.2,3 | |
| Bone loss | Hormone therapy prevents bone loss and fractures, according to The Menopause Society and FDA.2,4 |
Ratings explained: how we rate. Always talk to a doctor or pharmacist before starting a medicine or supplement.
Related
Sources
- Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes, Cochrane (2004)
- The 2022 hormone therapy position statement of The North American Menopause Society, summary via Australasian Menopause Society (2022)
- Hormone therapy: Is it right for you?, Mayo Clinic
- FDA approves labeling changes for menopausal hormone therapy products, US FDA (February 12, 2026)
- FDA initiates removal of boxed warnings from hormone therapy for menopause, Contemporary OB/GYN (November 10, 2025)
- FDA removes black boxed warning from hormone therapies for menopause, Pharmacy Times (November 10, 2025)
- FDA approves label changes for first batch of menopausal hormone therapy products, Urology Times (February 12, 2026)
- Menopause: identification and management (NG23), update information, NICE (November 2024)
- NICE draft updated guideline recommends more treatment choices for menopause symptoms, NICE (November 2023)