Is HRT Safe? Risks, Benefits and What Changed in 2025

Is HRT safe? The Menopause Society says the benefits particularly outweigh the risks when HRT is used in early menopause to relieve hot flashes, night sweats and sleep problems, which generally means starting before age 60 or within 10 years of menopause. It is not risk-free. Depending on the type, HRT can raise the risk of blood clots, stroke, breast cancer and uterine cancer, and some women should not take it at all.

This guide sets out the risks, the benefits, what changed in the official warnings in 2025, and how risk is kept as low as possible.

Is HRT safe for most women?

The Menopause Society’s position is that, for most women, hormone therapy helps control moderate to severe symptoms when started within 10 years of menopause or under age 60. It adds that the balance depends on your own medical history.

The Endocrine Society explains where the earlier fears came from. In 2002 a large trial, the Women’s Health Initiative, reported that risks outweighed benefits. The women in it were aged 50 to 79. Later analyses by age and time since menopause found that “risks are very small” when hormone therapy is started before age 60 or within 10 years of menopause.

The risks of HRT

The American College of Obstetricians and Gynecologists (ACOG) lists these:

Uterine cancer. Estrogen alone thickens the lining of the uterus, which increases the risk of endometrial cancer. Adding progestin decreases this risk.
Breast cancer. Combined therapy is associated with a small increased risk.
Heart attack. Combined therapy is associated with a small increased risk for older women. The risk may be related to age, existing conditions and when therapy is started.
Stroke and blood clots. Both types are associated with a small risk, which rises with age, heart disease, kidney disease and obesity.
Gallbladder disease. There is a small increased risk, greatest with pills.

On timing, The Menopause Society says the breast cancer risk usually does not rise until after about five years of combined therapy, or seven years of estrogen alone, and that the stroke risk goes away soon after stopping.

The benefits to weigh against them

ACOG describes systemic estrogen as the best treatment for hot flashes and night sweats. Systemic and local estrogen both relieve vaginal dryness, and systemic estrogen protects against early bone loss.

The Menopause Society adds that hormone therapy helps prevent fractures later in life, and that starting within 10 years of menopause could lower the risk of cardiovascular disease. ACOG is more cautious on that last point. It says more research is needed and that combined therapy should not be used solely to protect against heart disease.

What changed in 2025

In November 2025 the FDA announced that it was initiating the removal of the broad boxed warnings from menopause hormone products. It said it was working with manufacturers to remove label references to cardiovascular disease, breast cancer and probable dementia.

Two details matter:

the boxed warning about endometrial cancer for systemic estrogen-alone products stays;
the FDA’s labeled recommendation is to start systemic HRT within 10 years of menopause or before age 60.

The change does not mean HRT has no risks. The risks ACOG and The Menopause Society describe above still apply, and the decision is still an individual one.

Who should not take HRT

ACOG says systemic hormone therapy is usually not recommended if you have ever had breast or endometrial cancer, a stroke, a heart attack, blood clots or liver disease. The FDA and MedlinePlus add pregnancy and unexplained vaginal bleeding.

If one of these applies to you, ask about non-hormonal options. Our guide What is HRT? lists them.

How the risks are kept low

Start at the right time. Before age 60 or within 10 years of menopause.
Choose the form carefully. ACOG says patches, sprays and rings may pose less clot risk than pills. The Menopause Society says the same of transdermal estrogen.
Use local therapy if dryness is the only symptom. Very little reaches the bloodstream, so the risks are far lower.
Take progestin if you have a uterus. It protects the uterine lining.
Use the lowest dose that helps, as the FDA advises.
Review it every year. ACOG recommends an annual conversation about whether to continue.
Use FDA-approved products. The FDA recommends them over compounded hormones. See our guide to bioidentical hormone therapy.

HRT is for symptoms, not prevention

The U.S. Preventive Services Task Force recommends against using hormone therapy for the primary prevention of chronic conditions in postmenopausal women who have no symptoms. That recommendation does not apply to women treating hot flashes or vaginal dryness, or to those with premature or surgical menopause.

Frequently asked questions

Is HRT safe long term?

There is no fixed limit. The Menopause Society says there is no “right” time to stop, but that risks may be greater with longer use and with age, so the decision is reviewed regularly.

Does HRT cause weight gain?

The Menopause Society says hormone therapy is not associated with weight gain.

Is HRT safe after 60?

The favourable evidence is for starting before age 60 or within 10 years of menopause. ACOG notes the small increased heart attack risk is for older women. This is a decision to make with your clinician.