What Women 50-Plus Need to Know About Menopausal Hormone Therapy

Health officials call for the removal of a warning label, hoping to ease confusion among patients

Kim Painter,

AARP

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Published November 10, 2025

illustration of a woman doing a warrior pose in a snowglobe with pills around her

Kiersten Essenpreis

Health officials on Nov. 10 announced plans to remove boxed warning labels from packaging on hormone therapies used to treat menopause symptoms — a change that experts say could encourage more women to seek care for debilitating hot flashes and other symptoms.

Since 2003, these labels have warned that hormone therapy may raise the risk of certain cancers and cardiovascular problems. But women’s health experts say that those dangers have been overstated and that for many women the benefits of treatment outweigh the risks, especially in the early years of menopause.

The Food and Drug Administration will work with companies to update labels “to remove references to risks of cardiovascular disease, breast cancer, and probable dementia,” according to a news release from the U.S. Department of Health and Human Services. For systemic estrogen-alone products, the FDA won’t try to remove warnings for endometrial cancer, the release says.

The changes will affect labels for so-called systemic therapies, like estrogen pills and patches, as well as labels for lower-dose vaginal products.

“The modifications to certain warning labels for estrogen products are years in the making, reflecting the dedicated advocacy of physicians and patients across the country,” Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists (ACOG), said in a statement.

“The updated labels will better allow patients and clinicians to engage in a shared decision-making process, without an unnecessary barrier, when it comes to the treatment of menopausal symptoms,” Fleischman said.

Health officials said that the boxed warning label on hormone therapies has confused women and even deterred them from treating symptoms like hot flashes and vaginal dryness. Research from AARP, published in 2024, found that only 15 percent of women surveyed had tried hormone therapy for menopause symptoms, while nearly half of the women treated their symptoms with supplements.

Many women today find themselves “in the Wild, Wild West,” says Rebecca Thurston, director of the Center for Women’s Biobehavioral Health Research at the University of Pittsburgh.

They may be getting information from unreliable online sources or from medical professionals not following the latest science, she says, which fuels confusion about what hormone treatments can and can’t do and what the risks and benefits are.

Here’s what you need to know about hormone therapy for menopause, including the risks, benefits and questions you should be asking your doctor.

Hormone therapy’s complicated history

Hormone therapies are prescribed to replace the estrogen the body stops making after menopause and can help some women with common menopause symptoms, such as hot flashes and vaginal dryness. In the ’80s and ’90s, Thurston says, “we used to think that hormone therapy was great for all that ailed you, from your skin to your bones to your heart to your brain.”

Then, in 2002, initial results from a large Women’s Health Initiative (WHI) study punctured that balloon. The study, which included postmenopausal women ages 50 to 79, found that hormone pills raised risks of heart disease, stroke, blood clots and breast cancer while offering some protection from bone loss.

“What we learned in the Women’s Health Initiative was that women who started hormone therapy at an average age of 63 had more risks than benefits,” says Dr. JoAnn Pinkerton, a professor of obstetrics and gynecology at the University of Virginia.

The study was mostly designed to see if hormones could prevent diseases, not if they could safely treat symptoms like hot flashes, which are most common in the early menopausal years. That’s “a completely different question,” says Dr. JoAnn Manson, a leading WHI researcher and a professor of medicine at Harvard Medical School.

Subsequent research shows that using hormones to treat symptoms in early menopause can be a reasonable choice for many women, she says. And yet, women and many of their doctors haven’t gotten that message, says Dr. Stephanie Faubion, medical director of the Menopause Society, a group representing medical professionals who treat menopausal symptoms, and director of the Mayo Clinic Center for Women’s Health.

A study published in JAMA Health Forum in 2024 found that just 4.7 percent of postmenopausal women used hormone therapy in 2020, down from 26.9 percent in 1999. Newer unpublished data show even lower use, Faubion says.

“Any way you look at it, there are very few women in the United States actually receiving hormone therapy,” she says. That means many are “undertreated,” she adds, for bothersome, disruptive symptoms.

Who can benefit from hormone therapy?

The FDA says new labels on systemic hormone therapies will recommend starting them within 10 years of menopause or before age 60 – though it says individual decisions remain between women and their doctors. That’s in line with guidelines from the Menopause Society, last updated in 2022.

Those guidelines say that healthy women under age 60 or no more than 10 years past menopause usually see more benefits than risks when they take estrogen or combinations of estrogen and progestogens to ease hot flashes, night sweats and vaginal and urinary symptoms, the Menopause Society says.

With age, risks may rise and benefits may diminish, at least when the hormones come from pills, patches and other “systemic” therapies that significantly raise blood hormone levels, the group says.

But usually women of any age with vaginal dryness, painful sex and symptoms like leaking urine can safely use low-dose vaginal hormone treatments, such as estrogen creams, that don’t significantly raise blood levels, the Menopause Society says.

Other groups, including ACOG and societies representing endocrinologists (hormone doctors), have similar guidelines. All emphasize that hormone therapy is primarily a treatment for menopausal symptoms, with risks and benefits that vary among women.

Systemic hormone therapy is generally not recommended for people with a history of blood clots in the legs or lungs, breast cancer, uterine cancer or heart attack.

It’s also not advised for individuals with coronary artery disease, active liver disease, uncontrolled high blood pressure or undiagnosed genital bleeding.

Hormone therapy choices

Taking hormones for symptom relief is called menopausal hormone therapy (MHT) or just hormone therapy (HT). An older term, hormone replacement therapy (HRT), is best used to describe treatment for women experiencing menopause early, before age 40, Faubion says.

The distinction matters, she says, because women who go through menopause at more typical ages (an average of 52) don’t need to “replace” or restore their hormones to premenopausal levels to get symptom relief.

HT forms include:

Pills containing estrogen alone or estrogen combined with progestin or progesterone, in varying doses and formulations. A woman who still has a uterus needs the combination form, because estrogen alone can raise uterine cancer risks.
Transdermal patches, gels and sprays that deliver the same hormones through the skin.
Vaginal creams, tablets, suppositories or rings that use low doses of estrogen to relieve dryness, painful sex and urinary symptoms. A higher-dose ring can treat body-wide symptoms like hot flashes.

One common point of confusion is whether hormones marketed as “bioidentical” by pharmacies that sell compounded, custom-made mixes are better than menopausal hormone therapies approved by the Food and Drug Administration.

In fact, Faubion says, many FDA-approved products contain bioidentical hormones, which are plant-derived hormones that essentially match those made by the body. Compounded mixes may not have the same purity, potency or effectiveness, she says.

Risks and benefits of hormone therapy

Varying forms and doses of HT have varying risks and benefits for different women, which is why it’s important to work with your doctor to determine the best option for you.

Experts don’t have all the comparative data they’d like. But benefits can include:

Fewer hot flashes and night sweats. Systemic hormone therapy remains the most effective treatment for these symptoms.
Less vaginal dryness and related symptoms, like pain with sex. Systemic and vaginal estrogens (or another vaginal hormone called dehydroepiandosterone, or DHEA) can help. Women who don’t need hot flash treatment can use low-dose vaginal hormones alone if over-the-counter moisturizers and lubricants aren’t enough.
Less bone loss. Systemic hormone therapy is FDA-approved for preventing bone loss in postmenopausal women without osteoporosis.

If hot flashes and night sweats are causing poor sleep and brain fog, hormone therapy could help with those symptoms, too, Faubion says.

In comments accompanying the label change announcement, FDA officials suggested women might also take hormones to reduce their risks of heart disease and dementia, citing decades-old studies.

But, right now, the Menopause Society recommends hormone therapy only for symptom relief and bone loss prevention, not the prevention of other health problems.

ACOG says that hormone therapy might reduce the risk of colon cancer. Recent studies also suggest that combination therapy (estrogen and progestin) may protect against heart attacks in women who start it within 10 years of menopause and are younger than 60, the group says on an information page for patients. But it also says more research is needed and “at this time, combined hormone therapy should not be used solely to protect against heart disease.”

Side effects of hormone therapy can include tender breasts, nausea and irregular vaginal bleeding. More serious risks can include:

More heart disease, if you start systemic hormone therapy more than 10 years after menopause starts. A recent update from the WHI showed particularly high risks in women with hot flashes starting HT after age 70.
More blood clots and strokes. Transdermal products may be less likely to cause these problems.
More breast cancers in some women. This small increased risk amounted to an extra single case in 1,000 women who were WHI participants taking combination therapy for five years. Women who took estrogen alone in the WHI saw no increase in seven years.
An increased risk of dementia in women who start combination hormone therapy after age 65.

An important detail: None of these major risks have ever been found in studies of low-dose vaginal hormone treatments, Manson says. She and other experts urged the FDA to remove the warning label from those products.

The issue is important, Manson says, because many women have worsening vaginal symptoms with age and may not realize vaginal hormones remain an option, whether they’ve ever taken systemic therapy or not.

Stopping hormone therapy

Though doctors strongly consider age when initially prescribing systemic hormone therapy, “we’re not saying that everyone has to be off of hormone therapy by any predetermined age,” Manson says.

In general, she says, it’s a good idea for women on combination therapy “to start thinking about discontinuing” hormones within five to seven years because of the rising breast cancer risk. Some women might safely take estrogen alone for longer than that, she says.

The best policy is to have yearly talks with your doctor about your individual balance of risks and benefits, Pinkerton says. Your age, health, other risk factors and preferences all matter, she says.

Hot flashes and other symptoms may or may not come back after a woman stops using hormones. It’s not clear if stopping “cold turkey” makes symptoms more likely, but many doctors advise tapering off slowly to make the adjustment easier, Pinkerton says.

Alternatives to hormones

Not all women with menopausal symptoms can take or want to take hormones.

Systemic therapy isn’t recommended for those with a history of breast cancer, uterine cancer, unexplained uterine bleeding, liver disease, blood clots or heart disease, according to the Menopause Society, which represents health care professionals specializing in menopause.

Nonhormonal options for hot flashes include:

A newly approved drug called elinzanetant (Lynkuet), which joins fezolinetant (Veozah) and low-dose paroxetine (Brisdelle) as FDA-approved hot flash treatments
Some antidepressant drugs
Gabapentin, a pain and seizure drug
Weight loss and cognitive behavior therapy can also help, according to the Menopause Society.

Women with persistent symptoms can consider lower doses or different formulations — such as switching from pills to patches — to potentially lower their risks, she says. Or they can try nonhormonal options.

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Kim Painter is a contributing writer who specializes in health and psychology. She frequently writes for AARP's Staying Sharp and previously worked as a health reporter and columnist at USA Today.