Impulsive, anxious, overheated, scatter-brained, depressed and in pain are just some of the terms that many women use to describe themselves when they reach perimenopause, or the years that precede reaching menopause. These descriptions were brought on by the mental and physical symptoms caused by declining hormonal levels.
Yet after starting hormone replacement therapy (HRT), also called hormone therapy, these same women say they finally have relief from these symptoms. They describe feeling like they’ve “lost” years of their lives to the impact of hormonal changes, but regain clarity and sense of self after HRT.
Over the past few decades, controversy surrounding HRT’s side effects has led to declining rates of use.
However, thanks to the efforts of doctors, researchers and medical institutions, the Food and Drug Administration announced in November 2025 it would remove a misleading black box warning from combination HRT therapy products that has historically discouraged women from taking hormone therapy.
What Is Hormone Replacement Therapy?
Hormone replacement therapy is a medical treatment that uses estrogen and progestin, a form of progesterone, to help reduce symptoms women may experience in perimenopause and menopause, when these hormones naturally decrease.
The surgical removal of the ovaries, an oophorectomy, is often performed to prevent or treat ovarian cancer. This procedure can induce early menopause, a condition referred to as surgical menopause, and is often treated with HRT to reduce the risk for heart disease and bone loss.
Also referred to as hormone therapy (HT), this treatment can also be used in other circumstances, such as for infertility, cancer or gender transition, says Dr. Kecia Gaither, double board-certified in OB-GYN and maternal fetal medicine and director of perinatal services/maternal fetal medicine at NYC Health + Hospitals/Lincoln in the Bronx, New York.
Types of hormone replacement therapy
HRT is available in two main forms:
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A health care professional will review the pros and cons of each form of hormone therapy based on any other health conditions you may have and your individual needs. For example, if you have psoriasis, you may want to avoid a patch as it’s placed on the skin and instead opt for a pill.
The 2025 FDA announcement of the removal of the black box label will apply to combination therapy products and low-dose estrogen-only therapy. However, systemic estrogen-only medications, like the estrogen-only pills, will retain their warning labels.
[At-Home Menopause Tests: Pros and Cons, What They Test and When to See a Provider]
Benefits of Hormone Replacement Therapy
Hormone therapy in perimenopausal and menopausal women can help treat several symptoms including:
— Hot flashes
— Joint aches
— Night sweats
— Bone loss
— Vaginal dryness, which also may lead to painful intercourse
Although some women going through menopause may have virtually no symptoms, others may experience many symptoms.
In fact, an estimated 80% of women will experience hot flashes during or around menopause, according to the American College of Obstetrics & Gynecology.
Hot flashes can occur as frequently as six times a day, disrupting sleep and mental well-being. As a result, these symptoms can significantly affect a woman’s quality of life.
“You’re going to be irritable, and you’re not going to be a very pleasant person to be around,” Dr. Wen Shen, associate professor of clinical gynecology and obstetrics and director of the Women’s Wellness & Healthy Aging Program at Johns Hopkins Medicine in Baltimore.
[READ: The Menopause Diet: The best diet plan for mitigating symptoms and weight gain.]
Risks of Hormone Replacement Therapy
Hormone therapy has certain risks; however, the extent of these risks may vary depending on the HRT preparation, dosage and method of use.
— Blood clots. The risk for blood clots increases a small amount when using oral hormone therapy. Skin and vaginal use of hormone therapy aren’t metabolized through the liver, so the risk associated with blood clots is lower. If you’re already at a higher risk for blood clots, talk with your health care professional about the best options for you.
— Breast cancer. The risk for breast cancer increases the most after three to five years of estrogen plus progestin therapy and after seven years of using vaginal estrogen hormone therapy, according to The Menopause Society.
— Endometrial and ovarian cancers. The risk of endometrial and ovarian cancers is lowered when both estrogen and progestin are used versus estrogen alone, according to an analysis of clinical trial data presented at the 2024 American Society for Clinical Oncology meeting.
— Heart attacks. Although heart attack risk can increase when HRT is used in women age 70 and older, the risk isn’t present in postmenopausal women who are younger than this, according to a November 2025 study in JAMA Internal Medicine.
It’s important to consider if hormone therapy is right for you. Your health care professional may advise against HRT if you have a history of:
— Abnormal vaginal bleeding
— Blood clots
— Breast, ovarian or uterine cancer
— Heart attack
— Stroke
It’s important to talk to your health care professional, specifically from a health care professional who specializes in hormone therapy and menopause, about the benefits and risk factors based on your medical history.
If a woman is having hot flashes or other menopausal symptoms at age 60 or beyond, health care professionals will typically discuss nonhormonal treatments. Some women may choose to continue hormone therapy beyond age 60 despite associated risks.
[READ: Health Questions to Ask Your Doctor]
Side Effects of Hormone Therapy for Menopause
Not everyone using hormone therapy for menopause will have side effects from it, but certain side effects may occur.
Common side effects of hormone therapy include:
— Breast sensitivity
— Irritation on the skin where the hormonal patch is placed
— Mood changes
— Vaginal bleeding
Hormone therapy isn’t associated with weight gain, although weight gain may occur during menopause due to decreasing estrogen levels.
Changes to Hormone Replacement Therapy Guidance
The November 2025 announcement that the FDA would be removing the broad “black box” warning from most hormone replacement therapies for menopause comes after decades of pushback from gynecologists, patients and medical organizations. Specifically, the FDA will remove warnings related to the risk of cardiovascular disease, breast cancer and probably dementia — all of which were based on a flawed 2002 study from the Women’s Health Initiative.
The shift in messaging comes as a result of new research showing benefits outweigh risks for many when started early.
Here’s a brief history of the misconceptions and controversy surrounding HRT.
1960s through 1990s: Hormone therapy was regularly recommended to treat menopause symptoms and to prevent chronic health conditions, like heart disease and dementia. Initially, estrogen-only HRT was used, but after findings of increased risk of endometrial cancer, progestin was added to create the combination HRT.
2002: A study from the Women’s Health Initiative, which included 68,000 women between the ages of 50 and 79, focused on the effects of estrogen plus progestin hormone therapy and found that it raised the risk for blood clots, breast cancer, dementia, heart attacks and stroke. This led to a marked decrease in the use of HRT.
However, the average age of women in the study was 65, or 14 years beyond the average age for menopause. That represents a long time period when the body may undergo a variety of health changes, including development of a greater risk for blood clots and heart disease.
The decrease in HRT use “was rather unfortunate because we’re still suffering from the consequences of that misinterpreted result,” Shen says. “To this day, I have patients who come to me and say their doctor refused to prescribe hormone therapy for them even though they’re having horrific symptoms.”
2025: The FDA announced that it will initiate the removal of black box warnings on hormone therapy products for menopause and is working with companies to update product labeling and remove references to the risk of health issues, such as cardiovascular disease, breast cancer and probable dementia. Instead, age-specific guidelines will be printed on the medication, indicating its long-term benefits for those who are within 10 years of the onset of menopause.
The FDA is not seeking to remove the label warning for endometrial cancer from systemic estrogen-alone products. However, the warning will be removed from products with combined estrogen and progesterone and low-dose vaginal estrogen therapies.
“For women who are under the age of 60 and within 10 years of menopause onset, the benefits (of hormone therapy) will typically outweigh the risks,” says Dr. Stephanie Faubion, director of the Mayo Clinic Center for Women’s Health and medical director of The Menopause Society. She hopes that more women will be offered and will use hormone therapy to manage their menopause symptoms and prevent bone loss.
Both ACOG and The Menopause Society issued statements in support of the black box warning label removal.
Other Ways to Manage Hot Flashes and Other Menopause Symptoms
If you don’t qualify for hormone therapy, there are other options to help with hot flashes and related menopause symptoms:
— Nonhormonal menopause drugs. Two drugs specifically geared toward menopause hot flashes are fezolinetant and elinzanetant. Additionally, a generic version of Premarin (conjugated estrogens) was also approved in November 2025 for moderate to severe hot flashes and night sweats.
— Antidepressants. Low-dose antidepressant drug paroxetine is approved by the Food and Drug Administration to treat hot flashes.
— Birth control pills. In women who are perimenopausal, the use of birth control pills, another type of hormone therapy, is an option. These have the dual purpose of preventing pregnancy.
— Lifestyle changes. Lifestyle changes such as regular exercise, avoiding hot drinks, adopting a plant-based diet and reducing stress can improve symptoms.
Shen cautions against spending lots of money on herbs and supplements that are said to help with menopause, as their effectiveness is often not based on medical evidence. Plus, they aren’t regulated by the FDA like prescription drugs are.
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Hormone Replacement Therapy for Menopause originally appeared on usnews.com
