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In November 2025, the U.S. Food and Drug Administration (FDA) announced plans to remove a black box warning from hormone therapy products for menopause.

The FDA placed the black box warning on hormone therapy products in 2003 because of potential health risks. However, the potential benefits outweigh the risks for many people, the FDA says.

There is a lot of misinformation and confusion about hormone therapy for menopause. In this article, discover common hormone therapy myths. Learn about hormone therapy benefits and risks, and get information on midlife wellness strategies.

Is Hormone Therapy Safe for Menopause?

Myth: Hormone therapy for menopause is dangerous.

Fact: Hormone therapy to treat menopausal symptoms can help many women.

The FDA placed a black box warning on hormone therapy for menopause in 2003. The decision came in the wake of a 2002 study that identified several potential long-term risks of the treatment, including:

• Blood clots
• Breast cancer
• Dementia
• Heart disease
• Stroke

The FDA placed a black box label on hormone therapy products to warn consumers of breast cancer, cardiovascular disease, and dementia risks. Estrogen-only hormone therapy products also received a label warning about an increased risk of endometrial cancer. Use of hormone therapy products dropped significantly after the decision.

However, the average age of women in the study was 63. That’s older than when many people would begin hormone therapy, the FDA says. People who begin hormone therapy before age 60 or within 10 years of symptom onset face a lower risk, the FDA adds.

Hormone therapy also carries many potential benefits. It can reduce debilitating menopause symptoms such as:

• Bone loss.
• Hot flashes and night sweats.
• Incontinence.
• Painful sexual intercourse.
• Urinary tract infections.
• Vaginal dryness.

But hormone therapy is not right for everyone. It may carry a risk of:

• Blood clots.
• Breast cancer.
• Endometrial cancer (for estrogen-only therapy).
• Gallbladder disease.
• Heart disease (especially in older women).
• Stroke.

People with a personal or family history of these conditions may not be candidates for hormone therapy. You should talk to your ob-gyn about your personal benefit-to-risk ratio to make an informed decision.

What Are the Types of Hormone Therapy?

Myth: All hormone therapy is the same.

Fact: There are several distinguishing factors of hormone therapy.

There are two major types of hormone therapy: estrogen-only and combination therapy.

• Estrogen-only therapy — Estrogen-only therapy boosts your level of estrogen. Your body’s estrogen production drops sharply after menopause.
• Combination therapy — Along with estrogen, your body also produces less of the hormone progesterone after menopause. Combination therapy includes estrogen and progestogen to boost your body’s levels of these hormones.

Hormone therapy can also be systemic or local.

• Systemic hormone therapy — This type of hormone therapy addresses systemwide menopause symptoms, such as hot flashes, night sweats, and bone loss.
• Local hormone therapy — This type of therapy can improve vaginal and bladder health. It restores and maintains healthy vaginal tissue, improving elasticity, thickness, and moisture. This can address symptoms of dryness and other vaginal symptoms related to menopause.

Beyond these differences, hormone therapy can come in many different forms, including:

• Creams
• Gels
• Injections
• Pills
• Skin patches
• Sprays
• Vaginal rings

The various types and delivery methods of hormone therapy come with different benefits and risks, too. That’s why it’s so important to talk to your ob-gyn about the best option for you.

Does Hormone Therapy Cause Cancer?

Myth: Hormone therapy raises your risk of breast and endometrial cancer.

Fact: Your cancer risk depends on the type of hormone therapy you receive, along with other factors.

There is a slightly higher risk of breast cancer with hormone therapy. But the absolute risk is very low.

According to the Menopause Society, the risk of breast cancer doesn’t begin to rise until after five years of combination therapy or seven years of estrogen-only therapy. Estrogen-only therapy has also been associated with a 22% decreased lifetime risk of breast cancer.

Estrogen-only hormone therapy can raise your risk of endometrial (uterine) cancer. Taking progestogen can lower this risk. In fact, combination therapy can decrease the risk of endometrial cancer. People who have not had a hysterectomy should have combination hormone therapy (estrogen and progestogen).

On the positive side, hormone therapy has been associated with a lower risk of colorectal cancer.

Does Hormone Therapy for Menopause Increase the Risk of Heart Disease?

Myth: Hormone therapy for menopause increases your risk of heart disease.

Fact: The heart disease risk with hormone therapy depends on many factors, including when you begin it.

The Women’s Health Initiative trial that led to the black box warning on hormone therapy reported that hormone therapy led to a higher risk of heart disease, stroke, and venous thromboembolism (VTE).

More recent research indicates that the timing of hormone therapy matters for heart disease risk.

Women who begin hormone therapy before age 60 or within 10 years of menopause onset face a lower cardiovascular risk.

Hormone therapy itself is not recommended to prevent heart disease at this time. Ongoing studies are exploring this possibility. More data should be available in the future.

Beginning hormone therapy after age 60 or more than 10 years after menopause onset carries higher cardiovascular risks.

Other factors that may affect your cardiovascular risk include:

• The delivery method of hormone therapy (transdermal hormone therapy versus oral hormone therapy).
• The type of hormone therapy (estrogen-only therapy versus combined therapy).
• Your other cardiovascular risk factors, such as obesity, type 2 diabetes, high cholesterol, and high blood pressure.

Talk to your provider about your specific risks for hormone therapy.

Does Hormone Therapy Cause Weight Gain?

Myth: Hormone therapy makes you gain weight.

Fact: Hormone therapy is not associated with weight gain.

Weight gain can occur as we get older and our hormones change, and it’s common during menopause.

But hormone therapy itself does not cause weight gain.

There are some common side effects of hormone therapy, which include:

• Bloating.
• Breast tenderness.
• Headaches.
• Nausea.
• Vaginal spotting or bleeding.

These side effects are typically temporary.

Are Bioidentical Hormones Safer Than Traditional Hormone Therapy?

Myth: Compounded bioidentical hormones are safer than traditional FDA-approved hormone therapy.

Fact: There are FDA-approved bioidentical formulations that are safer than compounded bioidentical hormones.

Bioidentical hormones come from plants. They look just like the hormones our bodies make during reproductive years. But many of the hormone therapies marketed as “bioidentical” are actually compounded drugs.

Compounding is a process in which a pharmacist or physician changes, mixes, or combines ingredients to create a medication for an individual patient’s needs.

Compounded bioidentical hormones are marketed as safer, more natural alternatives to traditional hormone therapy for menopause. However, there is no scientific evidence to back that they are safer or more effective.

The FDA does not regulate the compounding process. Compounded bioidentical hormones may have different potencies or inconsistent ingredients. This may make them riskier.

The American College of Obstetricians and Gynecologists (ACOG) recommends FDA-approved hormone therapies over compounded bioidentical hormone therapies.

Are There Alternatives to Hormone Therapy?

Myth: Hormone therapy is the only solution for menopause symptoms.

Fact: Nonhormonal treatments and lifestyle changes can also help with menopause symptoms.

Hormone therapy may be beneficial for many women with symptoms of menopause. But many women may either not be candidates for the treatment or may prefer other treatments.

Nonhormonal treatments for menopause symptoms may include:

• Antidepressants, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).
• Clinical hypnosis.
• Cognitive behavioral therapy.
• Elinzanetant.
• Fezolinetant.
• Gabapentin (an antiseizure medication).
• Oxybutynin.
• Selective estrogen modulators (SERMs).
• Vaginal moisturizers and lubricants.

Are There Natural Alternatives to Hormone Therapy for Healthy Aging?

Myth: Herbal remedies and supplements are an effective alternative to hormone therapy.

Fact: There is no evidence-backed science to support herbal remedies as a hormone therapy alternative.

Many different supplements and herbal remedies claim to help with menopause symptoms. But the Menopause Society does not recommend herbal remedies, supplements, cannabinoids, and other “natural” treatments, aside from lifestyle optimization.

Weight loss can help reduce menopause symptoms, the Menopause Society says.

Other lifestyle tips for healthy aging include:

• Eating a healthy diet.
• Exercising regularly.
• Getting enough sleep.
• Managing stress.