Is HRT Safe? Benefits and Risks of Hormone Therapy for Menopause

For many healthy women under 60, or within 10 years of menopause, hormone therapy (HRT) eases hot flashes and night sweats, and the benefits often outweigh the risks. HRT still has risks, including blood clots, stroke and some cancers. They depend on your age, health history, the hormone and how it is taken. Not everyone is a candidate.

Key facts

  • ACOG says systemic estrogen (with or without progestin) has been shown to be the most effective treatment for hot flashes and night sweats.
  • The Menopause Society's 2022 position statement: for women younger than 60 or within 10 years of menopause onset, with no reasons to avoid it, the benefit-risk balance is favorable for bothersome hot flashes and for preventing bone loss.
  • In November 2025, FDA asked makers of menopausal hormone therapy to remove heart disease, breast cancer and probable dementia statements from the boxed warning. Those risks stay in the Warnings and Precautions section of the label.
  • The boxed warning about endometrial (uterine) cancer stays for systemic estrogen-alone products.
  • People who have had blood clots, a stroke, a heart attack, certain cancers or liver disease, or who have unexplained vaginal bleeding, should not use hormone therapy (MedlinePlus).

What are the benefits of HRT for menopause?

According to ACOG:

  • Systemic estrogen relieves hot flashes and night sweats.
  • Systemic and vaginal estrogen both relieve vaginal dryness.
  • Systemic estrogen protects against the bone loss that happens early in menopause and helps prevent hip and spine fractures.
  • Combined estrogen and progestin may lower the risk of colon cancer.

FDA's February 2026 announcement also noted that randomized studies found women who start HRT within 10 years of menopause (generally before 60) had lower death rates from all causes and fewer fractures. Results like these are averages across groups. They don't promise any one person a benefit.

What are the risks of HRT?

ACOG lists these risks:

  • Uterine cancer: estrogen alone makes the lining of the uterus grow and can raise the risk of uterine cancer. That is why women who still have a uterus take a progestogen with estrogen.
  • Heart attack: combined therapy is linked to a small increase in risk. This may depend on age, health conditions and when therapy starts.
  • Stroke and blood clots (DVT): both combined and estrogen-only therapy are linked to a small increase. Forms that are not taken by mouth, such as patches, sprays and rings, may carry less clot risk than pills.
  • Breast cancer: combined therapy is linked to a small increase in risk.
  • Gallbladder disease: a small increase, greatest with pills.

The Menopause Society notes that starting hormone therapy more than 10 years after menopause, or after 60, carries greater absolute risks of heart disease, stroke, blood clots and dementia. Timing matters.

What changed with the FDA "black box" warning?

The boxed warning is FDA's most prominent safety warning. Since the early 2000s, hormone therapy labels carried boxed warnings about heart disease, breast cancer and probable dementia. In November 2025, FDA asked companies to remove those three statements from the box, and approved the first six updated labels on 12 February 2026. HHS later reported that more labels, for estradiol patches, were updated too.

What did not change:

  • The heart disease and breast cancer risks are still listed in the Warnings and Precautions section.
  • The boxed warning on endometrial cancer remains for systemic estrogen-alone products.
  • The changes apply to specific FDA-approved products, not to compounded hormones.

So the update gives women and clinicians clearer, more balanced information. It does not mean HRT has no risks.

What are common HRT side effects?

MedlinePlus lists side effects such as headache, bloating, breast pain or tenderness, vaginal bleeding, upset stomach, swelling of the hands or feet, and mood changes. Many settle with time or a dose change. Call your clinician right away about unusual vaginal bleeding, a sudden severe headache, chest pain, trouble speaking, vision changes, or pain and swelling in one leg.

Who should not take HRT?

MedlinePlus says you should not use hormone therapy for menopause if you:

  • are pregnant or may be pregnant;
  • have unexplained vaginal bleeding;
  • have had certain cancers, such as breast or endometrial cancer;
  • have had a stroke or heart attack;
  • have had blood clots in your veins or lungs;
  • have liver disease.

If HRT isn't right for you, ACOG notes there are non-hormone prescription options for hot flashes, including certain antidepressants, gabapentin and clonidine. Vaginal moisturizers and lubricants can help with dryness.

What to ask your clinician

  • Based on my age and history, do the benefits of HRT likely outweigh the risks for me?
  • Would a patch, gel or spray be a better fit than a pill for my clot risk?
  • Do I need a progestogen, and which kind?
  • What dose will we start with, and when will we review it?
  • Which side effects should make me call right away?
  • What non-hormone options could I try instead?

FAQs

Does HRT cause breast cancer? ACOG says combined estrogen-progestin therapy is linked to a small increase in breast cancer risk. FDA kept this risk in the Warnings and Precautions section of the label. Your personal and family history matter, so talk them through with your clinician.

Does HRT cause dementia? FDA removed the "probable dementia" statement from the boxed warning. The Menopause Society notes greater absolute risk of dementia when hormone therapy is started after 60 or more than 10 years after menopause. HRT is not approved to prevent dementia.

Is HRT safer as a patch than a pill? ACOG says forms not taken by mouth may carry less risk of blood clots than pills. Whether a patch fits you depends on your health and preferences.

How long can I stay on HRT? There is no single cutoff. MedlinePlus notes that some professional groups support longer use when there is no medical reason to stop, with regular reviews of benefits and risks.

Did FDA say HRT is safe now? No. FDA updated the boxed warnings on certain products so the risks are described more clearly. The risks still exist and depend on age, timing and health history.

Book a visit

Weigh the benefits and risks of HRT for your own health. Book a visit or call (210) 903-1030. In-clinic in San Antonio • Telehealth for women located in Texas Yaso Wellness Health Clinic, 1907 Goliad Rd, San Antonio, TX 78223

Education only, not medical advice. Not everyone is a candidate for hormone therapy. In an emergency, call 911.

About the clinician

Leticia Vargas, MD, OB/GYN, sees patients at Yaso Wellness Health Clinic in San Antonio. About Dr. Vargas

Sources

Education only, not medical advice or a diagnosis. In an emergency, call 911.