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Hormone Therapy for Menopause: Safe or Risky?

Your Guide to Making an Informed Decision

Menopause is a natural stage of life, but its symptoms can feel anything but natural. Hot flashes and night sweats can disrupt sleep and daily routines, contributing to mood swings and irritability.

Menopausal hormone therapy (MHT), also called hormone replacement therapy (HRT), can ease symptoms for many women in menopause. But is it safe?

According to statements from the U.S. Food and Drug Administration (FDA) and The Menopause Society, hormone therapy can help most healthy women manage their moderate to severe menopause symptoms, such as hot flashes, when started within 10 years of the onset of menopause or under age 60.

What Is MHT?

As women approach the end of their reproductive years, their ovaries gradually produce less estrogen. This transition, called perimenopause, continues until menstrual cycles stop completely. The average age of menopause is 51, but it can happen sooner due to genetics or medical treatments, such as chemotherapy or surgery.

As estrogen levels drop, vasomotor symptoms such as hot flashes, vaginal dryness, brain fog and sleep disturbances can occur. The lower progesterone level also contributes to vaginal dryness.

MHT adds, blocks or balances female hormones, primarily estrogen and progesterone, to treat symptoms of menopause and conditions like bone loss.

There are two main types of hormone therapy:

  • Systemic therapy: Especially effective in treating hot flashes, this therapy comes as pills, patches, sprays, gels or a vaginal ring. The medications contain estrogens or progestogens, a synthetic form of progesterone, or a combination of both.
  • Low-dose therapy: Also called vaginal estrogen therapy (ET) for genitourinary syndrome of menopause (GSM), this therapy is applied inside the vagina and helps moisturize and rebuild tissue. Because only a small amount is absorbed into the bloodstream, the risks are low.

“Low-dose vaginal estrogen can be life-changing for many women,” says Kristin A. Dolling, MD, a gynecologist at Northwestern Medicine. “Vaginal estrogen has minimal systemic absorption into the bloodstream, and is safe and effective for most women.”  

Dr.Dolling says systemic hormone therapy can also be an important treatment option. Patients and physicians should evaluate all the risks and benefits, and then make a treatment decision together.

“We’ll look at factors such as your medical history, family history, age and how long you’ve been in menopause,” adds Dr. Dolling. “In many cases, the benefits of hormone therapy might outweigh the risks.”

Benefits of MHT

For women with severe symptoms of menopause, MHT can improve quality of life. These benefits are strongest when therapy begins near the onset of menopause and before age 60.

Benefits could include:

  • Relieving symptoms such as hot flashes, night sweats and vaginal dryness
  • Improving sleep, irritability and brain fog 
  • Easing vaginal discomfort, including thinning tissue and dryness
  • Relaxing an overactive bladder
  • Protecting your bones
  • Lowering your risk of cardiovascular disease
  • Reducing your risk of developing Type 2 diabetes

Risks of MHT

MHT is not risk-free. Research shows hormone therapy may increase the chance of certain health conditions, including:

  • Breast cancer
  • Uterine cancer
  • Blood clots
  • Cardiovascular disease

These risks can vary depending on the type of MHT, how many years you’ve been in menopause, personal factors and family history.

What’s Changed

In 2002, the Women’s Health Initiative (WHI) study made headlines when it linked MHT to higher risks of breast cancer, stroke and heart disease. As a result, millions of women stopped taking hormones, and physicians became cautious about prescribing them.

Since then, scientists have re-examined the data. New findings show that the risks reported in 2002 were mostly seen in older women who started MHT many years after menopause. For women who begin therapy near the onset of menopause, the risks are lower, and the benefits — such as relief from vasomotor symptoms and bone protection — are greater.

Scientists at Northwestern Medicine, one of the research institutions that conducted secondary analysis of the WHI data, found that hormone therapy did not significantly affect cardiovascular disease risk in younger postmenopausal women (ages 50 to 59). The study was published in JAMA Internal Medicine.

“All of these updated analyses have shaped the latest guidelines: start early, use the lowest effective dose and limit duration,” says Dr. Dolling.

FDA Updates

Reflecting new evidence, the FDA removed black-box warnings from MHT products in November 2025. These warnings were added in response to the original WHI study. The decision to remove the warnings underscores that, for many women, MHT can be safe when used appropriately under medical supervision.

“I'm very happy with the FDA's decision to remove the boxed warning for low-dose vaginal estrogen and systemic hormone therapy,” says Dr. Dolling. “These changes mean that many more women will feel comfortable considering hormone therapy for treatment of their menopausal symptoms and overall bone and heart health.”

Who Should Avoid Hormone Therapy?

MHT may not be safe if you have a medical history of:

  • Breast cancer
  • Endometrial cancer
  • Blood clots or stroke
  • Liver disease
  • Heart disease

If you have one of these conditions, your physician can discuss treatment options other than hormones.

Outlook for Treating Menopause Symptoms

Research is emerging on new therapies and alternatives such as nonhormonal therapies that relieve hot flashes.

“We now have more nonhormonal options for treatment of vasomotor symptoms, including medications that block neurokinin receptors in the brain, such as fezolinetant and elinzanetant. These can be very effective,” says Dr. Dolling.

Talk with your doctor about menopause, your symptoms, health concerns and goals. Together, you can discuss the risks and benefits and choose the best path forward.