What the 2025 FDA Label Change Means for Menopause Hormone Therapy

In 2002, a large trial called the Women's Health Initiative reported higher rates of breast cancer, heart disease, stroke and blood clots in women taking one specific estrogen-plus-progestin product. Hormone therapy prescriptions fell sharply. The FDA added boxed warnings, the strongest kind, to every menopause hormone product.

Over the next two decades, researchers reanalyzed that trial and ran new ones. Two points kept coming up. First, the women in the original trial were 63 years old on average, more than a decade past the typical age of menopause. The formulation studied is also less commonly used today. Second, the risk picture looked different for women who started therapy closer to menopause, generally before 60 or within 10 years of their last period. That idea is often called the timing hypothesis.

The FDA asked manufacturers to update the labels of FDA-approved menopause hormone products, both systemic (pills, patches, gels, sprays) and local vaginal products, in the following ways:

• Remove the boxed-warning language about cardiovascular disease, breast cancer and probable dementia.
• Remove the “lowest dose for the shortest time” line from the boxed warning.
• For systemic products, add that treatment for moderate to severe hot flashes can be considered for women under 60 or within 10 years of menopause. Add data from women aged 50 to 59.

The FDA approved the first updated labels for six products on February 12, 2026. Other manufacturers have submitted updates, and the rollout is still under way. Your own product's pharmacy insert may still show the old warning for a while.

This is the part that's easy to miss.

• The warnings still exist in the label. Information about cardiovascular disease and breast cancer stays in the warnings section; it was removed from the box, not from the label.
• One boxed warning stays. Systemic estrogen-alone products keep the boxed warning about endometrial cancer, which is why women with a uterus who take systemic estrogen also take a progestogen.
• The reasons to avoid hormone therapy are unchanged: a history of breast cancer or other estrogen-sensitive cancer, blood clots, stroke or heart attack, active liver disease, and unexplained vaginal bleeding, among others.
• No new uses were approved. The products are approved for the same symptoms as before. Hormone therapy is not approved to prevent heart disease, dementia or aging, and the Menopause Society's position is that it should not be used to prevent dementia at any age.
• Dosing guidance is still individualized. The updated labels still say to start with the lowest effective dose and reassess periodically.

The American College of Obstetricians and Gynecologists said the announcement does not change its guidance. It said systemic products are not without risk, and that low-dose vaginal estrogen has a different safety profile from systemic therapy. The Menopause Society supported removing the warning from low-dose vaginal estrogen, which it had long considered overstated. It also noted that systemic estrogen still carries potential risks for some women, depending on age, time since menopause, and health history. The original trial's own investigators said no new large trial has changed the benefit-risk balance for oral hormone therapy and that it should not be used for chronic disease prevention.

The updated labels do not say that hormone therapy prevents heart disease or Alzheimer's disease, and the major societies don't recommend it for prevention. If you've seen large prevention numbers online, they aren't what the labels say.

• Compounded hormones and pellets. These are prepared by compounding pharmacies, are not FDA-approved, and never had an FDA label. The label change says nothing about them. ACOG made this point explicitly.
• Testosterone for women. There is no FDA-approved testosterone product for women; it's prescribed off-label.
• Men's testosterone therapy. A separate FDA labeling action in February 2025 addressed testosterone products for men.

Consider a woman with bothersome symptoms who is under 60 or within 10 years of menopause, with no reasons to avoid it. For her, the benefit-risk balance of FDA-approved hormone therapy is generally favorable. That was true before the label change. For women starting later, or with certain histories, the decision needs more care. Either way, the decision is yours and your provider's. It's made from your symptoms, your age and timing, your personal and family history, and your preferences, and it's revisited over time.

One practical note: the news drove a sharp rise in prescriptions, and some estrogen patch strengths have been harder to fill in 2026. If that's happened to you, our guide on estrogen patch availability covers what to do.

To see what a visit includes, start with menopause and perimenopause care or women's hormone therapy in Fort Collins; if you're still having periods, our guide to perimenopause in your 40s is the place to begin.