Hormone therapy treats the hot flashes and night sweats that often start in perimenopause, and in November 2025 the FDA began changing how these medications are labeled. Here is what the treatment does, what the label change means, and why the type and timing of therapy matter for your decision.
Perimenopause is the stretch before your final period, when cycles become irregular. If you are still working out whether that is what you are having, the signs and symptoms are covered here.
What hormone therapy treats
Hot flashes and night sweats. This is the main reason women start. Hormone therapy is effective for bothersome hot flashes and night sweats.
Vaginal and urinary symptoms. Dryness, pain with sex and urinary changes are grouped as genitourinary syndrome of menopause. Low-dose vaginal estrogen treats these where the problem is, and much less of it reaches the bloodstream.
Bone. Hormone therapy has been shown to prevent bone loss and fracture.
Why the type matters
If you still have your uterus, estrogen has to be paired with progesterone or a progestin. Estrogen alone can overstimulate the lining of the uterus, and the added hormone protects against uterine cancer. If you have had a hysterectomy, estrogen alone is an option. *conjugated estrogens and bazedoxifene together is also an option
The route matters too. Systemic therapy reaches your whole body through a pill, patch, spray, gel or vaginal ring. Pills carry a higher risk of blood clots. Transdermal routes and lower doses lower the risk of clots and stroke.
Perimenopause adds a wrinkle. You are still having periods, so standard hormone therapy can cause breakthrough bleeding. For that reason, continuous combined birth control pills, patches or rings are often used at this stage. A hormonal IUD paired with estrogen is another option.
Why timing matters
For healthy women under 60, or within 10 years of menopause, with no contraindications, the benefits of hormone therapy outweigh the risks for most women with bothersome symptoms. Starting later, the balance appears less favorable. The FDA's summary of randomized studies says women who started within 10 years of menopause had lower all-cause mortality and fewer fractures.
There is no automatic stop date. Hormone therapy does not need to be routinely stopped at 60 or 65. Whether to continue is decided with you, based on your symptoms, your bones and your overall health.
What changed at the FDA
Since 2003, estrogen products have carried a boxed warning, the FDA's strongest warning. It was based on the Women's Health Initiative study of one specific pill combination (conjugated equine estrogens plus medroxyprogesterone acetate, or MPA). The warning was applied to every dose and form, including low-dose vaginal products.
On November 10, 2025, HHS and the FDA began removing it. That followed an FDA review of the research, an expert panel in July 2025 and a public comment period. Since February 2026 the FDA has been progressively removing those warning statements, approving the new labels product by product, and that work is still underway. At the FDA's request, 29 drug companies have submitted proposed label changes.
What came out of the box is narrower than the headlines suggested. Statements about cardiovascular disease, breast cancer and probable dementia left the boxed warning. For systemic products the cardiovascular and breast cancer information stays elsewhere in the labeling, with the Women's Health Initiative findings for women in their fifties added. For systemic estrogen-alone products, the warning about uterine cancer stays in the box.
The updated labeling also drops the "lowest dose for the shortest time" instruction from the boxed warning and adds guidance on starting within 10 years of menopause or before age 60.
Your own package insert may not reflect this yet. The relabeling is happening product by product, so you may pick up a prescription and read warning language the FDA has already asked to have changed.
Where experts differ
The supportive view. The FDA and a group of researchers writing in Obstetrics & Gynecology say the old warning was applied too broadly and kept women from treatment. They see the change as a move toward accurate information and individual decisions.
The more cautious view. The Menopause Society agreed with removing the warning from low-dose vaginal estrogen, and said the warning may have kept women from using it. For systemic estrogen, it said the treatment still carries potential risks for certain women, and those risks should be reviewed in detail before starting. In its view, risks are low for younger, healthy women who start near menopause and higher for women who start later.
Who should not use it
Women with breast cancer, high-grade uterine cancer, unexplained vaginal bleeding, liver disease, a history of blood clots or cardiovascular disease should generally avoid systemic hormone therapy. Both estrogen alone and estrogen plus MPA, the progestin used in that study, raise the risk of stroke, and that risk drops soon after stopping.
Women who smoke or have cardiovascular disease should not use combined oral contraceptives.
Low-dose vaginal estrogen is a separate question. For some women who have had breast or uterine cancer and have not gotten relief from nonhormonal treatment, it may still be worth discussing.
What this means for you
The label changed. Your own risk did not. Your age, the time since your last period, your personal and family history and how much your symptoms affect you decide whether hormone therapy fits, and which type and route.
Bring three things to your visit: a list of your symptoms, a record of your cycles and your family history of breast cancer, blood clots and heart disease.
If you would like to talk through whether hormone therapy fits you, use the Schedule Today button at the top of this page, call or text (513) 960-5360, or email info@myprecisionendo.com. Membership details are on our pricing page.
Allison Johns, MD
