Short answer: Estrogen products such as Premarin are FDA approved for moderate to severe hot flashes from menopause. In November 2025 FDA began removing the boxed warnings about heart disease, breast cancer and dementia, but kept the endometrial cancer warning for estrogen alone. Two non-hormonal pills, Veozah and Lynkuet, are also approved for hot flashes. Veozah carries a boxed warning for liver injury.
| Compound | Best evidence | What it shows |
|---|---|---|
| Estrogen therapy (e.g. Premarin) | FDA-approved for this | Approved to treat moderate to severe hot flashes and vaginal atrophy due to menopause. For women with a uterus, the label says a progestin should be considered to lower endometrial cancer risk. |
| Fezolinetant (Veozah) | FDA-approved for this | A non-hormonal NK3 receptor blocker approved for moderate to severe hot flashes. Its label has a boxed warning for liver injury and asks for liver blood tests. |
| Elinzanetant (Lynkuet) | FDA-approved for this | A non-hormonal NK1 and NK3 receptor blocker approved for moderate to severe hot flashes due to menopause. |
"Animal or lab studies only" means no published human trial for this goal that we could find. Results in rats or cells often do not carry over to people. Compounds that are not FDA-approved have no tested label for dose, purity or safety.
On November 10, 2025, FDA announced it was initiating removal of the boxed warnings on hormone therapy products for menopause. It said it would work with companies to remove references to risks of heart disease, breast cancer and probable dementia from the boxed warning. FDA is not removing the boxed warning for endometrial cancer on systemic estrogen-alone products.
FDA also said the labeled recommendation will be to start systemic hormone therapy within 10 years of menopause or before age 60. It noted that the average woman in the Women's Health Initiative (WHI) study was 63, more than a decade past typical menopause.
Labels change one product at a time. When we checked in October 2026, the Premarin tablet label on DailyMed still showed the older boxed warning covering endometrial cancer, heart disorders, breast cancer and probable dementia. Read the current label for the exact product you are prescribed.
The WHI estrogen plus progestin trial was stopped in 2002 after a mean of 5.2 years, because breast cancer crossed a preset stopping line and overall risks outweighed benefits in healthy postmenopausal women. In absolute terms, per 10,000 women per year, it found 7 more heart disease events, 8 more strokes, 8 more blood clots in the lung and 8 more invasive breast cancers, along with 6 fewer colorectal cancers and 5 fewer hip fractures. Deaths overall did not differ.
Those numbers apply to the drug and age group studied. FDA's 2025 change rests on the point that most women start hormones much younger than the WHI average. The Premarin label still says to use the lowest effective dose for the shortest time that fits treatment goals.
Fezolinetant (Veozah) is a non-hormonal NK3 (neurokinin 3) receptor blocker. In the SKYLIGHT 1 trial, women aged 40 to 65 with at least 7 moderate to severe hot flashes a day had fewer and milder hot flashes on fezolinetant than on placebo at weeks 4 and 12. On the label, women in one trial started at about 10 moderate to severe hot flashes a day; at week 12 the 45 mg group had 6.4 fewer per day vs 3.9 fewer on placebo.
Terms on this page: Half-life