Quick answer: On November 10, 2025 the FDA announced it would remove the warnings about cardiovascular disease, breast cancer and probable dementia from the boxed warning on menopausal hormone therapy, MHT (HRT). The first six updated labels were approved on February 12, 2026. The endometrial cancer warning stays on systemic estrogen-only products, and the risks are still described inside the label. For women who train, nothing about how to train changes: MHT (HRT) eases symptoms, but it does not build muscle or strength for you. Training and nutrition do that.
For more than twenty years, every box of menopausal hormone therapy in the US carried the FDA’s most serious warning. In November 2025 the FDA said most of that warning would go. Since then, interest in MHT (HRT) and the number of prescriptions have both jumped, and many women who run or lift are starting it for the first time. This page sets out what the FDA changed and when, what it did not change, and what it means for your training.
This article is informational and not medical advice. Whether MHT (HRT) is right for you is a decision for you and your clinician.
Last checked: 31 October 2026.
What did the FDA change, and when?
On November 10, 2025, the FDA announced that it would work with manufacturers to remove references to cardiovascular disease, breast cancer and probable dementia from the boxed warning on MHT (HRT) products. On February 12, 2026, it approved the first six updated labels, covering combined estrogen and progestogen products, estrogen-only products, progestogen-only products and vaginal estrogen. The FDA said 29 companies had submitted proposed changes, so more labels follow in batches.
| Date | What happened |
|---|---|
| 2003 | Boxed warning added to all estrogen products after the Women’s Health Initiative trials |
| July 17, 2025 | FDA expert panel on MHT (HRT), followed by a 60-day public comment period |
| November 10, 2025 | FDA announces removal of the heart, breast cancer and dementia warnings from the box |
| February 12, 2026 | First six products approved with updated labels |
| 2026 onward | Remaining products relabeled as the FDA reviews each submission |
A review in Obstetrics and Gynecology (2026) explains the background: the original warning drew on one set of Women’s Health Initiative results, mostly in women well past menopause, and was applied to every dose, formulation and route, including low-dose vaginal products. The authors note that the new labels are product-specific, drop the instruction to use the lowest dose for the shortest time, and add guidance about starting within 10 years of menopause or before age 60.
What stayed the same?
Three things did not change, and they matter more than the headline.
- The endometrial cancer warning stays. The FDA is keeping the boxed warning about endometrial cancer on systemic estrogen-only products, because estrogen without a progestogen raises that risk in women with a uterus. The updated Divigel label (revised February 2026) shows this: its box now covers only endometrial cancer.
- The risks are still in the label. The same label still has warnings sections on cardiovascular disorders and on breast and other cancers. They moved out of the box, not out of the prescribing information.
- Timing still matters. The FDA’s announcement points to starting MHT (HRT) within 10 years of menopause onset or before age 60. That matches The Menopause Society’s 2022 hormone therapy position statement, which says that for women under 60 or within 10 years of menopause without contraindications, the benefit-risk balance for treating symptoms and preventing bone loss is generally favorable, and that risks are higher when therapy starts later.
Why are so many more women starting MHT (HRT)?
The label change made it easier for women and clinicians to talk about MHT (HRT), and prescribing was already rising. Health data company Truveta found estrogen prescriptions up 26 percent in women aged 45 to 54 and 20 percent in women aged 55 to 64 between July 2025 and February 2026, as reported by eMarketer. For training, that means a growing group of women who are adjusting to a new regimen while trying to keep running and lifting.
Does the label change mean MHT (HRT) will help my training?
The label change does not change what MHT (HRT) does in the body. The evidence on training is the same as before November 2025:
- Symptoms and sleep. MHT (HRT) is the most effective treatment for hot flashes and night sweats, according to The Menopause Society’s position statement. Better sleep is the most likely way it helps your training, indirectly.
- Bone. Preventing bone loss and fracture is an established benefit in the same statement.
- Muscle. A 2019 meta-analysis in JAMA Network Open of 12 randomized trials found no significant difference in lean mass between women on hormone therapy and women not on it.
Our guide to strength training on MHT (HRT) covers the muscle and bone evidence in detail, and MHT (HRT) and endurance training covers running, racing and anti-doping rules.
How should I train if I am starting MHT (HRT) now?
Train the same way you would without therapy, with a little more flexibility in the first few months. The Phaes method for perimenopause and menopause:
- Lift heavy for your level: 3 sets of 8 twice a week as a beginner, 5 sets of 5 three times a week at intermediate, 5 sets of 3 four times a week when advanced. One exercise per body part, plus core every session.
- One sprint interval session a week, inside a run under 60 minutes: short all-out efforts of 15 to 30 seconds with 1:30 of easy jogging between.
- Easy days truly easy: a walk, a very easy run or yoga.
- One full rest day a week, and every fourth week a reset week with no intensity and weights about 30 percent lighter.
- Protein, healthy fats, fluids and sleep in place every day.
In the first weeks on a regimen, side effects such as breast tenderness, bloating, headaches or spotting are common and often settle. On a rough day, keep the session but make it lighter rather than skipping the week. Our page on MHT (HRT) side effects lists what is common.
Does the change affect drug testing?
No. The FDA label is about how risk is described, not about sport. Estrogen and progesterone prescribed for menopause are generally permitted without a Therapeutic Use Exemption, according to Sport Ireland’s MHT (HRT) guidance. Testosterone, tibolone and DHEA remain prohibited under the World Anti-Doping Agency list. If you race in tested events, check your regimen with your national anti-doping agency.
Questions to take to your clinician
The label change is a good reason to have the conversation, not a reason to skip it. Useful questions:
- Given my age and how long since my last period, how does the benefit-risk balance look for me?
- Which type and route suit me (patch, gel, tablet), and why?
- Do I need a progestogen, and which one?
- What side effects should settle, and by when?
- When is my review, and what should I track before it?
Our guide to when to start MHT (HRT) and the overview of types of MHT (HRT) can help you prepare.
Where Phaes fits
Phaes has free MHT (HRT) tracking: set up your regimen, log doses in one tap, record dose changes, and review your symptom score over 8 to 12 weeks, so you and your clinician can see what changed and when. It is informational. Your training plan follows your level, your check-ins and how you slept, not your prescription. See running and MHT (HRT) for how it works.
The bottom line
The FDA removed the heart, breast cancer and dementia statements from the MHT (HRT) boxed warning, starting with six products in February 2026. The endometrial cancer warning stays on systemic estrogen-only products, and the risks are still described in every label. Nothing about how you should train changed: MHT (HRT) can ease symptoms and protect bone, but lifting heavy, sprinting once a week, keeping easy days easy, resting and eating enough protein are what make you stronger.
Frequently asked questions
Did the FDA remove the black box warning on HRT?
Mostly. On November 10, 2025 the FDA said it would remove references to cardiovascular disease, breast cancer and probable dementia from the boxed warning on menopausal hormone therapy. The boxed warning about endometrial cancer stays on systemic estrogen-only products, because estrogen without a progestogen raises that risk in women with a uterus.
When did the HRT label changes take effect?
Product by product. The FDA approved the first six updated labels on February 12, 2026, covering combined, estrogen-only, progestogen-only and vaginal estrogen products, and 29 manufacturers had submitted proposed changes. Some products still show the older label while their updates are reviewed, so the leaflet in your box may lag behind the news.
Does the label change mean HRT is risk-free?
No. The risks moved out of the box, not out of the label: the updated prescribing information still describes cardiovascular disorders, breast cancer and other risks in its warnings section. What changed is how prominently they are framed. Whether MHT (HRT) suits you still depends on your age, time since menopause, health history and the type of product, which is a conversation with your clinician.
Should I change my training if I start HRT after the label change?
Not because of the label. Train the way that works in perimenopause and menopause with or without therapy: lift heavy for your level, one short sprint session a week, easy days truly easy, one full rest day and a lighter reset week every fourth week. Expect a few weeks of side effects and day-to-day variation when you start, and log how you feel.
Will HRT help me build muscle now that it is easier to get?
MHT (HRT) eases symptoms, but it does not build muscle or strength for you. A 2019 meta-analysis of randomized trials found no significant difference in lean mass between women on hormone therapy and women not on it. It does protect bone. Heavy lifting and enough protein are what build muscle.
Does the FDA change affect drug testing for athletes?
No. The label change is about how the FDA describes risk, not about anti-doping rules. Estrogen and progesterone are generally permitted for menopause without a Therapeutic Use Exemption, while testosterone, tibolone and DHEA remain prohibited under the World Anti-Doping Agency code. If you can be tested, check your regimen before you race.
