FDA HRT Label Change Tracker: Every FDA-Listed 2026 Menopausal Hormone Therapy Label Update, Verified

The bottom line at a glance

Which HRT products have updated FDA labels right now?

Six products, spanning all four FDA hormone-therapy categories, currently appear on the FDA’s public list of menopausal hormone therapies with updated prescribing information. They are not evenly split across the categories — three of the six are systemic estrogen-alone products. We opened each label PDF and recorded its application number, FDA Reference ID, and the specific warning change, so you can verify any row without opening a file yourself. Every label in this table was revised 2/2026 and approved February 12, 2026.

Who holds each application, and when it moved. These fields draw on the FDA supplement approval letters where we could retrieve them, and on the current label otherwise. Submission dates are shown only where confirmed from a product’s FDA approval letter.

What exactly did the FDA change on the labels?

For the affected products, the FDA removed three risk topics — cardiovascular disease, breast cancer, and probable dementia — from the boxed warning, which is the agency’s most prominent, black-bordered safety alert. It also dropped the old “use the lowest effective dose for the shortest time” instruction from the box and, for systemic products, added language inviting earlier treatment. The changes are not identical across categories, which is the part most summaries flatten.

Here is the change broken down by category. This matrix is assembled from the FDA’s November 10, 2025 formal request to manufacturers, then checked against what the six approved labels actually say.

The Divigel, Cenestin, and Enjuvia labels each carry a “Recent Major Changes” section that reads, almost word for word, “Boxed Warning, Cardiovascular Disorders, Breast Cancer, Probable Dementia removed 2/2026.” Bijuva’s version goes one item further and also lists “Endometrial Cancer removed,” because a combination estrogen-plus-progestogen product does not need the endometrial-cancer boxed warning in the first place — the progestogen protects the uterine lining.

One nuance the fast coverage missed: the FDA removed the probable-dementia warningfrom the boxed warning and, in the modern-format labels, from the Warnings and Precautions section — but the underlying Women’s Health Initiative Memory Study dementia data still appears in the Clinical Studies section of the estrogen-containing labels. The warning language went; the study data stayed. If you are describing this change, “the dementia warning was removed” is accurate; “dementia was erased from the labels” is not.

The one warning that did not disappear

If you take one caveat from this page, take this: the boxed warning did not vanish for every product. Systemic estrogen-alone products still carry a boxed warning about endometrial cancer in women who have a uterus and take estrogen without a progestogen. We confirmed it on the current Divigel, Cenestin, and Enjuvia labels, where the only remaining boxed warning is titled, in the label’s own words, “Endometrial Cancer With Unopposed Estrogen in Women With a Uterus.”

This is the detail that trips up fast coverage. “The FDA removed the HRT black box warning” is true for the cardiovascular, breast-cancer, and dementia language, and true across the board for probable dementia. It is not true for endometrial cancer on estrogen-alone products. The FDA’s own November request drew this line explicitly: remove the endometrial-cancer language from boxed warnings “except in the systemic estrogen-alone drugs.” Leave that exception out and you have overstated the change.

For a broader look at the terminology used in FDA HRT labels, including boxed warnings, Warnings and Precautions, and Clinical Studies sections, see the Menopause and HRT Glossary.

How we built and verified this FDA HRT label change tracker

We built this the slow way. We started from the FDA’s public product list, pulled the six label PDFs it links to, and read each one — recording the application and supplement number, the FDA Reference ID printed on the pages, the boxed-warning content, and, where present, the “Recent Major Changes” changelog. For three products (Prometrium, Divigel, Cenestin), we also pulled the FDA supplement approval letters to confirm the application holder and the submission and approval dates. We then reconciled the removed-versus-retained detail against the FDA’s formal November 10, 2025 request to manufacturers, which itemizes the intended changes category by category.

• Primary sources first. FDA product pages, FDA label PDFs, and FDA approval letters are the authority for every cell in the tracker. FDA press materials establish the policy context. Trade and news coverage is used only for background, never as the basis for a factual claim in the tracker.
• What we captured per product.Product name, FDA category, active ingredient and form, NDA and supplement number, FDA Reference ID, boxed-warning status, warnings retained elsewhere, and — where the approval letter was available — application holder and submission/approval dates.
• Verification date.July 1, 2026. Every “verified” claim on this page reflects a source we opened on that date.
• Inclusion rule.A product appears here only if it is listed on the FDA’s “Menopausal Hormone Therapies with Updated Prescribing Information” page and we confirmed the change in its actual FDA label.
• Honest gaps.Two labels (Prometrium and Estring) use an older format without a “Recent Major Changes” section; for those, we report the current label’s actual boxed-warning content and say so plainly. We retrieved three of the six approval letters; submission dates appear only for those three.
• Refresh sources. For ongoing updates we monitor the FDA product page, FDA press announcements, the FDA Drug Safety-related Labeling Changes database, and Drugs@FDA.

The timeline: how the HRT boxed warning appeared, and how it is disappearing

The boxed warning is roughly two decades old. It grew out of the Women’s Health Initiative (WHI), the large federal trials that reshaped how hormone therapy was prescribed. Understanding the 2026 change means understanding that arc — the studies, the 2003 labeling, and the 2025–2026 reversal.

Two dates in that table do a lot of work. November 10, 2025 is when the FDA asked for the changes. February 12, 2026 is when the FDA approvedthe first six. Coverage that treats November 2025 as the moment the labels changed is early by three months. (A small primary-source detail we noticed in the approval letters: the FDA’s request letters to manufacturers were actually dated November 9, 2025 — one day before the public announcement.)

Why the FDA reopened the HRT boxed warning

According to the FDA, the change followed its review of the scientific literature published since the original WHI trials, an updated look at how the drugs are actually prescribed, public input, and the July 2025 expert panel. The agency’s central argument is about age and timing: the women in the WHI trials were, on average, well past the age when most women start hormone therapy for symptoms.

Here is that rationale reduced to the specific figures the FDA cited, so it is quotable without paraphrasing the agency’s narrative.

That is the FDA’s reasoning, presented as the FDA states it. Whether the reassessment goes too far, especially for systemic therapy, is genuinely contested — which is the next section.

How medical societies responded

The reaction split along a clear line: broad support for lifting the warning on low-dose vaginal estrogen, and support-with-caveats for doing the same on systemic therapy. Two leading menopause societies weighed in within a week, and both paired approval with an explicit warning against over-prescribing.

The announcement also arrived with strong benefit claims from HHS about hormone therapy’s advantages when started early. Those figures are the government’s framing, not label-tracker findings, and this page deliberately does not repeat them as established benefit statistics — our scope is what the labels say, verifiably.

The rollout so far: six products approved, more supplements to watch

The reason this needs to be a tracker rather than a one-time article is the gap between what has been approved and what is coming. The FDA has said 29 drug companies submitted proposed labeling changes, and it described the six approved products as the first batch. As of July 1, 2026, the FDA’s public list still shows those same six.

A few things to keep straight. “29 companies” is a count of companies, not products — a single company can hold several hormone-therapy products, so the eventual number of updated labels is not simply “29.” The six approved so far were chosen to represent all four categories, which is why the list looks broad despite being short. And the companies did not move in lockstep: per the FDA approval letters, Cenestin’s supplement was received November 20, 2025 and Divigel’s November 25, 2025, while Prometrium’s was not received until January 7, 2026 — yet all six were approved the same day, February 12, 2026. Because each product’s label updates only when its own supplement is approved, your specific medication may not have an updated label yet, even if a sibling product in the same category does.

We re-check the FDA’s list and the underlying labels on a schedule and update the verification date whenever we confirm a change.

For context on which HRT products are currently available and categorized, see the FDA-Approved HRT Reference. For supply-side news, see the Estradiol Patch Shortage Tracker.

What this tracker does — and does not — show

This is a regulatory-label reference, and it is worth being blunt about its edges, because a good source discloses them.

• It tracks public FDA source material, not private manufacturer submissions still in review.
• Six products on the FDA’s page does not equal every hormone-therapy product; more are likely.
• “29 companies submitted proposals” is a company count, not a product count, and not a countdown.
• A risk statement removed from the boxed warning is not a statement that the risk is impossible or irrelevant. In several labels, cardiovascular and breast-cancer information remains in the Warnings and Precautions section, and the WHI Memory Study dementia data remains in Clinical Studies.
• Labels can be revised again. That is exactly why the page carries a visible verification date.
• This page is educational and not medical advice. Decisions about starting, continuing, or stopping hormone therapy belong with a qualified clinician, using your current FDA-approved label and your personal medical history.

Frequently asked questions