Hormone Therapy Label Tracker
Menopause — Living Evidence Monitor
How this page is produced
Generated by the ModernDoc Research Monitor from peer-reviewed literature. Every statistic is automatically checked against its cited source and screened for retractions before it is published. This is an AI-assisted evidence summary, not a clinician endorsement and not medical advice. Read how we build and check these pages.
KEY FINDINGS
PRODUCT LABEL STATUS
What each product’s current FDA label document says about its boxed warning — read from the label itself and checked against the version published on DailyMed. A product’s status here is a fact about its label document on the date shown, not a statement about a regulatory decision.
How to read this table
In November 2025 the FDA announced it was initiating removal of boxed warnings from menopausal hormone therapy products, and it approved a first batch of six rewritten labels on 12 February 2026. Manufacturers submit labeling changes for FDA approval; the agency has published no timetable, so which products have updated labels changes over time — which is what this page tracks.
A boxed warning still being present does not mean a label is out of date. The endometrial-cancer boxed warning is retained on systemic estrogen-alone products, so a rewritten label for one of them still carries a boxed warning — covering endometrial cancer only. That is why this table reports what each warning covers rather than whether one exists.
| Product | What its boxed warning says | Label document |
|---|---|---|
Prometrium progesterone Systemic progestogen-alone | No boxed warning in the current label | Label version 4, published Published by Acertis Pharmaceuticals, LLC Read the label on DailyMedChecked |
Divigel estradiol gel Systemic estrogen-alone | Boxed warning covers endometrial cancer only Warning covers: endometrial cancer “WARNING: ENDOMETRIAL CANCER WITH UNOPPOSED ESTROGEN IN WOMEN WITH A UTERUS” | Label version 31, published Published by Vertical Pharmaceuticals, LLC Read the label on DailyMedChecked |
Cenestin synthetic conjugated estrogens, A Systemic estrogen-alone | Not verified no current FDA label record published for this product | — Checked |
Enjuvia synthetic conjugated estrogens, B Systemic estrogen-alone | Not verified no current FDA label record published for this product | — Checked |
Estring estradiol vaginal ring Vaginal (local) estrogen | No boxed warning in the current label | Label version 7, published Published by Pfizer Laboratories Div Pfizer Inc Read the label on DailyMedChecked |
Bijuva estradiol/progesterone Systemic estrogen + progestogen | No boxed warning in the current label | Label version 13, published Published by Mayne Pharma LLC Read the label on DailyMedChecked |
Premarin conjugated estrogens Systemic estrogen-alone | Boxed warning still carries the pre-2026 language Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia “WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA” | Label version 37, published Published by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. Read the label on DailyMedChecked |
Prempro conjugated estrogens/medroxyprogesterone Systemic estrogen + progestogen | Boxed warning still carries the pre-2026 language Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia “WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER and PROBABLE DEMENTIA” | Label version 39, published Published by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. Read the label on DailyMedChecked |
Estrace Vaginal Cream estradiol vaginal cream Vaginal (local) estrogen | Boxed warning still carries the pre-2026 language Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia “WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA” | Label version 25, published Published by Allergan, Inc. Read the label on DailyMedChecked |
Climara estradiol transdermal system Systemic estrogen-alone | Boxed warning still carries the pre-2026 language Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia “WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER” | Label version 25, published Published by Bayer HealthCare Pharmaceuticals Inc. Read the label on DailyMedChecked |
Climara Pro estradiol/levonorgestrel transdermal system Systemic estrogen + progestogen | Boxed warning still carries the pre-2026 language Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia “WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER” | Label version 27, published Published by Bayer HealthCare Pharmaceuticals Inc. Read the label on DailyMedChecked |
Vivelle-Dot estradiol transdermal system Systemic estrogen-alone | Boxed warning still carries the pre-2026 language Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia “WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, and BREAST CANCER” | Label version 17, published Published by Sandoz Inc Read the label on DailyMedChecked |
Vagifem estradiol vaginal inserts Vaginal (local) estrogen | Boxed warning still carries the pre-2026 language Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia “WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, and BREAST CANCER” | Label version 22, published Published by Novo Nordisk Read the label on DailyMedChecked |
Imvexxy estradiol vaginal inserts Vaginal (local) estrogen | Boxed warning still carries the pre-2026 language Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia “WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, and BREAST CANCER” | Label version 13, published Published by Mayne Pharma LLC Read the label on DailyMedChecked |
Activella estradiol/norethindrone acetate Systemic estrogen + progestogen | Boxed warning still carries the pre-2026 language Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia “WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER” | Label version 18, published Published by Amneal Pharmaceuticals LLC Read the label on DailyMedChecked |
Angeliq drospirenone/estradiol Systemic estrogen + progestogen | Boxed warning still carries the pre-2026 language Warning covers: breast cancer, cardiovascular disorders, endometrial cancer, lowest dose, shortest duration, probable dementia “WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER” | Label version 20, published Published by Bayer HealthCare Pharmaceuticals Inc. Read the label on DailyMedChecked |
All 16 tracked products last checked .
How this table is produced
Each row is copied from FDA-published product labeling: retrieved from openFDA, then confirmed against the authoritative label document published by the National Library of Medicine (DailyMed) at the version shown — the warning text quoted above is verified to appear in that document before the row is written. No text here is model-generated or paraphrased.
Label documents are not journal articles: they carry no DOI, are not peer reviewed, and cannot be retracted, so the citation and retraction checks that apply to the study findings elsewhere on this monitor do not apply here. When a product cannot be verified, the table says so instead of guessing. This page is AI-assembled and has not been reviewed by a clinician — it is not medical advice, and a drug’s label is the authority, not this summary of it.
SOURCES
- [1]Cömert, Erhan Hüseyin et al.. Regulatory awareness, counseling priorities, and treatment choices in menopausal hormone therapy: a cross-sectional survey of obstetricians and gynecologists.. Menopause (New York, N.Y.). 2026. DOI (opens in new tab)
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