The short answer
Activella is a daily oral tablet containing estradiol and norethindrone acetate, in 1 mg/0.5 mg and 0.5 mg/0.1 mg strengths. Its current label approves it in women with a uterus for moderate-to-severe hot flashes due to menopause, moderate-to-severe vulvar and vaginal atrophy due to menopause, and prevention of postmenopausal osteoporosis. Taking both hormones every day is called continuous combined therapy.
Boxed warning on the current Activella label
The current Activella label (DailyMed, November 2023) carries a boxed warning for cardiovascular disorders, probable dementia, breast cancer, and endometrial cancer. In November 2025 the FDA asked hormone therapy manufacturers to remove some boxed-warning language, but a product's warning changes only when its own label is revised.
Contraindications on the label include undiagnosed abnormal genital bleeding, current or past breast cancer, estrogen-dependent cancer, current or past blood clots, current or past stroke or heart attack, liver disease, known blood-clotting disorders, serious allergic reaction to the product, and pregnancy.
Current label check
The medication-specific claims on this page were checked against these current product labels on 2026-10-03.
| Product label | Label date | Boxed warning on that label |
|---|---|---|
| Activella (estradiol/norethindrone acetate) tablets | 2023-11-30 | Cardiovascular disorders, probable dementia, breast cancer, endometrial cancer |
Established evidence
FDA-approved uses
- Moderate-to-severe vasomotor symptoms due to menopause
- Moderate-to-severe vulvar and vaginal atrophy due to menopause (topical vaginal products should be considered first when this is the only symptom)
- Prevention of postmenopausal osteoporosis (non-estrogen medicines should be considered first when this is the only goal)
Limited human evidence
Oral vs transdermal combination therapy
Oral estrogen passes through the liver first, which raises clotting factors and triglycerides. Observational studies associate oral estrogen with higher venous clot risk than standard-dose transdermal estrogen, so people with clot risk factors are often steered toward a patch such as CombiPatch or Climara Pro, or a transdermal estradiol with a separate progestogen. These are observational findings, not head-to-head trials.
Bleeding pattern
Irregular bleeding or spotting is common in the first months of continuous combined therapy and often settles. Bleeding that is heavy, persistent, or starts after a period of no bleeding should be evaluated.
Established evidence
Common side effects
- Breast pain
- Irregular vaginal bleeding
- Headache
- Nausea or abdominal pain
- Back pain
Questions to ask a healthcare professional
- Is an oral combination right given my clot risk?
- Which strength fits my symptoms?
- How long should I expect irregular bleeding?
Questions, answered
What people ask about Activella
Is Activella the same as CombiPatch?+
They contain the same two hormones, but Activella is a daily tablet and CombiPatch is a twice-weekly patch.
Does Kindr Health offer Activella?+
This page is educational and does not state or imply availability through Kindr Health.
Kindr Health does not claim to offer Activella on this page. Availability and prescribing are not implied.
A broader care pathway
Explore menopause care
Learn how Kindr Health care pathways work. An educational page is not a statement that this medication is available or appropriate for you.
SOURCES & REFERENCES
Every clinical claim on this page is sourced.
- Activella (estradiol/norethindrone acetate) tablets prescribing information (2023) — DailyMed, U.S. National Library of Medicine. dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0
- FDA initiates removal of boxed warnings from menopausal hormone therapy products (2025) — U.S. Department of Health and Human Services / FDA. www.hhs.gov/press-room/fact-sheet-fda-initiates-removal-of-black-box-warnings-from-menopausal-hormone-replacement-therapy-products.html
- FDA approves labeling changes to menopausal hormone therapy products (first six labels) (2026) — U.S. Food and Drug Administration. www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products
- The 2022 hormone therapy position statement of The North American Menopause Society (2022) — The Menopause Society (Menopause journal). pubmed.ncbi.nlm.nih.gov/35797481
This resource is educational and does not replace individualized medical advice. Do not start, stop, or change a prescription without guidance from a licensed healthcare professional.