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Activella
Estradiol and Norethisterone
$123.00
1mg / 0.5mg · 3 × 28 tablets · 3 months supply
BrandBranded medicine· By NovoNordisk
$41.00 per month
How long a supply?
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Annual cost
$533a year at this pack size
Prescription required
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FDA boxed warningCardiovascular
DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women
Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia.
Breast Cancer
Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Estrogen-Alone Therapy
Endometrial Cancer
The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone, relative to placebo.
The WHIMS estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
About Activella
Overview
Activella is a tablet containing estradiol, an estrogen, and norethindrone acetate, a progestin, for women who have a uterus. It is used to treat moderate to severe hot flashes and symptoms of vulvar and vaginal atrophy due to menopause, and to prevent osteoporosis after menopause. If treatment is only for vaginal symptoms, topical vaginal products should be considered first; if only for osteoporosis prevention, non-estrogen medicines should be considered first, and estrogen therapy considered only for women at significant risk. Estradiol acts on estrogen receptors, while the progestin counteracts some of estrogen’s effects in the body.
What it treats
- Moderate to severe hot flashes due to menopause in women with a uterus. - Moderate to severe vulvar and vaginal atrophy symptoms due to menopause in women with a uterus. If these are the only symptoms being treated, topical vaginal products should be considered first. - Prevention of osteoporosis after menopause in women with a uterus. If used solely for prevention, non-estrogen medicines should be considered first, and estrogen therapy should be considered only for women at significant risk of osteoporosis.
Safety information
Side effects
Common side effects include back pain, headache, pain in the arms or legs, nausea, diarrhea, stomach or intestinal infection, trouble sleeping, mood changes, respiratory infections, sinusitis, weight gain, breast pain, bleeding after menopause, vaginal bleeding associated with uterine fibroids, ovarian cysts, thickening of the uterine lining, viral infections, genital yeast infections, and accidental injury. Serious risks include heart and blood vessel disorders, cancer, and an increased risk of gallbladder disease. Contact a doctor if you develop bleeding after menopause or other unusual vaginal bleeding. Seek urgent medical advice if you experience loss of vision, severe high blood calcium, severely elevated blood triglycerides, or jaundice caused by impaired bile flow; the label directs stopping estrogen if these occur.
FDA boxed warning
Cardiovascular
DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women
Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia.
Breast Cancer
Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Estrogen-Alone Therapy
Endometrial Cancer
The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone, relative to placebo.
The WHIMS estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not take Activella if you have: • Unexplained abnormal genital bleeding. • Breast cancer or a history of breast cancer. • An estrogen-dependent tumour. • A blood clot in a deep vein or the lungs, or a history of either. • A blood clot in an artery, including a stroke or heart attack, or a history of these conditions. • A known allergy to Activella, including a previous severe allergic reaction or angioedema (swelling beneath the skin). • Liver disease or impaired liver function. • Protein C, protein S or antithrombin deficiency, or another known disorder that increases the risk of blood clots. Estrogens increase the risk of gallbladder disease. Treatment must be stopped if severely elevated blood calcium, loss of vision, severely elevated triglycerides (blood fats), or jaundice caused by impaired bile flow occurs. If you take thyroid replacement medicine, your thyroid function should be monitored.
Interactions
St. John’s wort, phenobarbital, carbamazepine and rifampin may lower estrogen levels, potentially reducing Activella’s effects or changing uterine bleeding patterns. Erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may raise estrogen levels and increase the risk of adverse reactions. Other medicines or herbal products that affect certain liver enzymes, including CYP3A4, may also lower or raise norethindrone levels. Discuss these medicines, supplements and grapefruit juice with your doctor.
Using Activella
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label ACTIVELLA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] (DailyMed, retrieved 19 September 2026).
Patient information and references
Official and supporting information to read alongside advice from your prescriber or pharmacist.
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