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Medication Guide — Mimvey Estradiol 1 Mg Norethindrone Acetate 0 5 Mg

Patient-friendly FDA guidance and safety information.

Last updated · May 16, 2026Source: DailyMed ↗
Boxed Warning

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

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer .

Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile.

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

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding .

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 .

Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia .

Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known.  Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.

WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER

See full prescribing information for complete boxed warning

  • 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)
  • The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
  • 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
  • Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia
  • There is an increased risk of endometrial cancer in a woman with a uterus who use unopposed estrogens
  • The WHI estrogen-alone substudy reported increased risks of stroke and DVT
  • The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
  • Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia

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If you suspect an overdose or accidental ingestion, call Poison Control: 1-800-222-1222 (free, 24/7, U.S.). For life-threatening symptoms, call 911.

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PATIENT INFORMATION

Mimvey®
(estradiol and norethindrone acetate) Tablets

Read this Patient Information before you start using Mimvey and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.

What is the most important information I should know about Mimvey

(a combination of estrogen and progestogen)?

  • Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
  • Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
  • Using estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age and older.
  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb).
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).
  • Using estrogen-alone may increase your chances of getting strokes or blood clots.
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age and older.
  • Only one estrogen with progestogen product and dose have been shown to increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia. Only one estrogen-alone product and dose have been shown to increase your chances of getting strokes, blood clots, and dementia. Because other products and doses have not been studied in the same way, it is not known how the use of Mimvey will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with Mimvey.

What is Mimvey?
Mimvey is a prescription medicine that contains two kinds of hormones, an estrogen and a progestogen.

What is Mimvey used for?
Mimvey is used after menopause to:

  • Reduce moderate to severe hot flushes
    Estrogens are hormones made by a woman’s ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the “change of life” or menopause, the end of monthly menstrual periods. Sometimes both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.”

    When estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden, intense feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need to use estrogens. In other women, symptoms can be more severe.
  • Treat moderate to severe menopausal changes in and around the vagina
    You and your healthcare provider should talk regularly about whether you still need treatment with Mimvey 1 mg/0.5 mg to treat these problems. If you use Mimvey 1 mg/0.5 mg only to treat your menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.
  • Help reduce your chances of getting osteoporosis (thin weak bones)
    Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break. If you use Mimvey to prevent osteoporosis due to menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.

You and your healthcare provider should talk regularly about whether you still need treatment with Mimvey.

Who should not use Mimvey?

Do not use Mimvey if you have had your uterus (womb) removed (hysterectomy).
Mimvey contains a progestogen to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestogen and you should not use Mimvey.

Do not start using Mimvey if you:

  • have unusual vaginal bleeding
    Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • have been diagnosed with a bleeding disorder
  •   currently have or have had certain cancers
    Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus (womb). If you have or have had cancer, talk with your healthcare provider about whether you should use Mimvey.
  • had a stroke or heart attack
  •   currently have or have had blood clots
  •   currently have or have had liver problems
  •   are allergic to Mimvey or any of the ingredients in it.
    See the list of ingredients in Mimvey at the end of this leaflet.

Before you use Mimvey, tell your healthcare provider about all of your medical conditions, including if you:

  • have any unusual vaginal bleeding
    Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • have any other medical conditions that may become worse while you are using Mimvey
    Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
  • are going to have surgery or will be on bed rest
    Your healthcare provider will let you know if you need to stop using Mimvey.
  • are pregnant or think you may be pregnant
    Mimvey is not for pregnant women.
  • are breastfeeding
    The hormones in Mimvey can pass into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how Mimvey works. Mimvey may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get new medicine.

How should I use Mimvey?

  • Use Mimvey exactly as your healthcare provider tells you to use it.
  • Take 1 tablet at the same time each day.
  • You and your healthcare provider should talk regularly (every 3 to 6 months) about your dose and whether you still need treatment with Mimvey.

What are the possible side effects of Mimvey?

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

  • heart attack
  • stroke
  • blood clots
  • breast cancer
  • cancer of the lining of the uterus (womb)
  • cancer of the ovary
  • liver problems
  • changes in your thyroid hormone levels
  • fluid retention
  • cancer changes of endometriosis
  • enlargement of benign tumors of the uterus (“fibroids”)
  • dementia
  • high or low blood calcium levels
  • gallbladder disease
  • visual abnormalities
  • high blood pressure
  • high levels of fat (triglycerides) in your blood
  • worsening swelling of face and tongue (angioedema) in women who have a history of angioedema
  • changes in laboratory tests results such as bleeding times and high blood sugar levels

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

  • new breast lumps
  • unusual vaginal bleeding
  • changes in vision or speech
  • sudden new severe headaches
  • severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Common side effects of Mimvey include:

  • irregular vaginal bleeding or spotting
  • nausea
  • stomach or abdominal cramps, bloating
  • headache
  • vomiting
  • back pain
  • breast pain
  • diarrhea
  • fluid retention
  • vaginal yeast infection

These are not all the possible side effects of Mimvey. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away.

You may report side effects to Teva at 1-888-838-2872 or to FDA at 1-800-FDA-1088.

What can I do to lower my chances of a serious side effect with Mimvey?

  • Talk with your healthcare provider regularly about whether you should continue using Mimvey.
  • If you have a uterus, talk with your healthcare provider about whether Mimvey is right for you.
  • In general, the addition of a progestogen is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).
  • See your healthcare provider right away if you get vaginal bleeding while using Mimvey.
  • Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else.
  • If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram (breast x-ray), you may need to have breast exams more often.
  • If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease.
  • Ask your healthcare provider for ways to lower your chances for getting heart disease.

How should I store Mimvey?

  • Store Mimvey at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store Mimvey in a dry place protected from light.

Keep Mimvey and all medicines out of the reach of children.

General information about the safe and effective use of Mimvey

Medicines are sometimes prescribed for purposes other than those listed in patient information leaflets. Do not use Mimvey for conditions for which it was not prescribed. Do not give Mimvey to other people, even if they have the same symptoms you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about Mimvey that is written for health professionals.

For more information call 1-888-838-2872.

What are the ingredients in Mimvey?

Active ingredients: estradiol and norethindrone acetate

Inactive Ingredients : colloidal silicon dioxide, copovidone, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, and titanium dioxide.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rev. H 5/2024

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Sources

RxCUI: 1359129

NDC: 935455

Last fetched: May 16, 2026

Source: DailyMed ↗

⚠️ Disclaimer

This information is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.