PillSeek

Medication Guide — Enjuvia

Patient-friendly FDA guidance and safety information.

Last updated · May 19, 2026Source: DailyMed ↗
Boxed Warning

Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer .)

CARDIOVASCULAR AND OTHER RISKS

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Dementia .)

The estrogen alone substudy of the Women’s Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) alone per day, relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders .)

The estrogen-plus-progestin substudy of the WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo. (See CLINICAL STUDIES, and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer ).

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES, WARNINGS, Dementia and PRECAUTIONS, Geriatric Use .)

Other doses of conjugated  estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins, were not studied in the WHI clinical trials, and in the absence of comparable data, these risks should be assumed to be similar.  Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Poison Help

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.

On this page

PATIENT INFORMATION

ENJUVIA®
(synthetic conjugated estrogens, B) Tablets

Read this Patient Information leaflet before you start taking ENJUVIA, and read what you get each time you refill ENJUVIA. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

WHAT IS THE MOST IMPORTANT INFORMATION

I SHOULD KNOW ABOUT ENJUVIA (AN ESTROGEN HORMONE MIXTURE)?

  • Estrogens increase the chance of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking ENJUVIA. 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.
  • Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes, or dementia. Using estrogens with or without progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.   Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women age 65 years or older. You and your healthcare provider should talk regularly about whether you still need treatment with ENJUVIA.

What is ENJUVIA?

ENJUVIA is a medicine that contains a mixture of estrogen hormones.

What is ENJUVIA used for?

ENJUVIA is used after menopause to:

  • Reduce moderate to severe hot flashes

    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 the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with ENJUVIA.
  • Treat moderate to severe vaginal dryness and pain with sex, associated with menopause

    You and your healthcare provider should talk regularly about whether you still need treatment with ENJUVIA to control these problems. If you use ENJUVIA only to treat your vaginal dryness, or pain with sex, talk with your healthcare provider about whether a topical vaginal product might be better for you.

Who should not take ENJUVIA?

Do not start taking ENJUVIA if you:

  • Have unusual vaginal bleeding
  • Currently have or have had certain cancers

    Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take ENJUVIA.
  • Had a stroke or heart attack in the past year
  • Currently have or have had blood clots
  • Currently have or have had liver problems
  • Are allergic to ENJUVIA or any of its ingredients

    See the end of this leaflet for a list of ingredients in ENJUVIA.
  • Think you may be pregnant

Tell your healthcare provider:

  • If you are breastfeeding

    The hormones in ENJUVIA can pass into your milk.
  • About all of your medical problems

    Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
  • About all the medicines you take

    This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how ENJUVIA works. ENJUVIA may also affect how your other medicines work.
  • If you are going to have surgery or will be on bedrest

    You may need to stop taking estrogens.

How should I take ENJUVIA?

  • Take one ENJUVIA tablet by mouth at the same time each day.
  • If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your normal schedule. Do not take 2 doses at the same time.
  • Estrogens should be used at the lowest dose possible for your treatment only as long as needed. You and your healthcare provider should talk regularly (e.g., every 3 to 6 months) about the dose you are taking and whether you still need treatment with ENJUVIA.
  • ENJUVIA may be taken with or without food.

What are the possible side effects of estrogens?

Less common but serious side effects include:

Some of the warning signs of serious side effects include:

  • Breast lumps
  • Unusual vaginal bleeding
  • Dizziness and faintness
  • Changes in speech
  • Severe headaches
  • Chest pain
  • Shortness of breath
  • Pains in your legs
  • Changes in vision
  • Vomiting

Call your healthcare provider right away if you get any of these warning signs, or any other symptoms that concern you.

Common side effects include:

  • Headache
  • Breast pain
  • Irregular vaginal bleeding or spotting
  • Stomach/abdominal cramps, bloating
  • Nausea and vomiting
  • Hair loss

Other side effects include:

  • High blood pressure
  • Liver problems
  • High blood sugar
  • Fluid retention
  • Enlargement of benign tumors of the uterus (“fibroids”)
  • Vaginal yeast infection

These are not all the possible side effects of ENJUVIA. For more information, ask your health-care provider or pharmacist.

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

  • Talk with your healthcare provider regularly about whether you should continue taking ENJUVIA.
  • If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you.
  • In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.
  • See your healthcare provider right away if you get vaginal bleeding while taking ENJUVIA.
  • Have a breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you otherwise. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, 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 a higher chance of getting heart disease. Ask your healthcare provider for ways to lower your chance of getting heart disease.

Have an annual gynecologic exam.

General information about safe and effective use of ENJUVIA.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take ENJUVIA for conditions for which it is not prescribed. Do not give ENJUVIA to other people, even if they have the same symptoms you have. It may harm them.

Keep ENJUVIA out of the reach of children.

This leaflet provides a summary of the most important information about ENJUVIA. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about ENJUVIA that is written for healthcare professionals.

You may also obtain further information by calling the toll free number 1-877-405-0369 or by visiting our website at www.ENJUVIA.com.

What are the ingredients in ENJUVIA?

ENJUVIA tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg strengths of synthetic conjugated estrogens, B. These tablets contain the following inactive ingredients: ascorbyl palmitate, butylated hydroxyanisole, colloidal silicon dioxide, edetate disodium dehydrate, plasticized ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, purified water, iron oxide red, titanium dioxide, polyethylene glycol, polysorbate 80, triacetate and triacetin/glycerol. In addition, the 0.45 mg tablets contain iron oxide black and iron oxide yellow; the 0.9 mg tablets also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake and FD& C yellow no. 6 aluminum lake; and the 1.25 mg tablets contain iron oxide yellow.

Teva Women's Health, Inc.
Subsidiary of Teva Pharmaceuticals USA, Inc.
Sellersville, PA 18960

Iss. 3/2010
11001651

Sources

RxCUI: 730880

NDC: [{'@sourceNdc9': '51285-0409', 'ndc9': ['54868-6165']}]

Last fetched: May 19, 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.