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Full Safety Information Full Prescribing Information Healthcare Professionals

Frequently asked questions

BIJUVA is a prescription combination hormone therapy that combines 2 kinds of hormones: body-identical* estrogen and body-identical progesterone. BIJUVA is approved to treat moderate to severe vasomotor symptoms (VMS) due to menopause in women less than 60 years old with a uterus (womb) who entered menopause within the past 10 years.1

BIJUVA may be an option for you if you1,2:

  • Need relief from your moderate to severe VMS
  • Entered menopause within the past 10 years or are younger than 60 years
  • Are lacking relief from your current VMS treatment

Talk to your doctor to see if you could be a candidate for BIJUVA.

Yes, BIJUVA is a once-daily oral capsule that contains an estrogen and a progesterone. It is a body-identical product, which means that the hormones in BIJUVA are chemically and structurally identical to the hormones your body produces naturally.1,3,4 The estrogen helps to replace what the body isn’t producing anymore during menopause to treat moderate to severe hot flashes, while the progesterone decreases the chance of getting cancer of the uterus (womb).5

BIJUVA is not for everyone, as there are risks associated with MHT. However, professional medical guidelines suggest that estrogen therapies, such as BIJUVA, are effective treatments for menopausal symptoms, like hot flashes.5,6

For women in menopause that have a uterus (womb) and entered menopause within the last 10 years, healthcare providers often prescribe 2 hormones for hormone therapy: estrogen and progesterone.4,7

The estrogen helps replace what the body isn’t producing anymore during menopause, relieving symptoms like hot flashes. The progesterone helps protect the uterine lining.4,5

Estrogen and progesterone often come in 2 separate prescriptions. However, a combination MHT means that both hormones are combined into a single treatment.5

  • Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function)1
  • Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots1

BIJUVA is approved to help treat VMS in women who are younger than 60 years or who entered menopause within the past 10 years.1

When it comes to VMS, earlier treatment is associated with better outcomes. That means the sooner you start treatment with BIJUVA, the quicker you regain the benefits of estrogen.8

While results vary person to person, more women taking BIJUVA in the clinical trials had relief from their VMS in as little as 4 weeks.1

Do not use BIJUVA if you1:

  • Have had a hysterectomy, meaning the removal of your uterus (womb). BIJUVA contains progesterone to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need progesterone and you should not use BIJUVA
  • 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
  • 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 (womb). If you have or have had cancer, talk with your healthcare provider about whether you should use BIJUVA
  • Currently have or have had blood clots
  • Had a stroke or heart attack
  • Currently have or have had liver problems
  • Have been diagnosed with a bleeding disorder
  • Are allergic to BIJUVA or any of its ingredients. See the list of ingredients in BIJUVA here

Before you use BIJUVA, tell your healthcare provider about all of your medical conditions, including if you1:

  • Have high levels of fat in your blood, known as triglycerides
  • 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 certain medical conditions that may become worse while you are using BIJUVA. Your healthcare provider may need to check you more carefully if you have certain conditions, such as:
    • Asthma or wheezing
    • Diabetes
    • Epilepsy or seizures
    • Migraine
    • A genetic problem called porphyria
    • Lupus
    • Hypertension or high blood pressure
    • High calcium in your blood
    • Endometriosis
    • Angioedema or swelling of the face or tongue
    • Problems with your heart, liver, thyroid, or kidneys
  • Are going to have surgery or will be on bed rest. Your healthcare provider will let you know if you need to stop using BIJUVA
  • Are pregnant or think you may be pregnant. BIJUVA is not for pregnant women
  • Are breastfeeding. The hormones in BIJUVA can pass into your breast milk

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how BIJUVA works. Some other medicines and food products may increase or decrease the concentrations of the hormones in BIJUVA in the blood. BIJUVA may affect how your other medicines work, and other medicines may affect how BIJUVA works.1

  • Take BIJUVA exactly as your healthcare provider tells you to take it1
  • Take 1 capsule by mouth each evening with food1
  • If you miss a dose of BIJUVA, take the missed dose as soon as possible with food, unless it is within 2 hours of the next evening dose of BIJUVA1
  • Estrogens should be used at the lowest dose possible for your treatment and only for as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with BIJUVA1

  • Store BIJUVA at room temperature between 68 °F to 77 °F (20 °C to 25 °C)1
  • Keep BIJUVA and all medicines out of the reach of children1

Side effects are grouped by how serious they are and how often they happen during treatment. Serious but less common side effects include1

  • Heart attack
  • Stroke
  • Blood clots
  • Breast cancer
  • Cancer of the lining of the uterus (womb)
  • Cancer of the ovary
  • Dementia
  • Gallbladder disease
  • High or low blood calcium levels
  • Changes in vision
  • High blood pressure
  • High levels of fat in your blood, known as triglycerides
  • Liver problems
  • Changes in thyroid hormone levels
  • Swelling or fluid retention
  • Cancer changes of endometriosis
  • Enlargement of benign tumors of the uterus (womb), known as fibroids
  • Worsening in swelling of the face or tongue in women who have a history of angioedema
  • Changes in laboratory test results, such as bleeding time 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 you1:

  • 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
  • Vomiting

The most common side effects of BIJUVA include1

  • Breast tenderness
  • Vaginal bleeding
  • Pelvic pain
  • Headache
  • Vaginal discharge
  • Nausea

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of BIJUVA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If you miss a dose of BIJUVA, you should take the missed dose as soon as possible with food unless it’s within 2 hours of your next evening dose.1

Women taking BIJUVA in the clinical studies did not have significant differences in weight compared to women who were not receiving any treatment.9

Here are some ways to help minimize risk while taking BIJUVA1:

  • Talk with your healthcare provider regularly about whether you should continue using BIJUVA
  • If you have a uterus (womb), talk with your healthcare provider about whether BIJUVA is right for you
  • The addition of a progestogen is generally recommended for a woman with a uterus (womb) to reduce the chance of getting cancer of the uterus
  • See your healthcare provider right away if you get vaginal bleeding while using BIJUVA
  • 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), or diabetes, if you 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
*A body-identical hormone is one that has the exact same chemical and molecular structure as the hormones your body naturally produces.3 There are no data that suggest that body-identical hormones are superior to synthetic hormones.

References: 1. BIJUVA [package insert]. Raleigh, NC: Mayne Pharma. February 2026. 2. English M, Stoykova B, Slota C, et al. Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS Sleep Disturbance and Sleep-Related Impairment measures for assessment of VMS impact on sleep. J Patient Rep Outcomes. 2021;5(1):37. 3. Stuenkel CA. Compounded bioidentical hormone therapy: new recommendations from the 2020 National Academies of Sciences, Engineering, and Medicine. Menopause. 2021;28(5):576-578. 4. Kolatorova L, Vitku J, Suchopar J, Hill M, Parizek A. Progesterone: a steroid with wide range of effects in physiology as well as human medicine. Int J Mol Sci. 2022;23(14):7989. 5. Crandall CJ, Mehta JM, Manson JE. Management of menopausal symptoms: a review. JAMA. 2023;329(5):405-420. 6. North American Menopause Society Advisory Panel. The 2022 hormone therapy position statement of The North American Menopause Society. Menopause. 2022;29(7):767-794. 7. Panay N, Fenton A, Hamoda H, et al; IMS Recommendations Writing Group. International Menopause Society (IMS) recommendations and key messages on women’s midlife health and menopause. Climacteric. 2025;28(6):634-656. 8. Cho L, Kaunitz AM, Faubion SS, et al; ACC CVD in Women Committee. Rethinking menopausal hormone therapy: for whom, what, when, and how long? Circulation. 2023;147(7):597-610. 9. Black DR, Minkin MJ, Graham S, Bernick B, Mirkin S. Effects of combined 17β-estradiol and progesterone on weight and blood pressure in postmenopausal women of the REPLENISH trial. Menopause. 2020;28(1):32-39.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about BIJUVA® (a combination of estrogen and progestogen)?
  • Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).
  • Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
Who should not use BIJUVA?

Do not use BIJUVA if you have had your uterus (womb) removed (hysterectomy). BIJUVA 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 BIJUVA.

Do not start using BIJUVA 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 chances of getting certain types of cancers, including cancer of the breast or uterus (womb). If you have or have had cancer, talk to your healthcare provider about whether you should use BIJUVA.
  • Currently have or have had blood clots.
  • Had a stroke or heart attack.
  • Currently have or have had liver problems.
  • Are allergic to BIJUVA or any of its ingredients.
Before you use BIJUVA, tell your healthcare provider about all of your medical conditions, including if you:
  • Have high levels of fat in your blood (triglycerides).
  • Have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
  • Have any other medical conditions that may become worse while you are using BIJUVA.
  • Are going to have surgery or will be on bed rest. Your healthcare provider will let you know if you need to stop using BIJUVA.
  • Are pregnant or think you may be pregnant.
  • Are breastfeeding.

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 BIJUVA works. BIJUVA may 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.

What are the possible side effects of BIJUVA?

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
  • dementia
  • gallbladder disease
  • high or low blood calcium levels
  • changes in vision
  • high blood pressure
  • high levels of fat in your blood (triglycerides)
  • liver problems
  • changes in thyroid hormone levels
  • swelling or fluid retention
  • cancer changes of endometriosis
  • enlargement of benign tumors of the uterus (“fibroids”)
  • worsening swelling of face or tongue (angioedema) in women who have a history of angioedema
  • changes in laboratory test results such as bleeding time 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
  • vomiting

Common side effects of BIJUVA include:

  • breast tenderness
  • headache
  • nausea
  • vaginal bleeding
  • vaginal discharge
  • pelvic pain

Tell your healthcare provider if you have any side effects that bother you or do not go away. These are not all of the possible side effects of BIJUVA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Mayne Pharma at 1-844-825-8500.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about BIJUVA® (a combination of estrogen and progestogen)?
  • Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).
  • Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
Who should not use BIJUVA?

Do not use BIJUVA if you have had your uterus (womb) removed (hysterectomy). BIJUVA 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 BIJUVA.