Full Safety Information Full Prescribing Information
For US Residents Healthcare Professionals
Full Safety Information Full Prescribing Information Healthcare Professionals

The onethat helps you live in the moment
—even through menopause1

You’ve never experienced a menopause
hormone therapy (MHT) quite like BIJUVA®.1

BIJUVA is the first and only FDA-approved available body‑identical* MHT that combines estrogen and progesterone into a single treatment.1

Here’s what that means:

Shown to provide relief in as little as 4 weeks1
Hormones that are one with your own1,2
Protection of your uterine lining3

All in one single pill1

*A body-identical hormone is one that has the exact same chemical and molecular structure as the hormones your body naturally produces.4 There are no data that suggest that body-identical hormones are superior to synthetic hormones.
Relief in more ways than one5
One pill, once a day, is all it takes for you to feel better, sleep better, and live better through menopause.1,6,7
In a study of women in menopause, BIJUVA was proven to reduce the frequency and severity of moderate to severe hot flashes1
Women taking BIJUVA also reported improvement in their quality of life6
Women taking BIJUVA also reported improvement in their sleep7

One pill without

one-size-fits-all dosing

Every woman and her experience with menopause is different. That’s why BIJUVA comes in 2 different doses so that you can work with your healthcare provider to decide what works best for you.1
A woman loads shopping bags into her parked convertible.

Your body, your
body-identical

BIJUVA is the first and only available body-identical hormone therapy approved by the FDA. This means that the estrogen and progesterone in BIJUVA are chemically identical to the hormones naturally produced by your body.1,2,8,9

By combining body-identical estrogen and body-identical progesterone in a single pill, BIJUVA helps to reduce VMS while protecting the uterine lining.1,9,10

BIJUVA side effects

The most common side effects of BIJUVA include breast tenderness, vaginal bleeding, pelvic pain, nausea, headache, and vaginal discharge.1
A woman glows with confidence as her partner twirls her on the dance floor.

References: 1. BIJUVA [package insert]. Raleigh, NC: Mayne Pharma. February 2026. 2. Files JA, Ko MG, Pruthi S. Bioidentical hormone therapy. Mayo Clin Proc. 2011;86(7):673-680. 3. Mirkin S, Goldstein SR, Archer DF, Pickar JH, Graham S, Bernick B. Endometrial safety and bleeding profile of a 17β-estradiol/progesterone oral softgel capsule (TX-001HR). Menopause. 2020;27(4):410-417. 4. Stuenkel CA. Compounded bioidentical hormone therapy: new recommendations from the 2020 National Academies of Sciences, Engineering, and Medicine. Menopause. 2021;28(5):576-578. 5. Lobo RA, Kaunitz AM, Santoro N, Bernick B, Graham S, Mirkin S. Metabolic and cardiovascular effects of TX-001HR in menopausal women with vasomotor symptoms. Climacteric. 2019:22(6):610-616. 6. Simon JA, Kaunitz AM, Kroll R, Graham S, Bernick B, Mirkin S. Oral 17β-estradiol/progesterone (TX-001HR) and quality of life in postmenopausal women with vasomotor symptoms. Menopause. 2019:26(5):506-512. 7. Kagan R, Constantine G, Kaunitz AM, Bernick B, Mirkin S. Improvement in sleep outcomes with a 17β-estradiol–progesterone oral capsule (TX-001HR) for postmenopausal women. Menopause. 2018;26(6):622-628. 8. Panay N, Ang SB, Cheshire R, Goldstein SR, Maki P, Nappi RE; International Menopause Society Board. Menopause and MHT in 2024: addressing the key controversies – an International Menopause Society White Paper. Climacteric. 2024;27(5):441-457. 9. 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. 10. Crandall CJ, Mehta JM, Manson JE. Management of menopausal symptoms: a review. JAMA. 2023;329(5):405-420.

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.