Short answer: In the label's 1-year trial, the most common Bijuva side effects were breast tenderness (10.4% on 1 mg/100 mg and 4.0% on 0.5 mg/100 mg vs 0.7% on placebo), headache, nausea, vaginal bleeding, vaginal discharge and pelvic pain. Since February 2026 Bijuva has no boxed warning; its warnings cover blood clots, stroke and heart attack and breast cancer from the WHI estrogen plus progestin trial.
What Bijuva is approved for: Bijuva combines an estrogen (estradiol) and progesterone in one capsule. It is approved for a woman with a uterus to treat moderate to severe hot flashes (vasomotor symptoms) due to menopause (section 1.1). The label says timing matters, and to consider starting it in women under 60 or within 10 years of menopause onset (section 2).
Source
BIJUVA (estradiol and progesterone) capsules, for oral use, prescribing information and Patient Information. Mayne Pharma. DailyMed, version published October 1, 2026. DailyMed setid bc52489a-5149-411d-9665-2c75405ad15d
No. The current Bijuva label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Bijuva.
| Adverse reaction | Bijuva 0.5 mg/100 mg (N=424) | Bijuva 1 mg/100 mg (N=415) | Placebo (N=151) |
|---|---|---|---|
| Breast tenderness | 17 (4.0) | 43 (10.4) | 1 (0.7) |
| Headache | 17 (4.0) | 14 (3.4) | 1 (0.7) |
| Nausea | 15 (3.5) | 9 (2.2) | 1 (0.7) |
| Vaginal bleeding | 10 (2.4) | 14 (3.4) | 0 |
| Vaginal discharge | 8 (1.9) | 14 (3.4) | 1 (0.7) |
| Pelvic pain | 12 (2.8) | 13 (3.1) | 0 |
One-year trial of 1,835 postmenopausal women. Values are number of women (percent).
Endometrial hyperplasia after up to 12 months: 1 of 303 women (0.33%) on 0.5 mg/100 mg, 1 of 281 (0.36%) on 1 mg/100 mg, and 0 of 92 on placebo. No endometrial cancer was found.
At 52 weeks, cumulative amenorrhea (no bleeding or spotting) was 67.6% on 0.5 mg/100 mg, 56.1% on 1 mg/100 mg and 78.9% on placebo.
WHI estrogen plus progestin (oral CE 0.625 mg plus MPA 2.5 mg), women 50 to 79: DVT 25 vs 14 per 10,000 women-years on placebo; pulmonary embolism 18 vs 9; stroke 33 vs 24; coronary heart disease 41 vs 35. In women 50 to 59: DVT 15 vs 5, pulmonary embolism 11 vs 5, stroke 15 vs 10.
WHI invasive breast cancer, women 50 to 79: 43 vs 35 per 10,000 women-years (relative risk 1.24). A meta-analysis of 24 studies found a relative risk of 2.08 with 5 to 14 years of current estrogen plus progestin use.
Reported after approval: abdominal pain and bloating, diarrhea, nausea, vomiting, fatigue, weight gain, fluid retention, muscle spasms, dizziness, headache, sleepiness, insomnia, breast pain, uterine bleeding, night sweats, itching and hot flush.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. Women with undiagnosed abnormal genital bleeding, current or past breast cancer, estrogen-dependent cancer, current or past DVT, pulmonary embolism, stroke or heart attack, a known anaphylactic reaction, angioedema or allergy to Bijuva, liver impairment or disease, or protein C, protein S or antithrombin deficiency or other clotting disorders.
Blood clots, stroke and heart attack. The WHI estrogen plus progestin trial found more pulmonary embolism, DVT, stroke and heart attack. Bijuva is stopped right away if one occurs or is suspected and, if feasible, 4 to 6 weeks before surgery linked to clots or during long immobilization. Only oral CE plus MPA was studied, so how the findings apply to Bijuva is not known.
Breast and ovarian cancer. Bijuva is stopped if a hormone-sensitive cancer is diagnosed. Estrogen plus progestin has been linked to more abnormal mammograms, and breast exams and mammography are recommended. A meta-analysis of current estrogen plus progestin use found an ovarian cancer relative risk of 1.37.
Gallbladder disease. A 2- to 4-fold rise in gallbladder disease needing surgery has been reported in postmenopausal women taking estrogens.
Vision problems. Blood clots in the retina have been reported. Bijuva is stopped pending exam for sudden vision loss, bulging eyes, double vision or migraine, and permanently if papilledema or retinal vessel lesions are found.
Triglycerides, liver and calcium. In women with high triglycerides, estrogen can raise them and cause pancreatitis (5.7). Bijuva is stopped if jaundice from bile blockage returns (5.8). Estrogen can cause severe high calcium in breast cancer spread to bone (5.4) and low calcium in hypoparathyroidism (5.11).
Thyroid, fluid and other conditions. Women on thyroid hormone may need higher doses. Bijuva can cause fluid retention and may worsen hereditary angioedema, asthma, diabetes, epilepsy, migraine, porphyria, lupus and liver hemangiomas (sections 5.9 to 5.13).
From the Patient Information that comes with Bijuva:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.