Bijuva
- Generic Name: estradiol and progesterone capsules
- Brand Name: Bijuva
Bijuva (Estradiol and Progesterone Capsules) side effects drug center
Bijuva Side Effects Center
What Is Bijuva?
Bijuva (estradiol and progesterone) is a combination of the female hormones estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.
What Are Side Effects of Bijuva?
Common side effects of Bijuva include:
- breast tenderness,
- headache,
- vaginal bleeding,
- vaginal discharge, and
- pelvic pain
Dosage for Bijuva
The dose of Bijuva is one capsule orally each evening with food.
What Drugs, Substances, or Supplements Interact with Bijuva?
Bijuva may interact with St. John's wort, phenobarbital, carbamazepine, rifampin, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice. Tell your doctor all medications and supplements you use.
Bijuva During Pregnancy and Breastfeeding
Bijuva is not indicated for use in females of reproductive potential and it is not likely to be used during pregnancy or while breastfeeding.
Additional Information
Our Bijuva (estradiol and progesterone) Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Bijuva Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision;
- signs of a blood clot--sudden vision loss, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
- swelling, rapid weight gain;
- jaundice (yellowing of the skin or eyes);
- unusual vaginal bleeding, pelvic pain;
- a lump in your breast; or
- high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.
Common side effects may include:
- pelvic pain;
- vaginal bleeding or discharge;
- breast tenderness; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Bijuva (Estradiol and Progesterone Capsules)
Bijuva Professional Information
SIDE EFFECTS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see WARNINGS AND PRECAUTIONS].
- Malignant Neoplasms [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of estradiol and progesterone capsules was assessed in a 1-year, Phase 3 trial that included 1,835 postmenopausal women (1,684 were treated with estradiol and progesterone capsules once daily and 151 women received placebo). Most women (~70%) in the active treatment groups were treated for ≥ 326 days.
Treatment related adverse reactions with an incidence of ≥ 3% in the BIJUVA (estradiol and progesterone) capsule, 1 mg/100 mg, group and numerically greater than those reported in the placebo group are listed in Table 1.
Table 1: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥ 3% and Numerically More Common in Women Receiving BIJUVA (estradiol and progesterone) 1 mg/100 mg
| Preferred Term | BIJUVA 1 mg/100 mg (N=415) |
Placebo (N=151) |
| Breast tenderness | 43 (10.4) | 1 (0.7) |
| Headache | 14 (3.4) | 1 (0.7) |
| Vaginal bleeding | 14 (3.4) | 0 |
| Vaginal discharge | 14 (3.4) | 1 (0.7) |
| Pelvic pain | 13 (3.1) | 0 |
DRUG INTERACTIONS
No drug-drug interaction studies have been conducted with BIJUVA.
Metabolic Interactions
Effects Of Other Drugs On Estrogens And Progestins
In-vitro and in-vivo studies have shown that estrogens and progestins are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen and progestin drug metabolism. Inducers of CYP3A4 such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens and progestins, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4, such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice, may increase plasma concentrations of the estrogen or the progestin or both and may result in side effects.
Read the entire FDA prescribing information for Bijuva (Estradiol and Progesterone Capsules)
© Bijuva Patient Information is supplied by Cerner Multum, Inc. and Bijuva Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.