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Bijuva Side Effects

Generic name: estradiol / progesterone

Medically reviewed by Drugs.com. Last updated on Apr 5, 2022.

Note: This document contains side effect information about estradiol / progesterone. Some of the dosage forms listed on this page may not apply to the brand name Bijuva.

For the Consumer

Applies to estradiol / progesterone: oral capsule

Warning

Oral route (Capsule)

Estrogen Plus Progestin TherapyThe Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of pulmonary embolism (PE), deep vein thrombosis (DVT), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia.The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer.Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile.Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Estrogen-Alone TherapyThere is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone relative to placebo.The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia.Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Side effects requiring immediate medical attention

Along with its needed effects, estradiol/progesterone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking estradiol / progesterone:

More common

  • Breast tenderness

Less common

Incidence not known

  • Blurred vision
  • breast pain
  • chest pain
  • chills
  • clay-colored stools
  • confusion
  • dark urine
  • decrease in the amount of urine
  • diarrhea
  • fast or irregular heartbeat
  • fever
  • general feeling of discomfort or illness
  • itching, skin rash
  • lightheadedness, dizziness, or fainting
  • loss of appetite
  • nausea
  • noisy, rattling breathing
  • stomach pain
  • swelling of the fingers, hands, feet, or lower legs
  • trouble breathing
  • unpleasant breath odor
  • unusual tiredness or weakness
  • unusually heavy or unexpected menstrual bleeding
  • vaginal bleeding or spotting
  • vomiting of blood
  • weight gain
  • yellow eyes or skin

Side effects not requiring immediate medical attention

Some side effects of estradiol / progesterone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

  • Muscle spasms
  • night sweats
  • pain in the arms or legs
  • sleepiness or unusual drowsiness
  • stomach discomfort or swelling
  • trouble sleeping
  • vomiting

For Healthcare Professionals

Applies to estradiol / progesterone: oral capsule

General

The most commonly reported adverse reactions have included breast tenderness, headache, vaginal bleeding, vaginal discharge and pelvic pain.[Ref]

Genitourinary

Common (1% to 10%): Vaginal bleeding, vaginal discharge, pelvic pain, disordered proliferative endometrium

Uncommon (0.1% to 1%): Endometrial hyperplasia

Postmarketing reports: Uterine bleeding[Ref]

During clinical trials, an endometrial biopsy revealed 1 case of endometrial hyperplasia (n=281). There were no cases in the placebo group (n=92). Four cases of disordered proliferative endometrium were reported in women receiving this drug.[Ref]

Endocrine

Very common (10% or more): Breast tenderness (10.4%)

Postmarketing reports: Breast pain[Ref]

Nervous system

Common (1% to 10%): Headache

Postmarketing reports: Dizziness, headache, somnolence[Ref]

Musculoskeletal

Postmarketing reports: Muscle spasms, pain in extremity

Metabolic

Postmarketing reports: Increased weight, fluid retention

Psychiatric

Postmarketing reports: Insomnia, sleep disorder

Other

Postmarketing reports: Fatigue, feeling abnormal, malaise

Cardiovascular

Postmarketing reports: Hot flush

Dermatologic

Postmarketing reports: Nightsweats, pruritus

Gastrointestinal

Postmarketing reports: Abdominal pain and discomfort, abdominal distention, diarrhea, nausea, vomiting

Frequently asked questions

References

1. "Product Information. Bijuva (estradiol-progesterone)." TherapeuticsMD (2018):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.