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Bijuva Side Effects

Generic Name: estradiol / progesterone

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 TherapyEstrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of stroke, DVT, PE, and myocardial infarction.The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer.The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age of older.Estrogen-Alone TherapyThere is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.The WHI estrogen-alone substudy reported increased risks of stroke and DVT.The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age or older.

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
  • chest pain
  • confusion
  • lightheadedness, dizziness, or fainting
  • fast or irregular heartbeat
  • sudden fainting
  • unusual tiredness or weakness

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[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%)[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

References

1. "Product Information. Bijuva (estradiol-progesterone)." TherapeuticsMD, Boca Raton, FL.

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.

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