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Bazedoxifene / conjugated estrogens Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 31, 2024.

Applies to bazedoxifene / conjugated estrogens: oral tablet.

Warning

Oral route (Tablet)

Endometrial Cancer, Cardiovascular Disorders, and Probable DementiaWomen taking bazedoxifene/conjugated estrogens should not take additional estrogens. There is an increased risk of endometrial cancer in women with a uterus that use unopposed estrogens. Bazedoxifene acetate/conjugated estrogens has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. 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. Estrogen therapy should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (0.625 mg)-alone, relative to placebo. The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily conjugated estrogens (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. In the absence of comparable data, these risks should be assumed to be similar for other doses of conjugated estrogens and other dosage forms of estrogens. Estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Serious side effects

Along with its needed effects, bazedoxifene / conjugated estrogens 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 bazedoxifene / conjugated estrogens:

Incidence not known

Other side effects

Some side effects of bazedoxifene / conjugated estrogens 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:

More common

Less common

For Healthcare Professionals

Applies to bazedoxifene / conjugated estrogens: oral tablet.

General

The most common side effect were muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness, and neck pain.[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Frequency not reported: Venous thromboembolism, deep vein thrombosis[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, dyspepsia, upper abdominal pain[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasms, neck pain

Uncommon (0.1% to 1%): Tendonitis[Ref]

Nervous system

Common (1% to 10%): Dizziness, hypoesthesia[Ref]

Ocular

Frequency not reported: Retinal vein thrombosis

Bazedoxifene Monotherapy:

Postmarketing reports: Reduced visual acuity, blurred vision, photopsia, visual field defect, visual impairment, dry eye, eyelid edema, blepharospasm, eye pain, eye swelling[Ref]

Respiratory

Common (1% to 10%): Oropharyngeal pain, sinus headache, cough, dyspnea, nasal congestion, pharyngolaryngeal pain, allergic rhinitis, sinus congestion

Frequency not reported: Pulmonary embolism[Ref]

Metabolic

Common (1% to 10%): Blood triglycerides increased

Genitourinary

Common (1% to 10%): Dysuria, vaginal discharge, vulvovaginal pruritus

Uncommon (0.1% to 1%): pelvic pain

Hepatic

Uncommon (0.1% to 1%): Cholecystitis

Dermatologic

Common (1% to 10%): Acne, alopecia, contact dermatitis, dry skin, pruritus, rash

Endocrine

Common (1% to 10%): Breast pain, breast tenderness

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Duavee (bazedoxifene-conjugated estrogens). Pfizer U.S. Pharmaceuticals Group. 2013.

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.

Medical Disclaimer