Summary
More frequently reported side effects include: diarrhea, dizziness, muscle spasm, and nausea. Continue reading for a comprehensive list of adverse effects.
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
- Acid or sour stomach
- anxiety
- backache
- belching
- bloating
- change in vaginal discharge
- chest pain
- chills
- clear or bloody discharge from the nipple
- confusion
- constipation
- cough
- darkened urine
- difficulty with speaking
- dimpling of the breast skin
- dizziness or lightheadedness
- double vision
- fainting
- fast heartbeat
- fever
- full or bloated feeling or pressure in the stomach
- headache
- heartburn
- inability to move the arms, legs, or facial muscles
- inability to speak
- indigestion
- inverted nipple
- loss of appetite
- lump in the breast or under the arm
- nausea
- pain or feeling of pressure in the pelvis
- pain, redness, or swelling in the arm or leg
- pains in the stomach, side, or abdomen, possibly radiating to the back
- persistent crusting or scaling of the nipple
- redness or swelling of the breast
- slow speech
- sore on the skin of the breast that does not heal
- stomach discomfort, upset, or pain
- sudden shortness of breath or troubled breathing
- swelling of the abdominal or stomach area
- vaginal bleeding
- vomiting
- yellow eyes or skin
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
- Diarrhea
- muscle spasm
- throat pain
- upper abdominal or stomach pain
Less common
- Neck pain
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
