Bazedoxifene / Conjugated Estrogens Side Effects
Medically reviewed by Drugs.com. Last updated on Jul 5, 2024.
Applies to bazedoxifene / conjugated estrogens: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
Endometrial Cancer, Cardiovascular Disorders, and Probable Dementia. Women 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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments.
Do not take other medicines that contain estrogen or progestin while you are being treated with this medicine.
It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Using this medicine may increase your risk for having blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes or are overweight or smoke cigarettes. Contact your doctor immediately if you experience chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.
Using this medicine may increase your risk of endometrial cancer, breast cancer, or uterine cancer. Talk with your doctor about this risk. Check with your doctor immediately if your experience abnormal vaginal bleeding.
Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.
Check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine before you have surgery or if you need to stay in bed for an extended time. This medicine may affect the results of certain medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
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 side effects
- diarrhea
- muscle spasm
- throat pain
- upper abdominal or stomach pain
Less common side effects
- neck pain
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
For healthcare professionals
Applies to bazedoxifene / conjugated estrogens: oral tablet.
General adverse events
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
See also:
Paxil
Paxil is used to treat depression, obsessive-compulsive disorder and anxiety. Learn about side ...
Prolia
Prolia (denosumab) is an injection that is administered subcutaneously (under the skin) once every ...
Evenity
Evenity (romosozumab) injection is used to treat osteoporosis in postmenopausal women to reduce the ...
Fosamax
Fosamax (alendronate) is used to treat or prevent postmenopausal osteoporosis and steroid-induced ...
Calcium carbonate
Calcium carbonate systemic is used for duodenal ulcer, erosive esophagitis, GERD, hypocalcemia ...
Paroxetine
Paroxetine is used treat depression, obsessive-compulsive disorder and anxiety disorders. Learn ...
Estradiol
Estradiol is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning ...
Alendronate
Alendronate systemic is used for aseptic necrosis, osteoporosis, paget's disease, prevention of ...
Premarin
Premarin is used to treat symptoms of menopause such as hot flashes, and vaginal dryness. Learn ...
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2013) "Product Information. Duavee (bazedoxifene-conjugated estrogens)." Pfizer U.S. Pharmaceuticals Group
More about bazedoxifene / conjugated estrogens
- Check interactions
- Compare alternatives
- Reviews (35)
- Dosage information
- During pregnancy
- Drug class: sex hormone combinations
- En español
Patient resources
- Bazedoxifene and conjugated estrogens drug information
- Conjugated estrogens and bazedoxifene (Advanced Reading)
Other brands
Professional resources
Other brands
Related treatment guides
Further information
Bazedoxifene/conjugated estrogens side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.