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Bazedoxifene

Published: July 26, 2026Updated: July 26, 2026

Bazedoxifene is a selective estrogen receptor modulator (SERM) that is used in combination with conjugated estrogens in postmenopausal women. It helps relieve menopausal symptoms such as hot flashes and prevents postmenopausal osteoporosis while providing endometrial protection. This combination therapy allows women with a uterus to receive estrogen therapy without increased risk of endometrial hyperplasia.

Quick summary

Bazedoxifene is a SERM combined with conjugated estrogens to treat menopause symptoms and prevent bone loss in postmenopausal women while protecting the uterus.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy
BOXED WARNING

This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.

Key facts at a glance

ATC
G03XC02
RxNorm
1441386
Generic
Bazedoxifene
Class
atc-g03
Brands
Duavee
Availability
rx
Lactation
unknown
Routes
oral
Forms
tablet
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Consult local poison control center for specific information
Chronic overdose: Varies by patient
Immediate actions
Call poison control center: 1-800-222-1222
Poison Control: 1-800-222-1222

Special Populations

6 groups
✗

pregnancy

all trimesters
contraindicated
FDA Category
X
Dose Adjustment

avoid completely

Key Recommendations

do not use bazedoxifene during pregnancy contraindicated in pregnant women

Monitor

not applicable - avoid use

Use of this medication in this population requires careful consideration of risks and benefits.

✗

lactation

breastfeeding
unsafe
FDA Category
X
Dose Adjustment

avoid

Key Recommendations

do not use bazedoxifene during breastfeeding secretion in breast milk unknown

Monitor

not applicable - avoid use

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pediatric_age

children adolescents
contraindicated
FDA Category
X
Dose Adjustment

avoid completely

Key Recommendations

not indicated for use in pediatric patients safety and efficacy not established

Monitor

not applicable - avoid use

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

elderly over 65
caution
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

use with caution monitor for adverse effects no dose adjustment needed for patients over 65

Monitor

regular assessment of efficacy and adverse effects

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe renal impairment
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

not recommended in severe renal impairment CrCl less than 30 mL/min use with caution

Monitor

monitor renal function periodically

Use with caution and monitor for adverse effects.

✗

hepatic_impairment

severe hepatic impairment
contraindicated
FDA Category
X
Dose Adjustment

avoid completely

Key Recommendations

contraindicated in severe hepatic impairment including biliary cirrhosis

Monitor

not applicable - avoid use

Use of this medication in this population requires careful consideration of risks and benefits.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2013

FDA approval for bazedoxifene/conjugated estrogens combination (Duavee)

drug_classWHO
2023

Drug class

Value:Selective Estrogen Receptor Modulator (SERM)

Pharmacological classification based on mechanism of action

usageFDA
2023

Primary indication

Value:Treatment of menopausal vasomotor symptoms

Therapeutic use for moderate to severe vasomotor symptoms associated with menopause

formulationFDA
2023

Available formulation

Value:Oral tablet (bazedoxifene 20mg + conjugated estrogens 0.45mg)

Commercial formulation as combination therapy

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy