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Bazedoxifene Side Effects

The most commonly reported side effects of bazedoxifene include hot flush, nausea, and off label use, based on 1,054 FDA adverse event reports from 2006 to 2025. 13.5% of reports found the drug to be ineffective.

Bazedoxifene side effects

Percentages show how often each reaction appears relative to total reports for bazedoxifene.

1
Drug Ineffective13.5%142
2
Hot Flush7.5%79
3
Nausea4.7%50
4
Off Label Use4.3%45
5
Muscle Spasms3.9%41
6
Headache3.4%36
7
Weight Increased3.3%35
8
Pain3.2%34
9
Feeling Abnormal3.2%34
10
Dizziness3.1%33
11
Insomnia3.0%32
12
Fatigue2.5%26
13
Malaise2.4%25
14
Therapeutic Response Unexpected2.4%25
15
Arthralgia2.4%25

These are voluntary reports and do not establish that bazedoxifene caused these reactions.

Report severity

29.2%Serious308 reports
9.2%Hospitalizations97 reports
1.7%Fatal18 reports

Seriousness is determined by the reporter, not by OpenClaim.

Bazedoxifene drug interactions

Other drugs that appear in adverse event reports alongside bazedoxifene. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Estrogens80.3%846
2
Estradiol2.5%26
3
Progesterone1.2%13
4
Sodium-oxybate1.0%11
5
Adalimumab0.9%9
6
Pregabalin0.7%7
7
Celecoxib0.7%7
8
Denosumab0.7%7
9
Levothyroxine-sodium0.7%7
10
Rosuvastatin0.6%6
11
Palbociclib0.6%6
12
Lecanemab-irmb0.6%6
13
Medroxyprogesterone-acetate0.5%5
14
Etanercept0.5%5
15
Fingolimod0.5%5

Taken alongside

1
Estrogens10.3%109
2
Ergocalciferol5.6%59
3
Levothyroxine-sodium4.8%51
4
Acetaminophen3.3%35
5
Aspirin3.1%33
6
Atorvastatin-calcium3.0%32
7
Calcium2.8%29
8
Omeprazole2.5%26
9
Montelukast-sodium2.2%23
10
Fluticasone2.2%23
11
Amlodipine1.9%20
12
Ibuprofen1.8%19
13
Clonazepam1.7%18
14
Cyanocobalamin1.7%18
15
Ascorbic-acid1.5%16

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports bazedoxifene side effects

84.9% of bazedoxifene adverse event reports involve female patients and 0.5% involve male patients. The largest age group is adult at 76%. These figures reflect who reports side effects, not underlying risk.

Sex

Female84.9%
Male0.5%
Unknown14.6%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6475.8%
65+24.2%

What is bazedoxifene used for

Conditions and purposes for which patients were taking bazedoxifene when the adverse event was reported.

Affective DisorderAmenorrhoeaAngiopathyAstheniaAtrophic VulvovaginitisAutonomic Nervous System ImbalanceAmnesiaAngiopathyBlood Oestrogen AbnormalBlood Oestrogen DecreasedBone Density AbnormalBone Density DecreasedBone DisorderBone LossBreast Cancer

Showing 15 of 89 indications

Bazedoxifene brand names and reporting trend

Bazedoxifene is sold under the brand name Duavee.

Brand names

Duavee123

Quarterly reports (20062025)

2006201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking bazedoxifene with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.