Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bazedoxifene acetate
Drug ID BADD_D00215
Description Bazedoxifene is a third generation selective estrogen receptor modulator (SERM), developed by Pfizer following the completion of their takeover of Wyeth Pharmaceuticals. In late 2013, Pfizer received approval for bazedoxifene as part of the combination drug DUAVEE in the prevention (not treatment) of postmenopausal osteoporosis. It is approved in the European Union (marketed in Italy and Spain) and Japan as monotherapy. In 2013, the combination product containing conjugated estrogens and bazedoxifene was approved by the FDA for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as the prevention of postmenopausal osteoporosis in women.
Indications and Usage Indicated for following conditions alone or in combination with conjugated estrogens in women with a uterus: - Treatment of moderate to severe vasomotor symptoms associated with menopause - Prevention of postmenopausal osteoporosis
Marketing Status approved; investigational
ATC Code G03XC02
DrugBank ID DB06401
KEGG ID D03062
MeSH ID C447119
PubChem ID 154256
TTD Drug ID D0JY8T
NDC Product Code 55111-949
UNII J70472UD3D
Synonyms bazedoxifene | TSE 424 | TSE424 | TSE-424 | WAY-140424 | bazedoxifene acetate
Chemical Information
Molecular Formula C32H38N2O5
CAS Registry Number 198481-33-3
SMILES CC1=C(N(C2=C1C=C(C=C2)O)CC3=CC=C(C=C3)OCCN4CCCCCC4)C5=CC=C(C=C5)O.CC(=O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Alanine aminotransferase increased13.03.04.005--
Aspartate aminotransferase increased13.03.04.011--
Blepharospasm17.17.02.001; 06.05.01.001--Not Available
Blood triglycerides increased13.12.03.001--Not Available
Bone disorder15.02.04.004--Not Available
Dermatitis23.03.04.002--Not Available
Dry eye06.08.02.001--
Dry mouth07.06.01.002--
Eye disorder06.08.03.001--Not Available
Eye pain06.08.03.002--
Eye swelling06.08.03.003--Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.004--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Hypersensitivity10.01.03.003--
Immune system disorder10.02.01.001--Not Available
Menopausal symptoms21.02.02.002--Not Available
Muscle spasms15.05.03.004--
Nervous system disorder17.02.10.001--Not Available
Oedema peripheral08.01.07.007; 02.05.04.007; 14.05.06.011--
Palpitations02.11.04.012--
Photopsia17.17.01.006; 06.02.06.004--
Pruritus23.03.12.001--
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Rash23.03.13.001--Not Available
Retinal vein thrombosis24.01.07.002; 06.10.01.003--Not Available
Skin disorder23.03.03.007--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Urticaria23.04.02.001; 10.01.06.001--
Vision blurred17.17.01.010; 06.02.06.007--
Visual acuity reduced06.02.10.012; 17.17.01.011--
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