Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lasofoxifene
Drug ID BADD_D01250
Description Lasofoxifene is a non-steroidal 3rd generation selective estrogen receptor modulator (SERM) that selectively binds to both ERα and ERβ with high affinity. It is a naphthalene derivative marketed for prevention and treatment of osteoporosis and for the treatment of vaginal atrophy. It was initially developed as Oporia by Pfizer as a treatment for postmenopausal osteoporosis and vaginal atrophy, in which were both rejected for approval by FDA. Later Fablyn was developed as a result of a research collaboration between Pfizer and Ligand Pharmaceuticals with a newly submitted New Drug Application in 2008. It gained approval by European Commission in March 2009. Ligand Pharmaceuticals signed a license agreement with Sermonix Pharmaceuticals for the development and commercialization of oral lasofoxifene in the USA.
Indications and Usage Investigated for use/treatment in postmenopausal osteoporosis to reduce the risk of both vertebral and novertebral fractures, as well as address other postmenopausal conditions, including reduction in risk of breast cancer and treatment of vulvar and vaginal atrophy (VVA)
Marketing Status Not Available
ATC Code Not Available
DrugBank ID DB06202
KEGG ID Not Available
MeSH ID C111332
PubChem ID 216416
TTD Drug ID D09NMD
NDC Product Code Not Available
Synonyms Lasofoxifene | (-)-cis-5,6,7,8-tetrahydro-6-phenyl-5-(p-(2-(1-pyrrolidinyl)ethoxy)phenyl)-2-naphthol | CP 336156 | CP-336,156 | lasofoxifene hydrochloride | cis-1R-(4'-pyrrolidinoethoxyphenyl)-2S-phenyl-6-hydroxy-1,2,3,4-tetrahydronaphthalene, tartrate salt | LAS estrogen receptor modulator
Chemical Information
Molecular Formula C28H31NO2
CAS Registry Number 180916-16-9
SMILES C1CCN(C1)CCOC2=CC=C(C=C2)C3C(CCC4=C3C=CC(=C4)O)C5=CC=CC=C5
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Vaginal wall congestion21.08.01.002--Not Available
Varicose veins vulval24.10.03.002; 21.08.01.011--Not Available
Vascular headache17.14.01.005; 24.03.05.007--Not Available
Vasomotor rhinitis22.04.04.009--Not Available
Venous thrombosis24.01.01.008--Not Available
Vertigo positional17.02.12.004; 04.04.01.005--Not Available
Visual acuity reduced17.17.01.011; 06.02.03.001--
Visual impairment06.02.06.008--Not Available
Vulval disorder21.08.01.007--Not Available
Vulvovaginal candidiasis21.14.02.003; 11.03.03.005--Not Available
Vulvovaginitis11.01.10.003; 21.14.02.005--Not Available
Weight increased13.15.01.006--
Post thrombotic syndrome24.01.01.019--Not Available
Onychoclasis23.02.05.005--Not Available
Seasonal allergy06.04.01.013; 22.04.04.008; 10.01.04.001--Not Available
Bone density decreased13.16.01.001--Not Available
Urethral haemorrhage24.07.03.006; 20.07.01.003--Not Available
Urinary bladder polyp20.03.04.004; 16.27.02.001--Not Available
Excoriation12.01.06.007; 23.03.11.003--Not Available
Thoracic vertebral fracture15.08.05.003; 12.04.04.004--Not Available
Adnexa uteri cyst21.07.04.004; 16.04.01.003--Not Available
Electrocardiogram T wave abnormal13.14.05.009--
Fallopian tube cyst21.11.01.010; 16.04.01.004--Not Available
Extremity contracture15.03.01.017--Not Available
Hypochromasia01.07.02.011--Not Available
Deep vein thrombosis24.01.02.003--Not Available
Conjunctival hyperaemia06.04.01.004--Not Available
Hydrometra21.10.01.013--Not Available
Ear discomfort04.03.01.005--Not Available
Eye pruritus06.04.05.006--Not Available
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