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 approved; investigational
ATC Code G03XC03
DrugBank ID DB06202
KEGG ID Not Available
MeSH ID C111332
PubChem ID 216416
TTD Drug ID D09NMD
NDC Product Code Not Available
UNII 337G83N988
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
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)
Soft tissue injury12.01.08.026; 15.03.02.010---
Spinal fracture12.04.04.002; 15.08.05.001--
Stomatitis07.05.06.005--
Supraventricular extrasystoles02.03.03.011---
Tachycardia02.03.02.007---
Tenosynovitis15.07.01.004---
Tetany05.04.02.003; 14.04.01.005; 15.05.03.013---
Therapeutic response unexpected08.06.01.001---
Thrombocytopenia01.08.01.002---
Thrombophlebitis24.01.02.001---
Thrombosis24.01.01.006---
Tricuspid valve incompetence02.07.05.001---
Ultrasound breast abnormal13.20.03.002---
Urethral disorder20.07.01.002---
Urinary incontinence17.05.01.008; 20.02.02.010--
Urinary tract disorder20.08.01.001---
Urinary tract infection11.01.14.004; 20.08.02.001--
Urticaria10.01.06.001; 23.04.02.001--
Uterine haemorrhage21.07.01.005; 24.07.03.004--
Uterine leiomyoma16.04.02.001; 21.07.02.004---
Uterine polyp16.04.02.002; 21.07.02.001---
Uterine prolapse21.07.05.006---
Vaginal discharge21.08.02.002--
Vaginal haemorrhage21.08.01.001; 24.07.03.005--
Vaginal infection11.01.10.002; 21.14.02.002--
Vaginal prolapse21.07.05.002---
Vaginal wall congestion21.08.01.002---
Varicose veins vulval21.08.01.011; 24.10.03.002---
Vascular headache17.14.01.005; 24.03.05.007---
Vasomotor rhinitis22.04.04.009---
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