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)
Plasmacytoma01.14.02.002; 16.23.02.002---
Platelet count decreased13.01.04.001--
Pollakiuria20.02.02.007--
Presyncope02.11.04.013; 17.02.05.009; 24.06.02.010--
Prurigo23.03.04.017---
Pruritus23.03.12.001--
Pruritus genital21.10.01.002; 23.03.12.008---
Pulmonary embolism22.06.02.001; 24.01.06.001---
Pulmonary granuloma22.01.01.014---
Pyelonephritis11.01.14.002; 20.01.09.001---
Pyometra11.01.10.016; 21.14.01.003---
Rash maculo-papular23.03.13.004--
Rectal polyp07.20.01.005; 16.05.02.003---
Rectal ulcer07.04.01.002--
Rectocele07.16.06.003; 21.07.05.005---
Retinal detachment06.09.03.003; 12.01.04.004--
Retinal disorder06.08.03.005---
Retinal vascular disorder06.10.01.002; 24.03.07.002--
Retinal vein thrombosis06.10.01.003; 24.01.07.002---
Rheumatoid arthritis10.04.06.001; 15.01.03.001---
Rhinitis allergic10.01.04.003; 22.04.04.003--
Rosacea23.02.08.001---
Rotator cuff syndrome12.01.07.018; 15.01.08.002--
Sciatica15.10.01.001; 17.10.03.001---
Sinus arrest02.03.03.007---
Skin disorder23.03.03.007---
Skin hyperpigmentation23.05.01.003--
Skin irritation23.03.04.009---
Skin lesion23.03.03.010---
Smear cervix abnormal13.20.02.001---
The 7th Page    First    Pre   7 8 9 10 11    Next   Last    Total 11 Pages