Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ospemifene
Drug ID BADD_D01630
Description Ospemifene is a new selective non-hormonal estrogen receptor modulator (SERM) that is used for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. FDA approved on February 26, 2013.
Indications and Usage Ospemifene is used for the treatment of moderate to dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Marketing Status Prescription
ATC Code G03XC05
DrugBank ID DB04938
KEGG ID D08958
MeSH ID C119141
PubChem ID 3036505
TTD Drug ID D02CTS
NDC Product Code 63069-601; 66039-912; 75929-178; 69037-0026; 50056-2021; 59630-580
Synonyms Ospemifene | Z-2-(4-(4-chloro-1,2-diphenyl-but-1-enyl)phenoxy)ethanol | Osphena | Senshio | FC-1271a
Chemical Information
Molecular Formula C24H23ClO2
CAS Registry Number 128607-22-7
SMILES C1=CC=C(C=C1)C(=C(C2=CC=CC=C2)C3=CC=C(C=C3)OCCO)CCCl
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)
Hypoaesthesia17.02.06.0230.001237%Not Available
Insomnia19.02.01.002; 17.15.03.0020.000825%
Lip swelling10.01.05.005; 07.05.04.005; 23.04.01.0070.000825%Not Available
Menopausal symptoms21.02.02.002--Not Available
Metrorrhagia21.01.01.0060.000825%Not Available
Middle insomnia19.02.01.003; 17.15.03.0030.000825%Not Available
Migraine24.03.05.003; 17.14.02.0010.001650%Not Available
Mood swings19.04.03.0010.000825%Not Available
Muscle spasms15.05.03.0040.010311%
Nausea07.01.07.001--
Neoplasm malignant16.16.01.001--Not Available
Nervousness19.06.02.0030.000825%Not Available
Night sweats23.02.03.006; 08.01.03.0310.002062%Not Available
Pain in extremity15.03.04.0100.003300%
Palpitations02.01.02.0030.002062%
Paraesthesia17.02.06.0050.001237%
Pollakiuria20.02.02.0070.000825%
Pruritus23.03.12.0010.001650%
Pulmonary embolism24.01.06.001; 22.06.02.0010.000825%Not Available
Rash23.03.13.0010.003300%Not Available
Rash erythematous23.03.06.003--Not Available
Rash generalised23.03.13.0020.000825%Not Available
Rash pruritic23.03.12.0020.001237%Not Available
Skin disorder23.03.03.0070.000825%Not Available
Somnolence19.02.05.003; 17.02.04.0060.000825%
Swelling face10.01.05.018; 23.04.01.0180.001650%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.000825%Not Available
Urinary tract infection20.08.02.001; 11.01.14.0040.001237%
Urticaria23.04.02.001; 10.01.06.001--
Vaginal discharge21.08.02.0020.007837%
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