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)
Abdominal distension07.01.04.0010.000825%
Abdominal pain07.01.05.0020.001237%
Abdominal pain upper07.01.05.0030.000825%
Acne23.02.01.0010.000825%Not Available
Alopecia23.02.02.0010.003712%
Angioedema23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Back pain15.03.04.0050.000825%
Bone pain15.02.01.0010.000825%
Burning sensation17.02.06.001; 08.01.09.0290.001237%Not Available
Cardiovascular disorder02.01.01.001; 24.03.02.009--Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.003--Not Available
Crying08.01.03.005; 19.04.02.002; 17.02.05.013; 12.02.11.0010.000825%Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry skin23.03.03.0010.000825%
Dysmenorrhoea21.01.01.0020.000825%
Dyspareunia21.03.02.016; 19.08.05.0040.002062%
Dyspnoea22.02.01.004; 02.01.03.002--
Dysuria20.02.02.0020.000825%
Embolic stroke24.01.04.010; 17.08.01.032--Not Available
Endometrial cancer21.07.02.002; 16.12.02.0010.000323%Not Available
Erythema23.03.06.0010.001237%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.002062%Not Available
Haemorrhagic stroke24.07.04.014; 17.08.01.011--Not Available
Headache17.14.01.0010.006187%
Heart rate increased13.14.04.0020.000825%Not Available
Hyperhidrosis08.01.03.028; 23.02.03.0040.002887%
Hypersensitivity10.01.03.0030.002887%
Hypertension24.08.02.0010.000825%
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