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 approved; investigational
ATC Code G03XC05
DrugBank ID DB04938
KEGG ID D08958
MeSH ID C119141
PubChem ID 3036505
TTD Drug ID D02CTS
NDC Product Code 69037-0026; 55494-580; 63069-601; 59630-580; 50056-2021; 66039-912
UNII B0P231ILBK
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
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)
Abdominal pain upper07.01.05.0030.000611%
Acne23.02.01.0010.000611%-
Alopecia23.02.02.0010.002535%
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Back pain15.03.04.0050.000611%
Bone pain15.02.01.0010.000611%
Burning sensation08.01.09.029; 17.02.06.0010.000611%-
Cardiovascular disorder02.11.01.010; 24.03.02.009---
Cerebral haemorrhage17.08.01.003; 24.07.04.001---
Condition aggravated08.01.03.0040.000701%-
Crying08.01.03.005; 12.02.11.001; 17.02.05.013; 19.04.02.0020.000917%-
Dry skin23.03.03.0010.000611%
Dysmenorrhoea21.01.01.0020.000611%
Dyspareunia19.08.05.004; 21.03.02.0160.001528%
Dysuria20.02.02.0020.000611%
Embolic stroke17.08.01.032; 24.01.04.010---
Emotional disorder19.04.02.0050.000611%-
Endometrial cancer16.12.02.001; 21.07.02.0020.000270%-
Erythema23.03.06.0010.000701%-
Feeling abnormal08.01.09.0140.001312%-
Flatulence07.01.04.0020.000396%
Gastrointestinal pain07.01.05.0050.000396%
Haemorrhagic stroke17.08.01.011; 24.07.04.014---
Headache17.14.01.0010.004153%
Hyperhidrosis08.01.03.028; 23.02.03.0040.002139%
Hypersensitivity10.01.03.0030.000881%
Hypertension24.08.02.0010.000180%
Hypoaesthesia17.02.06.023; 23.03.03.0810.001007%-
Insomnia17.15.03.002; 19.02.01.0020.000611%
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.0070.000611%-
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