Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Flibanserin
Drug ID BADD_D00904
Description Flibanserin is the first drug to be approved for hypoactive sexual desire disorder (HSDD) in premenopausal women by the FDA in August 2015. It was originally developed as an antidepressant medication by Boehringer Ingelheim, but showed lack of efficacy in trials and was further developed as a hypoactive sexual disorder drug by Sprout Pharmaceuticals. Flibanserin's mechanism of action is attributed to its high affinity for 5-HTA1 and 5-HTA2 receptors, displaying agonist activity on 5-HTA1 and antagonist on 5-HTA2, resulting in lowering of serotonin in the brain as well as an effect on increasing norepinephrine and dopamine neurotransmitters.
Indications and Usage For the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.
Marketing Status Prescription
ATC Code G02CX02
DrugBank ID DB04908
KEGG ID D02577
MeSH ID C098107
PubChem ID 6918248
TTD Drug ID D0S9CB
NDC Product Code 58604-214; 73223-006
Synonyms flibanserin | 1-(2-(4-(3-trifluoromethylphenyl)piperazin-1-yl)ethyl)benzimidazol(1H)-2-one | BIMT 17 | BIMT-17 | Addyi
Chemical Information
Molecular Formula C20H21F3N4O
CAS Registry Number 167933-07-5
SMILES C1CN(CCN1CCN2C3=CC=CC=C3NC2=O)C4=CC=CC(=C4)C(F)(F)F
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 pain07.01.05.002--
Anxiety19.06.02.002--
Appendicitis07.19.01.001; 11.01.07.001--
Constipation07.02.02.001--
Death08.04.01.001--
Depressed level of consciousness17.02.04.002--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry mouth07.06.01.002--
Fatigue08.01.01.002--
Hypotension24.06.03.002--
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Metrorrhagia21.01.01.006--Not Available
Nausea07.01.07.001--
Rash23.03.13.001--Not Available
Sedation17.02.04.005--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Syncope24.06.02.012; 17.02.04.008; 02.01.02.008--
Vertigo17.02.12.002; 04.04.01.003--
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