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 approved; investigational
ATC Code G02CX02
DrugBank ID DB04908
KEGG ID D02577
MeSH ID C098107
PubChem ID 6918248
TTD Drug ID D0S9CB
NDC Product Code 73223-006; 58604-214
UNII 37JK4STR6Z
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
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 pain07.01.05.002--
Abnormal dreams17.15.02.001; 19.02.03.0010.000138%-
Anxiety19.06.02.002--
Appendicitis07.19.01.001; 11.01.07.001--
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.0030.000138%-
Constipation07.02.02.001--
Death08.04.01.001--
Depressed level of consciousness17.02.04.0020.000179%
Depressed mood19.15.02.0010.000138%-
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.0070.000642%
Drug ineffective08.06.01.0060.000276%-
Dry mouth07.06.01.002--
Dyspnoea02.11.05.003; 22.02.01.0040.000089%
Fatigue08.01.01.002--
Headache17.14.01.0010.000089%
Hypotension24.06.03.0020.000207%
Injury12.01.08.004---
Insomnia17.15.03.002; 19.02.01.0020.000415%
Lethargy08.01.01.008; 17.02.04.003; 19.04.04.0040.000041%
Mood altered19.04.02.0070.000138%-
Nausea07.01.07.0010.000159%
Rash23.03.13.001---
Sedation17.02.04.0050.000228%-
Somnolence17.02.04.006; 19.02.05.0030.000159%
Syncope02.11.04.015; 17.02.04.008; 24.06.02.012--
Tachycardia02.03.02.0070.000199%-
Therapeutic response unexpected08.06.01.0010.000780%-
Unresponsive to stimuli17.02.05.0310.000061%-
Vertigo04.04.01.003; 17.02.12.0020.000228%
Vomiting07.01.07.0030.000041%
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