Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Flumazenil
Drug ID BADD_D00919
Description Fumazenil is an imidazobenzodiazepine derivative and a potent benzodiazepine receptor antagonist that competitively inhibits the activity at the benzodiazepine recognition site on the GABA/benzodiazepine receptor complex, thereby reversing the effects of benzodiazepine on the central nervous system.
Indications and Usage For the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, and where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures. Also for the management of benzodiazepine overdose as an adjunct for appropriate supportive and symptomatic measures.
Marketing Status approved
ATC Code V03AB25
DrugBank ID DB01205
KEGG ID D00697
MeSH ID D005442
PubChem ID 3373
TTD Drug ID D0D5GD
NDC Product Code 51916-311; 0404-9860; 71872-7008; 14778-0101; 36000-148; 0143-9784; 51662-1254; 0404-9859; 70518-3456; 58175-0365; 0143-9783; 51662-1579; 52584-088; 65129-2026; 36000-149; 0143-9684; 52584-089; 51662-1253; 63323-424; 71872-7038; 71872-7206; 0143-9683
UNII 40P7XK9392
Synonyms Flumazenil | Flumazepil | Romazicon | Lanexat | Ro 15-1788 | Ro 15 1788 | Ro 151788 | Anexate
Chemical Information
Molecular Formula C15H14FN3O3
CAS Registry Number 78755-81-4
SMILES CCOC(=O)C1=C2CN(C(=O)C3=C(N2C=N1)C=CC(=C3)F)C
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)
Drug withdrawal syndrome08.06.02.004; 19.07.06.013---
Dry mouth07.06.01.002--
Dysphonia17.02.08.004; 19.19.03.002; 22.12.03.006--
Dysphoria19.04.02.004---
Dyspnoea02.11.05.003; 22.02.01.004--
Epilepsy17.12.03.002---
Erythema23.03.06.001---
Euphoric mood19.04.02.006--
Fatigue08.01.01.002--
Fear19.06.03.001---
Feeling abnormal08.01.09.014---
Feeling cold08.01.09.008---
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Hallucination19.10.04.003--
Headache17.14.01.001--
Hiccups07.01.06.009; 22.12.01.001--
Hyperacusis04.02.02.001; 17.04.03.003---
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hyperventilation19.01.02.004; 22.02.01.006---
Hypoaesthesia17.02.06.023; 23.03.03.081---
Hypopnoea22.02.01.021---
Hypotension24.06.03.002--
Injection site pain08.02.03.010; 12.07.03.011---
Injection site reaction08.02.03.014; 12.07.03.015--
Insomnia17.15.03.002; 19.02.01.002--
Lacrimation increased06.08.02.004--
Malaise08.01.01.003--
Menopausal symptoms21.02.02.002---
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ADReCS-Target
Drug Name ADR Term Target
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