Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Flecainide
Drug ID BADD_D00902
Description Flecainide is a Class I anti-arrhythmic agent like [encainide] and [propafenone].[A186880] Flecainide’s development began in 1966 and was first synthesized in 1972 as an attempt to generate new anesthetics.[A186931] It is used to prevent supraventricular and ventricular arrhythmias, as well as paroxysmal atrial fibrillation and flutter.[L8878,L5056] Flecainide was granted FDA approval on 31 October 1985.[L8875]
Indications and Usage In New Zealand and America, flecainide is indicated to prevent supraventricular arrhythmias and ventricular arrhythmias.[L8878] In the United States, it is also indicated to prevent paroxysmal atrial fibrillation and flutter.[A186886,L5056]
Marketing Status approved; withdrawn
ATC Code C01BC04
DrugBank ID DB01195
KEGG ID D07962
MeSH ID D005424
PubChem ID 3356
TTD Drug ID D03DAP
NDC Product Code Not Available
UNII K94FTS1806
Synonyms Flecainide | Flecainide Acetate | Flecainide Monoacetate | Flecainide Monoacetate, (R)-Isomer | Flecainide Monoacetate, (S)-Isomer | Flecainide, (R)-Isomer | Flecainide, (S)-Isomer | Flecainide, 5-HO-N-(6-oxo)-Derivative | Flecainide, 5-HO-N-(6-oxo)-Derivative, (+-)-Isomer | Flecatab | R818 | Tambocor | Flecadura | Flecainide Monoacetate, (+-)-Isomer | Flecainid-Isis | Flecainid Isis | Flécaïne | Apocard
Chemical Information
Molecular Formula C17H20F6N2O3
CAS Registry Number 54143-55-4
SMILES C1CCNC(C1)CNC(=O)C2=C(C=CC(=C2)OCC(F)(F)F)OCC(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)
Ventricular arrhythmia02.03.04.0060.000367%
Ventricular fibrillation02.03.04.0080.000245%
Ventricular tachycardia02.03.04.0100.001101%
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Visual field defect17.17.01.001; 06.02.07.003--Not Available
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Tachyarrhythmia02.03.02.0080.000612%Not Available
Bradyarrhythmia02.03.02.0150.000489%Not Available
Balance disorder08.01.03.081; 17.02.02.007--Not Available
Haemodynamic instability24.03.02.0060.000367%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Pulseless electrical activity02.03.04.0200.000367%Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Urine output increased13.13.03.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.000245%
Erectile dysfunction21.03.01.007; 19.08.04.001--
Ill-defined disorder08.01.03.049--Not Available
Urinary tract obstruction20.08.01.004--
Blood disorder01.05.01.004--Not Available
Adverse drug reaction08.06.01.0090.000245%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.000245%Not Available
Treatment failure08.06.01.0170.000245%Not Available
Acute kidney injury20.01.03.0160.000979%
Mouth swelling07.05.04.007; 23.04.01.020; 10.01.05.020--Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000245%
Depersonalisation/derealisation disorder19.14.01.004--Not Available
Coeliac disease10.04.04.012; 07.17.01.008; 14.02.01.0070.000245%Not Available
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