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Marketing Status approved; withdrawn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)
Lip swelling10.01.05.005; 23.04.01.007; 07.05.04.005--Not Available
Loss of consciousness17.02.04.004--Not Available
Lung infiltration22.01.02.004--Not Available
Malaise08.01.01.003--
Metabolic acidosis14.01.01.0030.000489%Not Available
Micturition disorder20.02.02.005--Not Available
Muscle twitching15.05.03.005--Not Available
Myalgia15.05.02.001--
Myoclonus17.02.05.0080.000245%Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.003--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Neurotoxicity17.02.10.002; 12.03.01.0110.000245%Not Available
Nodal arrhythmia02.03.03.0200.000245%Not Available
Nystagmus17.02.02.006; 06.05.02.006--
Oedema14.05.06.010; 08.01.07.006--Not Available
Pain08.01.08.004--
Palpitations02.11.04.012--
Paraesthesia23.03.03.094; 17.02.06.005--
Paranoia19.05.01.005--Not Available
Paresis17.01.04.008--Not Available
Parosmia22.04.03.007; 17.04.04.002--Not Available
Peripheral ischaemia24.04.03.002--
Photophobia17.17.02.006; 06.01.01.004--
Photosensitivity reaction23.03.09.003--
Pneumonia11.01.09.003; 22.07.01.003--Not Available
Pneumonitis22.01.01.006--
Polyuria20.02.03.002--Not Available
Presyncope02.11.04.013; 24.06.02.010; 17.02.05.009--
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