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Marketing Status approved; withdrawn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)
Pruritus23.03.12.001--
Pulmonary alveolar haemorrhage24.07.01.015; 22.01.02.0050.000612%Not Available
Pulmonary fibrosis22.01.02.006--
Pulmonary oedema22.01.03.003; 02.05.02.003--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Renal failure20.01.03.005--Not Available
Respiratory arrest22.02.01.0090.000489%Not Available
Seizure17.12.03.0010.000367%
Shock24.06.02.0020.000367%Not Available
Sinus arrest02.03.03.007--Not Available
Sinus bradycardia02.03.03.009--
Skin discolouration23.03.03.005--Not Available
Skin disorder23.03.03.007--Not Available
Somnolence19.02.05.003; 17.02.04.0060.000245%
Speech disorder17.02.08.003; 22.12.03.027; 19.19.02.002--Not Available
Stupor19.02.05.004; 17.02.04.007--Not Available
Suicide attempt19.12.01.0040.000979%
Supraventricular tachycardia02.03.03.0120.000245%
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.003--Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.000857%
Tachycardia02.03.02.0070.000979%Not Available
Tension19.06.02.005--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Torsade de pointes02.03.04.0050.000489%Not Available
Tremor17.01.06.002--
Unresponsive to stimuli17.02.05.0310.000489%Not Available
Urinary retention20.02.02.011--
Urticaria23.04.02.001; 10.01.06.001--
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