Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Flecainide acetate
Drug ID BADD_D00903
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Marketing Status approved; withdrawn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 D00638
MeSH ID D005424
PubChem ID 41022
TTD Drug ID D03DAP
NDC Product Code 57741-0800; 42806-817; 50268-321; 57237-064; 65862-622; 50090-5306; 62135-661; 0054-0012; 65862-621; 50090-6035; 53746-641; 57237-063; 65862-623; 65162-641; 62135-662; 63629-7982; 0054-0011; 53069-1020; 59651-123; 53746-643; 62135-660; 65162-642; 71335-1487; 71335-2172; 57741-3300; 72640-021; 50090-2968; 50268-320; 53746-642; 63629-7979; 65162-643; 65571-0001; 42806-819; 50090-5267; 57237-065; 0054-0010; 42806-818
UNII M8U465Q1WQ
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 C19H24F6N2O5
CAS Registry Number 54143-56-5
SMILES CC(=O)O.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)
Granulocytopenia01.02.03.003--Not Available
Headache17.14.01.001--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypertension24.08.02.001--
Hypotension24.06.03.002--
Insomnia17.15.03.002; 19.02.01.002--
Irritability08.01.03.011; 19.04.02.013--
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.005--Not Available
Lung infiltration22.01.02.004--Not Available
Malaise08.01.01.003--
Muscle twitching15.05.03.005--Not Available
Myalgia15.05.02.001--
Nausea07.01.07.001--
Neuropathy peripheral17.09.03.003--Not Available
Nystagmus17.02.02.006; 06.05.02.006--
Oedema08.01.07.006; 14.05.06.010--Not Available
Palpitations02.11.04.012--
Paraesthesia23.03.03.094; 17.02.06.005--
Paresis17.01.04.008--Not Available
Photophobia17.17.02.006; 06.01.01.004--
Pneumonitis22.01.01.006--
Polyuria20.02.03.002--Not Available
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Seizure17.12.03.001--
Sinus arrest02.03.03.007--Not Available
Somnolence19.02.05.003; 17.02.04.006--
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