Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dofetilide
Drug ID BADD_D00701
Description Dofetilide is a class III antiarrhythmic agent that is approved by the Food and Drug Administration (FDA) for the maintenance of sinus rhythm in individuals prone to the formation of atrial fibrillation and flutter, and for the chemical cardioversion to sinus rhythm from atrial fibrillation and flutter.
Indications and Usage For the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm
Marketing Status Prescription
ATC Code C01BD04
DrugBank ID DB00204
KEGG ID D00647
MeSH ID C063533
PubChem ID 71329
TTD Drug ID D0NW3X
NDC Product Code 62756-179; 42794-044; 16714-841; 69539-131; 16729-490; 51862-125; 72205-040; 69539-132; 16714-842; 42291-411; 69452-132; 72205-039; 69452-131; 69766-022; 69452-133; 47335-061; 63190-0670; 16714-840; 42291-413; 42794-045; 0069-5800; 72205-041; 59651-038; 49812-0261; 76055-0013; 59651-118; 47335-062; 0069-5810; 51862-025; 16729-492; 0904-6681; 42413-0170; 59651-120; 63190-0680; 0069-5820; 59651-119; 70595-001; 0904-6683; 29902-0014; 47335-063; 16729-491; 14096-192; 42794-046; 42291-412; 63278-1079; 69539-130; 51862-005; 0904-6682; 50137-4245
Synonyms dofetilide | 1-(4-methanesulfonamidophenoxy)-2-(N-(4-methanesulfonamidophenethyl)-N-methylamine)ethane | 1-MSPMPE | Tikosyn | UK 68798 | UK-68,798
Chemical Information
Molecular Formula C19H27N3O5S2
CAS Registry Number 115256-11-6
SMILES CN(CCC1=CC=C(C=C1)NS(=O)(=O)C)CCOC2=CC=C(C=C2)NS(=O)(=O)C
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Poisoning and toxicityCytochrome P450 2D6P10635T57392Not Available
Sudden cardiac deathPotassium voltage-gated channel subfamily H member 2Q12809T202519927398; 10810773; 10082151; 10408028
Sudden cardiac deathPotassium voltage-gated channel subfamily KQT member 1P51787T495269927398; 10810773; 10082151; 10408028
Sudden cardiac deathSodium channel protein type 5 subunit alphaQ14524T397169927398; 10810773; 10082151; 10408028
Sudden cardiac deathPotassium voltage-gated channel subfamily E member 1P15382Not Available9927398; 10810773; 10082151; 10408028
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.001484%
Onychomycosis11.03.05.007; 23.09.02.0070.000371%Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Palpitations02.01.02.0030.005007%
Paraesthesia17.02.06.005--
Paralysis17.01.04.004--Not Available
Pneumonia22.07.01.003; 11.01.09.0030.003894%Not Available
Pollakiuria20.02.02.0070.000371%
Presyncope24.06.02.010; 17.02.05.009; 02.01.02.0070.000556%
Pruritus23.03.12.001--
Pulmonary fibrosis22.01.02.0060.000145%
Pulmonary hypertension22.06.01.001; 24.08.03.0020.000242%
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Renal disorder20.01.02.0020.001298%Not Available
Renal failure20.01.03.005--Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000194%
Restlessness19.11.02.002; 17.02.05.0210.000371%
Rhinorrhoea22.02.05.0100.000371%
Sedation17.02.04.0050.000371%Not Available
Seizure17.12.03.001--
Sepsis11.01.11.003--
Shock24.06.02.002--Not Available
Sinus bradycardia02.03.03.0090.000371%
Sinusitis22.07.03.007; 11.01.13.0050.000742%
Sleep apnoea syndrome17.15.05.001; 22.02.01.013; 19.02.05.0020.000371%
Small intestinal obstruction07.13.06.0010.000371%
Sneezing22.02.05.0110.000371%
Somnolence19.02.05.003; 17.02.04.006--
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