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 approved; investigational
ATC Code C01BD04
DrugBank ID DB00204
KEGG ID D00647
MeSH ID C063533
PubChem ID 71329
TTD Drug ID D0NW3X
NDC Product Code 0069-5810; 51862-005; 69452-133; 63190-0670; 42291-413; 42794-044; 51862-125; 14096-192; 29902-0014; 42291-411; 69452-131; 72205-041; 72664-229; 49812-0261; 16714-842; 42794-046; 47335-061; 47335-063; 59651-120; 72603-130; 72603-132; 16714-840; 16729-490; 16729-492; 59651-118; 69539-131; 0069-5820; 69452-132; 72664-231; 0904-6681; 50137-4245; 42291-412; 42794-045; 51862-025; 59651-119; 69539-130; 72664-230; 0904-6682; 0904-6683; 59651-038; 63190-0680; 0069-5800; 72205-040; 42413-0170; 63278-1079; 76055-0013; 16714-841; 16729-491; 69539-132; 72205-039; 72603-131; 69766-022; 47335-062
UNII R4Z9X1N2ND
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
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)
Obesity14.03.02.0090.000127%
Oedema08.01.07.006; 14.05.06.010---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.0110.000990%
Pain08.01.08.004--
Palpitations02.11.04.0120.002715%
Pancreatic carcinoma07.21.09.002; 16.13.10.0010.000085%-
Paraesthesia17.02.06.005; 23.03.03.094--
Paralysis17.01.04.004---
Pollakiuria20.02.02.0070.000288%
Presyncope02.11.04.013; 17.02.05.009; 24.06.02.0100.000228%
Pulmonary fibrosis22.01.02.0060.000127%
Pulmonary hypertension22.06.01.001; 24.08.03.0020.000254%
Rash23.03.13.001---
Renal disorder20.01.02.0020.000702%-
Respiratory failure14.01.04.003; 22.02.06.0020.000169%
Restlessness17.02.05.021; 19.11.02.0020.000288%
Rhinorrhoea22.12.03.0210.000288%
Sedation17.02.04.0050.000186%-
Shock24.06.02.002---
Sinus bradycardia02.03.03.0090.000228%
Sleep apnoea syndrome17.15.05.001; 19.02.05.002; 22.02.01.0130.000186%
Small intestinal obstruction07.13.06.0010.000085%
Sneezing22.12.03.0240.000288%
Stress19.06.02.0040.000169%-
Sudden death02.03.04.013; 08.04.01.003--
Supraventricular tachycardia02.03.03.012--
Surgical procedure repeated12.02.05.044---
Swelling08.01.03.0150.000474%-
Swollen tongue07.14.02.003; 10.01.05.015; 23.04.01.0140.000127%-
Syncope02.11.04.015; 17.02.04.008; 24.06.02.0120.000397%
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ADReCS-Target
Drug Name ADR Term Target
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