Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sotalol
Drug ID BADD_D02060
Description Sotalol is a methanesulfonanilide developed in 1960.[A178579] It was the first of the class III anti arrhythmic drugs.[A178579] Sotalol was first approved as an oral tablet on 30 October 1992.[L6334] A racemic mixture of sotalol is currently formulated as a tablet, oral solution, and intravenous injection indicated for life threatening ventricular arrhythmias and maintaining normal sinus rhythm in atrial fibrillation or flutter.[Label,L6373,L6376]
Indications and Usage For the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Also for the treatment of documented life-threatening ventricular arrhythmias.
Marketing Status Prescription; Discontinued
ATC Code C07AA07
DrugBank ID DB00489
KEGG ID D08525
MeSH ID D013015
PubChem ID 5253
TTD Drug ID D04VMT
NDC Product Code Not Available
Synonyms Sotalol | Sotalol Hydrochloride | Sotalol Monohydrochloride | MJ-1999 | MJ 1999 | MJ1999 | Darob
Chemical Information
Molecular Formula C12H20N2O3S
CAS Registry Number 3930-20-9
SMILES CC(C)NCC(C1=CC=C(C=C1)NS(=O)(=O)C)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Adverse drug reactionCytochrome P450 2D6P10635T57392Not Available
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)
Presyncope24.06.02.010; 17.02.05.009; 02.01.02.0070.003094%
Pruritus23.03.12.001--
Pulmonary alveolar haemorrhage24.07.01.015; 22.01.02.0050.004951%Not Available
Pulmonary fibrosis22.01.02.0060.000484%
Pulmonary oedema22.01.03.003; 02.05.02.0030.001856%
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rash maculo-papular23.03.13.0040.001238%
Renal failure20.01.03.0050.000323%Not Available
Respiratory distress22.02.01.012--Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000323%
Retroperitoneal fibrosis20.06.01.006; 10.02.01.026; 07.07.03.003--Not Available
Sexual dysfunction19.08.05.002; 21.03.02.003--Not Available
Shock24.06.02.0020.001238%Not Available
Sinus arrest02.03.03.0070.001238%Not Available
Sinus bradycardia02.03.03.0090.002475%
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Sudden death08.04.01.003; 02.03.04.013--
Suicide attempt19.12.01.0040.001238%
Supraventricular tachycardia02.03.03.0120.001856%
Syncope24.06.02.012; 17.02.04.008; 02.01.02.0080.002475%
Tachycardia02.03.02.0070.004951%Not Available
Thrombocytopenia01.08.01.0020.001238%Not Available
Torsade de pointes02.03.04.0050.022277%Not Available
Tracheobronchitis11.01.13.008; 22.07.03.010--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection20.08.02.001; 11.01.14.0040.001238%
Urogenital disorder21.10.05.010; 20.08.01.002--Not Available
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