Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Sotalol hydrochloride
Drug ID BADD_D02061
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 Sotalol is indicated to treat life threatening ventricular arrhytmias and maintain normal sinus rhythm in patients with atrial fibrillation or flutter.[Label] There are also oral solutions and intravenous injections indicated for patients requiring sotalol, but for whom a tablet would not be appropriate.[Label,L6373,L6376]
Marketing Status approved
ATC Code C07AA07
DrugBank ID DB00489
KEGG ID D01026
MeSH ID D013015
PubChem ID 66245
TTD Drug ID D04VMT
NDC Product Code 12828-0071; 59651-777; 63629-2422; 63629-2423; 70515-105; 70515-119; 76385-115; 58032-0803; 59651-775; 60429-748; 72789-137; 52932-0715; 0093-1062; 42806-122; 0245-0014; 70515-116; 59651-776; 60505-0080; 63187-426; 63629-2421; 69584-842; 71335-0260; 42806-123; 50268-724; 50268-725; 69584-844; 70518-3341; 71205-046; 71610-474; 76385-114; 10920-572; 60429-749; 69584-843; 72789-136; 0093-1061; 0245-0013; 60429-751; 69724-112; 71610-074; 0093-1063; 24338-530; 42806-121; 51655-450; 68084-654; 71335-1917; 72789-138; 76385-116; 0904-7143; 0245-0012; 55154-8179; 60505-0159; 63187-804; 70515-115; 71335-1189; 72789-135; 43353-616; 60429-750; 60505-0081; 60505-0082; 60505-0222; 60505-0223; 60505-0224; 69584-841; 70515-106; 70515-109; 0093-1060; 50090-1299; 0245-0015
UNII HEC37C70XX
Synonyms Sotalol | Sotalol Hydrochloride | Sotalol Monohydrochloride | MJ-1999 | MJ 1999 | MJ1999 | Darob
Chemical Information
Molecular Formula C12H21ClN2O3S
CAS Registry Number 959-24-0
SMILES CC(C)NCC(C1=CC=C(C=C1)NS(=O)(=O)C)O.Cl
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)
Abdominal pain07.01.05.002--
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.003--Not Available
Anxiety19.06.02.002--
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Atrial flutter02.03.03.003--
Atrioventricular block complete02.03.01.003--
Back pain15.03.04.005--
Blood glucose increased13.02.02.002--Not Available
Bradycardia02.03.02.002--Not Available
Cardiac failure02.05.01.001--
Cardiovascular disorder02.11.01.010; 24.03.02.009--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Coordination abnormal17.02.02.004--Not Available
Death08.04.01.001--
Depressed level of consciousness17.02.04.002--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Electrocardiogram abnormal13.14.05.001--Not Available
Electrocardiogram QT prolonged13.14.05.004--
Eosinophilia01.02.04.001--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Headache17.14.01.001--
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