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)
Heart rate13.14.04.012--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypertension24.08.02.001--
Hypotension24.06.03.002--
Increased insulin requirement14.06.01.006; 05.06.01.006--Not Available
Infection11.01.08.002--Not Available
Laboratory test abnormal13.18.01.001--Not Available
Leukopenia01.02.02.001--Not Available
Lung disorder22.02.07.001--Not Available
Mood altered19.04.02.007--Not Available
Myalgia15.05.02.001--
Nausea07.01.07.001--
Neuropathy peripheral17.09.03.003--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Palpitations02.11.04.012--
Paraesthesia23.03.03.094; 17.02.06.005--
Paralysis17.01.04.004--Not Available
Peripheral vascular disorder24.03.01.003--Not Available
Photosensitivity reaction23.03.09.003--
Presyncope02.11.04.013; 24.06.02.010; 17.02.05.009--
Pruritus23.03.12.001--
Pulmonary oedema22.01.03.003; 02.05.02.003--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Respiratory disorder22.02.07.002--Not Available
Sexual dysfunction21.03.02.003; 19.08.05.002--Not Available
Sinus arrest02.03.03.007--Not Available
Sleep disorder19.02.04.001--Not Available
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