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 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 D01026
MeSH ID D013015
PubChem ID 66245
TTD Drug ID D04VMT
NDC Product Code 60505-0224; 63629-2421; 60429-751; 0904-7143; 71610-474; 60429-748; 63629-2422; 69584-841; 0245-0013; 60505-0081; 10135-717; 60505-0082; 63629-2423; 71610-294; 58032-0803; 42806-122; 60429-750; 76385-116; 50268-724; 72789-135; 55154-8179; 10135-715; 70515-106; 42806-121; 71335-0860; 71335-1125; 76385-114; 10135-716; 63187-426; 50268-725; 10135-661; 0093-1062; 72789-138; 69584-844; 69724-112; 71610-385; 70515-119; 43353-616; 71205-046; 70515-115; 10920-572; 60505-0159; 52932-0715; 0093-1060; 0245-0012; 50090-1299; 71335-0260; 0093-1061; 71335-1189; 70515-116; 60505-0080; 42806-123; 60505-0223; 72789-137; 10135-662; 0245-0014; 68084-654; 60505-0222; 70515-109; 76385-115; 70515-105; 60429-749; 69584-843; 10135-663; 72789-136; 71335-1917; 70518-3341; 12828-0071; 0093-1063; 69584-842; 24338-530; 71610-074; 0245-0015; 63187-804
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
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 KQT member 1P51787T49526Not Available
Sudden cardiac deathSodium channel protein type 5 subunit alphaQ14524T39716Not Available
Sudden cardiac deathPotassium voltage-gated channel subfamily E member 1P15382Not AvailableNot Available
Sudden cardiac deathPotassium voltage-gated channel subfamily H member 2Q12809T20251Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Heart rate13.14.04.012--Not Available
Hyperhidrosis08.01.03.028; 23.02.03.004--
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--
Palpitations02.01.02.003--
Paraesthesia17.02.06.005--
Paralysis17.01.04.004--Not Available
Peripheral vascular disorder24.03.01.003--Not Available
Photosensitivity reaction23.03.09.003--
Presyncope24.06.02.010; 17.02.05.009; 02.01.02.007--
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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