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 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 D08525
MeSH ID D013015
PubChem ID 5253
TTD Drug ID D04VMT
NDC Product Code Not Available
UNII A6D97U294I
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
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)
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.000900%Not Available
Feeling cold08.01.09.008--Not Available
Flatulence07.01.04.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Foetal distress syndrome18.03.02.0030.000562%Not Available
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.0020.000900%
Gastrointestinal pain07.01.05.005--
Gout15.01.06.001; 14.09.01.0010.000281%Not Available
Haemoglobin13.01.05.018--Not Available
Haemoptysis02.11.04.009; 22.02.03.004; 24.07.01.0060.000281%Not Available
Headache17.14.01.001--
Hepatic function abnormal09.01.02.0010.000422%Not Available
Hydrops foetalis18.03.02.0080.000562%Not Available
Hyperglycaemia05.06.02.002; 14.06.02.002--
Hyperhidrosis23.02.03.004; 08.01.03.0280.000703%
Hyperkalaemia14.05.03.0010.000562%
Hypertension24.08.02.001--
Hypoglycaemia14.06.03.001; 05.06.03.0010.000844%
Hyponatraemia14.05.04.0020.000703%
Hypotension24.06.03.0020.003234%
Hypoxia22.02.02.0030.000281%
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Interstitial lung disease22.01.02.003; 10.02.01.0330.000844%Not Available
Joint swelling15.01.02.0040.000956%Not Available
Laryngospasm22.04.02.002--
Lethargy08.01.01.008; 19.04.04.004; 17.02.04.0030.000281%
Leukopenia01.02.02.001--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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