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)
Pre-eclampsia24.08.07.002; 20.01.08.002; 18.02.03.0020.000422%Not Available
Premature baby18.04.02.0010.001265%Not Available
Premature delivery18.07.01.0060.000562%
Presyncope02.11.04.013; 24.06.02.010; 17.02.05.0090.000844%
Pruritus23.03.12.001--
Psoriasis23.03.14.002; 10.02.01.0360.000422%Not Available
Pulmonary alveolar haemorrhage24.07.01.015; 22.01.02.0050.001125%Not Available
Pulmonary fibrosis22.01.02.0060.000422%
Pulmonary oedema22.01.03.003; 02.05.02.0030.000422%
Purpura01.01.04.003; 24.07.06.005; 23.06.01.004--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rash maculo-papular23.03.13.0040.000281%
Renal failure20.01.03.0050.000844%Not Available
Respiratory distress22.02.01.012--Not Available
Respiratory failure14.01.04.003; 22.02.06.0020.000422%
Retroperitoneal fibrosis20.06.01.006; 10.02.01.026; 07.07.03.003--Not Available
Rhabdomyolysis15.05.05.0020.000281%
Sexual dysfunction21.03.02.003; 19.08.05.002--Not Available
Shock24.06.02.0020.000281%Not Available
Sinus arrest02.03.03.0070.000281%Not Available
Sinus bradycardia02.03.03.0090.001265%
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Sudden death02.03.04.013; 08.04.01.003--
Suicide attempt19.12.01.0040.001125%
Supraventricular tachycardia02.03.03.0120.000984%
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.001406%
Tachycardia02.03.02.0070.001546%Not Available
Tachycardia foetal18.03.02.005; 02.03.02.0170.000422%Not Available
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ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene