FDA label
What is sotalol used for?
The FDA-approved uses of sotalol, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for sotalol lists 2 uses: Life-Threatening Ventricular Arrhythmias; Delay in Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL).
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Sotalol Hydrochloride, tablet
Indications and Usage, quoted from the label by Apotex Corp. (ANDA076140). Cross-references to other label sections are left out.
Life-Threatening Ventricular Arrhythmias
Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT).
Limitation of Use:
Sotalol hydrochloride/Sotalol hydrochloride AF has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias.
Delay in Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL)
Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm.
Limitation of Use:
Because sotalol hydrochloride/sotalol hydrochloride AF tablets can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB that is easily reversed (by Valsalva maneuver, for example) should usually not be given sotalol hydrochloride/sotalol hydrochloride AF tablets.
Source: DailyMed label, set id 1a56c82e-7ecd-43b0-2899-f89e47adf7db, version 18, effective September 17, 2026. NDC 60505-0080, one of 72 listings for this product.
Questions
What is sotalol used for?
The FDA label for sotalol lists 2 uses: Life-Threatening Ventricular Arrhythmias; Delay in Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL).
What drug class is sotalol?
FDA lists sotalol in the Antiarrhythmic established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.