Sotalol Af side effects: what 2,492 FDA adverse event reports show
Drug class
Antiarrhythmic
Label matched
Sotalol Hydrochloride (Sotalol)
Who reports
2,492 reports · 84% serious · 251 with death outcome · 52% female
Used for
1. INDICATIONS AND USAGE Sotalol/Sotalol AF is an antiarrhythmic indicated for: • the treatment of life-threatening ventricular arrhythmias (1.1) • the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2) .
What it is
Sotalol/Sotalol AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol Hydrochloride Tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration.
Boxed warning
LIFE THREATENING PROARRHYTHMIA To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 29 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Ventricular tachycardia | 71 | 36.2 28.8–45.6ROR 37.2 · χ² 2,387 / p <1e-300 | 35.7 EB05 29.3 · IC025 +4.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 25.0 · 92% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 146 | 34.3 29.3–40.1ROR 36.3 · χ² 4,671 / p <1e-300 | 34.0 EB05 29.6 · IC025 +4.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 23.7 | no trial data cached |
| Hypomagnesaemia | 33 | 20.1 14.3–28.2ROR 20.3 · χ² 578 / p 6e-128 | 19.8 EB05 14.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 · ♀ 4% (drug 52%) | no trial data cached |
| Bradycardia (slow heart rate) | 110 | 17.5 14.5–21.0ROR 18.2 · χ² 1,691 / p <1e-300 | 17.4 EB05 14.8 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.8 | no trial data cached |
| Ventricular fibrillation | 20 | 15.1 9.8–23.4ROR 15.2 · χ² 250 / p 1e-56 | 14.6 EB05 9.5 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 10.9 | no trial data cached |
| Atrial fibrillation | 173 | 14.9 12.9–17.3ROR 16.0 · χ² 2,244 / p <1e-300 | 14.9 EB05 13.1 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.4 | no trial data cached |
| Sinus bradycardia | 17 | 14.8 9.2–23.8ROR 14.9 · χ² 205 / p 9e-47 | 14.0 EB05 8.7 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.5 | no trial data cached |
| International normalised ratio increased | 46 | 13.5 10.1–17.9ROR 13.7 · χ² 518 / p 5e-115 | 13.2 EB05 10.2 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 10.3 | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 14 | 11.6 6.9–19.5ROR 11.6 · χ² 125 / p 3e-29 | 10.2 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Cardiomegaly | 17 | 11.5 7.2–18.5ROR 11.6 · χ² 153 / p 2e-35 | 10.4 EB05 6.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Ventricular extrasystoles | 14 | 11.3 6.7–19.1ROR 11.4 · χ² 122 / p 1e-28 | 9.9 EB05 5.7 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.7 | no trial data cached |
| Cardiogenic shock | 19 | 11.2 7.2–17.6ROR 11.3 · χ² 167 / p 2e-38 | 10.2 EB05 6.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 | no trial data cached |
| Mitral valve incompetence | 14 | 10.4 6.2–17.6ROR 10.5 · χ² 110 / p 5e-26 | 8.9 EB05 5.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Arrhythmia | 54 | 9.6 7.3–12.5ROR 9.8 · χ² 406 / p 1e-90 | 9.2 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.6 | no trial data cached |
| Dizziness postural | 10 | 8.8 4.7–16.3ROR 8.8 · χ² 61 / p 3e-15 | 6.8 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Hepatic cytolysis | 12 | 8.3 4.7–14.5ROR 8.3 · χ² 70 / p 4e-17 | 6.7 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Subdural haematoma | 14 | 8.2 4.9–13.8ROR 8.2 · χ² 82 / p 9e-20 | 6.8 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Drug toxicity | 12 | 7.3 4.2–12.9ROR 7.3 · χ² 59 / p 7e-15 | 5.9 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Melaena (black stool) | 18 | 6.9 4.3–10.9ROR 6.9 · χ² 85 / p 2e-20 | 6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Presyncope (near-fainting) | 19 | 6.6 4.2–10.3ROR 6.7 · χ² 85 / p 2e-20 | 5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Hepatocellular injury | 11 | 6.5 3.6–11.7ROR 6.5 · χ² 46 / p 6e-12 | 5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Lactic acidosis | 22 | 5.8 3.8–8.8ROR 5.8 · χ² 82 / p 6e-20 | 5.2 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 95% clinician | no trial data cached |
| Cardio-respiratory arrest | 28 | 5.6 3.9–8.1ROR 5.7 · χ² 101 / p 4e-24 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Renal failure acute | 27 | 5.3 3.6–7.7ROR 5.3 · χ² 90 / p 1e-21 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Drug interaction | 99 | 5.3 4.3–6.4ROR 5.4 · χ² 339 / p 5e-76 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Hypotension (low blood pressure) | 124 | 5.2 4.4–6.2ROR 5.4 · χ² 422 / p 5e-94 | 5.1 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.1 | no trial data cached |
| Heart rate irregular | 14 | 5.2 3.1–8.7ROR 5.2 · χ² 43 / p 2e-11 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Cardiac arrest (heart stopping) | 49 | 5.0 3.8–6.6ROR 5.1 · χ² 152 / p 3e-35 | 4.8 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Hyperkalaemia (high potassium) | 20 | 4.8 3.1–7.5ROR 4.9 · χ² 57 / p 2e-14 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Metabolic acidosis | 18 | 4.8 3.0–7.6ROR 4.8 · χ² 50 / p 7e-13 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Cardiac failure (heart failure) | 45 | 4.7 3.5–6.3ROR 4.8 · χ² 128 / p 5e-30 | 4.5 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.3 | no trial data cached |
| Palpitations (pounding heartbeat) | 62 | 4.5 3.5–5.7ROR 4.5 · χ² 164 / p 8e-38 | 4.3 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Syncope (fainting) | 50 | 4.2 3.2–5.5ROR 4.3 · χ² 119 / p 4e-28 | 4.1 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Pericardial effusion | 11 | 4.0 2.2–7.3ROR 4.0 · χ² 22 / p 1e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Rectal haemorrhage | 20 | 3.9 2.5–6.0ROR 3.9 · χ² 40 / p 1e-10 | 3.6 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 · ♀ 30% (drug 52%) | no trial data cached |
| Hypoglycaemia (low blood sugar) | 22 | 3.8 2.5–5.8ROR 3.8 · χ² 43 / p 3e-11 | 3.6 EB05 2.5 · IC025 +1.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.9 | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 15 | 3.7 2.2–6.2ROR 3.7 · χ² 27 / p 9e-8 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Intentional overdose | 28 | 3.7 2.6–5.3ROR 3.7 · χ² 53 / p 2e-13 | 3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Medication error | 22 | 3.3 2.2–5.1ROR 3.4 · χ² 34 / p 3e-9 | 3.2 EB05 2.2 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Completed suicide (death by suicide) | 30 | 3.0 2.1–4.3ROR 3.0 · χ² 38 / p 3e-10 | 2.9 EB05 2.1 · IC025 +0.9 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 2.1 · 97% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Atrial fibrillation | 173 | 14.9 12.9–17.3ROR 16.0 · χ² 2,244 / p <1e-300 | 14.9 EB05 13.1 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.4 | no trial data cached |
| Electrocardiogram qt prolonged | 146 | 34.3 29.3–40.1ROR 36.3 · χ² 4,671 / p <1e-300 | 34.0 EB05 29.6 · IC025 +4.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 23.7 | no trial data cached |
| Hypotension (low blood pressure) | 124 | 5.2 4.4–6.2ROR 5.4 · χ² 422 / p 5e-94 | 5.1 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.1 | no trial data cached |
| Bradycardia (slow heart rate) | 110 | 17.5 14.5–21.0ROR 18.2 · χ² 1,691 / p <1e-300 | 17.4 EB05 14.8 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.8 | no trial data cached |
| Drug interaction | 99 | 5.3 4.3–6.4ROR 5.4 · χ² 339 / p 5e-76 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Ventricular tachycardia | 71 | 36.2 28.8–45.6ROR 37.2 · χ² 2,387 / p <1e-300 | 35.7 EB05 29.3 · IC025 +4.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 25.0 · 92% clinician | no trial data cached |
| Palpitations (pounding heartbeat) | 62 | 4.5 3.5–5.7ROR 4.5 · χ² 164 / p 8e-38 | 4.3 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Toxicity to various agents | 58 | 2.9 2.3–3.8ROR 3.0 · χ² 71 / p 2e-17 | 2.9 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Arrhythmia | 54 | 9.6 7.3–12.5ROR 9.8 · χ² 406 / p 1e-90 | 9.2 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.6 | no trial data cached |
| Syncope (fainting) | 50 | 4.2 3.2–5.5ROR 4.3 · χ² 119 / p 4e-28 | 4.1 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Cardiac arrest (heart stopping) | 49 | 5.0 3.8–6.6ROR 5.1 · χ² 152 / p 3e-35 | 4.8 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| International normalised ratio increased | 46 | 13.5 10.1–17.9ROR 13.7 · χ² 518 / p 5e-115 | 13.2 EB05 10.2 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 10.3 | no trial data cached |
| Cardiac failure (heart failure) | 45 | 4.7 3.5–6.3ROR 4.8 · χ² 128 / p 5e-30 | 4.5 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.3 | no trial data cached |
| Myocardial infarction (heart attack) | 42 | 2.0 1.5–2.7ROR 2.0 · χ² 20 / p 3e-6 | 2.0 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Hypomagnesaemia | 33 | 20.1 14.3–28.2ROR 20.3 · χ² 578 / p 6e-128 | 19.8 EB05 14.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 · ♀ 4% (drug 52%) | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Hypomagnesaemia — n=33, PRR 20.1
- Lactic acidosis — n=22, PRR 5.8
- Cardio-respiratory arrest — n=28, PRR 5.6
- Renal failure acute — n=27, PRR 5.3
- Hyperkalaemia — n=20, PRR 4.8
- Palpitations — n=62, PRR 4.5
- Syncope — n=50, PRR 4.2
- Rectal haemorrhage — n=20, PRR 3.9
✓ A hand-written Bradford Hill causality assessment exists for this drug: Sotalol ↔ QT prolongation / torsades.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Sotalol Af?
In FDA FAERS, the most frequently co-reported reaction terms for Sotalol Af are atrial fibrillation, electrocardiogram qt prolonged, hypotension, bradycardia, ventricular tachycardia, palpitations. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Sotalol Af have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: LIFE THREATENING PROARRHYTHMIA To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation.
Do FAERS signals prove that Sotalol Af causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 56879738-8662-4f5c-8386-761ab2b5e46f, effective 20260422; matched on
openfda.generic_name.exact:"SOTALOL HYDROCHLORIDE TABLETS AF") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 69 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.