Drug · FAERS side-effect profile with label screen

Sotalol side effects: what 16,526 FDA adverse event reports show

Sotalol Hydrochloride · 1,137 reaction terms · 60,698 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Sotalol Hydrochloride (Sotalol Hydrochloride)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

16,526 reports · 79% serious · 1,704 with death outcome · 50% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Sotalol hydrochloride/Sotalol hydrochloride AF tablets are 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/A.

FDA label, Indications and Usage

What it is

Sotalol hydrochloride/Sotalol hydrochloride AF tablets, USP contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties.

FDA label, Description section

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.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled — boxed warning 6Labeled adverse reaction 2Labeled (related wording) 1Likely indication confounding 3Lab value / disease marker 4Not in label — unassessed 24

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.
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.
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. 1,097 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Accidental poisoning	295	355.4 312.6–404.1ROR 361.9 · χ² 80,921 / p <1e-300	272.1 EB05 247.0 · IC025 +7.4 3/3 methods agree	Not in label — unassessed	serious n=295 · 100% clinician	no trial arm names this drug
Pacemaker generated rhythm	11	327.6 168.7–636.1ROR 327.8 · χ² 2,585 / p <1e-300	179.5 EB05 106.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Antiacetylcholine receptor antibody positive	10	198.5 101.9–386.8ROR 198.6 · χ² 1,530 / p <1e-300	129.7 EB05 75.3 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious n=10	no trial arm names this drug
Cardioactive drug level decreased	18	147.1 90.3–239.7ROR 147.3 · χ² 2,209 / p <1e-300	115.9 EB05 77.5 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious n=18	no trial arm names this drug
Medical observation	11	143.3 76.8–267.4ROR 143.4 · χ² 1,270 / p 2e-278	105.6 EB05 62.9 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Cardiospasm	43	105.9 77.6–144.5ROR 106.1 · χ² 4,022 / p <1e-300	93.7 EB05 72.5 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=43 · ♀ 100% (drug 50%)	no trial arm names this drug
Immunisation	29	90.9 62.4–132.5ROR 91.1 · χ² 2,321 / p <1e-300	80.5 EB05 58.8 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=29 · ♀ 100% (drug 50%)	no trial arm names this drug
Palmoplantar keratoderma	43	80.5 59.2–109.5ROR 80.7 · χ² 3,098 / p <1e-300	73.3 EB05 56.7 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=43 · ♀ 100% (drug 50%)	no trial arm names this drug
Hydrops foetalis	23	49.5 32.6–75.1ROR 49.6 · χ² 1,005 / p 6e-221	46.0 EB05 32.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=23 · 100% clinician	no trial arm names this drug
Atrial tachycardia	71	44.2 34.9–55.9ROR 44.3 · χ² 2,851 / p <1e-300	42.2 EB05 34.6 · IC025 +4.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=71 · ♀ 85% (drug 50%)	no trial arm names this drug
Apallic syndrome	23	41.3 27.2–62.5ROR 41.3 · χ² 836 / p 3e-184	38.8 EB05 27.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=23 · 100% clinician	no trial arm names this drug
Drug-genetic interaction	10	39.8 21.2–74.7ROR 39.9 · χ² 330 / p 4e-74	36.2 EB05 21.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	–	no trial arm names this drug
Torsade de pointes	214	35.5 31.0–40.6ROR 35.9 · χ² 6,941 / p <1e-300	34.4 EB05 30.7 · IC025 +4.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 25.4 · ♀ 74% (drug 50%) · 96% clinician	no trial arm names this drug
Cardiac ablation	48	35.3 26.5–47.1ROR 35.4 · χ² 1,524 / p <1e-300	34.0 EB05 26.6 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=48	no trial arm names this drug
Tachycardia foetal	13	34.2 19.7–59.2ROR 34.2 · χ² 376 / p 6e-84	31.9 EB05 19.8 · IC025 +3.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=13	no trial arm names this drug
Long qt syndrome	59	31.8 24.6–41.2ROR 31.9 · χ² 1,688 / p <1e-300	30.8 EB05 24.7 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious n=59 · 100% clinician	no trial arm names this drug
Cardioversion	28	25.8 17.7–37.5ROR 25.8 · χ² 629 / p 4e-139	24.9 EB05 18.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=28 · ♀ 30% (drug 50%)	no trial arm names this drug
Pruritus genital	45	25.0 18.6–33.5ROR 25.0 · χ² 992 / p 5e-218	24.3 EB05 18.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=43 · ♀ 100% (drug 50%)	no trial arm names this drug
Sick sinus syndrome	21	23.3 15.1–35.8ROR 23.3 · χ² 418 / p 4e-93	22.4 EB05 15.4 · IC025 +3.2 3/3 methods agree	Labeled — boxed warning exact term	serious n=21	no trial arm names this drug
Ventricular tachycardia	296	23.1 20.6–25.8ROR 23.5 · χ² 6,115 / p <1e-300	22.6 EB05 20.5 · IC025 +4.3 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 16.6	no trial arm names this drug
Stenotrophomonas infection	23	22.1 14.7–33.4ROR 22.2 · χ² 436 / p 5e-97	21.4 EB05 15.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=23 · ♀ 0% (drug 50%) · 100% clinician	no trial arm names this drug
Ventricular arrhythmia	61	21.5 16.7–27.7ROR 21.6 · χ² 1,153 / p 6e-253	21.0 EB05 17.0 · IC025 +3.8 3/3 methods agree	Labeled — boxed warning exact term	serious n=61 · 100% clinician	no trial arm names this drug
Brash syndrome	22	20.9 13.7–31.8ROR 20.9 · χ² 391 / p 3e-87	20.2 EB05 14.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=22 · 100% clinician	no trial arm names this drug
Atrial flutter	126	20.2 17.0–24.1ROR 20.4 · χ² 2,251 / p <1e-300	19.9 EB05 17.1 · IC025 +3.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 14.8	no trial arm names this drug
Carotid artery occlusion	55	19.3 14.8–25.2ROR 19.4 · χ² 924 / p 3e-203	18.9 EB05 15.1 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=55 · ♀ 89% (drug 50%)	no trial arm names this drug
Haemorrhagic anaemia	67	19.3 15.2–24.6ROR 19.4 · χ² 1,129 / p 7e-248	19.0 EB05 15.4 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=67	no trial arm names this drug
Bradycardia foetal	12	18.9 10.7–33.3ROR 18.9 · χ² 183 / p 6e-42	17.7 EB05 10.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Implantable defibrillator insertion	18	17.6 11.0–28.0ROR 17.6 · χ² 262 / p 4e-59	16.8 EB05 10.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=18	no trial arm names this drug
Atrial thrombosis	27	16.7 11.4–24.4ROR 16.7 · χ² 377 / p 2e-84	16.2 EB05 11.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=27 · ♀ 0% (drug 50%)	no trial arm names this drug
Cardioactive drug level increased	17	16.4 10.2–26.5ROR 16.4 · χ² 228 / p 7e-52	15.6 EB05 9.8 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious n=17	no trial arm names this drug
Electrocardiogram qt prolonged	446	15.9 14.5–17.4ROR 16.3 · χ² 6,147 / p <1e-300	15.7 EB05 14.5 · IC025 +3.8 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 11.6 · 92% clinician	no trial arm names this drug
Atrial fibrillation	1,203	15.8 15.0–16.7ROR 17.0 · χ² 16,566 / p <1e-300	15.6 EB05 14.9 · IC025 +3.9 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 11.4	no trial arm names this drug
Left atrial dilatation	15	15.0 9.0–24.9ROR 15.0 · χ² 180 / p 3e-41	13.9 EB05 8.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Tension headache	48	14.3 10.8–19.0ROR 14.4 · χ² 575 / p 2e-127	14.0 EB05 10.9 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious n=45 · ♀ 100% (drug 50%)	no trial arm names this drug
Cardiac amyloidosis	12	14.1 8.0–25.0ROR 14.2 · χ² 132 / p 7e-31	12.6 EB05 6.8 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Sleep terror	45	13.7 10.2–18.4ROR 13.7 · χ² 512 / p 1e-113	13.3 EB05 10.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=44 · ♀ 100% (drug 50%)	no trial arm names this drug
Sinus node dysfunction	19	13.3 8.5–20.9ROR 13.3 · χ² 202 / p 4e-46	12.4 EB05 7.9 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious n=19	no trial arm names this drug
Cerebral haematoma	34	13.0 9.3–18.2ROR 13.0 · χ² 360 / p 1e-80	12.5 EB05 9.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=34 · 100% clinician	no trial arm names this drug
Echocardiogram abnormal	14	12.8 7.6–21.7ROR 12.8 · χ² 140 / p 1e-32	11.4 EB05 6.6 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious n=14	no trial arm names this drug
Daydreaming	15	12.4 7.5–20.6ROR 12.4 · χ² 145 / p 1e-33	11.1 EB05 6.5 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Sotalol only as a background or rescue medication (NCT00523978, NCT00911508); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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	1,203	15.8 15.0–16.7ROR 17.0 · χ² 16,566 / p <1e-300	15.6 EB05 14.9 · IC025 +3.9 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 11.4	no trial arm names this drug
Drug ineffective (drug did not work)	976	0.9 0.9–1.0ROR 0.9 · χ² 4 / p 0.024	0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 1.4	no trial arm names this drug
Dyspnoea (shortness of breath)	941	2.1 2.0–2.2ROR 2.2 · χ² 564 / p 5e-125	2.1 EB05 2.0 · IC025 +1.0	Labeled adverse reaction exact term	serious PRR 1.8	no trial arm names this drug
Fatigue (tiredness)	901	1.5 1.4–1.6ROR 1.5 · χ² 141 / p 9e-33	1.5 EB05 1.4 · IC025 +0.4	Labeled adverse reaction exact term	serious PRR 1.5	no trial arm names this drug
Dizziness	764	1.9 1.8–2.1ROR 2.0 · χ² 359 / p 2e-80	1.9 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 1.9	no trial arm names this drug
Diarrhoea (diarrhea)	741	1.5 1.4–1.6ROR 1.5 · χ² 111 / p 3e-26	1.5 EB05 1.4 · IC025 +0.4	Labeled — boxed warning exact term	serious PRR 1.3	no trial arm names this drug
Nausea	727	1.2 1.1–1.3ROR 1.2 · χ² 18 / p 1e-5	1.2 EB05 1.1 · IC025 +0.1	Labeled adverse reaction exact term	serious PRR 1.2	no trial arm names this drug
Off label use (used outside approved label)	692	1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.388	1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 1.1	no trial arm names this drug
Asthenia (weakness)	648	2.2 2.0–2.4ROR 2.2 · χ² 424 / p 2e-94	2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.8	no trial arm names this drug
Hypotension (low blood pressure)	617	3.9 3.6–4.2ROR 4.0 · χ² 1,346 / p 6e-295	3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 3.1	no trial arm names this drug
Fall	572	2.2 2.0–2.4ROR 2.2 · χ² 371 / p 5e-83	2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 1.8	no trial arm names this drug
Drug interaction	521	4.2 3.8–4.5ROR 4.3 · χ² 1,260 / p 2e-276	4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2	no trial arm names this drug
Death	511	0.8 0.7–0.8ROR 0.7 · χ² 43 / p 3e-11	0.8 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 0.6	no trial arm names this drug
Malaise (feeling unwell)	484	1.4 1.3–1.5ROR 1.4 · χ² 55 / p 5e-14	1.4 EB05 1.3 · IC025 +0.3	Not in label — unassessed	serious PRR 1.5	no trial arm names this drug
Headache	476	1.0 0.9–1.1ROR 1.0 · χ² 1 / p 0.217	1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 1.0	no trial arm names this drug

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.

Accidental poisoning — n=295, PRR 355.4
Cardiospasm — n=43, PRR 105.9
Immunisation — n=29, PRR 90.9
Palmoplantar keratoderma — n=43, PRR 80.5
Hydrops foetalis — n=23, PRR 49.5
Apallic syndrome — n=23, PRR 41.3
Cardiac ablation — n=48, PRR 35.3
Cardioversion — n=28, PRR 25.8
Pruritus genital — n=45, PRR 25.0
Stenotrophomonas infection — n=23, PRR 22.1

✓ 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?

In FDA FAERS, the most frequently co-reported reaction terms for Sotalol are atrial fibrillation, dyspnoea, fatigue, dizziness, diarrhoea, nausea. 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 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 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 1f2ee505-eb90-885d-e063-6394a90a46a1, effective 20240808; matched on openfda.generic_name.exact:"SOTALOL HYDROCHLORIDE")
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, field patient.drug.openfda.generic_name.exact, 1,137 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
ClinicalTrials.gov API v2 (query SOTALOL, results-bearing studies sorted by enrollment)

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.