Drug · FAERS side-effect profile with label screen

Propafenone Hydrochloride side effects: what 794 FDA adverse event reports show

Propafenone Hydrochloride · Propafenone Hydrochloride · 22 reaction terms · 364 drug–reaction co-reports · data 2026-09-14

Drug class

Antiarrhythmic

FDA label, Indications wording

Brand names

Propafenone Hydrochloride

openFDA label

Who reports

794 reports · 82% serious · 98 with death outcome · 59% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usa.

FDA label, Indications and Usage

What it is

Propafenone hydrochloride extended-release capsules, USP is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration.

FDA label, Description section

Boxed warning

MORTALITY •In the National Heart, Lung, and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind trial in patients with asymptomatic non-life-threatening v.

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 20 strongest signals

Labeled — boxed warning 3Labeled adverse reaction 4Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 4Outcome field, not a reaction 1Not in label — unassessed 5

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.
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. 2 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
Ventricular tachycardia	21	33.5 22.0–51.2ROR 34.4 · χ² 631 / p 2e-139	32.6 EB05 22.5 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 23.6	no trial data cached
Sinus bradycardia	11	30.1 16.7–54.1ROR 30.5 · χ² 280 / p 3e-63	28.6 EB05 17.0 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.6	no trial data cached
Atrial fibrillation	82	22.2 18.1–27.3ROR 24.7 · χ² 1,649 / p <1e-300	22.1 EB05 18.4 · IC025 +3.9 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 15.6	no trial data cached
Ischaemic stroke	15	22.2 13.5–36.7ROR 22.6 · χ² 283 / p 8e-64	21.6 EB05 13.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.5	no trial data cached
Heart rate irregular	19	22.1 14.2–34.5ROR 22.6 · χ² 362 / p 4e-81	21.6 EB05 14.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 17.1	no trial data cached
Supraventricular tachycardia	7	19.4 9.3–40.5ROR 19.5 · χ² 104 / p 9e-25	16.9 EB05 7.0 · IC025 +1.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 14.2	no trial data cached
Arrhythmia	31	17.2 12.2–24.4ROR 17.9 · χ² 459 / p 4e-102	17.0 EB05 12.4 · IC025 +3.2 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 11.7	no trial data cached
Squamous cell carcinoma	6	16.8 7.6–37.4ROR 17.0 · χ² 74 / p 3e-18	13.4 EB05 5.0 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 12.1	no trial data cached
Basal cell carcinoma	9	15.2 8.0–29.2ROR 15.4 · χ² 106 / p 4e-25	13.3 EB05 6.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Ventricular fibrillation	6	14.3 6.4–31.6ROR 14.4 · χ² 61 / p 2e-15	10.6 EB05 4.1 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.9	no trial data cached
Product taste abnormal	7	13.8 6.6–28.8ROR 13.9 · χ² 71 / p 2e-17	10.8 EB05 4.5 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
Bradycardia (slow heart rate)	27	13.4 9.3–19.5ROR 13.9 · χ² 299 / p 2e-67	13.0 EB05 9.1 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.7	no trial data cached
Myocardial ischaemia	5	11.5 4.8–27.6ROR 11.6 · χ² 38 / p 3e-10	7.5 EB05 3.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.0	no trial data cached
Generalised tonic-clonic seizure	7	11.3 5.4–23.7ROR 11.4 · χ² 56 / p 4e-14	8.3 EB05 3.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.0	no trial data cached
Pulmonary arterial hypertension	6	10.9 4.9–24.2ROR 11.0 · χ² 44 / p 1e-11	7.5 EB05 3.3 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.8	no trial data cached
Electrocardiogram qt prolonged	14	10.3 6.1–17.3ROR 10.5 · χ² 108 / p 1e-25	8.8 EB05 5.2 · IC025 +2.1 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 7.3	no trial data cached
Completed suicide (death by suicide)	32	10.1 7.2–14.1ROR 10.4 · χ² 253 / p 3e-57	9.4 EB05 6.8 · IC025 +2.6 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 7.0 · 100% clinician	no trial data cached
Product substitution issue	19	8.7 5.6–13.6ROR 8.9 · χ² 123 / p 8e-29	7.6 EB05 5.0 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 9.5	no trial data cached
Product quality issue	26	5.1 3.5–7.4ROR 5.2 · χ² 82 / p 6e-20	4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 10.9 · 88% consumer	no trial data cached
Intentional overdose	8	3.3 1.7–6.6ROR 3.3 · χ² 11 / p 5e-4	2.9 EB05 1.6 · IC025 +0.3	Reporting / coding artifact	serious PRR 2.4	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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	82	22.2 18.1–27.3ROR 24.7 · χ² 1,649 / p <1e-300	22.1 EB05 18.4 · IC025 +3.9 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 15.6	no trial data cached
Completed suicide (death by suicide)	32	10.1 7.2–14.1ROR 10.4 · χ² 253 / p 3e-57	9.4 EB05 6.8 · IC025 +2.6 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 7.0 · 100% clinician	no trial data cached
Arrhythmia	31	17.2 12.2–24.4ROR 17.9 · χ² 459 / p 4e-102	17.0 EB05 12.4 · IC025 +3.2 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 11.7	no trial data cached
Bradycardia (slow heart rate)	27	13.4 9.3–19.5ROR 13.9 · χ² 299 / p 2e-67	13.0 EB05 9.1 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.7	no trial data cached
Product quality issue	26	5.1 3.5–7.4ROR 5.2 · χ² 82 / p 6e-20	4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 10.9 · 88% consumer	no trial data cached
Ventricular tachycardia	21	33.5 22.0–51.2ROR 34.4 · χ² 631 / p 2e-139	32.6 EB05 22.5 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 23.6	no trial data cached
Product substitution issue	19	8.7 5.6–13.6ROR 8.9 · χ² 123 / p 8e-29	7.6 EB05 5.0 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 9.5	no trial data cached
Heart rate irregular	19	22.1 14.2–34.5ROR 22.6 · χ² 362 / p 4e-81	21.6 EB05 14.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 17.1	no trial data cached
Ischaemic stroke	15	22.2 13.5–36.7ROR 22.6 · χ² 283 / p 8e-64	21.6 EB05 13.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.5	no trial data cached
Electrocardiogram qt prolonged	14	10.3 6.1–17.3ROR 10.5 · χ² 108 / p 1e-25	8.8 EB05 5.2 · IC025 +2.1 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 7.3	no trial data cached
Sinus bradycardia	11	30.1 16.7–54.1ROR 30.5 · χ² 280 / p 3e-63	28.6 EB05 17.0 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.6	no trial data cached
Basal cell carcinoma	9	15.2 8.0–29.2ROR 15.4 · χ² 106 / p 4e-25	13.3 EB05 6.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Intentional overdose	8	3.3 1.7–6.6ROR 3.3 · χ² 11 / p 5e-4	2.9 EB05 1.6 · IC025 +0.3	Reporting / coding artifact	serious PRR 2.4	no trial data cached
Generalised tonic-clonic seizure	7	11.3 5.4–23.7ROR 11.4 · χ² 56 / p 4e-14	8.3 EB05 3.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.0	no trial data cached
Product taste abnormal	7	13.8 6.6–28.8ROR 13.9 · χ² 71 / p 2e-17	10.8 EB05 4.5 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Propafenone?

In FDA FAERS, the most frequently co-reported reaction terms for Propafenone are atrial fibrillation, arrhythmia, bradycardia, ventricular tachycardia, heart rate irregular, ischaemic stroke. 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 Propafenone have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: MORTALITY •In the National Heart, Lung, and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind trial in patients with asymptomatic non-life-threatening v.

Do FAERS signals prove that Propafenone 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 bc1d2548-15a3-4986-92b1-c3ddfb35343a, effective 20241226; matched on openfda.generic_name.exact:"PROPAFENONE")
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, 22 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.