Drug · FAERS side-effect profile with label screen
Propafenone side effects: what 4,208 FDA adverse event reports show
Drug class
Antiarrhythmic
FDA label, Indications wording
Brand names
Propafenone Hydrochloride
openFDA label
Who reports
4,208 reports · 81% serious · 504 with death outcome · 58% 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 40 strongest signals
Labeled — boxed warning 4Labeled adverse reaction 11Labeled (related wording) 3Likely indication confounding 2Reporting / coding artifact 3Outcome field, not a reaction 1Not in label — unassessed 16
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. 185 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Sinus bradycardia | 54 | 27.9 21.4–36.4ROR 28.3 · χ² 1,368 / p 8e-300 | 27.5 EB05 21.9 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.3 · 94% clinician | no trial data cached |
| Ventricular tachycardia | 80 | 24.2 19.4–30.0ROR 24.6 · χ² 1,746 / p <1e-300 | 23.9 EB05 19.8 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 17.2 · ♀ 37% (drug 58%) | no trial data cached |
| Supraventricular tachycardia | 37 | 19.3 14.0–26.7ROR 19.5 · χ² 623 / p 7e-138 | 19.1 EB05 14.4 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 14.4 | no trial data cached |
| Atrial fibrillation | 354 | 18.1 16.4–20.1ROR 19.7 · χ² 5,725 / p <1e-300 | 18.1 EB05 16.5 · IC025 +4.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 12.9 | no trial data cached |
| Subarachnoid haemorrhage | 34 | 16.6 11.9–23.3ROR 16.8 · χ² 483 / p 3e-107 | 16.4 EB05 12.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · ♀ 88% (drug 58%) · 100% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 170 | 16.0 13.8–18.5ROR 16.6 · χ² 2,373 / p <1e-300 | 15.9 EB05 14.0 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.7 · 94% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 49 | 15.0 11.3–19.8ROR 15.1 · χ² 623 / p 8e-138 | 14.8 EB05 11.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · 100% clinician | no trial data cached |
| Arrhythmia | 139 | 14.6 12.4–17.2ROR 15.1 · χ² 1,747 / p <1e-300 | 14.5 EB05 12.6 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.3 | no trial data cached |
| Heart rate irregular | 63 | 13.8 10.8–17.7ROR 14.0 · χ² 737 / p 1e-162 | 13.7 EB05 11.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 | no trial data cached |
| Drug level increased | 40 | 12.1 8.9–16.4ROR 12.2 · χ² 394 / p 5e-88 | 11.7 EB05 8.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 · 98% clinician | no trial data cached |
| Ventricular fibrillation | 26 | 11.7 7.9–17.1ROR 11.7 · χ² 242 / p 6e-55 | 11.0 EB05 7.5 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 · 92% clinician | no trial data cached |
| Cardiogenic shock | 31 | 10.8 7.6–15.4ROR 10.9 · χ² 267 / p 3e-60 | 10.2 EB05 7.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 · ♀ 85% (drug 58%) · 97% clinician | no trial data cached |
| Basal cell carcinoma | 32 | 10.2 7.2–14.5ROR 10.3 · χ² 257 / p 4e-58 | 9.6 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · ♀ 86% (drug 58%) | no trial data cached |
| Drug interaction | 325 | 10.2 9.2–11.4ROR 11.0 · χ² 2,711 / p <1e-300 | 10.2 EB05 9.3 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 · 92% clinician | no trial data cached |
| Ventricular extrasystoles | 21 | 10.1 6.6–15.4ROR 10.1 · χ² 163 / p 2e-37 | 9.1 EB05 6.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | no trial data cached |
| Electrocardiogram qt prolonged | 67 | 9.3 7.3–11.8ROR 9.4 · χ² 487 / p 3e-108 | 9.0 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.7 · ♀ 35% (drug 58%) · 98% clinician | no trial data cached |
| Myocardial ischaemia | 20 | 8.7 5.6–13.5ROR 8.7 · χ² 129 / p 4e-30 | 7.7 EB05 5.1 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 | no trial data cached |
| Metabolic acidosis | 55 | 8.7 6.7–11.3ROR 8.8 · χ² 366 / p 9e-82 | 8.3 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 96% clinician | no trial data cached |
| Upper gastrointestinal haemorrhage | 29 | 8.6 6.0–12.3ROR 8.6 · χ² 186 / p 1e-42 | 7.8 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.1 · ♀ 24% (drug 58%) | no trial data cached |
| Squamous cell carcinoma | 16 | 8.5 5.2–13.8ROR 8.5 · χ² 98 / p 2e-23 | 7.2 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Cardiac arrest (heart stopping) | 129 | 7.8 6.6–9.2ROR 8.0 · χ² 756 / p 1e-166 | 7.6 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.5 · 90% clinician | no trial data cached |
| Haematuria (blood in urine) | 51 | 7.4 5.6–9.7ROR 7.5 · χ² 277 / p 2e-62 | 7.0 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · ♀ 22% (drug 58%) | no trial data cached |
| Ischaemic stroke | 26 | 7.3 4.9–10.7ROR 7.3 · χ² 134 / p 3e-31 | 6.5 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 33% (drug 58%) · 92% clinician | no trial data cached |
| Toxicity to various agents | 238 | 7.1 6.3–8.0ROR 7.4 · χ² 1,244 / p 1e-272 | 7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 98% clinician | no trial data cached |
| Completed suicide (death by suicide) | 119 | 7.1 5.9–8.4ROR 7.2 · χ² 614 / p 7e-136 | 6.9 EB05 5.9 · IC025 +2.5 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 5.0 · 99% clinician | no trial data cached |
| International normalised ratio increased | 39 | 6.8 4.9–9.2ROR 6.8 · χ² 186 / p 1e-42 | 6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Scratch | 14 | 6.7 4.0–11.4ROR 6.8 · χ² 63 / p 1e-15 | 5.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Hypertensive crisis | 15 | 6.7 4.0–11.1ROR 6.7 · χ² 67 / p 1e-16 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Altered state of consciousness | 28 | 6.5 4.5–9.4ROR 6.5 · χ² 124 / p 4e-29 | 5.9 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 93% clinician | no trial data cached |
| Eye haemorrhage | 17 | 6.3 3.9–10.2ROR 6.4 · χ² 71 / p 2e-17 | 5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Mitral valve incompetence | 14 | 6.2 3.7–10.4ROR 6.2 · χ² 56 / p 5e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Drug-induced liver injury | 37 | 6.0 4.3–8.2ROR 6.0 · χ² 149 / p 2e-34 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 100% clinician | no trial data cached |
| Presyncope (near-fainting) | 29 | 6.0 4.2–8.6ROR 6.0 · χ² 115 / p 3e-27 | 5.5 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 93% clinician | no trial data cached |
| Shock | 26 | 5.7 3.9–8.3ROR 5.7 · χ² 96 / p 7e-23 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 92% clinician | no trial data cached |
| Mental status changes | 30 | 5.4 3.8–7.7ROR 5.4 · χ² 103 / p 2e-24 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 100% clinician | no trial data cached |
| Obstructive airways disorder | 12 | 5.4 3.0–9.4ROR 5.4 · χ² 38 / p 3e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 36 | 5.3 3.8–7.3ROR 5.3 · χ² 121 / p 2e-28 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 16 | 5.3 3.2–8.6ROR 5.3 · χ² 51 / p 4e-13 | 4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Intentional overdose | 67 | 5.2 4.1–6.6ROR 5.3 · χ² 226 / p 2e-51 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 97% clinician | no trial data cached |
| Syncope (fainting) | 105 | 5.2 4.3–6.3ROR 5.3 · χ² 356 / p 8e-80 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | 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 | 354 | 18.1 16.4–20.1ROR 19.7 · χ² 5,725 / p <1e-300 | 18.1 EB05 16.5 · IC025 +4.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 12.9 | no trial data cached |
| Drug interaction | 325 | 10.2 9.2–11.4ROR 11.0 · χ² 2,711 / p <1e-300 | 10.2 EB05 9.3 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 · 92% clinician | no trial data cached |
| Dizziness | 264 | 2.6 2.4–3.0ROR 2.8 · χ² 274 / p 6e-62 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Toxicity to various agents | 238 | 7.1 6.3–8.0ROR 7.4 · χ² 1,244 / p 1e-272 | 7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 98% clinician | no trial data cached |
| Hypotension (low blood pressure) | 172 | 4.3 3.7–5.0ROR 4.4 · χ² 433 / p 2e-96 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Bradycardia (slow heart rate) | 170 | 16.0 13.8–18.5ROR 16.6 · χ² 2,373 / p <1e-300 | 15.9 EB05 14.0 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.7 · 94% clinician | no trial data cached |
| Arrhythmia | 139 | 14.6 12.4–17.2ROR 15.1 · χ² 1,747 / p <1e-300 | 14.5 EB05 12.6 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.3 | no trial data cached |
| Cardiac arrest (heart stopping) | 129 | 7.8 6.6–9.2ROR 8.0 · χ² 756 / p 1e-166 | 7.6 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.5 · 90% clinician | no trial data cached |
| Completed suicide (death by suicide) | 119 | 7.1 5.9–8.4ROR 7.2 · χ² 614 / p 7e-136 | 6.9 EB05 5.9 · IC025 +2.5 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 5.0 · 99% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 114 | 3.7 3.1–4.5ROR 3.8 · χ² 227 / p 2e-51 | 3.7 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Palpitations (pounding heartbeat) | 106 | 4.5 3.7–5.5ROR 4.6 · χ² 288 / p 6e-65 | 4.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Syncope (fainting) | 105 | 5.2 4.3–6.3ROR 5.3 · χ² 356 / p 8e-80 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Loss of consciousness | 104 | 4.0 3.3–4.9ROR 4.1 · χ² 237 / p 1e-53 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | no trial data cached |
| Overdose | 92 | 2.1 1.7–2.6ROR 2.1 · χ² 54 / p 1e-13 | 2.1 EB05 1.8 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Gastrointestinal haemorrhage | 85 | 5.0 4.1–6.2ROR 5.1 · χ² 272 / p 2e-61 | 4.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 | 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.
- Subarachnoid haemorrhage — n=34, PRR 16.6
- Generalised tonic-clonic seizure — n=49, PRR 15.0
- Heart rate irregular — n=63, PRR 13.8
- Basal cell carcinoma — n=32, PRR 10.2
- Metabolic acidosis — n=55, PRR 8.7
- Ischaemic stroke — n=26, PRR 7.3
- Toxicity to various agents — n=238, PRR 7.1
- Altered state of consciousness — n=28, PRR 6.5
- Drug-induced liver injury — n=37, PRR 6.0
- Presyncope — n=29, PRR 6.0
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, dizziness, toxicity to various agents, hypotension, bradycardia, arrhythmia. 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, fieldpatient.drug.openfda.generic_name.exact, 225 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.