Propafenone hydrochloride adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Propafenone hydrochloride
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Antiarrhythmic
Also reported as: Propafenone Hcl, Propafenone Hydrochloride Tablet, Propafenone Hydrochloride Tablets

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From March 2004 to June 2026, FDA received 1,071 adverse event reports that name Propafenone hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 1,132 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 18 reports in the 12 months to June 2026 and 31 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 18 (under 0.1%) name Propafenone hydrochloride. Reports for patients 75 and over were 19.1% of the reports that name Propafenone hydrochloride and 9.5% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Propafenone hydrochloride is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 3 reports that name Propafenone hydrochloride.
In January to March 2026, FDA received 5.
In April to June 2025, FDA received 11.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 119 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

This list is partial.

It covers 894 of the 1,071 reports (83.5%).

The site keeps reaction terms only for years in which the drug has 12 or more reports.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 119 terms.

Reaction terms in the reports that name Propafenone hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,071 reports
Atrial fibrillationan irregular heart rhythm	98	9.2%
Drug ineffectivethe medicine did not work as expected	78	7.3%
Hypotensionlow blood pressure	76	7.1%
Dizzinesslight-headedness or unsteadiness	72	6.7%
Completed suicidedeath by suicide	69	6.4%
Drug interactionan interaction between medicines	68	6.3%
Nauseafeeling sick	58	5.4%
Product quality issuea problem with the product itself	57	5.3%
Bradycardiaslow heart rate	53	4.9%
Electrocardiogram QRS complex prolonged	44	4.1%
Cardiac arrestthe heart stopped	37	3.5%
Arrhythmia	36	3.4%
Falla fall	36	3.4%
Overdosea dose above the recommended amount	34	3.2%
Vomitingbeing sick	34	3.2%
Astheniaweakness or lack of energy	33	3.1%
Syncopefainting	32	3%
Toxicity to various agentspoisoning or toxic effect of one or more substances	30	2.8%
Malaisegeneral feeling of being unwell	29	2.7%
Palpitationsawareness of the heartbeat	28	2.6%
Ventricular tachycardiaa fast rhythm from the lower heart chambers	28	2.6%
Dyspnoeashortness of breath	25	2.3%
Heart rate increaseda fast heart rate reading	25	2.3%
Heart rate irregular	25	2.3%
Loss of consciousnesspassing out	25	2.3%
Product substitution issuea problem after switching products	25	2.3%
Headachehead pain	23	2.1%
Chest pain	20	1.9%
Deaththe patient died; cause not stated by this term	19	1.8%
Fatiguetiredness	19	1.8%
Sinus bradycardia	19	1.8%
Suicide attempta suicide attempt	19	1.8%
Respiratory distressdifficulty breathing	18	1.7%
Chest discomfort	17	1.6%
Disease recurrencethe disease came back	16	1.5%
Diarrhoealoose or frequent stools	15	1.4%
Intentional overdosea deliberate overdose	15	1.4%
Convulsion	14	1.3%
Drug toxicity	14	1.3%
Coma	13	1.2%
Off label useused for a purpose or in a way not on the label	13	1.2%
Cardio-respiratory arrestthe heart and breathing stopped	12	1.1%
Electrocardiogram QT prolongeda QT prolongation on the ECG	12	1.1%
Hyperhidrosisexcessive sweating	12	1.1%
Incorrect dose administeredthe wrong dose was given	12	1.1%
Anxiety	11	1%
Atrial flutter	11	1%
Atrioventricular block first degree	11	1%
Brain scan abnormal	11	1%
Myocardial infarctionheart attack	11	1%

Download all 119 terms of Propafenone hydrochloride (CSV)

The counts add to more than 1,071 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Propafenone with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Propafenone	Generic name	1,266
Propafenone hydrochloride (this page)	Generic name	1,071

Sum of the separately reported names: 2,337. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Propafenone hydrochloride, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Other Serious (Important Medical Events)	Not serious
2004	23	23	3	3	15	0	7	0
2005	43	42	7	5	23	1	12	1
2006	36	35	7	4	14	1	15	1
2007	34	34	3	6	24	1	11	0
2008	96	88	17	7	56	2	27	8
2009	59	52	6	7	34	2	16	7
2010	90	83	13	9	47	1	35	7
2011	125	108	33	5	47	4	47	17
2012	82	76	10	8	47	2	34	6
2013	22	11	3	2	6	0	4	11
2014	31	22	4	0	9	0	15	9
2015	51	34	9	1	12	0	22	17
2016	50	25	4	1	17	0	16	25
2017	33	19	5	4	10	1	10	14
2018	47	34	7	3	10	0	26	13
2019	52	35	5	4	15	0	23	17
2020	29	22	1	0	12	0	17	7
2021	29	17	0	2	7	0	13	12
2022	30	21	1	3	10	0	18	9
2023	30	17	3	2	9	0	16	13
2024	36	24	1	2	12	0	20	12
2025	31	30	9	3	11	0	27	1
2026	12	9	6	1	7	0	8	3

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Propafenone hydrochloride, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Propafenone hydrochloride, by the year in which FDA received them
Year	Reports
2004	22
2005	34
2006	38
2007	38
2008	93
2009	55
2010	91
2011	123
2012	98
2013	21
2014	34
2015	57
2016	45
2017	31
2018	50
2019	53
2020	32
2021	26
2022	31
2023	31
2024	35
2025	25
2026	8

Reports that name Propafenone hydrochloride, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Propafenone hydrochloride
Age	Reports	Share
Under 2	11	1%
2 to 11	9	0.8%
12 to 17	20	1.9%
18 to 44	72	6.7%
45 to 64	181	16.9%
65 to 74	188	17.6%
75 and over	205	19.1%
Age not given	385	35.9%

Sex of the patient in the reports that name Propafenone hydrochloride
Sex	Reports	Share
Female	564	52.7%
Male	358	33.4%
Unknown or not given	149	13.9%

Type of reporter in the reports that name Propafenone hydrochloride
Reporter	Reports	Share
Physician	221	20.6%
Pharmacist	73	6.8%
Other health professional	192	17.9%
Lawyer	7	0.7%
Consumer or non-health professional	435	40.6%
Not given	143	13.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 58.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Propafenone hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Atrial fibrillation	262	24.5%
Arrhythmia	81	7.6%
Supraventricular tachycardia	12	1.1%
Heart rate irregular	10	0.9%
Arrhythmia supraventricular	8	0.7%
Tachycardia	7	0.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,071 reports.

Pages near this one

Propafenone same ingredient
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Propacet 100 next in the A to Z list
Propanolol Hcl next in the A to Z list
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Promethazine hydrochloride and codeine phosphate next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Propafenone hydrochlorideThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Propafenone hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/propafenone-hydrochloride/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Propafenone hydrochloride as a suspect or interacting product. The 1,132 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Propafenone hydrochloride was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Propafenone hydrochloride?

No. It is a count of what people reported to FDA: 1,071 reports from March 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (40.6%), physician (20.6%) and other health professional (17.9%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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