Propranolol adverse event reports that FDA received

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

Name type: Generic name
Class: beta-Adrenergic blocker
Also reported as: Propranolol Er, Propranolol Tablet 40mg, Propranolol /00030002/

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 January 2004 to June 2026, FDA received 13,733 adverse event reports that name Propranolol. In these reports the drug is a suspect or interacting product.

In the same period, 34,484 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 1,177 reports in the 12 months to June 2026 and 1,790 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, 1,177 (0.1%) name Propranolol. Reports from consumers or other non-health professionals were 14.6% of the reports that name Propranolol and 45.8% 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 Propranolol 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 358 reports that name Propranolol.
In January to March 2026, FDA received 321.
In April to June 2025, FDA received 337.

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 1,000 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 13,694 of the 13,733 reports (99.7%).

The reports of the other years are not in the counts.

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 1,000 terms.

Reaction terms in the reports that name Propranolol, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 13,733 reports
Off label useused for a purpose or in a way not on the label	2,763	20.1%
Drug ineffectivethe medicine did not work as expected	1,888	13.7%
Product use in unapproved indicationused for a purpose not on the label	1,662	12.1%
Toxicity to various agentspoisoning or toxic effect of one or more substances	1,332	9.7%
Completed suicidedeath by suicide	1,240	9%
Product use issuea problem in how the product was used	1,049	7.6%
Hypotensionlow blood pressure	918	6.7%
Bradycardiaslow heart rate	883	6.4%
Nauseafeeling sick	793	5.8%
Headachehead pain	773	5.6%
Drug interactionan interaction between medicines	757	5.5%
Dizzinesslight-headedness or unsteadiness	670	4.9%
Cardiac arrestthe heart stopped	628	4.6%
Overdosea dose above the recommended amount	599	4.4%
Intentional overdosea deliberate overdose	578	4.2%
Somnolencedrowsiness	557	4.1%
Coma	552	4%
Drug ineffective for unapproved indication	535	3.9%
Fatiguetiredness	535	3.9%
Hyperhidrosisexcessive sweating	512	3.7%
Drug intolerancethe medicine was not tolerated	511	3.7%
Dyspnoeashortness of breath	499	3.6%
Cardio-respiratory arrestthe heart and breathing stopped	481	3.5%
Nightmarenightmares	450	3.3%
Sedationdrowsiness	430	3.1%
Vomitingbeing sick	428	3.1%
Diarrhoealoose or frequent stools	408	3%
Falla fall	373	2.7%
Nephrolithiasiskidney stones	347	2.5%
Astheniaweakness or lack of energy	345	2.5%
Malaisegeneral feeling of being unwell	335	2.4%
Insomniadifficulty sleeping	333	2.4%
Product administered to patient of inappropriate age	329	2.4%
Syncopefainting	329	2.4%
Tachycardiafast heart rate	310	2.3%
Blood pressure increaseda raised blood pressure reading	307	2.2%
Hypoglycaemialow blood sugar	297	2.2%
Cardiogenic shockshock from the heart failing to pump	290	2.1%
Condition aggravatedthe condition being treated got worse	290	2.1%
Abdominal painstomach or belly pain	289	2.1%
Arthralgiajoint pain	288	2.1%
Cough	280	2%
Myalgiamuscle pain	280	2%
Treatment failurethe treatment did not work	279	2%
Deaththe patient died; cause not stated by this term	278	2%
Suicide attempta suicide attempt	273	2%
Migraine	265	1.9%
Electrocardiogram QT prolongeda QT prolongation on the ECG	259	1.9%
Altered state of consciousness	251	1.8%
Hypertensionhigh blood pressure	246	1.8%

Download all 1,000 terms of Propranolol (CSV)

The counts add to more than 13,733 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 Propranolol with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Propranolol (this page)	Generic name	13,733
Propranolol hydrochloride	Generic name	6,102
Hemangeol	Brand name	4,383
Inderal	Brand name	307

Sum of the separately reported names: 24,525. 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 Propranolol, 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	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	58	53	12	13	23	3	1	17	5
2005	89	83	28	2	31	2	2	31	6
2006	102	95	32	13	32	3	3	34	7
2007	115	106	28	10	49	5	1	27	9
2008	202	189	56	12	57	7	11	85	13
2009	178	173	58	24	72	7	1	48	5
2010	283	272	51	23	132	2	11	112	11
2011	422	409	99	55	150	4	14	221	13
2012	279	273	71	25	96	4	3	143	6
2013	295	284	68	15	66	5	0	175	11
2014	321	301	99	22	102	9	1	147	20
2015	506	476	156	35	186	13	2	225	30
2016	441	372	108	37	157	8	6	203	69
2017	529	472	207	29	188	7	1	259	57
2018	791	709	196	93	327	18	15	445	82
2019	859	780	142	98	349	30	10	455	79
2020	940	877	250	118	414	25	19	537	63
2021	845	791	186	77	347	9	6	535	54
2022	1,065	945	219	116	426	7	15	608	120
2023	1,217	1,108	264	103	453	11	7	760	109
2024	2,023	1,316	205	160	485	15	16	987	707
2025	1,339	1,177	213	162	451	24	20	940	162
2026	834	697	167	97	264	10	10	527	137

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 Propranolol, 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 Propranolol, by the year in which FDA received them
Year	Reports
2004	55
2005	89
2006	93
2007	123
2008	196
2009	185
2010	256
2011	439
2012	320
2013	298
2014	329
2015	515
2016	459
2017	569
2018	878
2019	935
2020	959
2021	904
2022	1,130
2023	1,401
2024	1,727
2025	1,194
2026	679

Reports that name Propranolol, 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 Propranolol
Age	Reports	Share
Under 2	864	6.3%
2 to 11	285	2.1%
12 to 17	361	2.6%
18 to 44	3,721	27.1%
45 to 64	3,114	22.7%
65 to 74	1,034	7.5%
75 and over	626	4.6%
Age not given	3,728	27.1%

Sex of the patient in the reports that name Propranolol
Sex	Reports	Share
Female	6,859	49.9%
Male	4,352	31.7%
Unknown or not given	2,522	18.4%

Type of reporter in the reports that name Propranolol
Reporter	Reports	Share
Physician	4,081	29.7%
Pharmacist	1,000	7.3%
Other health professional	6,024	43.9%
Lawyer	4	under 0.1%
Consumer or non-health professional	2,007	14.6%
Not given	617	4.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 36.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Propranolol record
Indication as recorded (MedDRA)	Reports	Share
Migraine	1,334	9.7%
Hypertension	595	4.3%
Anxiety	267	1.9%
Infantile haemangioma	196	1.4%
Suicide attempt	169	1.2%
Hyperthyroidism	158	1.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 13,733 reports.

Drugs in the same reports

Other drugs that the reports of Propranolol name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	1,266
Amitriptyline	1,010
Botulinum toxin type a	606
Codeine	717
Duloxetine	611
Gabapentin	1,123
Hydromorphone	583
Topiramate	1,146
Venlafaxine	687
Venlafaxine hydrochloride	751

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

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.

Pages near this one

Propranolol hydrochloride same ingredient
Hemangeol same ingredient
Inderal same ingredient
Nebivolol hydrochloride same class
Propranolol hcl same class
Nebivolol same class
Nadolol same class
Tenormin same class
Propoxyphene Napsylate/Acetaminophen Tablets next in the A to Z list
Propoxyphene Napsylate W/Acetaminophen next in the A to Z list
Propoxyphene Napsylate and Acetaminophen next in the A to Z list
Propulsid 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 PropranololThe 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.

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Reported Reactions. Propranolol: adverse event reports that FDA received. https://reportedreactions.com/drug/propranolol/ 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 Propranolol as a suspect or interacting product. The 34,484 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 Propranolol 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 Propranolol?

No. It is a count of what people reported to FDA: 13,733 reports from January 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?

Other health professional (43.9%), physician (29.7%) and consumer or non-health professional (14.6%). 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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