Metoprolol adverse event reports that FDA received

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

Name type: Generic name
Class: beta-Adrenergic blocker
Also reported as: Metoprolol Sr, Metoprolol Tab, Metoprolol 50mg

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 27,410 adverse event reports that name Metoprolol. In these reports the drug is a suspect or interacting product.

In the same period, 165,686 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 1,520 reports in the 12 months to June 2026 and 1,884 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, 1,520 (0.1%) name Metoprolol. Reports from consumers or other non-health professionals were 22.9% of the reports that name Metoprolol 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 Metoprolol 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 361 reports that name Metoprolol.
In January to March 2026, FDA received 487.
In April to June 2025, FDA received 471.

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 1,773 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 27,103 of the 27,410 reports (98.9%).

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 1,773 terms.

Reaction terms in the reports that name Metoprolol, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 27,410 reports
Completed suicidedeath by suicide	3,102	11.3%
Hypotensionlow blood pressure	2,521	9.2%
Dizzinesslight-headedness or unsteadiness	2,237	8.2%
Toxicity to various agentspoisoning or toxic effect of one or more substances	2,171	7.9%
Dyspnoeashortness of breath	2,141	7.8%
Drug ineffectivethe medicine did not work as expected	2,135	7.8%
Bradycardiaslow heart rate	1,758	6.4%
Fatiguetiredness	1,693	6.2%
Drug interactionan interaction between medicines	1,496	5.5%
Falla fall	1,280	4.7%
Nauseafeeling sick	1,225	4.5%
Hypertensionhigh blood pressure	1,150	4.2%
Off label useused for a purpose or in a way not on the label	1,137	4.1%
Headachehead pain	1,067	3.9%
Syncopefainting	1,053	3.8%
Atrial fibrillationan irregular heart rhythm	1,003	3.7%
Astheniaweakness or lack of energy	871	3.2%
Diarrhoealoose or frequent stools	866	3.2%
Cough	811	3%
Painpain, site not specified	789	2.9%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	757	2.8%
Condition aggravatedthe condition being treated got worse	750	2.7%
Malaisegeneral feeling of being unwell	704	2.6%
Cardiac arrestthe heart stopped	669	2.4%
Blood pressure increaseda raised blood pressure reading	666	2.4%
Arthralgiajoint pain	648	2.4%
Deaththe patient died; cause not stated by this term	639	2.3%
Intentional overdosea deliberate overdose	639	2.3%
Overdosea dose above the recommended amount	625	2.3%
Chest pain	599	2.2%
Weight decreasedweight loss	596	2.2%
Vomitingbeing sick	585	2.1%
General physical health deteriorationgeneral decline in health	578	2.1%
Heart rate increaseda fast heart rate reading	531	1.9%
Cardiac failureheart failure	523	1.9%
Pain in extremitypain in an arm or leg	517	1.9%
Oedema peripheralswelling of the legs, ankles or hands	516	1.9%
Insomniadifficulty sleeping	505	1.8%
Somnolencedrowsiness	493	1.8%
Peripheral swellingswelling of the arms or legs	491	1.8%
Palpitationsawareness of the heartbeat	487	1.8%
Tachycardiafast heart rate	487	1.8%
Blood pressure decreaseda low blood pressure reading	480	1.8%
Abdominal painstomach or belly pain	478	1.7%
Rashskin rash	475	1.7%
Weight increasedweight gain	472	1.7%
Anxiety	467	1.7%
Heart rate decreased	455	1.7%
Feeling abnormalfeeling odd or not right	449	1.6%
Asthma	447	1.6%

Download all 1,773 terms of Metoprolol (CSV)

The counts add to more than 27,410 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 Metoprolol with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Metoprolol (this page)	Generic name	27,410
Metoprolol succinate	Generic name	10,416
Metoprolol tartrate	Generic name	9,103
Lopressor	Brand name	1,418
Toprol Xl	Brand name	3,341

Sum of the separately reported names: 51,688. 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 Metoprolol, 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	119	114	15	12	77	0	2	23	5
2005	133	126	23	7	73	4	0	33	7
2006	78	70	14	11	45	2	0	17	8
2007	45	40	14	3	22	0	0	9	5
2008	84	79	29	7	31	2	0	24	5
2009	195	183	79	17	65	2	3	54	12
2010	219	205	62	23	79	2	4	95	14
2011	199	186	77	10	70	1	1	61	13
2012	297	242	49	15	112	11	1	116	55
2013	1,093	992	376	50	335	34	30	403	101
2014	1,154	1,053	366	56	368	28	37	477	101
2015	1,264	1,098	487	55	423	16	9	430	166
2016	1,340	1,019	302	53	442	17	40	499	321
2017	1,504	1,256	492	109	538	15	6	661	248
2018	2,513	2,264	448	163	1,359	41	87	1,086	249
2019	2,371	2,137	399	213	1,222	48	43	1,164	234
2020	2,656	2,420	554	249	1,303	39	48	1,520	236
2021	2,257	1,981	339	179	1,057	23	16	1,357	276
2022	2,370	2,107	400	154	1,167	28	23	1,375	263
2023	2,314	1,963	417	170	1,005	20	11	1,489	351
2024	2,044	1,764	350	227	883	23	14	1,322	280
2025	2,110	1,903	283	280	955	43	35	1,493	207
2026	1,051	971	335	110	549	31	16	669	80

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 Metoprolol, 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 Metoprolol, by the year in which FDA received them
Year	Reports
2004	119
2005	128
2006	84
2007	38
2008	80
2009	197
2010	224
2011	271
2012	410
2013	1,105
2014	1,144
2015	1,349
2016	1,379
2017	1,594
2018	2,684
2019	2,447
2020	2,851
2021	2,378
2022	2,166
2023	2,259
2024	1,991
2025	1,663
2026	848

Reports that name Metoprolol, 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 Metoprolol
Age	Reports	Share
Under 2	322	1.2%
2 to 11	86	0.3%
12 to 17	325	1.2%
18 to 44	3,223	11.8%
45 to 64	6,941	25.3%
65 to 74	4,427	16.2%
75 and over	5,542	20.2%
Age not given	6,544	23.9%

Sex of the patient in the reports that name Metoprolol
Sex	Reports	Share
Female	13,205	48.2%
Male	11,535	42.1%
Unknown or not given	2,670	9.7%

Type of reporter in the reports that name Metoprolol
Reporter	Reports	Share
Physician	8,501	31%
Pharmacist	2,679	9.8%
Other health professional	8,820	32.2%
Lawyer	30	0.1%
Consumer or non-health professional	6,269	22.9%
Not given	1,111	4.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 52.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Metoprolol record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	3,198	11.7%
Atrial fibrillation	844	3.1%
Suicide attempt	249	0.9%
Blood pressure abnormal	240	0.9%
Cardiac failure	217	0.8%
Ventricular tachycardia	182	0.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 27,410 reports.

Drugs in the same reports

Other drugs that the reports of Metoprolol name, in any role, in order of name
Drug	Reports that name the two
Amlodipine	3,467
Aspirin	2,508
Atorvastatin	2,301
Furosemide	2,480
Lisinopril	2,076
Metformin	2,074
Pantoprazole	1,534
Ramipril	2,228
Simvastatin	1,239
Spironolactone	1,340

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

Metoprolol succinate same ingredient
Metoprolol tartrate same ingredient
Lopressor same ingredient
Toprol Xl same ingredient
Labetalol hydrochloride same class
Labetalol hcl same class
Nadolol same class
Metopirone next in the A to Z list
Metolazone next in the A to Z list
Metolate next in the A to Z list
Metreleptin next in the A to Z list
Metoject Pen 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 MetoprololThe 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. Metoprolol: adverse event reports that FDA received. https://reportedreactions.com/drug/metoprolol/ 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 Metoprolol as a suspect or interacting product. The 165,686 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 Metoprolol 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 Metoprolol?

No. It is a count of what people reported to FDA: 27,410 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 (32.2%), physician (31%) and consumer or non-health professional (22.9%). 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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