Mirabegron adverse event reports that FDA received

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

Name type: Generic name
Class: beta3-Adrenergic agonist

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 2012 to June 2026, FDA received 2,202 adverse event reports that name Mirabegron. In these reports the drug is a suspect or interacting product.

In the same period, 4,397 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 327 reports in the 12 months to June 2026 and 288 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, 327 (under 0.1%) name Mirabegron. Reports for patients 75 and over were 32.9% of the reports that name Mirabegron 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 Mirabegron 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 77 reports that name Mirabegron.
In January to March 2026, FDA received 70.
In April to June 2025, FDA received 84.

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 368 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 all 2,202 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 368 terms.

Reaction terms in the reports that name Mirabegron, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,202 reports
Drug ineffectivethe medicine did not work as expected	198	9%
Off label useused for a purpose or in a way not on the label	143	6.5%
Dizzinesslight-headedness or unsteadiness	139	6.3%
Falla fall	128	5.8%
Dyspnoeashortness of breath	121	5.5%
Confusional stateconfusion	105	4.8%
Product use in unapproved indicationused for a purpose not on the label	103	4.7%
Headachehead pain	95	4.3%
Painpain, site not specified	92	4.2%
Urinary retentionbeing unable to empty the bladder	89	4%
Hypertensionhigh blood pressure	86	3.9%
Fatiguetiredness	84	3.8%
Rashskin rash	84	3.8%
Drug interactionan interaction between medicines	81	3.7%
Condition aggravatedthe condition being treated got worse	80	3.6%
Nauseafeeling sick	79	3.6%
Arrhythmia	78	3.5%
Dry mouth	69	3.1%
Insomniadifficulty sleeping	68	3.1%
Dyspepsiaindigestion	67	3%
Urinary tract infectionbladder or urinary infection	67	3%
Pollakiuriapassing urine more often	66	3%
Malaisegeneral feeling of being unwell	65	3%
Constipation	64	2.9%
Diarrhoealoose or frequent stools	61	2.8%
Depressionlow mood	59	2.7%
Vomitingbeing sick	57	2.6%
Blood pressure increaseda raised blood pressure reading	56	2.5%
Product use issuea problem in how the product was used	54	2.5%
Muscle spasmsmuscle cramps	53	2.4%
Memory impairmentmemory problems	51	2.3%
Therapeutic product effect incomplete	51	2.3%
Chest pain	48	2.2%
Drug intolerancethe medicine was not tolerated	48	2.2%
Fibromyalgia	48	2.2%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	47	2.1%
Migraine	47	2.1%
Gait disturbancedifficulty walking	45	2%
Hypoaesthesianumbness	44	2%
Facet joint syndrome	43	2%
Oedema peripheralswelling of the legs, ankles or hands	43	2%
Treatment failurethe treatment did not work	43	2%
Urinary incontinenceleaking urine	43	2%
Abdominal pain upperupper stomach pain	42	1.9%
Angina pectoris	42	1.9%
General physical health deteriorationgeneral decline in health	42	1.9%
Muscular weaknessmuscle weakness	41	1.9%
Peripheral swellingswelling of the arms or legs	41	1.9%
C-reactive protein increased	40	1.8%
Swelling	40	1.8%

Download all 368 terms of Mirabegron (CSV)

The counts add to more than 2,202 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 Mirabegron with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Mirabegron (this page)	Generic name	2,202
Myrbetriq	Brand name	19,460

Sum of the separately reported names: 21,662. 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 Mirabegron, 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
2012	23	23	0	1	5	1	0	18	0
2013	49	44	4	1	15	2	0	27	5
2014	51	47	1	5	20	2	0	27	4
2015	82	72	5	5	29	7	0	53	10
2016	94	85	6	5	33	2	0	58	9
2017	66	62	4	10	18	4	0	42	4
2018	212	203	8	3	60	5	0	162	9
2019	145	134	4	0	37	4	0	122	11
2020	125	115	3	6	34	2	0	97	10
2021	140	123	2	4	43	1	0	108	17
2022	199	184	8	5	53	7	0	160	15
2023	228	222	11	8	66	7	0	191	6
2024	252	207	7	10	70	6	0	169	45
2025	350	279	45	46	112	46	32	233	71
2026	186	136	41	39	51	39	45	117	50

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 Mirabegron, 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 Mirabegron, by the year in which FDA received them
Year	Reports
2012	27
2013	50
2014	57
2015	91
2016	82
2017	75
2018	238
2019	153
2020	124
2021	142
2022	210
2023	227
2024	236
2025	343
2026	147

Reports that name Mirabegron, 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 Mirabegron
Age	Reports	Share
Under 2	0	0%
2 to 11	3	0.1%
12 to 17	14	0.6%
18 to 44	142	6.4%
45 to 64	278	12.6%
65 to 74	334	15.2%
75 and over	724	32.9%
Age not given	707	32.1%

Sex of the patient in the reports that name Mirabegron
Sex	Reports	Share
Female	1,109	50.4%
Male	882	40.1%
Unknown or not given	211	9.6%

Type of reporter in the reports that name Mirabegron
Reporter	Reports	Share
Physician	529	24%
Pharmacist	254	11.5%
Other health professional	453	20.6%
Lawyer	0	0%
Consumer or non-health professional	955	43.4%
Not given	11	0.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 26.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Mirabegron record
Indication as recorded (MedDRA)	Reports	Share
Hypertonic bladder	668	30.3%
Urinary incontinence	103	4.7%
Pollakiuria	71	3.2%
Micturition urgency	41	1.9%
Benign prostatic hyperplasia	31	1.4%
Bladder disorder	31	1.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,202 reports.

Drugs in the same reports

Other drugs that the reports of Mirabegron name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	106
Candesartan	86
Diclofenac sodium	87
Ergocalciferol	84
Folic acid	90
Leflunomide	81
Ramipril	114
Rituximab	87
Tamsulosin	90
Topiramate	83

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

Myrbetriq same ingredient
Gemtesa same class
Vibegron same class
Minoxidil next in the A to Z list
MiraLAX next in the A to Z list
Minocycline hydrochloride next in the A to Z list
Mirapex next in the A to Z list
Minocycline hcl next in the A to Z list
Mirapexin next in the A to Z list
Minocycline next in the A to Z list
Mircera next in the A to Z list
Minocin 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 MirabegronThe 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. Mirabegron: adverse event reports that FDA received. https://reportedreactions.com/drug/mirabegron/ 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 Mirabegron as a suspect or interacting product. The 4,397 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 Mirabegron 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 Mirabegron?

No. It is a count of what people reported to FDA: 2,202 reports from January 2012 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 (43.4%), physician (24%) and other health professional (20.6%). 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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