Pharmacologic class (EPC) · 3 drug pages

beta3-Adrenergic agonist: adverse event reports filed with FDA

27,466 reports list a drug in this class as a suspect or interacting product, 2012–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

27,466
reports across the class: 0.1% of all reports; 2,942
reports, 12 months to June 2026: 3,428 in the 12 months before; 31.6%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

beta3-Adrenergic agonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 27,466 adverse event reports received by FDA, 0.1% of the database, from January 2012 to June 2026.

2,942 reports arrived in the 12 months to June 2026, down 14% from 3,428 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 31.6% of the class's reports are marked serious, 6.6% record death among the outcomes and 9.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (20.9%), off label use (6.9%) and headache (6.2%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
MyrbetriqMirabegron	brand	19,460	761	29%	Drug ineffective
GemtesaVibegron	brand	5,804	1,854	19.1%	Drug ineffective
Mirabegron	generic	2,202	327	87.9%	Drug ineffective

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected20.9%5,747
Off label useused for a purpose or in a way not on the label6.9%1,900
Headachehead pain6.2%1,715
Dizzinesslight-headedness or unsteadiness5.7%1,562
Intentional product misusedeliberate use not as intended5.4%1,479
Dry mouthdry mouth4.8%1,329
Diarrhoealoose or frequent stools4.7%1,301
Blood pressure increaseda raised blood pressure reading4.7%1,289
Hypertensionhigh blood pressure4.4%1,205
Therapeutic product effect incomplete4.3%1,181
Painpain, site not specified4.1%1,135
Rashskin rash4.1%1,113
Constipationconstipation3.7%1,025
Fatiguetiredness3.7%1,003
Nauseafeeling sick3.6%1,000
Intentional product use issuedeliberate use not as intended3.6%997
Urinary retentionbeing unable to empty the bladder3.5%960
Abdominal pain upperupper stomach pain3.3%920
Peripheral swellingswelling of the arms or legs3.3%916
Condition aggravatedthe condition being treated got worse3.3%903
Confusional stateconfusion3.3%901
Product use in unapproved indicationused for a purpose not on the label3.3%901
Nocturia3.2%882
Arthralgiajoint pain3.2%878
Pollakiuriapassing urine more often3.1%851

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death6.6%1,803

Life-threatening5%1,386

Hospitalisation (initial or prolonged)9.8%2,690

Disability5.2%1,424

Congenital anomaly4.7%1,298

Other serious27.3%7,506

Not serious68.4%18,780

Patient age

Under 20%5

2 to 110.1%25

12 to 170.1%34

18 to 445.5%1,513

45 to 646.5%1,772

65 to 7410.9%3,006

75 and over24.4%6,694

Age not given52.5%14,417

Who reported

Physician6.3%1,725

Pharmacist1.8%498

Other health professional11.8%3,231

Lawyer0%8

Consumer or non-health professional79.4%21,809

Not given0.7%195

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about beta3-Adrenergic agonist reports

Which drugs are in the beta3-Adrenergic agonist class on this site?

Myrbetriq, Gemtesa and Mirabegron. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

27,466 reports through June 2026, 2,942 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (20.9%), off label use (6.9%), headache (6.2%), dizziness (5.7%) and intentional product misuse (5.4%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.