Myrbetriq: adverse event reports filed with FDA

19,460

reports as suspect product

0.1% of all reports · about 1,390 a year

761

reports, 12 months to June 2026

1,339 in the 12 months before

29%

marked serious by the reporter

31.6% across the class

7.4%

record death among outcomes, as reported

1,433 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Myrbetriq reports recording the termmedian drug in beta3-adrenergic agonist

1. Drug ineffectivethe medicine did not work as expected23.6%4,584
2. Off label useused for a purpose or in a way not on the label8.8%1,706
3. Intentional product misusedeliberate use not as intended7.5%1,453
4. Headachehead pain7%1,354
5. Dizzinesslight-headedness or unsteadiness6.7%1,297
6. Blood pressure increaseda raised blood pressure reading6%1,172
7. Dry mouthdry mouth5.8%1,138
8. Hypertensionhigh blood pressure5.6%1,087
9. Intentional product use issuedeliberate use not as intended5%970
10. Diarrhoealoose or frequent stools4.9%961
11. Painpain, site not specified4.9%958
12. Therapeutic product effect incomplete4.8%938
13. Rashskin rash4.8%929
14. Abdominal pain upperupper stomach pain4.3%832
15. Arthralgiajoint pain4.1%807
16. Peripheral swellingswelling of the arms or legs4.1%804
17. Fatiguetiredness4.1%798
18. Maternal exposure during pregnancythe mother took the medicine during pregnancy4.1%789
19. Constipationconstipation4%788
20. Hypoaesthesianumbness4%784
21. Gastrooesophageal reflux diseaseacid reflux4%783
22. Confusional stateconfusion4%776
23. Nasopharyngitisa cold4%772
24. Product use in unapproved indicationused for a purpose not on the label4%772
25. Nauseafeeling sick4%769
26. Condition aggravatedthe condition being treated got worse3.9%764
27. Memory impairmentmemory problems3.9%762
28. Paraesthesiatingling or pins and needles3.7%725
29. Vomitingbeing sick3.7%721
30. Abdominal discomfortstomach discomfort3.6%709

Top 30 of 904 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the beta3-adrenergic agonist class; it describes the reports, not the patients. 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."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 27,466 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 89.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 19,460 reports.

Drugs most often listed in the same reports

Other products listed in reports where Myrbetriq is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the beta3-adrenergic agonist class

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." A brand and its generic are separate rows because reporters name them separately.

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 report counts here when it lists Myrbetriq as a suspect or interacting product; reports listing it only as a concomitant medication (12,564) are excluded. 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.