Gemtesa: adverse event reports filed with FDA

5,804

reports as suspect product

0% of all reports · about 996 a year

1,854

reports, 12 months to June 2026

1,801 in the 12 months before

19.1%

marked serious by the reporter

31.6% across the class

3.8%

record death among outcomes, as reported

221 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 Gemtesa reports recording the termmedian drug in beta3-adrenergic agonist

1. Drug ineffectivethe medicine did not work as expected16.6%965
2. Diarrhoealoose or frequent stools4.8%279
3. Urinary retentionbeing unable to empty the bladder4.6%267
4. Headachehead pain4.6%266
5. Inability to afford medication4.5%264
6. Urinary tract infectionbladder or urinary infection4.2%244
7. Drug effect less than expected3.9%227
8. Deaththe patient died; cause not stated by this term3.5%201
9. Therapeutic product effect incomplete3.3%192
10. Urinary incontinenceleaking urine3.3%189
11. Pollakiuriapassing urine more often3.2%186
12. Nocturia3%175
13. Therapy interrupted3%175
14. Constipationconstipation3%173
15. Product availability issuethe product was not available2.8%163
16. Nauseafeeling sick2.6%152
17. Therapeutic product effect decreased2.5%146
18. Inappropriate schedule of product administrationthe product was taken at the wrong times2.5%145
19. Dizzinesslight-headedness or unsteadiness2.2%126
20. Dry mouthdry mouth2.1%122
21. Fatiguetiredness2.1%121
22. Product use issuea problem in how the product was used2.1%120
23. Dysuriapain on passing urine1.8%107
24. Rhinorrhoeaa runny nose1.8%107
25. Rashskin rash1.7%100
26. Hot flusha hot flush1.7%98
27. Micturition urgency1.6%90
28. Painpain, site not specified1.5%85
29. Falla fall1.4%84
30. Insomniadifficulty sleeping1.2%72

Top 30 of 518 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. 100% 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 5,804 reports.

Drugs most often listed in the same reports

Other products listed in reports where Gemtesa 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 Gemtesa as a suspect or interacting product; reports listing it only as a concomitant medication (1,599) 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.