What the label lists and what reports show
Vibegron side effects
Vibegron's FDA label: “Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.” FAERS holds 7,971 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (399 reports).
- No generic listed
Check it at the source: the vibegron FDA label on DailyMed (effective April 1, 2025, Sumitomo Pharma America, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of GEMTESA?GEMTESA may cause serious side effects, including: inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder. angioedema. GEMTESA may cause an allergic reaction with swelling of the lips, face, tongue, or throat, with or without difficulty breathing and may be life-threatening. Stop using GEMTESA and get emergency medical help right away if you have symptoms of angioedema or trouble breathing. The most common side effects of GEMTESA include: urinary tract infection headache nasal congestion, sore throat or runny nose diarrhea nausea upper respiratory tract infection These are not all the possible side effects of GEMTESA. […]
Source: FDA drug label, Sumitomo Pharma America, Inc., effective April 1, 2025 (SPL set 25f21d25-14f8-4fda-91f6-7aa8b68aa1c8), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.
Table 1: Adverse Reactions, Exceeding Placebo Rate, Reported in ≥2% of Patients Treated with GEMTESA 75 mg for up to 12 Weeks in Study 3003
| Reaction | GEMTESA 75 mg n (%) | Placebo n (%) |
|---|---|---|
| Number of Patients | 545 | 540 |
| Headache | 22 (4.0) | 13 (2.4) |
| Nasopharyngitis | 15 (2.8) | 9 (1.7) |
| Diarrhea | 12 (2.2) | 6 (1.1) |
| Nausea | 12 (2.2) | 6 (1.1) |
| Upper respiratory tract infection | 11 (2.0) | 4 (0.7) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reaction is described elsewhere in the labeling: Urinary retention [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sumitomo Pharma America, Inc. at 1-833-876-8268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overactive Bladder in Adults The safety of GEMTESA was evaluated in a 12-week, double-blind, placebo- and active-controlled study (Study 3003) in patients with OAB [see Clinical Studies ( 14.1 )]. A total of 545 patients received GEMTESA. The majority of the patients were White (78%) and female (85%) with a mean age of 60 years (range 18 to 93 years). Adverse reactions that were reported in Study 3003 at an incidence greater than placebo and in ≥2% of patients treated with GEMTESA are listed in Table 1 .
Source: FDA drug label, Sumitomo Pharma America, Inc., effective April 1, 2025 (SPL set 25f21d25-14f8-4fda-91f6-7aa8b68aa1c8), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,971 reports list vibegron among the medicines taken, each a report of something that happened, not proof the medicine caused it; 402 are coded as a death and 882 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (2,276, against a median of 19 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 16 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Vibegron: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions