vibegron
Brand names: Gems
Gemtesa is a medicine that helps control an overactive bladder. It relaxes the bladder muscle, so you don't have to go to the bathroom as often.
What it does
Gemtesa treats overactive bladder (OAB) in adults.
Common side effects
Headache, Urinary tract infection, Runny or stuffy nose
Key warnings
Gemtesa can cause urinary retention, which means you can't empty your bladder fully.
How It Works
Gemtesa is a beta-3 adrenergic agonist. It works by relaxing the bladder muscle. This helps to increase the bladder's capacity to hold urine and reduces the urge to go.
How to Take It
Take one 75 mg Gemtesa tablet once a day. You can take it with or without food. Swallow the tablet whole with water. If needed, you can crush the tablet and mix it with one tablespoon (15 mL) of applesauce and take it right away with water.
Pregnancy & Breastfeeding
There is not enough information about using Gemtesa during pregnancy to know if it is safe. Talk to your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store Gemtesa at room temperature, between 68°F and 77°F.
Side Effects (from patient reports)
Based on 3,219 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 6,501 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2016–2025.
Total Reports
6,501
Death-Related Reports
296
Hospitalization Reports
687
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 886 |
| 2 | DIARRHOEA | 328 |
| 3 | HEADACHE | 328 |
| 4 | URINARY TRACT INFECTION | 280 |
| 5 | INABILITY TO AFFORD MEDICATION | 265 |
| 6 | URINARY RETENTION | 258 |
| 7 | FATIGUE | 248 |
| 8 | NAUSEA | 219 |
| 9 | DEATH | 205 |
| 10 | CONSTIPATION | 202 |
| 11 | POLLAKIURIA | 196 |
| 12 | URINARY INCONTINENCE | 193 |
| 13 | THERAPEUTIC PRODUCT EFFECT INCOMPLETE | 183 |
| 14 | DIZZINESS | 181 |
| 15 | NOCTURIA | 174 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Gemtesa can cause urinary retention, which means you can't empty your bladder fully. Tell your doctor if you have trouble emptying your bladder or are taking other medicines for OAB. Angioedema (swelling of the face, tongue, or throat) has been reported with Gemtesa. If this happens, stop taking Gemtesa and get medical help right away.
Known Drug Interactions
7 DRUG INTERACTIONS Concomitant use of GEMTESA increases digoxin maximal concentrations (C max ) and systemic exposure as assessed by area under the concentration-time curve (AUC) [see Clinical Pharmacology ( 12.3 )] . Serum digoxin concentrations should be monitored before initiating and during therapy with GEMTESA and used for titration of the digoxin dose to obtain the desired clinical effect. Continue monitoring digoxin concentrations upon discontinuation of GEMTESA and adjust digoxin dose as needed.
Mechanism: Vibegron increases the amount of digoxin that stays in your body.
What to do: Your doctor should monitor your digoxin blood levels and adjust your dose before and during treatment.
Common Questions
What is the dose of Gemtesa?
Can I take Gemtesa with food?
What should I do if I have side effects?
Can I crush the tablet?
How long does it take for Gemtesa to work?
Can I drink alcohol while taking Gemtesa?
Will Gemtesa cure my overactive bladder?
Are there any other medicines I should avoid while taking Gemtesa?
What if I still have questions about Gemtesa?
Can Gemtesa cause constipation?
What are the common side effects of vibegron?
Does vibegron interact with other medications?
What drug class is vibegron?
Is vibegron safe during pregnancy?
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What the FDA Data Shows for vibegron
The FDA label for vibegron (sold under brand names such as Gems) classifies it as a prescription-only medication in the Beta-3 Agonist (Overactive Bladder) class. Gemtesa treats overactive bladder (OAB) in adults. Official labeling lists 6 commonly reported side effects, including Headache, Urinary tract infection, Runny or stuffy nose.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 3,219 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated minor severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 1, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages