Prescription medication · Beta-3 Agonist (Overactive Bladder)
vibegron
Also sold as Gems. Gemtesa treats overactive bladder (OAB) in adults.
Data updated 2026-05-15
- 6,501
- FDA reportsLightly reported
- 1
- InteractionFew interactions
- Rx
- Availability
What the data shows
vibegron (Gems) is a prescription Beta-3 Agonist (Overactive Bladder), reported less often than most tracked drugs (6,501 FDA reports), with 1 documented drug interaction.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
vibegron (Gems) is a prescription Beta-3 Agonist (Overactive Bladder). Gemtesa treats overactive bladder (OAB) in adults.
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.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from vibegron's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 6,501 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for vibegron, by number of reports
- Diarrhoea
Diarrhoea
328 reports
- Headache
Headache
328 reports
- Urinary Tract Infection
Urinary Tract Infection
280 reports
- Inability To Afford Medication
Inability To Afford Medication
265 reports
- Urinary Retention
Urinary Retention
258 reports
- Fatigue
Fatigue
248 reports
- Nausea
Nausea
219 reports
- Death
Death
205 reports
- Constipation
Constipation
202 reports
- Pollakiuria
Pollakiuria
196 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for vibegron each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where vibegron sits
vibegron has more FDA adverse-event reports than 30% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is vibegron; the line is the median (50th percentile).
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
Reports Mentioning Death
296
4.6% of reports — not proof of cause
Hospitalization Reports
687
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 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 |
| 16 | FALL | 172 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for vibegron?
Related Medications in Beta-3 Agonist (Overactive Bladder)
Other drugs grouped near vibegron - same-class peers and common alternatives.
alfuzosin
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bethanechol
Urecholine
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darifenacin
Enablex
Darifenacin (Enablex) is a medicine that helps control an overactive bladder.
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dutasteride
Avodart
Dutasteride and tamsulosin hydrochloride capsules contain two medicines to treat enlarged prostate in men.
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dutasteride/tamsulosin
Jalyn
This medicine combines two drugs to treat enlarged prostate in men.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for vibegron: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 6,501.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 4.55%.
- testosterone Δ 0.03 pts · 40,954 reports · Androgen Hormone 4.52%death share
- methyldopa Δ 0.07 pts · 4,692 reports · Central Alpha-2 Agonist 4.62%death share
- fluocinonide Δ 0.12 pts · 5,460 reports · Topical Corticosteroid 4.67%death share
- ciclesonide Δ 0.15 pts · 13,075 reports · Inhaled Corticosteroid 4.41%death share
Medication Guides
Understanding Drug Interactions
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Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 6,501 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: April 1, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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