Vibegron
Vibegron is a bladder-relaxing medicine (a beta-3 adrenergic agonist) used to treat overactive bladder in adults, including adult men who are also taking medicine for benign prostatic hyperplasia (BPH).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Vibegron (Gemtesa) is a once-daily tablet for overactive bladder in adults, including men taking medicine for an enlarged prostate (BPH); it relaxes the bladder muscle as it fills so the bladder holds more, and, on the U.S. market since about 2020, it is a newer alternative to older bladder medicines like oxybutynin. Most people tolerate it well, and the side effects they notice are usually headache, a stuffy nose or sore throat, and sometimes diarrhea or nausea. Stop it and get emergency help for any swelling of the face, lips, tongue or throat (angioedema), even after many doses, and call your prescriber if you struggle to pass urine.
Clinical pearls
- If you take digoxin, your digoxin blood level should be checked before starting vibegron and again while you take it.
- Taking it with an older bladder medicine such as oxybutynin or tolterodine (muscarinic antagonists) raises the chance of being unable to empty your bladder.
- If swallowing is hard, you can crush the tablet into a tablespoon of applesauce and take it right away with water.
- It is not recommended with end-stage kidney disease, including dialysis, or severe liver impairment, so make sure your prescriber knows.
Patient information guide A plain-language walkthrough of Vibegron, written from its FDA label.
What Vibegron is used for
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Vibegron treats overactive bladder in adults. The supported uses are:
- Overactive bladder (OAB) with urge urinary incontinence, urgency and urinary frequency in adults (Gemtesa).
- OAB with those same symptoms in adult males who are on medicine for benign prostatic hyperplasia (BPH) (Gemtesa).
How Vibegron works
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Vibegron is a selective beta-3 adrenergic receptor agonist. It switches on these receptors, which relaxes the bladder's detrusor muscle as the bladder fills.
A more relaxed bladder can hold more urine. This helps with urgency, frequency and urge leakage.
Vibegron dosage
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Gemtesa is a tablet taken by mouth once a day. You can take it with or without food.
- Swallow it whole with a glass of water.
- Adults can instead crush it, mix it into a tablespoon of applesauce, and take it right away with water.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Vibegron prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (adults)
- One 75 mg tablet orally, once daily with or without food
- Swallow tablets whole with a glass of water
- In adults, tablets also may be crushed, mixed with a tablespoon (approximately 15 mL) of applesauce and taken immediately with a glass of water.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION The recommended dose is one 75 mg tablet orally once daily. ( 2.1 ) Swallow tablet whole with water. ( 2.1 ) Tablet may be crushed and mixed with applesauce. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of GEMTESA is one 75 mg tablet orally, once daily with or without food. Swallow GEMTESA tablets whole with a glass of water. In adults, GEMTESA tablets also may be crushed, mixed with a tablespoon (approximately 15 mL) of applesauce and taken immediately with a glass of water [see Clinical Pharmacology ( 12.3 )] .
Read the full Dosage and Administration section on DailyMed →
Vibegron side effects
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The most common side effects in studies were:
Common side effects
- Headache
- Urinary tract infection
- Nasopharyngitis (stuffy or runny nose and sore throat)
- Diarrhea
- Nausea
- Upper respiratory tract infection (a cold-type infection)
When to get medical help
- Swelling of the face, lips, tongue or throat (angioedema) can be life-threatening and may start hours after the first dose or after many doses. Stop the medicine and get emergency help right away.
- Trouble urinating or being unable to empty your bladder (urinary retention). Contact your doctor, as the medicine should be stopped if this happens.
- Signs of an allergic reaction to vibegron or any ingredient in the tablet.
Get urgent help for swelling of the face, tongue or throat. Call your doctor if you cannot urinate or empty your bladder.
Vibegron warnings and precautions
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- Angioedema: swelling of the face and/or larynx (voice box) has been reported. It can be life-threatening and may appear hours after the first dose or after several doses. If the tongue, throat or larynx is involved, the medicine must be stopped right away and the airway protected.
- Urinary retention: this has been reported. The risk may be higher with a bladder outlet blockage or with muscarinic antagonist OAB medicines. The medicine should be stopped if retention develops.
Vibegron interactions
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Digoxin is the key interaction listed on the label.
- Digoxin: vibegron raises digoxin levels in the blood. Your doctor should check your level before you start, adjust the digoxin dose as needed, and keep checking after you stop vibegron.
- Muscarinic antagonist OAB medicines: taking these with vibegron may increase the risk of urinary retention.
Interactions listed in the FDA-approved label
From the Vibegron prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Digoxin: Concomitant use of GEMTESA increases digoxin maximal concentrations (Cmax) and systemic exposure as assessed by area under the concentration-time curve (AUC). Measure serum digoxin concentrations before initiating GEMTESA and monitor during therapy, using them to titrate the digoxin dose to obtain the desired clinical effect. Continue monitoring digoxin concentrations upon discontinuation of GEMTESA and adjust digoxin dose as needed.
Read the label’s full interactions text
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. Digoxin : Measure serum digoxin concentrations before initiating GEMTESA. Monitor serum digoxin concentrations to titrate digoxin dose to desired clinical effect. ( 7 )
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Vibegron
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- Do not take it if you are allergic to vibegron or any ingredient in Gemtesa. Angioedema is one type of reaction that has occurred.
- Tell your doctor if you have a bladder outlet obstruction.
- Tell your doctor if you take digoxin or another OAB medicine.
- Pregnancy: there are no human data on use in pregnancy.
- Breastfeeding: there are no human data on vibegron in breast milk. Radioactivity from the drug was seen in the milk of nursing rats.
- Children: safety and effectiveness have not been established.
- Older adults: no overall differences in safety or effectiveness were seen versus younger adults.
- Kidney disease: no dose adjustment is recommended for mild to severe renal impairment, but use is not recommended in end-stage renal disease, with or without hemodialysis.
- Liver disease: not recommended with severe hepatic impairment.
Vibegron overdose
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There is no experience with accidental Gemtesa overdose. If you think someone has taken too much, get medical help. Treatment would focus on relieving symptoms and supportive care.
What Vibegron does in the body
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In a 4-week study of people with OAB, daily Gemtesa did not cause clinically significant changes in blood pressure. This included people who already had high blood pressure or took blood pressure medicine. At a single dose 5.3 times the recommended dose, it did not prolong the QT interval (a measure of the heart's electrical rhythm) to any clinically relevant extent.
How your body processes Vibegron
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Blood levels of vibegron peak about 1 to 3 hours after a dose. A high-fat meal did not make a clinically significant difference. Steady levels build up within 7 days of daily use. The effective half-life is about 30.8 hours.
Metabolism plays a minor role in clearing it, and CYP3A4 is the main enzyme involved. Most of the drug leaves the body unchanged, in feces and urine. Age, sex and race did not cause clinically significant differences in how the body handles it.
How to store Vibegron
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Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Vibegron
157 supplements and herbal products have documented interactions with Vibegron in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 117
- Minor · 37
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Vibegron: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Vibegron — the kind of thing our pharmacy team would talk through with you at the counter.
What is vibegron for?
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How do I take it?
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What side effects should I expect?
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When should I call my doctor or get emergency help?
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Does it interact with my other medicines?
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Is it safe in pregnancy or while breastfeeding?
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Is Vibegron available over the counter?
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When was Vibegron first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Vibegron on HelloPharmacist
Vibegron forms and strengths (how it comes)
Vibegron is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Vibegron inactive ingredients by manufacturer.
Tablet
How this form is used
- Gemtesa is used to treat overactive bladder in adults.
- Gemtesa is used for overactive bladder in adult men on medicine for benign prostatic hyperplasia (BPH).
- Gemtesa is taken by mouth once daily, with or without food.
- Swallow Gemtesa tablets whole with a glass of water.
- In adults, Gemtesa may be crushed, mixed with about a tablespoon of applesauce, and taken right away with a glass of water.
Topical cream, ointment or gel
Vibegron on the U.S. market: products, makers and brands
How Vibegron appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Vibegron product record with the FDA, mostly as tablet, topical cream, ointment or gel; the earliest marketing or approval year on record is 2020. Brand names on the directory include Gemtesa; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Vibegron is used (Medicaid data)
A general measure of how commonly Vibegron is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Vibegron is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Vibegron prescribed? Of the 1,601 medications we measure, Vibegron ranks #535 by Medicaid prescriptions — more than 67% of them.
Utilization by Vibegron product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
vibegron 75 MG Oral Tablet
Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2472315
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Vibegron, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 3 listed Vibegron NDCs with Medicaid activity.
Compare Vibegron products
A representative set of FDA-listed product records for Vibegron — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 75 mg | Oral | Sumitomo Pharma America, Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Vibegron NDCs →
Vibegron side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Vibegron — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Vibegron in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Vibegron FDA approval history
How Vibegron went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Vibegron recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Vibegron recalls since July 2021.
✅No Vibegron recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2472254 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 2472314In current FDA listingsClinical drug / strength (SCD) 75 MGRxCUI 2472315
Look up RxCUI 2472254 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Vibegron supply and shortage status
Whether Vibegron is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Vibegron costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 75 mg | $16.46 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Vibegron brand names
Vibegron is sold under one brand name in the FDA directory — Gemtesa. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Vibegron: manufacturers and labelers
One company lists Vibegron products with the FDA. By number of product records, the largest are Sumitomo Pharma America, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Sources for this Vibegron page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Urovant Sciences, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →