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Gemtesa (Vibegron): Uses, Side Effects and Dosage

Status:
Prescription (Rx) Facts
Strength:
75 mg
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Gemtesa

What is GEMTESA?

GEMTESA is a prescription medicine used to treat the following symptoms due to a condition called overactive bladder in adults, and in adult males taking medicine for benign prostatic hyperplasia (BPH):

  • urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
  • urgency: the need to urinate right away
  • frequency: urinating often

It is not known if GEMTESA is safe and effective in children.

Do not take GEMTESA if you:

  • are allergic to vibegron or any of the ingredients in GEMTESA. See the end of this leaflet for a complete list of ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all of your medical conditions, including if you:

have liver problems.

  • have kidney problems.
  • have trouble emptying your bladder or you have a weak urine stream.
  • take medicines that contain digoxin.

  • are pregnant or plan to become pregnant. It is not known if GEMTESA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

  • are breastfeeding or plan to breastfeed. It is not known if GEMTESA passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take GEMTESA.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take GEMTESA?

  • Take GEMTESA exactly as your doctor tells you to take it.

  • Take 1 GEMTESA tablet, by mouth, 1 time a day with or without food.

  • Swallow GEMTESA tablets whole with a glass of water.
  • You may also crush GEMTESA tablets, mix with 1 tablespoon (about 15 mL) of applesauce, and take right away with a glass of water.

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. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store GEMTESA?

  • Store GEMTESA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Safely throw away medicine that is no longer needed in your household trash.
  • You may also dispose of the unused medicine through a take-back option, if available. See www.fda.gov/drugdisposal for more information.

Keep GEMTESA and all medicines out of the reach of children.

General information about the safe and effective use of GEMTESA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use GEMTESA for a condition for which it was not prescribed. Do not give GEMTESA to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your doctor or pharmacist for information about GEMTESA that is written for health professionals.

What are the ingredients in GEMTESA?

Active ingredient: vibegron

Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, and microcrystalline cellulose. The light green film coating contains FD&C Blue No. 2 - aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin.

Manufactured for and Distributed by:

Sumitomo Pharma America, Inc.

Marlborough, MA 01752

is a trademark of Sumitomo Pharma Co., Ltd., used under license.

SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license.

SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license.

Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd.

All other trademarks are the property of their respective owners.

For more information, go to www.GEMTESA.com or call 1-833-876-8268.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 213006 · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Gemtesa

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class beta3-Adrenergic Agonist
Active ingredient Vibegron 75 mg
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) SUMITOMO PHARMA AM
FDA approval NDA 213006New Drug Application (NDA) Approved December 23, 2020
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
75 mg – 30 in 1 bottle NDC 73336-075-30
75 mg – 90 in 1 bottle NDC 73336-075-90
75 mg – 7 in 1 bottle / 1 in 1 carton NDC 73336-075-07

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.