Generic drug: vibegron
Brand name: Gemtesa
What is Gemtesa (vibegron), and how does it work?
Gemtesa (vibegron) is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:
- 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.
What are the 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.
The most common side effects of Gemtesa include:
- urinary tract infection
- nasal congestion, sore throat or runny nose
- nausea
- headache
- upper respiratory tract infection
- diarrhea
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.
What is the dosage for Gemtesa?
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.
What drugs interact with Gemtesa?
- Concomitant use of Gemtesa increases digoxin maximal concentrations (Cmax) and systemic exposure as assessed by area under the concentration-time curve (AUC).
- 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.
Is Gemtesa safe to use while pregnant or breastfeeding?
- There are no available data on Gemtesa use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
- There are no data on the presence of vibegron in human milk, the effects of the drug on the breastfed infant, or the effects on milk production.

SLIDESHOW
Urinary Incontinence in Women: Types, Causes, and Treatments for Bladder Control See SlideshowSummary
Gemtesa (vibegron) is a prescription medicine for adults used to treat the symptoms of a condition called overactive bladder. Gemtesa may cause serious side effects, including the inability to empty your bladder (urinary retention). Common side effects of Gemtesa include urinary tract infection, nasal congestion, sore throat or runny nose, nausea, headache, upper respiratory tract infection, and diarrhea.
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Urinary Tract Infection (UTI)
A urinary tract infection (UTI) is an infection of the bladder, kidneys, ureters, or urethra. E. coli, a type of bacteria that lives in the bowel and near the anus, causes most UTIs. UTI symptoms include pain, abdominal pain, mild fever, urinary urgency, and frequency. Treatment involves a course of antibiotics.
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Is a Urinary Tract Infection (UTI) Contagious?
Bacteria such as E. coli or Pseudomonas can cause a urinary tract infection (UTI). The incubation period for a UTI ranges from three to eight days.
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Bladder Infection (Cystitis)
Bladder infection is an infection of the bladder, usually caused by bacteria or, rarely, by Candida. Certain people, including females, the elderly, men with enlarged prostates, and those with chronic medical conditions are at increased risk for bladder infection. Bladder infections are treated with antibiotics, but cranberry products and adequate hydration may help prevent bladder infections.
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Interstitial Cystitis (IC) and Painful Bladder Syndrome (PBS)
Interstitial cystitis (IC)/painful bladder syndrome (PBS) is an inflammatory disease of the bladder that can cause ulceration and bleeding of the bladder's lining and can lead to scarring and stiffening of the bladder. Symptoms of interstitial cystitis may vary among individuals and may even vary with time in the same individual.
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Urinary Tract Infection or Urinary Infection
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How Do You Know if You Have a Urinary Tract Infection?
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