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Who should not take Gemtesa?

Find out who should not take Gemtesa, important warnings, common side effects, and how this FDA-approved medication differs from other OAB treatments
Rx bottle with an exclamation point on label: Who should not take Gemtesa?

Key takeaways

  • Gemtesa is a medication used to treat an overactive bladder and can be safely taken by most people.

  • If you have an allergy or sensitivity to the active ingredient in Gemtesa (vibegron) or any inactive ingredients, you shouldn’t take it.

  • Precautions should be taken by people with uncontrolled high blood pressure, and Gemtesa shouldn’t be taken by children, pregnant people, or breastfeeding individuals.

Gemtesa is the brand name for vibegron, a beta-3 adrenergic agonist that’s FDA-approved to treat overactive bladder (OAB) symptoms of urinary frequency, urinary urgency, and incontinence. It’s also approved for the treatment of overactive bladder symptoms in adult males who take medication for benign prostatic hyperplasia (BPH).

 If you or a loved one is considering taking Gemtesa, you might want to know who should not. Overall, Gemtesa is well tolerated, and it is only contraindicated in people who have an allergy or sensitivity to vibegron or any of the medication’s inactive ingredients.

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Who should not take Gemtesa?

There are a few strict Gemtesa contraindications. Stay away from Gemtesa if you have allergies or hypersensitivities to the active ingredient in the medication. “Gemtesa is contraindicated in patients with known hypersensitivity to vibegron or any of its components,” says Justin Houman, MD, urologist at Tower Urology and assistant professor of Urology at Cedars-Sinai Medical Center.

 Sometimes people are concerned about the cognitive effects of overactive bladder medications. For example, there is some evidence—as outlined in a 2024 review published in Urology—that the overactive bladder medication oxybutynin may cause impaired memory, increased risk of dementia, and other adverse cognitive outcomes.

 But Dr. Houman assures that Gemtesa doesn’t carry similar risks. “Unlike some anticholinergic bladder medications, Gemtesa doesn’t carry the same cognitive side effect risks,” he says.

 Still, there are some groups that Dr. Houman says should approach Gemtesa with caution, including:

  • Pregnant or breastfeeding people. Data is limited on the impacts of Gemtesa on pregnant or breastfeeding people. “We generally avoid prescribing Gemtesa in these situations unless the potential benefit clearly outweighs the risk,” Dr. Houman says.
  • Children. Gemtesa is not approved for use in pediatric patients and should be avoided.
  • People with severe uncontrolled hypertension. Caution should be exercised in certain individuals with high blood pressure. “Because vibegron can slightly increase blood pressure, caution is warranted in patients with poorly controlled hypertension,” Dr. Houman explains.

There are no drug interaction warnings for Gemtesa. However, when taking Gemtesa with a heart medication called Lanoxin (digoxin), you should be cautious. “It can interact with digoxin, so monitoring drug levels is important in patients on both medications,” Dr. Houman says. You should also not combine Gemtesa with other overactive bladder medications.

How does Gemtesa work?

Gemtesa treats overactive bladder in adults and overactive bladder in males who are treated for benign prostatic hyperplasia (BPH).

 According to the American Urological Association, an overactive bladder is a condition where you experience a strong urge to urinate even when your bladder isn’t full. People with an overactive bladder tend to make many trips to the bathroom, and the urge to pee may wake them up at night. In some cases, individuals with an overactive bladder may simply feel the urge to urinate, while others feel the urge and end up leaking urine.

 Gemtesa works on the receptors in your bladder that promote urine storage, says David Sheyn, MD, OB-GYN and associate professor of urology at Case Western Reserve University. “It works by relaxing the bladder muscle and increasing how much urine can be stored,” he describes. “This leads to fewer symptoms of an overactive bladder, like urgency, frequency, and urge urinary incontinence.”

 Gemtesa is a type of medication called a beta-3 adrenergic agonist, which means it works differently in the body than other overactive bladder medications. “Unlike anticholinergics, Gemtesa doesn’t act on muscarinic receptors, so it avoids side effects like dry mouth, constipation, and cognitive changes,” Dr. Houman explains.

What are the side effects of Gemtesa?

 Serious side effects of Gemtesa are rare, Dr. Sheyn says. “The medication is generally well-tolerated,” he notes. Still, like any medication, side effects are possible.

 The most common side effects of Gemtesa are:

  • Headaches
  • Nausea
  • Diarrhea
  • Urinary tract infections (UTIs)
  • Nasal congestion
  • Cold symptoms, like a runny nose or sore throat
  • Upper respiratory tract infections

 Less commonly, Gemtesa may contribute to the development of the following medical conditions.

Urinary retention

According to the drug manufacturer, some people taking Gemtesa report urinary retention, which is when they are unable to completely empty their bladders. The overall risks of urinary retention are increased in people with bladder outlet obstruction and in people who take muscarinic antagonist medications for an overactive bladder. If you show signs of urinary retention, please seek medical advice from your healthcare provider.

Elevated blood pressure

Dr. Houman says some people who take Gemtesa note mild blood pressure elevations. As such, he advises that people with hypertension monitor their blood pressure regularly.

Angioedema

In rare cases, patients have reported angioedema (swelling) of the face or larynx when taking Gemtesa, according to the drug manufacturer. This is usually due to an allergy or hypersensitivity to Gemtesa. Angioedema typically occurs within a few hours after taking the drug, either the first time you take it or after multiple different times. When swelling of our upper airway happens, it can be life-threatening. If you experience any facial or throat swelling after taking Gemtesa, you should stop taking Gemtesa immediately and seek emergency medical care.

Liver or kidney problems

Some medications can be hard for your kidneys or liver to process. What about liver problems or kidney problems when it comes to Gemtesa? Thankfully, Gemtesa shouldn’t be an issue for most individuals with liver or kidney problems.

 “Gemtesa is metabolized minimally by the liver and excreted primarily via urine and feces,” Dr. Houman says. “It does not typically cause renal or hepatic toxicity, but dose adjustments may be needed in severe renal impairment.”

How to take Gemtesa safely

 Gemtesa is prescribed at a dose of 75 mg, taken by mouth once daily. How and when you take it are flexible, and it’s best to find a method that works best for you.

 “Gemtesa can be taken with or without food, so patients have flexibility,” Dr. Sheyn says. It can also be taken during the day or night, depending on what works best for you. “I usually tell people to take it in the morning if daytime symptoms are worse or before bedtime if nighttime symptoms are worse,” Dr. Sheyn shares. 

Minimizing side effects

 Some of the more common side effects of Gemtesa—like headaches, nausea, and diarrhea—will decrease as you get used to the medication. “If symptoms are mild, try to continue for a few weeks—many patients’ side effects lessen as the body adjusts,” Dr. Houman explains.

 Here are Dr. Houman’s general tips for minimizing side effects while taking Gemtesa:

  • Stay well hydrated.
  • Take Gemtesa at the same time each day to minimize gastrointestinal upset.
  • If you experience persistent or bothersome side effects, connect with your urologist before stopping Gemtesa. “We may adjust timing, assess other causes, or consider switching therapies,” Dr. Houman says.
  • If you experience severe side effects (allergic reactions, significant changes in blood pressure), stop Gemtesa right away and seek medical attention.

 As always, if you have any questions or concerns about Gemtesa, don’t hesitate to contact a healthcare professional who knows your medical history and can tailor a medication and treatment plan that works best for you.

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