Gemtesa is a brand-name prescription medication that’s FDA-approved to treat overactive bladder (OAB). With this condition, you may experience sudden urges to urinate. And the urges may be frequent or difficult to control.

Specifically, Gemtesa is approved to treat OAB in adults who have the following urinary symptoms:

Drug details

Gemtesa is only approved for use in adults. It’s not known if this medication is an effective treatment option in children.

Gemtesa comes as a tablet that’s taken by mouth. It’s available in one strength: 75 milligrams (mg).

Gemtesa contains the active drug vibegron. It belongs to a group of medications called beta-3 adrenergic agonists and helps manage symptoms of OAB. To learn more about how this drug works, see the “How Gemtesa works” section below.

FDA approval

In December 2020, Gemtesa was approved by the Food and Drug Administration (FDA) to treat OAB.

Effectiveness

For information about the effectiveness of Gemtesa, see the “Gemtesa uses” section below.

Gemtesa contains the active drug vibegron. It’s only available as a brand-name medication. Gemtesa isn’t currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Other drugs are available to treat overactive bladder (OAB). Some may be a better fit for you than others. If you’re interested in finding an alternative to Gemtesa, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat OAB. Off-label drug use is when an FDA-approved drug is used for a purpose other than what it’s approved for.

Examples of other drugs that may be used to treat OAB include:

Gemtesa has a standard dosage that most people will take. The dosage that your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition that you’re treating with Gemtesa
  • other medical conditions you may have

Always take the dosage of Gemtesa that your doctor recommends.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage that your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Gemtesa comes as tablets. It’s available in one strength: 75 milligrams (mg).

Dosage for overactive bladder

The recommended dosage of Gemtesa for overactive bladder is 75 mg taken by mouth once daily.

What if I miss a dose?

If you miss a dose of Gemtesa, take it as soon as you remember. However, if it’s almost time for your next dose, you may need to skip the missed dose and take your next dose at the scheduled time.

If you have any questions about when to take your next dose of Gemtesa after you miss a dose, talk with your doctor or pharmacist.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Gemtesa is meant to be used as a long-term treatment. If you and your doctor determine that Gemtesa is safe and effective for you, you’ll likely take it long term.

Gemtesa can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Gemtesa. These lists do not include all possible side effects.

For more information about the possible side effects of Gemtesa, talk with your doctor or pharmacist. They can give you tips about how to deal with any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs that it has approved. If you’d like to notify the FDA about a side effect you’ve had from Gemtesa, you can do so through MedWatch.

Mild side effects

Mild side effects* of Gemtesa can include:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Gemtesa. To learn about other mild side effects, talk with your doctor or pharmacist, or view Gemtesa’s patient information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Gemtesa aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects of Gemtesa can include:

  • Urinary retention (inability to empty all of the urine from your bladder). Symptoms can include:
    • having difficulty urinating, either constantly or sporadically
    • having to strain to urinate
    • needing to urinate again shortly after urinating
    • having a weak urine stream or one that stops and starts
    • not having sensations to urinate
  • Allergic reaction.*

* For more information about this side effect, see “Side effect details” below.

Side effect details

Here’s some detail about certain side effects that Gemtesa may cause.

Headache

You may experience a headache when you’re taking Gemtesa. Headaches were one of the most common side effects reported in people taking Gemtesa during studies.

To find out how often this side effect occurred in clinical studies, see the drug’s prescribing information.

If you have headaches that are frequent or bothersome while you’re taking Gemtesa, talk with your doctor. They may be able to recommend ways to decrease your headaches.

Urinary tract infection

It’s possible that you may develop a urinary tract infection (UTI) when you’re taking Gemtesa.

Symptoms of a UTI include:

UTIs were a common side effect that people reported when taking Gemtesa during studies. To find out how often this side effect occurred in clinical studies, see the drug’s prescribing information.

If you think that you have a UTI, tell your doctor. They’ll be able to discuss your symptoms with you and test your urine to see if you have an infection. If you do have a UTI, you’ll need to take antibiotics to treat it.

If you’re having frequent UTIs while taking Gemtesa, talk with your doctor. They may suggest ways to prevent the infections. In some cases, your doctor may recommend a different medication to treat your overactive bladder.

Common cold

You may develop a common cold while you’re taking Gemtesa.

Colds were a common side effect reported by people taking Gemtesa during studies. To find out how often this side effect occurred in clinical studies, see the drug’s prescribing information.

Symptoms of a common cold may include:

  • runny nose or congestion
  • cough
  • fever
  • headache
  • sore throat

If you have frequent common colds while you’re taking Gemtesa, talk with your doctor. They’ll be able to help you determine if Gemtesa is the cause. In some cases, your doctor may recommend a different medication to treat your overactive bladder.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Gemtesa. It isn’t known how often allergic reactions occurred in clinical studies of Gemtesa.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Gemtesa, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

The Food and Drug Administration (FDA) approves prescription drugs such as Gemtesa to treat certain conditions. Gemtesa may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Gemtesa for overactive bladder

Gemtesa is FDA-approved to treat overactive bladder (OAB) in adults.

With OAB, you may have sudden or uncontrollable urges to urinate. You may also experience urinary:

Sometimes, OAB symptoms may be managed with behavioral therapies. These include:

  • training your bladder to hold more urine or hold urine for longer periods of time
  • regulating your fluid intake
  • training your pelvic floor muscles so that they can help your bladder hold urine

For more information about behavioral therapies, see the “Common questions about Gemtesa” section below.

If behavioral therapies don’t improve OAB symptoms enough, medications may be needed. These could include Gemtesa or other alternative drugs.

Effectiveness for overactive bladder

Gemtesa is an effective treatment option for OAB. For information about how effective Gemtesa was in clinical studies, see Gemtesa’s prescribing information.

According to the American Urological Association’s guidelines, the first treatment recommendations for OAB include behavioral therapies, which are described above. Beta-3 adrenergic agonists, such as Gemtesa, are the next recommended treatment option for OAB.

Gemtesa and children

Gemtesa is only approved for use in adults. It’s not known if this medication is a safe or effective treatment option in children.

There are no known interactions between Gemtesa and alcohol.

However, alcohol may worsen symptoms of overactive bladder (OAB), which Gemtesa treats. This is because alcohol is a diuretic, which means that it makes you urinate more often than usual. So, drinking alcohol may worsen your OAB symptoms.

If you’re taking Gemtesa, talk with your doctor about drinking alcohol. They may recommend that you limit your alcohol intake.

Gemtesa can interact with other medications. But it’s not known to interact with supplements or foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects from the drug or worsen them.

Gemtesa and other medications

Below, we describe a medication that can interact with Gemtesa. This article does not describe all drugs that may interact with Gemtesa.

Before taking Gemtesa, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Gemtesa and digoxin

Digoxin is a medication that’s used to control certain heart problems, such as an irregular heartbeat. Taking digoxin while you’re taking Gemtesa may cause your digoxin levels to become too high.

Your doctor will monitor your digoxin levels throughout treatment with Gemtesa to be sure that your levels are within the normal range. In order to keep your levels within the normal range, your doctor may need to adjust your digoxin dosage while you’re taking Gemtesa.

If you have questions about using digoxin while taking Gemtesa or questions about any other drug interactions, talk with your doctor or pharmacist.

Gemtesa and herbs and supplements

No herbs or supplements have been specifically reported to interact with Gemtesa. However, you should still check with your doctor or pharmacist before using any of these products while taking Gemtesa.

Gemtesa and foods

No foods have been specifically reported to interact with Gemtesa. If you have any questions about eating certain foods with Gemtesa, talk with your doctor.

As with all medications, the cost of Gemtesa can vary. To find current prices of Gemtesa in your area, check out GoodRx.com.


The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Gemtesa. If your insurance company approves it, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or your insurance company.

Before approving coverage for Gemtesa, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover it. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Gemtesa, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Gemtesa, or if you need help understanding your insurance coverage, help is available.

Urovant Sciences GmbH, the manufacturer of Gemtesa, offers the Gemtesa Simple Savings Program. This program offers options to help lower the cost of Gemtesa. For more information and to find out if you’re eligible for support, call 833-UROVANT (833-876-8268) or visit the program’s website.

Mail-order pharmacies

Gemtesa may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If your doctor recommends it, you may be able to receive a 90-day supply of Gemtesa so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Gemtesa is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

You should take Gemtesa according to the instructions from your doctor or another healthcare professional.

Gemtesa comes as tablets that are taken by mouth once daily.

When to take

You should take your dose of Gemtesa at about the same time each day. This way, you’ll have a constant amount of the medication in your body.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Gemtesa with food

You can take Gemtesa with or without food. However, you should take Gemtesa with a glass of water.

Can Gemtesa be crushed, split, or chewed?

Yes, Gemtesa tablets can be crushed and mixed into 1 tablespoon of applesauce. Once you crush the tablet and mix it into the applesauce, be sure to take it immediately. Also, you should take your Gemtesa and applesauce dose with a full glass of water.

The drug’s manufacturer hasn’t stated whether Gemtesa can be split or chewed.

If you have any questions about crushing, splitting, or chewing Gemtesa, talk with your doctor or pharmacist.

Gemtesa is approved to treat overactive bladder (OAB) in adults.

With OAB, you may have sudden or uncontrollable urges to urinate. You may also have urinary:

Gemtesa works by relaxing the muscle in your bladder that controls your bladder capacity. This means that more urine can be stored in your bladder before you have to urinate. In this way, Gemtesa helps to decrease urinary incontinence, urgency, and frequency.

How long does it take to work?

Gemtesa begins working after you take your first dose of medication. In clinical studies, people had decreased urinary incontinence, urgency, and frequency within 12 weeks.

It’s not known if Gemtesa is a safe medication to take during pregnancy. Currently, there aren’t any studies available about Gemtesa use in people during pregnancy.

Animal studies seem to show that the use of Gemtesa during pregnancy doesn’t cause birth defects (problems with fetal development) at normal doses. However, in animal studies, Gemtesa slowed down fetal bone growth when it was given at very high doses.

It’s important to note that animal studies don’t always indicate what may happen in humans.

If you’re pregnant or planning to become pregnant, talk with your doctor or pharmacist. They may recommend a different treatment option for your overactive bladder.

It’s not known if Gemtesa is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re taking Gemtesa.

For more information about taking Gemtesa during pregnancy, see the “Gemtesa and pregnancy” section above.

It’s not known if Gemtesa is safe to take while you’re breastfeeding. It’s also unknown if the drug passes into breast milk.

In animal studies, Gemtesa was found in the breast milk of animals. However, animal studies don’t always indicate what may happen in humans.

If you’re breastfeeding, talk with your doctor before starting Gemtesa.

Here are answers to some frequently asked questions about Gemtesa.

Do I need to take Gemtesa every day, or can I just take it when I’m having symptoms?

Yes, it’s important that you take a dose of Gemtesa every day, even if you’re not having symptoms of overactive bladder (OAB). To learn more about OAB symptoms, see the “Gemtesa uses” section above.

This is because the medication works over time to:

  • relax your bladder muscles
  • increase the amount of fluid that can fit in your bladder

So, to manage symptoms of OAB, it’s important to take Gemtesa once every day, as recommended by your doctor.

Can older people take Gemtesa?

Yes, older people can take Gemtesa. In fact, many people over 65 years of age, and some people over 75 years of age, were included in clinical studies of the drug.

In these studies, the medication was safe and effective for older people.

If you have any questions about taking Gemtesa, given your age, talk with your doctor or pharmacist.

What else can I do to help manage overactive bladder symptoms while I’m taking Gemtesa?

While you’re taking Gemtesa, your doctor may recommend other ways to help manage your symptoms of overactive bladder (OAB). To learn more about OAB symptoms, see the “Gemtesa uses” section above.

For instance, your doctor may recommend that you limit your intake of foods or drinks that may irritate your bladder. (These foods and drinks are called irritants.) Examples of irritants include:

  • drinks that have caffeine, such as coffee
  • carbonated beverages, such as soda
  • citrus juices
  • spicy foods

Limiting your intake of irritants may help decrease your symptoms of OAB. Usually, it’s not recommended that you limit your fluid intake. But your doctor may recommend that you manage the types of fluids that you drink.

Additionally, your doctor may also recommend behavioral therapies to help with your OAB symptoms These therapies include:

  • training your bladder to hold more urine or hold urine for longer periods
  • managing your fluid intake
  • training your pelvic floor muscles so that they can help your bladder hold urine

After you start taking Gemtesa, your doctor may recommend tracking your OAB symptoms. The manufacturer of Gemtesa provides a chart to help you track your symptoms.

This chart can help you determine how often you’re having symptoms of OAB. It can also help you track whether you’re drinking or eating irritants before these symptoms occur. Bringing your symptom chart with you to your doctor may help them determine if Gemtesa is working for you.

Before taking Gemtesa, talk with your doctor about your health history. Gemtesa may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Weak urine stream or trouble emptying your bladder. It’s not common, but Gemtesa use may cause urinary retention (inability to empty your bladder). If you already have trouble emptying your bladder or have a weak urine stream, you may have a higher risk for this side effect. Your doctor can help determine if Gemtesa is safe for you to take.
  • Kidney or liver problems. Your liver and kidneys help get rid of Gemtesa after you take a dose. If you have severe kidney or liver problems, Gemtesa levels could build up in your body. This can increase your risk for side effects from the medication. Gemtesa hasn’t been studied in people with severe kidney or liver problems. And it isn’t recommended for use in people with a severe kidney or liver condition. If your kidney or liver condition isn’t severe, Gemtesa may be safe for you to take. Your doctor can determine whether Gemtesa is a safe treatment for you.
  • Allergic reaction. If you’ve had an allergic reaction to Gemtesa or any of its ingredients, you shouldn’t take Gemtesa. Ask your doctor what other medications are better options for you.
  • Pregnancy. It’s not known if Gemtesa is safe to take during pregnancy. If you are pregnant or planning to become pregnant, talk with your doctor. For more information, see the “Gemtesa and pregnancy” section above.
  • Breastfeeding. It’s not known if Gemtesa is safe to take while breastfeeding. If you’re breastfeeding, talk with your doctor before starting Gemtesa. For more information, see the “Gemtesa and breastfeeding” section above.

Note: For more information about the potential negative effects of Gemtesa, see the “Gemtesa side effects” section above.

Do not take more Gemtesa than your doctor recommends. With some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Gemtesa

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Gemtesa from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date when they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current guidance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication, and its expiration date has passed, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good to use can depend on many factors, including how and where you store the medication.

Gemtesa tablets should be stored at room temperature, between 68°F and 77°F (20°C and 25°C). If needed, you may store the drug between 59°F and 86°F (15°C and 30°C).

Disposal

If you no longer need to take Gemtesa and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.