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General Information

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Use

WHY is this medicine prescribed?

Mirabegron is used alone or in combination with solifenacin (Vesicare) to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination) in adults. It is also used to treat neurogenic detrusor overactivity (a bladder control condition caused by brain, spinal cord or nerve problem) in children 3 years of age and older. Mirabegron is in a class of medications called beta-3 adrenergic agonists. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination.

HOW should this medicine be used?

Mirabegron comes as an extended-release (long-acting) tablet and as an extended-release suspension to take by mouth. The tablets are usually taken with or without food once a day in adults and with food once a day in children. The suspension is usually taken with food once a day. Take mirabegron at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take mirabegron exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extend-release tablets whole with water; do not split, chew, or crush them.

It is important to use the oral dosing device to accurately measure and take your dose of the extended-release suspension. Ask your pharmacist for a device if it was not provided. Shake the bottle vigorously for 1 minute, then let it stand for 1 to 2 minutes until the foam on top of the suspension is gone. If the granules have not mixed well, shake the bottle vigorously again for 1 minute and let it stand until the foam is gone. Use the oral dosing device to draw up the suspension and ignore any bubbles in your measurement. Do not save the dose in the dosing syringe for later; use within 1 hour after preparation. After each use, wash the oral dosing device with mild soap, then rinse with tap water and allow it to air dry. If the suspension is not used for 2 or more days, shake the bottle for 1 minute each day.

Your doctor may increase your dose, depending on how well your symptoms are controlled and the side effects you experience. Talk to your doctor about how you are feeling during your treatment with mirabegron.

Mirabegron controls the symptoms of overactive bladder or neurogenic detrusor overactivity, but does not cure these conditions. It may take 8 weeks or longer before you feel the full benefit of mirabegron. Continue to take mirabegron even if you feel well. Do not stop taking mirabegron without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special

What SPECIAL PRECAUTIONS should I follow?

Before taking mirabegron,

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If it has been less than 12 hours since the missed dose, take it as soon as you remember it. If it has been more than 12 hours since the missed dose, skip it and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side Effects

What SIDE EFFECTS can this medicine cause?

Mirabegron may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

Mirabegron may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Overdose

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

Storage

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the suspension at room temperature for up to 28 days after the date the pharmacist prepares the suspension.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

Miscellaneous

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS® Patient Medication Information Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: June 15, 2021.