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Mirabegron Extended-Release: Uses, Side Effects and Dosage

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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Mirabegron Extended-Release

What are mirabegron extended-release tablets ?

Adults

  • Mirabegron extended-release tablets are a prescription medicine that can be used to treat adults with the following symptoms due to a condition called overactive bladder (OAB):
  • Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
  • Urgency: a strong need to urinate right away

  • Frequency: urinating often

    Children

  • Mirabegron extended-release is a prescription medicine used to treat children 3 years of age and older weighing at least 77 pounds (35 kg), with a condition called neurogenic detrusor overactivity (NDO).

It is not known if mirabegron extended-release tablets to treat NDO, are safe and effective in children under 3 years of age and older weighing at least 77 pounds (35 kg), with a condition called neurogenic detrusor overactivity (NDO).

Who should not take mirabegron extended-release tablets ?

Do not take mirabegron extended-release tablets if you are allergic to mirabegron or any of the ingredients in mirabegron extended-release tablets. See the end of this Patient Information leaflet for a complete list of ingredients in mirabegron extended-release tablets.

Before you take mirabegron extended-release tablets , tell your doctor about all of your medical conditions, including if you:

  • have liver problems.
  • have kidney problems.
  • have very high uncontrolled blood pressure.
  • have trouble emptying your bladder or you have a weak urine stream.

  • are pregnant or plan to become pregnant. It is not known if mirabegron extended-release tablets 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 mirabegron passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take mirabegron extended-release tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Mirabegron extended-release tablets may affect the way other medicines work, and other medicines may affect how mirabegron extended-release tablets work.

Especially tell your doctor if you take:

  • thioridazine (Mellaril or Mellaril-S)
  • flecainide (Tambocor)
  • propafenone (Rythmol)
  • digoxin (Lanoxin)

How should I take mirabegron extended-release tablets ?

  • Take mirabegron extended-release tablets exactly as your doctor tells you to take it.
  • You should take 1 mirabegron extended-release tablet 1 time a day.
  • You should take mirabegron extended-release tablets with water and swallow the tablet whole.
  • Do not chew, break, or crush the tablet.

  • Adults can take mirabegron extended-release tablets with or without food.

  • Childrenshould take mirabegron extended-release tabletwith food.
  • If you miss a dose of mirabegron extended-release tablets, take it as soon as possible. If it has been more than 12 hours since taking the last dose of mirabegron extended-release tablets, skip that dose and take the next dose at the usual time.
  • If you take too much mirabegron, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects of mirabegron extended-release tablets ?

Mirabegron extended-release tablets may cause serious side effects, including:

  • increased blood pressure. Mirabegron extended-release tablets may cause your blood pressure to increase or make your blood pressure worse if you have a history of high blood pressure. You and your doctor should check your blood pressure while you are taking mirabegron extended-release tablets. Call your doctor if you have increased blood pressure.
  • inability to empty your bladder (urinary retention). Mirabegron extended-release tablets may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction or if you are taking other medicines to treat overactive bladder. Tell your doctor right away if you are unable to empty your bladder.
  • angioedema. Mirabegron extended-release tablets may cause an allergic reaction with swelling of the lips, face, tongue, or throat with or without difficulty breathing. Stop using mirabegron extended-release tablets and go to the nearest hospital emergency room right away.

Adults with Overactive Bladder

The most common side effects of mirabegron extended-release tablets include:

  • high blood pressure
  • pain or swelling of the nose or throat (nasopharyngitis)
  • urinary tract infection
  • headache

Children with Neurogenic Detrusor Overactivity

The most common side effects of mirabegron extended-release tablets include:

  • urinary tract infection
  • pain or swelling of the nose or throat (nasopharyngitis)
  • constipation
  • headache

Tell your doctor if you have any side effect that bothers you, does not go away, or if you have swelling of the face, lips, tongue or throat, hives, skin rash or itching while taking mirabegron extended-release tablets.

These are not all the possible side effects of mirabegron extended-release tablets. 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 mirabegron extended-release tablets ?

  • Store mirabegron extended-release tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle closed. Throw away (discard) medicine that is out of date or no longer needed.

Keep mirabegron extended-release tablets , and all medicines out of the reach of children.

General information about the safe and effective use of mirabegron extended-release tablets .

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

This leaflet summarizes the most important information about mirabegron extended-release tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mirabegron extended-release tablets that is written for health professionals.

What are the ingredients in mirabegron extended-release tablets ?

Active ingredient: mirabegron

Inactive ingredients: hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polyethylene oxide, titanium dioxide.

Manufactured by:

MSN Laboratories Private Limited

Telangana - 509 228,

INDIA

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

For more information, go to www.amneal.com or call 1-877-835-5472.

The brands listed are trademarks or registered trademarks of their respective owners.

This Patient Information has been approved by the U.S. Food and Drug Administration. Rev. 03-2026-00

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 218543 · View the label on DailyMed

Revision date stated in the text: March 2026

Found a mistake? Write to us via the contact page.

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

Drug information for Mirabegron Extended-Release

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 Mirabegron
Dosage form Tablet, film coated, extended release
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) MSN
FDA approval ANDA 218543Abbreviated New Drug Application (ANDA) – generic drug Approved November 4, 2025
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Myrbetriq with the same TE code
Manufacturers 6 labelers list this drug on DailyMed
Recalls
  • August 5, 2026: Class II recall: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Packages (NDC)
Package
25 mg – 30 in 1 bottle NDC 69238-2860-1
25 mg – 90 in 1 bottle NDC 69238-2860-2
50 mg – 30 in 1 bottle NDC 69238-2861-1
50 mg – 90 in 1 bottle NDC 69238-2861-2

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.