Skip to the answer

Mirabegron

Mirabegron is a beta-3 adrenergic agonist used to treat overactive bladder in adults and neurogenic detrusor overactivity in children aged 3 and older.

Brand names MyrbetriqMirabgeorn
Drug class Beta3-adrenergic Agonist
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 14 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 7, 2026 🚨Recall on record
Mirabegron at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Mirabegron (Myrbetriq) treats overactive bladder in adults, and bladder control problems from nerve damage in children 3 and older, by relaxing the bladder muscle as it fills so it holds more before the urge hits; on the market since about 2012 and available generically, it is a common alternative to the older bladder drugs. Most people tolerate it well, without much of the dry mouth or mental fog those older drugs cause, though some notice headache or stuffy, cold-like symptoms. The one thing to watch is blood pressure, which it can raise, so have it checked regularly, and it is not recommended if yours is severe and uncontrolled.

Clinical pearls

  • Swallow the tablet whole, never crushed, chewed or split; adults may take it with or without food, children with food.
  • It raises digoxin levels and slightly raises warfarin levels, so whoever manages either one should know you started it.
  • It also boosts drugs cleared by a liver enzyme called CYP2D6, including certain antidepressants and heart medicines, which may need dose changes.
  • Swelling of the face, lips, tongue or throat, even after the first dose, means stop it and get emergency help.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asExtended-release tablet, Extended-release oral suspension
Earliest FDA record2012
Companies listing it with the FDA9
FDA label last updatedAug 1, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Mirabegron, written from its FDA label.

What Mirabegron is used for

▾

Mirabegron is approved across several products and formulations for two main conditions:

  • Overactive bladder (OAB) in adults: Mirabegron extended-release tablets treat the symptoms of urge urinary incontinence, urgency, and frequent urination. Myrbetriq extended-release tablets can be used alone or combined with solifenacin succinate for OAB in adults.
  • Neurogenic detrusor overactivity (NDO) in children aged 3 and older: Mirabegron extended-release tablets and Myrbetriq extended-release tablets treat NDO in children who weigh 35 kg or more. Myrbetriq extended-release oral suspension (granules) and mirabegron extended-release oral suspension treat NDO in children aged 3 and older regardless of weight, including those under 35 kg.

How Mirabegron works

▾

Mirabegron targets a specific receptor in the bladder called the beta-3 adrenergic receptor. When it activates this receptor, the smooth muscle of the bladder wall relaxes during the filling phase — meaning the bladder can stretch and hold more urine before signaling urgency. This reduces the sudden urges, leaks, and frequent trips to the bathroom that come with overactive bladder and related conditions.

Mirabegron dosage

▾

Mirabegron is taken once daily by mouth. Extended-release tablets must be swallowed whole with water — never chewed, crushed, or divided. Adults taking the tablet may do so with or without food. Children taking the tablet or oral suspension should always take it with food, which helps reduce the risk of exposure-related effects like increased heart rate.

  • The extended-release oral suspension is prepared and taken once daily with food in pediatric patients.
  • Myrbetriq granules and Myrbetriq tablets are not the same product and cannot be swapped milligram-for-milligram — do not combine them to make up a dose.
  • If you have kidney or liver impairment, your prescriber may adjust your dose — always follow their specific instructions.

Dosing details from the FDA-approved label

From the Mirabegron prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • OAB in adults (MYRBETRIQ monotherapy)
    • Starting dosage 25 mg orally once daily
    • If needed, increase to 50 mg orally once daily after 4 to 8 weeks
    • Maximum: 50 mg orally once daily
    • Adult patients swallow whole with water, do not chew, divide or crush; take with or without food
  • OAB in adults (combination therapy with solifenacin succinate)
    • Starting dosage MYRBETRIQ 25 mg orally once daily and solifenacin succinate 5 mg orally once daily
    • If needed, increase MYRBETRIQ to 50 mg orally once daily after 4 to 8 weeks
    • Maximum: MYRBETRIQ 50 mg orally once daily
    • Refer to solifenacin succinate prescribing information
  • NDO in pediatric patients 3 years and older weighing 35 kg or more (MYRBETRIQ tablets)
    • Starting dosage 25 mg orally once daily
    • If needed, increase to 50 mg orally once daily after 4 to 8 weeks
    • Maximum: 50 mg orally once daily
    • Take with food; swallow whole with water, do not chew, divide or crush
  • NDO in pediatric patients 3 years and older weighing 35 kg or more (MYRBETRIQ Granules)
    • Starting dosage 6 mL (48 mg) orally once daily as extended-release oral suspension
    • If needed, increase after 4 to 8 weeks
    • Maximum: 10 mL (80 mg) orally once daily
    • Take with food
  • NDO in pediatric patients 3 years and older weighing 11 kg to less than 22 kg (MYRBETRIQ Granules)
    • Starting dose 3 mL (24 mg) orally once daily as extended-release oral suspension
    • Maximum: 6 mL (48 mg)
    • Weight-based; take with food
  • NDO in pediatric patients 3 years and older weighing 22 kg to less than 35 kg (MYRBETRIQ Granules)
    • Starting dose 4 mL (32 mg) orally once daily as extended-release oral suspension
    • Maximum: 8 mL (64 mg)
    • Weight-based; take with food
  • Adults with renal impairment, eGFR 30 to 89 mL/min/1.73 m2
    • Starting dose 25 mg orally once daily
    • Maximum: 50 mg
    • Renal adjustment
  • Adults with renal impairment, eGFR 15 to 29 mL/min/1.73 m2
    • Starting dose 25 mg orally once daily
    • Maximum: 25 mg
    • Renal adjustment
  • Adults with renal impairment, eGFR < 15 mL/min/1.73 m2 or requiring dialysis
    • Not recommended
    • Renal adjustment
  • Adults with hepatic impairment, Child-Pugh Class A (mild)
    • Starting dose 25 mg orally once daily
    • Maximum: 50 mg
    • Child-Pugh Class B (moderate): start 25 mg, maximum 25 mg; Class C (severe): not recommended
Read the label’s full dosing text

2 DOSAGE AND A DM INISTRATION • MYRBETRIQ and MYRBETRIQ Granules are two different products and they are not substitutable on a milligram-per-milligram basis. Select the recommended product (MYRBETRIQ or MYRBETRIQ Granules) based on the indication and patient’s weight. Do not combine MYRBETRIQ and MYRBETRIQ Granules to achieve the total dose. A recommended dosage for MYRBETRIQ Granules for adults has not been determined. ( 2.1 ) OAB in Adults • The recommended starting dose of MYRBETRIQ is 25 mg orally once daily, either alone or in combination with solifenacin succinate 5 mg orally once daily. ( 2.2 ) • After 4 to 8 weeks, the MYRBETRIQ dose may be increased to 50 mg orally once daily. ( 2.2 ) NDO in Pediatric Patients 3 Years and Older • Pediatric Patients weighing less than 35 kg: Use MYRBETRIQ Granules: The recommended starting dose of MYRBETRIQ Granules is weight-based and administered as an extended-release oral suspension once daily. After 4 to 8 weeks, increase to the lowest effective dose without exceeding the maximum recommended dose. ( 2.3 ) • Pediatric Patients weighing 35 kg or more: Use MYRBETRIQ or MYRBETRIQ Granules: o The recommended starting dosage of MYRBETRIQ is 25 mg orally once daily. After 4 to 8 weeks, the MYRBETRIQ dose may be increased to 50 mg orally once daily. ( 2.3 ) o The recommended starting dosage of MYRBETRIQ Granules, administered as an extended-release oral suspension, is 6 mL (48 mg) orally once daily. After 4 to 8 weeks, increase to a maximum dosage of MYRBETRIQ Granules 10 mL (80 mg) orally once daily ( 2.3 ) Adult or Pediatric Patients with Renal or Hepatic Impairment : Refer to the full prescribing information for recommended dosage. ( 2.4 , 2.5 ) Preparation for MYRBETRIQ Granules : Refer to the full prescribing information. ( 2.6 ) Administration • MYRBETRIQ: o Adult patients: Swallow MYRBETRIQ whole with water. Do not chew, divide, or crush. Take with or without food. ( 2.7 ) o Pediatric patients: Swallow MYRBETRIQ whole with water. Do not chew, divide, or crush. Take with food. ( 2.7 ) • MYRBETRIQ Granules: o Pediatric patients: Take MYRBETRIQ Granules prepared as an extended-release oral suspension. Take with food.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Mirabegron side effects

▾

The most commonly reported side effects with mirabegron include:

Common side effects

  • High blood pressure (hypertension)
  • Urinary tract infection (UTI)
  • Nasopharyngitis (common cold-like symptoms)
  • Headache
  • Constipation
  • Rapid heartbeat (tachycardia)
  • Dry mouth (more common when combined with solifenacin succinate)
  • Dizziness

When to get medical help

  • Get emergency help right away if you notice swelling of your face, lips, tongue, or throat — this could be angioedema, a life-threatening allergic reaction
  • Call your doctor if you have a significant rise in blood pressure or worsening of existing high blood pressure
  • Contact your doctor if you have trouble urinating or cannot urinate at all (urinary retention), especially if you have a bladder outlet obstruction or take other bladder medications
  • Seek care promptly for any signs of a severe skin reaction such as rash, blistering, or peeling

More serious reactions — including angioedema (severe swelling of the face, lips, tongue, or throat) and significant rises in blood pressure — require prompt medical attention. Stop the medication and seek help immediately if you experience throat swelling or difficulty breathing.

Mirabegron warnings and precautions

▾
  • Blood pressure increase: Mirabegron can raise blood pressure in both adults and children. Your doctor should monitor blood pressure regularly. It is not recommended for people with severe uncontrolled high blood pressure. In younger children (especially under 8 years), blood pressure increases may be more pronounced.
  • Angioedema: Rare but serious swelling of the face, lips, tongue, or throat has been reported — sometimes after the first dose. This is a medical emergency. Stop mirabegron immediately and get emergency care if this occurs.
  • Urinary retention: Difficulty fully emptying the bladder has been reported, particularly in people with a bladder outlet obstruction or those also taking muscarinic antagonist medications (another class of bladder drug). Use with caution in these situations.
  • CYP2D6 drug interactions: Mirabegron inhibits an enzyme called CYP2D6 that breaks down many medications. This can raise blood levels of those drugs, which may require dose adjustments and closer monitoring.

Mirabegron interactions

▾

Mirabegron can affect how certain other medications work in your body. Key interactions to know about:

  • CYP2D6-metabolized drugs (such as certain antidepressants, antipsychotics, and heart medications) — mirabegron raises their blood levels; monitoring and possible dose adjustment are needed, especially for drugs with a narrow margin of safety.
  • Digoxin — mirabegron increases digoxin levels in the blood; start at the lowest digoxin dose and monitor blood levels to find the right amount.
  • Warfarin — mirabegron slightly increases warfarin exposure; the full effect on clotting has not been completely studied, so monitoring is advisable.
  • Muscarinic antagonists (other bladder medications such as solifenacin) — combining these with mirabegron increases the risk of urinary retention; use with caution and watch for signs of difficulty urinating.

Interactions listed in the FDA-approved label

From the Mirabegron prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Drugs metabolized by CYP2D6: Mirabegron is a moderate CYP2D6 inhibitor, so systemic exposure of drugs metabolized by CYP2D6 is increased when coadministered. Appropriate monitoring and possible dose adjustment may be necessary, especially with narrow therapeutic index CYP2D6 substrates.
  • Digoxin: 100 mg mirabegron increased mean digoxin Cmax from 1.01 to 1.3 ng/mL (29%) and AUC from 16.7 to 19.3 ng.h/mL (27%). When initiating the combination, use the lowest dose of digoxin; monitor serum digoxin concentrations to titrate the dose to desired clinical effect.
  • Warfarin: Mean Cmax of S- and R-warfarin increased by approximately 4% and AUC by approximately 9% after a single 25 mg dose; no effect on INR or prothrombin time after a single dose, but effect with multiple warfarin doses has not been fully investigated.
  • Ketoconazole, rifampin, solifenacin succinate, tamsulosin, and oral contraceptives: Interaction studies were conducted in adults; no dose adjustment is recommended when these drugs are coadministered with mirabegron. No dose adjustment recommended.
Read the label’s full interactions text

7 DRUG INTERACTIONS Drugs Metabolized by CYP2D6 : Mirabegron is a CYP2D6 inhibitor and, when used concomitantly with drugs metabolized by CYP2D6, especially narrow therapeutic index drugs, appropriate monitoring and possible dose adjustment of those drugs may be necessary. ( 5.4 , 7.1 , 12.3 ) Digoxin : When initiating a combination of mirabegron and digoxin, use the lowest dose of digoxin; monitor serum digoxin concentrations to titrate digoxin dose to desired clinical effect. ( 7.2 , 12.3 ) Pediatric use information is approved for Astellas Pharma Global Development, Inc.'s MYRBETRIQ (mirabegron extended-release tablets). However, due to Astellas Pharma Global Development, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Drug interaction studies were conducted in adult patients to investigate the effect of coadministered drugs on the pharmacokinetics of mirabegron and the effect of mirabegron on the pharmacokinetics of coadministered drugs (e.g., ketoconazole, rifampin, solifenacin succinate, tamsulosin, and oral contraceptives) [see Clinical Pharmacology ( 12.3 )] . No dose adjustment is recommended when these drugs are coadministered with mirabegron. The following are drug interactions for which monitoring is recommended: 7.1 Drugs Metabolized by CYP2D6 Since mirabegron is a moderate CYP2D6 inhibitor, the systemic exposure of drugs metabolized by CYP2D6 enzyme is increased when coadministered with mirabegron. Therefore, appropriate monitoring and dose adjustment may be necessary when mirabegron extended-release tablet is coadministered with these drugs, especially with narrow therapeutic index CYP2D6 substrates [see Warnings and Precautions ( 5.4 ) and Clinical Pharmacology ( 12.3 )] . 7.2 Digoxin When given in combination, 100 mg mirabegron increased mean digoxin C max from 1.01 to 1.3 ng/mL (29%) and AUC from 16.7 to 19.3 ng.h/mL (27%).

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿20 supplements and herbs with documented Mirabegron interactions, ranked by severity Check Mirabegron against a supplement or herb →

Before taking Mirabegron

▾
  • Do not take mirabegron if you have had a serious allergic reaction (including angioedema) to mirabegron or any of its inactive ingredients.
  • Tell your doctor if you have severe uncontrolled high blood pressure — mirabegron is not recommended in this case.
  • Tell your doctor if you have a bladder outlet obstruction (something blocking normal urine flow) — mirabegron should be used carefully in this situation.
  • Tell your doctor if you have severe kidney disease or are on dialysis — mirabegron has not been studied in these patients and is not recommended.
  • Tell your doctor if you have moderate or severe liver disease — dose restrictions apply, and mirabegron is not recommended for severe liver impairment.
  • Tell your doctor if you are pregnant or trying to become pregnant — there are no human studies, and animal studies showed fetal effects at high doses.
  • Tell your doctor if you are breastfeeding — it is unknown whether mirabegron passes into human milk.
  • For children: blood pressure should be monitored regularly; younger children may see larger increases in blood pressure.
  • Older adults (65 and older) were included in clinical studies with no overall difference in safety or effectiveness compared to younger adults, but still tell your doctor about all other health conditions and medications.

Mirabegron overdose

▾

Taking too much mirabegron can cause a fast heart rate (pulse over 100 beats per minute) and palpitations. In the event of overdose, the recommended approach is supportive care — monitoring pulse rate, blood pressure, and heart rhythm (ECG). Contact poison control or emergency services immediately if overdose is suspected.

What Mirabegron does in the body

▾

At recommended doses, mirabegron relaxes the bladder muscle during filling without meaningfully affecting urine flow or bladder pressure at the time of urination. It can cause modest, dose-related increases in blood pressure and heart rate — effects that are more pronounced at doses above the approved maximum. Mirabegron does not appear to raise pressure inside the eye (intraocular pressure) at studied doses.

How your body processes Mirabegron

▾

After swallowing an extended-release tablet, mirabegron reaches peak blood levels in roughly 3.5 to 5 hours. It spreads widely throughout the body and is about 71% bound to proteins in the blood. The drug is broken down in the liver through several pathways and has a half-life (the time it takes for half the drug to leave your system) of about 50 hours in adults, meaning it takes several days to fully clear. In children, the half-life is somewhat shorter, around 26 to 31 hours. About 55% of the drug is eventually eliminated through urine and about 34% through stool. In adults, taking the tablet with or without food does not meaningfully change how much drug is absorbed, but children should take it with food because fasting significantly increases drug exposure and the risk of side effects.

How to store Mirabegron

▾

Store and Dispense Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) . Store and Dispense Store MYRBETRIQ Granules at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

20

Supplements & herbs that interact with Mirabegron

20 supplements and herbal products have documented interactions with Mirabegron in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 10
  • Minor · 9
ACTIVATED CHARCOAL Major COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate FEVER BARK Moderate GLUCOMANNAN Moderate GUAR GUM Moderate GUM ARABIC Moderate IBOGA Moderate +12 more
Every supplement checked against Mirabegron — ranked by severity The full interaction hub: 1 major · 10 moderate · 9 minor · every one linked to its full report. Check Mirabegron against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Mirabegron: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Mirabegron — the kind of thing our pharmacy team would talk through with you at the counter.

What is mirabegron actually supposed to do for me?

▾
Mirabegron helps your bladder muscle relax so it can hold more urine before you feel a sudden urge to go. If you're dealing with overactive bladder — the urgency, the leaks, the constant trips to the bathroom — mirabegron is meant to reduce all of those. You may not notice a big difference right away; it typically takes a few weeks for the full benefit to build up, so stick with it as prescribed.

Does it matter if I take it with food or on an empty stomach?

▾
For adults taking the tablet, it doesn't matter — you can take it with or without food. But if a child is taking either the tablet or the oral suspension (granules), it should always be taken with food. Taking it with food in children helps reduce the risk of side effects like a faster heart rate. And no matter who is taking it, swallow the tablet whole — don't chew, crush, or split it.

What side effects should I expect, and which ones should make me call my doctor?

▾
The most common things people notice are high blood pressure, urinary tract infections, cold-like symptoms (runny nose, sore throat), and headache. These are usually manageable. What you should call your doctor about right away is any significant rise in your blood pressure or trouble urinating. And if you ever notice swelling of your face, lips, tongue, or throat — even after just the first dose — stop taking mirabegron and get emergency help immediately, because that can be a life-threatening allergic reaction called angioedema.

Can mirabegron affect any of my other medications?

▾
Yes, and this is an important one to flag with your pharmacist. Mirabegron can raise the blood levels of certain other drugs — especially ones broken down by a liver enzyme called CYP2D6, which includes some antidepressants and heart medications. It also increases digoxin and slightly increases warfarin levels, so those need monitoring. Make sure your doctor and pharmacist have a full list of everything you take, including over-the-counter products.

I already have high blood pressure — is mirabegron safe for me?

▾
Mirabegron can raise blood pressure modestly, so your doctor will want to keep an eye on it — especially if you already have hypertension. It's not recommended if your blood pressure is severely uncontrolled. That said, many people with high blood pressure do take mirabegron safely under monitoring. Just make sure your doctor knows about your blood pressure history before you start, and get it checked regularly while you're on it.

Is it safe to take mirabegron during pregnancy or while breastfeeding?

▾
There are no studies in pregnant women, so we can't say it's safe during pregnancy. Animal studies did show some effects on developing fetuses at high doses. If you're pregnant, planning to become pregnant, or breastfeeding, talk to your doctor before taking mirabegron. It's also not known whether mirabegron passes into human breast milk, so your doctor will help you weigh the benefits and risks based on your situation.

Is Mirabegron available over the counter?

▾
No. Mirabegron is a prescription medicine: every Mirabegron product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Mirabegron first available?

▾
The earliest FDA record we hold for Mirabegron is from 2012: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Mirabegron was first used.

Who makes Mirabegron?

▾
9 companies currently list Mirabegron products in the FDA's NDC Directory, including Bryant Ranch Prepack, Astellas Pharma US, Inc., Remedyrepack Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Mirabegron on HelloPharmacist

📊Mirabegron supplement interactions20 checked — ranked by severity 🌿Drug & Supplement CheckerMirabegron vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Mirabegron NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Mirabegron Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Mirabegron forms and strengths (how it comes)

Mirabegron is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Mirabegron inactive ingredients by manufacturer.

Extended-release tablet

By mouth
Brands Mirabgeorn Myrbetriq
How this form is used
What it may be used for
  • Treats overactive bladder (OAB) in adults with urge urinary incontinence, urgency, and frequent urination
  • Myrbetriq extended-release tablets also treat OAB in adults when combined with solifenacin succinate
  • Treats neurogenic detrusor overactivity (NDO) in children aged 3 and older who weigh 35 kg or more
Important instructions
  • Swallow the tablet whole with water — do not chew, crush, or divide it
  • Adult patients may take the tablet with or without food
  • Pediatric patients should take the tablet with food
  • Taken once daily by mouth; follow your prescriber's dosing guidance
Available strengths 2 strengths
25 mg 50 mg
22 FDA-listed product records ⓘ

Extended-release oral suspension

By mouth
Brands Myrbetriq
How this form is used
What it may be used for
  • Myrbetriq extended-release oral suspension (granules) treats neurogenic detrusor overactivity (NDO) in children aged 3 and older, including those weighing less than 35 kg
  • Mirabegron extended-release oral suspension treats NDO in children aged 3 and older
Important instructions
  • Taken by mouth once daily as a prepared extended-release oral suspension
  • Always take with food
  • Myrbetriq granules and extended-release tablets are not interchangeable milligram-for-milligram — do not combine or substitute without prescriber guidance
  • Follow preparation instructions provided in the full prescribing information or by your pharmacist
Available strengths 1 strength
8 mg/mL
3 FDA-listed product records ⓘ

Mirabegron on the U.S. market: products, makers and brands

How Mirabegron appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

9 companies list 21 Mirabegron product records with the FDA, mostly as extended-release tablet, extended-release oral suspension; the earliest marketing or approval year on record is 2012. Brand names on the directory include Myrbetriq, Mirabgeorn; the rest are generics.

2
Dose forms ⓘ
9
Labelers (makers, repackagers, distributors)
3
Brand names
21
FDA-listed product records ⓘ
2012
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (25) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack19%
Astellas Pharma US, Inc.14%
Remedyrepack Inc.14%
Amneal Pharmaceuticals NY LLC10%
Lupin Pharmaceuticals, Inc.10%
Qilu Pharmaceutical Co., Ltd.10%
Other makers24%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Mirabegron is used (Medicaid data)

A general measure of how commonly Mirabegron is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Mirabegron is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

293,458
Medicaid prescriptions filled (Q1–Q4 2025)
$139.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Mirabegron prescribed? Of the 1,601 medications we measure, Mirabegron ranks #328 by Medicaid prescriptions — more than 80% of them.

Where Mirabegron ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #328 of 1,601
#323 Galcanezumab-gnlm Inje... 300,085 Rx #324 Clindamycin and Benzoy... 299,589 Rx #325 Ethinyl Estradiol / Et... 298,425 Rx #326 Ipratropium Oral Inhal... 298,032 Rx #327 Donepezil 295,048 Rx #328 Mirabegron 293,458 Rx #329 Mycophenolate 292,779 Rx #330 Mycophenolate Mofetil 292,779 Rx #331 Valproic Acid 292,052 Rx #332 Bumetanide 291,494 Rx #333 Sodium Bicarbonate 289,349 Rx

Utilization by Mirabegron product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 50 mg 24 hr extended release oral tablet is the most-dispensed Mirabegron product — about 55% of these Medicaid prescriptions.

24 HR mirabegron 50 MG Extended Release Oral Tablet Most dispensed

162,339 Medicaid prescriptions (Q1–Q4 2025) 55% of Mirabegron prescriptions shown $79.3M gross reimbursement (before rebates) ≈ $489 per prescription (gross)

Summed across the 6 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1300801

24 HR mirabegron 25 MG Extended Release Oral Tablet

124,768 Medicaid prescriptions (Q1–Q4 2025) 43% of Mirabegron prescriptions shown $58M gross reimbursement (before rebates) ≈ $465 per prescription (gross)

Summed across the 6 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1300791

24 HR mirabegron 8 MG/ML Extended Release Suspension

6,351 Medicaid prescriptions (Q1–Q4 2025) 2% of Mirabegron prescriptions shown $1.8M gross reimbursement (before rebates) ≈ $282 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2541233

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Mirabegron, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 13 of 47 listed Mirabegron NDCs with Medicaid activity.

Compare Mirabegron products

A representative set of FDA-listed product records for Mirabegron — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 21 of 21 products — FDA National Drug Code Directory. See every product, package size and price: browse all 21 Mirabegron NDCs →

Mirabegron recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Mirabegron recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Aug 5, 2026 · Zydus Pharmaceuticals (USA) Inc
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
  • Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington,… Lots: Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3 FDA record D-0745-2026 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Mirabegron RxCUI 1300786 2 dose forms · 3 strengths
  2. Dose form (SCDF) Extended Release Suspension RxCUI 2541232 In current FDA listings
    Clinical drug / strength (SCD) 24 HR mirabegron 8 MG/ML RxCUI 2541233

Look up RxCUI 1300786 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Mirabegron costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated, Extended Release · Oral 50 mg $14.70 per tablet NDC details & price history
Tablet, Film Coated, Extended Release · Oral 25 mg $14.68 per tablet NDC details & price history
Granule, For Suspension, Extended Release · Oral 8 mg/mL $2.21 per mL NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Mirabegron brand names

Mirabegron is sold under 2 brand names in the FDA directory — Myrbetriq, Mirabgeorn. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Myrbetriq Mirabgeorn

Who makes Mirabegron: manufacturers and labelers

9 companies list Mirabegron products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Astellas Pharma US, Inc., Remedyrepack Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 4 Astellas Pharma US, Inc. 3 Remedyrepack Inc. 3 Amneal Pharmaceuticals NY LLC 2 Lupin Pharmaceuticals, Inc. 2 Qilu Pharmaceutical Co., Ltd. 2 Zydus Lifesciences Limited 2 Zydus Pharmaceuticals (USA) Inc. 2 Ascend Laboratories, LLC 1

Mirabegron drug class (RxNorm)

Mirabegron belongs to the beta3-Adrenergic Agonist class.

Pharmacologic class beta3-Adrenergic Agonist
Drug family (ATC) Drugs for urinary frequency and incontinence
How it works Cytochrome P450 2D6 Inhibitors, Adrenergic beta3-Agonists, P-Glycoprotein Inhibitors, Cytochrome P450 3A Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Mirabegron page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 1, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Mirabegron.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Mirabegron after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
14
Finished products in the current FDA directory
21
Companies listing them (makers, repackagers, distributors)
9
FDA labeler codes behind them ⓘ
9
Linked representative label ⓘ
Astellas Pharma US, Inc.
Linked label effective
Aug 1, 2024
Composite sections available
22
Linked SPL Set ID
ba9e9e15-e666-4c56-9271-2e24739cfa2d
Linked SPL Document ID
fe8998d8-cf08-4e07-b966-33e8de20abf1
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Astellas Pharma US, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →