Prescription medicine
Mirabegron Brand names: Myrbetriq
Mirabegron (Myrbetriq) is a prescription medicine with an FDA approval on record since 2012. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $9.39 per mirabegron ER 50 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the mirabegron FDA label on DailyMed (effective December 24, 2025, Lupin Pharmaceuticals, Inc.); the NDA 202611 record on Drugs@FDA; every mirabegron label on DailyMed.
Highlights of the record
FDA label of December 24, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageMirabegron extended-release tablets are beta-3 adrenergic agonist indicated for the treatment of: Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Forms and strengths
- 25 mg
- 50 mg
- 8 mg/ml
Film-coated extended-release tablet; extended-release tablet; extended-release for suspension; extended-release granule for suspension.
On the market
- Earliest approval on file
- June 28, 2012 Myrbetriq, Apgdi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first December 27, 2019; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 8 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 28, 2030 Myrbetriq tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $9.39 per tablet Mirabegron ER 50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2026 0 Class I among all firms' recalls; latest August 5, 2026
- FAERS reports
- 38,466 through July 30, 2026
What is mirabegron used for?
From the label: indications and usageMirabegron extended-release tablets are beta-3 adrenergic agonist indicated for the treatment of: Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1.1 ) 1.1 Adult Overactive Bladder (OAB) Mirabegron Extended-Release Tablets Monotherapy Mirabegron extended-release tablets are indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. Pediatric use information is approved for Astellas Pharma Global Development, Inc.'s MYRBETRIQ (mirabegron extended-release tablets). […]
Conditions named in the indications of mirabegron's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: beta3-Adrenergic Agonist.
Source: FDA drug label (MIRABEGRON), Lupin Pharmaceuticals, Inc., effective December 24, 2025 (SPL set d22d3d12-8466-46db-bc19-d13e87c6115c), via openFDA; the full label on DailyMed
Is there a generic for mirabegron (Myrbetriq)?
The FDA approved the first generic mirabegron on December 27, 2019. 10 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists mirabegron from 8 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 5 patents for Myrbetriq tablets, the last expiring on March 28, 2030; a patent listed only for Myrbetriq Granules for oral suspension runs to September 30, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2019 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for mirabegron (Myrbetriq)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $9.39 per Mirabegron ER 50 mg tablet, down 2% from $9.62 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Mirabegron ER 25 mg tablet (generic)
- Myrbetriq ER 25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Mirabegron ER 25 mg tablet | Generic | $9.18 per tablet | $275.30 | -10% |
| Mirabegron ER 50 mg tablet | Generic | $9.39 per tablet | $281.60 | -2% |
| Myrbetriq ER 25 mg tablet | Brand | $14.68 per tablet | $440.35 | -0.1% |
| Myrbetriq ER 50 mg tablet | Brand | $14.70 per tablet | $440.97 | no change |
| Myrbetriq ER 8 mg/mL suspension | Brand | $2.21 per mL | n/a | -0.3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has mirabegron been recalled?
The FDA's Enforcement Report lists 1 recall naming mirabegron since 2026: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 5, 2026 | Class II | Zydus Pharmaceuticals (USA) Inc | CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the mirabegron label say about other medicines?
The mirabegron label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name mirabegron. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Digoxin | drug interactions | 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 … |
| Ketoconazole | drug interactions | 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 … |
| Rifampin | drug interactions | 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 … |
| Solifenacin | drug interactions | 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 … |
| Tamsulosin | drug interactions | … mirabegron on the pharmacokinetics of coadministered drugs (e.g., ketoconazole, rifampin, solifenacin succinate, tamsulosin, and oral contraceptives) [see Clinical Pharmacology ( 12.3 )]. |
| Warfarin | drug interactions | Following a single dose administration of 25 mg warfarin, mirabegron had no effect on the warfarin pharmacodynamic endpoints such as International Normalized Ratio (INR) and prothrombin time. |
Source: FDA drug label (MIRABEGRON), Lupin Pharmaceuticals, Inc., effective December 24, 2025 (SPL set d22d3d12-8466-46db-bc19-d13e87c6115c), via openFDA; the full label on DailyMed
What do FAERS reports show for mirabegron?
The FDA Adverse Event Reporting System holds 38,466 reports that list mirabegron among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,197 are coded as a death and 7,785 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as mirabegron?
7 other medicines are given the same way (oral) and in the same FDA class as mirabegron or labeled mainly for the same use (overactive bladder), the same class first. Overactive bladder lists all 9 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Vibegron | Overactive bladder | none listed | $16.46 per tablet 75 mg tablet | No current entry |
| Oxybutynin | Overactive bladder | 41 labelers | $0.048 per tablet 5 mg tablet | No current entry |
| Solifenacin | Overactive bladder | 20 labelers | $0.162 per tablet 10 mg tablet | No current entry |
| Tolterodine | Overactive bladder | 14 labelers | $0.268 per capsule 2 mg capsule | No current entry |
| Trospium | Overactive bladder | 20 labelers | $0.211 per tablet 20 mg tablet | No current entry |
| Fesoterodine | Overactive bladder | 11 labelers | $0.794 per tablet 4 mg tablet | No current entry |
| Darifenacin | Overactive bladder | 8 labelers | $0.432 per tablet 15 mg tablet | No current entry |
Every medicine labeled for the same conditions as mirabegron
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does mirabegron compare with medicines for the same use?
5 side-by-side pages set mirabegron beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to mirabegron
- 7 medicines for the same use
- Other beta3-adrenergic agonists
- the pharmacologic class, with prices and generics
- Mirabegron side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other