Mirabegron is a once-daily extended-release oral tablet. In the United States it is approved as Myrbetriq for adults with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency, and for children aged 3 years and older with neurogenic detrusor overactivity (NDO).[1]
This page explains the medicine using official sources and lists 13 products as listed from Bangladesh drug listings. The originator Myrbetriq is described from the official label. It is not a complete global list, and regulatory status differs by product and country.[4]
Availability enquiries are handled by Medicine for World. Submission of an enquiry does not confirm regulatory eligibility, supply or delivery. Ownership and commercial disclosure
Mirabegron is the international non-proprietary name of an oral beta-3 adrenergic receptor agonist. According to the US prescribing information, it relaxes the bladder's detrusor muscle during the storage phase of the urine cycle, which increases bladder capacity.[1]
According to the US prescribing information, Myrbetriq is indicated for adults with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency, alone or together with solifenacin, and for children aged 3 years and older with neurogenic detrusor overactivity (NDO).[1] In the European Union, where it is authorised as Betmiga (20 December 2012), the indications are OAB symptoms in adults and NDO in patients aged 3 to under 18 years.[3] Myrbetriq was first approved in the United States on 28 June 2012.[2] Approved uses and available strengths differ between countries.
Whether mirabegron is suitable, and at which dose, is decided by the treating doctor. Full warnings are in the official product information:
The products below are included for identification and availability-enquiry purposes. Inclusion does not mean that a product is authorised, approved, therapeutically equivalent or available in every country. Confirm regulatory status with the relevant national medicines authority.
Products are listed in alphabetical order. The list is not a ranking and makes no claim that one product is better than another.[4]
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Product listing data last checked October 12, 2026.
Myrbetriq is the originator mirabegron medicine, marketed in the EU as Betmiga. It was first approved by the US FDA on 28 June 2012 and authorised in the European Union on 20 December 2012 (Astellas Pharma Europe B.V.). The originator itself is not part of the Medicine for World listing; its card links to the official US prescribing information. Other products represented as containing mirabegron are made by other manufacturers and sold under their own brand names.[1][2][3]
The originator is shown here separately from the other listed products.
This comparison covers identity and listing information only. It does not establish regulatory approval, pharmaceutical equivalence, bioequivalence, quality, safety or clinical effectiveness.
| Attribute | Other listed mirabegron products | Originator (Myrbetriq) |
|---|---|---|
| Active substance | Mirabegron, as listed. Formulation details are not stated in the product listing.[4] | Mirabegron[1] |
| Brand name | Each manufacturer's own brand name (13 products listed, for example Mirabeg, Mirasol XR, Uroben XR)[4] | Myrbetriq (US) / Betmiga (EU)[1][3] |
| Company | 13 manufacturers, for example General Pharmaceuticals, Beximco, Incepta, Square; manufacturing country listed: Bangladesh[4] | Astellas[1][3] |
| Dosage form | Extended-release tablet (one brand: prolonged-release tablet), as listed[4] | Extended-release tablets or extended-release granules for oral suspension (US label)[1] |
| Strength | 25 mg and/or 50 mg, as listed[4] | Tablets 25 mg and 50 mg (US label)[1] |
| Pack | Not stated in the listing (for Mirabeg: 20 or 30 tablets in a strip)[4] | Not listed by Medicine for World[4] |
| Regulatory approval | Varies by product and country. Not independently verified for this page; check with your national medicines authority. | US FDA approval 28 June 2012 · EU authorisation 20 December 2012[2][3] |
| Classification | Product represented by its manufacturer or supplier as containing mirabegron. Regulatory classification must be confirmed in the relevant jurisdiction.[4] | Originator product[1][2] |
| What must be the same | Same active ingredient, strength, dosage form and route of administration as the originator, where the product is approved as a generic[5] | Reference product[1] |
| Bioequivalence | Must deliver the same amount of active ingredient at the same rate and extent as the originator[5][6] | Reference product for the comparison[6] |
| Clinical trial data | Does not have to repeat the originator's animal and clinical studies; shows equivalence to the originator instead[5][6] | Full safety and efficacy programme submitted for approval[2][6] |
| Inactive ingredients and appearance | May differ (for example colour or excipients); minor differences are generally allowed and rarely matter clinically[6] | Its own formulation and appearance[1] |
| Manufacturing standards | Made under the same strict good-manufacturing-practice standards as the originator; plants are inspected[5] | Same standards[5] |
| Price | Tends to cost less, because the maker does not repeat the original studies[5]. No prices are shown on this page. | Usually higher[5] |
| Market entry | Generally approved once the originator's patents and exclusivities have expired or been successfully challenged[5] | Protected by patents and marketing exclusivity during that period[5] |
The information below summarises the US prescribing information. It is not complete; read the full label and talk to your doctor.[1]
| Side effect | Share of patients |
|---|---|
| Hypertension | 7.5% at 50 mg; 11.3% at 25 mg (placebo 7.6%) |
| Nasopharyngitis | 3.9% at 50 mg; 3.5% at 25 mg (placebo 2.5%) |
| Urinary tract infection | 2.9% at 50 mg; 4.2% at 25 mg (placebo 1.8%) |
| Headache | 3.2% at 50 mg; 2.1% at 25 mg (placebo 3.0%) |
| Tachycardia | 1.2% at 50 mg; 1.6% at 25 mg (placebo 0.6%) |
Mirabegron tablets are taken by mouth once a day with or without food and swallowed whole with water – not chewed, divided or crushed. Your doctor decides the dose.[1]
| Use | Daily dose | Notes |
|---|---|---|
| Adult OAB, starting dose | 25 mg once daily | Taken with or without food |
| Adult OAB, after 4 to 8 weeks | May increase to 50 mg once daily | Depending on efficacy and tolerability |
| Adult OAB with solifenacin | 25 mg + solifenacin 5 mg once daily to start | May increase to 50 mg after 4 to 8 weeks |
| Severe kidney impairment (eGFR 15 to 29) or moderate liver impairment (Child-Pugh B) | 25 mg once daily maximum | Not recommended if eGFR is below 15 / on dialysis, or in severe liver impairment (Child-Pugh C) |
| Children aged 3 years and older with NDO, tablets (35 kg or more) | 25 mg once daily to start, up to 50 mg | Granules are used for lower body weights; see the full label tables |
The doses in the table are US label information, not a personal recommendation. Tablets in the US label come in 25 mg and 50 mg strengths.[1]
Mirabegron activates beta-3 adrenergic receptors in the bladder. This relaxes the detrusor muscle during the storage phase of the urine cycle and increases bladder capacity.[1]
Unlike antimuscarinic OAB medicines, it does not work by blocking muscarinic receptors; the label still advises caution when it is combined with them because of the risk of urinary retention.[1]
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Mirabegron is a prescription-only, once-daily oral extended-release medicine that relaxes the bladder muscle. The originator brand is Myrbetriq (Betmiga in the EU), made by Astellas.
In the US label, Myrbetriq is used in adults for overactive bladder with urge urinary incontinence, urgency and urinary frequency, alone or with solifenacin, and in children aged 3 years and older for neurogenic detrusor overactivity. Approved uses differ by country.
Astellas. Myrbetriq was first approved in the United States on 28 June 2012; Betmiga was authorised in the European Union on 20 December 2012 (Astellas Pharma Europe B.V.).
The US label says adults start with 25 mg once daily, with or without food, swallowed whole with water, and may increase to 50 mg after 4 to 8 weeks. Lower maximum doses apply in severe kidney impairment and moderate liver impairment.
In adult OAB trials in the US label, hypertension (7.5% at 50 mg), nasopharyngitis (3.9%), urinary tract infection (2.9%) and headache (3.2%) were most often reported.
No. The US label has no boxed warning, but it warns about increased blood pressure, urinary retention, angioedema and CYP2D6 interactions.
Mirabegron raises levels of CYP2D6 substrates such as metoprolol and desipramine and of digoxin. Ketoconazole raised mirabegron exposure by 80%. Ask your doctor or pharmacist about everything you take.
13 products represented by their manufacturers or suppliers as containing mirabegron, from 13 Bangladesh manufacturers (for example Mirabeg, Mirasol XR, Uroben XR, Uroblock). It is not a complete global list, and inclusion does not mean that a product is authorised in any specific country.
Equivalence is established by the regulator product by product, through bioequivalence data compared with the originator, so it cannot be assumed from a listing alone. The listed products are represented by their manufacturers as containing mirabegron. Their regulatory status and equivalence to Myrbetriq should be confirmed with your national medicines authority and your doctor.
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Medical and regulatory facts come from official product information. Product listing details come from a supplied dataset. Numbers in square brackets on this page refer to the sources below.