Mirabegron: uses, dosing, side effects & brands
Mirabegron is a beta3-adrenergic agonist sold in the U.S. under 3 brand and generic names, for overactive urinary bladder and urge urinary incontinence. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Beta3-Adrenergic Agonist
- Treats (across its forms)
- Overactive Urinary Bladder and Urge Urinary Incontinence
- Available as
- Tablet, extended release · Powder, extended release
- Sold as
- 3 products — Mirabegron, Myrbetriq and Myrbetriq Granules
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 50 hours
- What the pharmacy pays
- about $289 for a 30-count supply — not your price
How mirabegron is dosed
From the FDA label for Myrbetriq (application NDA202611). Other mirabegron products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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…
Mirabegron side effects
The following adverse reactions are discussed in more detail in other sections of the labeling. • Hypertension [see Warnings and Precautions ( 5.1 )] • Urinary Retention [see Warnings and Precautions ( 5.2 )] • Angioedema [see Warnings and Precautions ( 5.3 )] • Most commonly reported adverse reactions with MYRBETRIQ monotherapy in adult patients with OAB (> 2% and > placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache. ( 6.1 ) • Most commonly reported adverse reactions with MYRBETRIQ, in combination with solifenacin succinate in adult patients with OAB (> 2% and > placebo and > comparator), were dry mouth, urinary tract infection, constipation, and tachycardia. ( 6.1 ) • Most commonly reported adverse reactions with MYRBETRIQ/MYRBETRIQ Granules in pediatric patients with NDO (≥ 3%) were UTI, nasopharyngitis, constipation, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. MYRBETRIQ Monotherapy for Adult OAB In three, 12-week, double-blind,…
Who shouldn’t take mirabegron
Granules is contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet or oral suspension [see Adverse Reactions ( 6.1 , 6.2 )] . Hypersensitivity to mirabegron or any inactive ingredients. ( 4 )
Mirabegron 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 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: • 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 with or without solifenacin succinate, use the lowest dose of digoxin; monitor serum digoxin concentrations to titrate digoxin dose to desired clinical effect. ( 7.2 , 12.3 ) 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 MYRBETRIQ/MYRBETRIQ Granules 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%). Concomitant administration of 0.25 mg digoxin with a combination of 5 mg solifenacin and 50 mg mirabegron increased digoxin AUC tau and C max by approximately 10% and 14%, respectively. For patients who are initiating a combination of mirabegron and digoxin, the lowest dose for digoxin should initially be considered. Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect [see Clinical Pharmacology ( 12.3 )] . 7.3 Warfarin The mean C max of S - and R -warfarin was increased by approximately 4% and AUC by approximately 9% when administered as a single dose of 25 mg after multiple doses of 100 mg mirabegron. 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. However, the effect of mirabegron on multiple doses of warfarin and on warfarin pharmacodynamic end points such as INR and prothrombin time has not been fully investigated [see Clinical Pharmacology ( 12.3 )] .
Every mirabegron product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 68/100 | Prescription | Tablet | Generic | $289 | View → | |
| 2 | Not yet rated | Prescription | Suspension | Generic | $289 | View → | |
| 3 | Not yet rated | Prescription | Suspension | Generic | $289 | View → |
What mirabegron pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Mirabegron recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Can you crush or split mirabegron?
At least one mirabegronproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each mirabegron label says about crushing, splitting and chewingHow long mirabegron keeps
The date on a sealed pack is not the only one: some mirabegron labels start a second clock once the product is opened or mixed, as short as 28 days.
Does mirabegron expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about mirabegron
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 6,371 reports naming mirabegron, and the FDA flagged 88% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fall408 reports
- fatigue355 reports
- dyspnoea332 reports
- dizziness291 reports
- headache281 reports
- diarrhoea280 reports
- nausea280 reports
- malaise234 reports
Read these as a signal, not a rate. A report does not mean mirabegron caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
How long mirabegron stays in your system
The elimination half-life of mirabegron is about 50 hours. The FDA label gives a terminal elimination half-life of roughly 50 hours for adults taking the extended-release tablets (all US oral mirabegron products are extended-release; the label reports no separate immediate-release value — IR tablets appear only in drug-interaction studies). Because of that long half-life, blood levels keep rising for about a week, and the label states steady state is reached within 7 days of once-daily dosing, with steady-state exposure roughly double that of a single dose. No active metabolite outlasts the parent: the two major circulating metabolites are phase-2 glucuronides (16% and 11% of total exposure) that the label describes as not pharmacologically active at the beta-3 adrenergic receptor, so mirabegron itself is the main active compound. Age does not change it much — the label reports Cmax and AUC in volunteers 65 and older were similar to those in adults 18 to 45. Reduced kidney or liver function raises how much drug is in the body rather than a stated change in half-life: AUC was 31%, 66%, and 118% higher in mild, moderate, and severe renal impairment, and 19% and 65% higher in mild and moderate (Child-Pugh A and B) hepatic impairment; mirabegron has not been studied in end-stage renal disease, dialysis, or severe (Child-Pugh C) hepatic impairment. Children are different: in pediatric patients treated for neurogenic detrusor overactivity with the tablets or granules, the mean terminal half-life is about 26 to 31 hours.
MYRBETRIQ (mirabegron) extended-release tablets and granules — FDA prescribing information, section 12.3 Pharmacokinetics ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is mirabegron?
MYRBETRIQ (mirabegron extended-release tablets) for oral use and MYRBETRIQ Granules (mirabegron for extended-release oral suspension) are beta-3 adrenergic agonists.
What kind of drug is mirabegron?
The FDA classifies mirabegron as a beta3-adrenergic agonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does mirabegron stay in your system?
The elimination half-life of mirabegron is about 50 hours — that is how long the body takes to clear half of a dose. The FDA label gives a terminal elimination half-life of roughly 50 hours for adults taking the extended-release tablets (all US oral mirabegron products are extended-release; the label reports no separate immediate-release value — IR tablets appear only in drug-interaction studies). Because of that long half-life, blood levels keep rising for about a week, and the label states steady state is reached within 7 days of once-daily dosing, with steady-state exposure roughly double that of a single dose. No active metabolite outlasts the parent: the two major circulating metabolites are phase-2 glucuronides (16% and 11% of total exposure) that the label describes as not pharmacologically active at the beta-3 adrenergic receptor, so mirabegron itself is the main active compound. Age does not change it much — the label reports Cmax and AUC in volunteers 65 and older were similar to those in adults 18 to 45. Reduced kidney or liver function raises how much drug is in the body rather than a stated change in half-life: AUC was 31%, 66%, and 118% higher in mild, moderate, and severe renal impairment, and 19% and 65% higher in mild and moderate (Child-Pugh A and B) hepatic impairment; mirabegron has not been studied in end-stage renal disease, dialysis, or severe (Child-Pugh C) hepatic impairment. Children are different: in pediatric patients treated for neurogenic detrusor overactivity with the tablets or granules, the mean terminal half-life is about 26 to 31 hours. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take mirabegron with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run mirabegron against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is mirabegron sold under?
We track 3 mirabegron-containing products in the U.S.: Mirabegron, Myrbetriq and Myrbetriq Granules. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does mirabegron come in?
Across the brands we track, mirabegron is currently marketed as tablet, extended release and powder, extended release, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic mirabegron?
Yes. Our catalog lists 1 generic mirabegron product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has mirabegron been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions mirabegron. The most recent: Mirabegron Extended-Release Tablets (Aug 5, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Mirabegron: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/mirabegron
- MLA
- “Mirabegron: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/mirabegron.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for mirabegron on DailyMed (NIH) ↗.