Mirabegron STADA: Uses, Dosage & Side Effects
A beta-3 adrenoceptor agonist for the symptomatic treatment of overactive bladder (OAB) with urgency, increased frequency, and urge incontinence in adults
Mirabegron STADA is a prescription medication containing mirabegron, a selective beta-3 adrenoceptor agonist used for the symptomatic treatment of overactive bladder (OAB) syndrome in adults. It helps reduce urgency, increased urinary frequency, and urge urinary incontinence by relaxing the detrusor (bladder) muscle during the filling phase without affecting the voiding contraction. Unlike traditional anticholinergic medications, mirabegron works through a distinct pharmacological mechanism, offering an alternative treatment option with a different side effect profile. It is taken as a once-daily 50 mg prolonged-release tablet and is supported by robust clinical trial evidence from the SCORPIO, ARIES, and CAPRICORN studies demonstrating sustained improvements in overactive bladder symptoms.
Quick Facts: Mirabegron STADA
Key Takeaways
- Mirabegron STADA is a beta-3 adrenoceptor agonist – the first non-anticholinergic oral treatment for overactive bladder – that reduces urgency, frequency, and urge incontinence by relaxing the bladder muscle through a different mechanism than traditional anticholinergics.
- The recommended dose is one 50 mg prolonged-release tablet taken once daily, with or without food. The tablet must be swallowed whole and must not be crushed, chewed, or divided.
- Clinical trials (SCORPIO, ARIES, CAPRICORN) demonstrated statistically significant reductions in daily incontinence episodes and daily micturitions, with benefits maintained for at least 12 months of treatment.
- Common side effects include urinary tract infections, tachycardia, and palpitations. Mirabegron may cause small increases in blood pressure and must not be used in patients with severe uncontrolled hypertension.
- Mirabegron is a moderate CYP2D6 inhibitor and can increase plasma concentrations of drugs metabolized by CYP2D6 (such as metoprolol, desipramine, and thioridazine); dose adjustments of co-administered medications may be necessary.
What Is Mirabegron STADA and What Is It Used For?
Mirabegron STADA contains the active substance mirabegron, which belongs to a class of medications known as beta-3 adrenoceptor agonists. It represents a fundamentally different pharmacological approach to the management of overactive bladder compared with the anticholinergic (antimuscarinic) agents that have been the mainstay of OAB treatment for several decades. While anticholinergics such as oxybutynin, tolterodine, solifenacin, and darifenacin work by blocking muscarinic acetylcholine receptors in the bladder wall, mirabegron acts by stimulating beta-3 adrenergic receptors – a mechanism that relaxes the detrusor smooth muscle without interfering with the cholinergic pathways responsible for many of the troublesome side effects associated with older OAB medications.
Overactive bladder syndrome is a common and often debilitating condition characterized by a constellation of urinary symptoms. The International Continence Society (ICS) defines OAB as the presence of urinary urgency, usually accompanied by increased daytime frequency and nocturia (nighttime urination), with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. OAB affects an estimated 12–17% of the adult population worldwide, with prevalence increasing significantly with age. Both men and women are affected, although the presentation may differ between the sexes. In women, urgency urinary incontinence is more common, while in men, urgency and frequency without incontinence tend to predominate, often overlapping with symptoms of benign prostatic hyperplasia (BPH).
The pathophysiology of overactive bladder is multifactorial and not fully understood. Several mechanisms have been implicated, including myogenic changes in the detrusor muscle (involuntary contractions during the filling phase), altered sensory signaling from the urothelium and suburothelial afferent nerves, changes in the central nervous system processing of bladder signals, and age-related structural changes in the bladder wall. Beta-3 adrenergic receptors are the predominant adrenoceptor subtype in the human detrusor muscle, accounting for approximately 97% of all beta-adrenoceptor mRNA expression in the bladder. When activated, these receptors trigger a signaling cascade through Gs proteins and cyclic AMP (cAMP) that leads to relaxation of the detrusor smooth muscle during the filling (storage) phase of the micturition cycle.
Mirabegron selectively binds to and activates beta-3 adrenergic receptors, promoting relaxation of the detrusor muscle and thereby increasing bladder capacity without affecting the voiding contraction. This is a critical distinction, as it means that mirabegron helps the bladder hold more urine comfortably during filling without impairing the ability to empty the bladder when urination is initiated. The result is a reduction in the frequency and intensity of urgency episodes, fewer trips to the bathroom during the day and night, and fewer episodes of involuntary urine leakage associated with urgency.
The clinical efficacy of mirabegron has been established through a comprehensive programme of phase III clinical trials:
- SCORPIO (Study 046): A randomized, double-blind, placebo- and active-controlled (tolterodine 4 mg) trial involving 1,978 patients with OAB symptoms for at least 3 months. Mirabegron 50 mg demonstrated statistically significant reductions in the mean number of incontinence episodes per 24 hours (−1.57 vs. −1.17 for placebo; p<0.05) and mean number of micturitions per 24 hours (−1.75 vs. −1.34 for placebo; p<0.05) at 12 weeks.
- ARIES (Study 047): A randomized, double-blind, placebo-controlled trial enrolling 1,328 patients. Mirabegron 50 mg again showed significant improvements versus placebo in incontinence episodes and micturition frequency, confirming the results of the SCORPIO trial.
- CAPRICORN (Study 049): A 12-month, randomized, double-blind, active-controlled study comparing mirabegron 50 mg with tolterodine extended-release 4 mg in 2,444 patients, demonstrating sustained efficacy over long-term treatment and confirming the favorable tolerability profile of mirabegron.
Mirabegron was first approved as the originator product Myrbetriq (Betmiga in some countries) by the U.S. Food and Drug Administration (FDA) in June 2012 and by the European Medicines Agency (EMA) in December 2012. Mirabegron STADA is a generic formulation manufactured by STADA Arzneimittel AG that contains the same active substance and has been demonstrated to be bioequivalent to the originator product, meaning it delivers the same amount of mirabegron into the bloodstream and is expected to produce the same clinical effects. The availability of generic mirabegron formulations helps improve patient access to this important treatment option.
Mirabegron offers a meaningful alternative for patients who cannot tolerate or have not responded adequately to anticholinergic medications. Because it does not block muscarinic receptors, it avoids the classic anticholinergic side effects such as dry mouth, constipation, blurred vision, drowsiness, and cognitive impairment. This makes it particularly attractive for elderly patients, who are especially vulnerable to anticholinergic cognitive effects and are at the highest risk of developing OAB symptoms.
What Should You Know Before Taking Mirabegron STADA?
Contraindications
Mirabegron STADA must not be used in the following situations:
- Hypersensitivity: Do not take Mirabegron STADA if you are allergic to mirabegron or any of the other ingredients in the tablet, including sucrose, hypromellose, hydroxypropylcellulose, butylhydroxytoluene (E321), magnesium stearate, polyethylene glycol, titanium dioxide, and iron oxide yellow.
- Severe uncontrolled hypertension: Mirabegron must not be used in patients with severe uncontrolled high blood pressure, defined as systolic blood pressure of 180 mmHg or higher and/or diastolic blood pressure of 110 mmHg or higher. Because mirabegron can cause small increases in blood pressure through its beta-3 adrenergic activity, it is contraindicated in this population to avoid potentially dangerous further increases in blood pressure.
Warnings and Precautions
Your doctor should measure your blood pressure before starting Mirabegron STADA and periodically during treatment. In clinical trials, mean increases of approximately 1 mmHg in both systolic and diastolic blood pressure were observed. If you experience symptoms such as severe headache, visual disturbances, or nosebleeds during treatment, contact your doctor promptly.
Talk to your doctor before taking Mirabegron STADA if any of the following apply to you:
- Urinary retention or bladder outlet obstruction: Mirabegron relaxes the bladder muscle, which could theoretically worsen urinary retention in patients with significant bladder outlet obstruction (such as from an enlarged prostate in men). If you have difficulty emptying your bladder or have a weak urinary stream, your doctor should carefully evaluate whether mirabegron is appropriate for you. Although clinical trial data have not shown a significant increase in urinary retention with mirabegron, patients with a known obstruction should be monitored.
- Kidney problems: In patients with severe kidney impairment (eGFR 15–29 mL/min/1.73 m²), the daily dose of mirabegron should not exceed 25 mg. Mirabegron has not been studied in patients on dialysis (eGFR <15 mL/min/1.73 m²) and is not recommended in this population. For patients with mild or moderate kidney impairment, no dose adjustment is needed.
- Liver problems: In patients with moderate hepatic impairment (Child-Pugh Class B), the daily dose should not exceed 25 mg. Mirabegron has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and is not recommended in this group. No dose adjustment is needed for mild hepatic impairment.
- Heart problems: Although no specific increase in cardiovascular events has been identified with mirabegron use, patients with a history of QT prolongation or those taking medications that can prolong the QT interval should be treated with caution. Beta-3 agonism may also result in tachycardia (increased heart rate) in some patients. Tell your doctor if you have a history of irregular heart rhythm (arrhythmia) or heart failure.
Pregnancy and Breastfeeding
Mirabegron STADA should not be used during pregnancy unless clearly necessary. There are no adequate data on the use of mirabegron in pregnant women. Animal studies have shown some reproductive toxicity at doses several times higher than the therapeutic human dose, including reduced foetal body weight and skeletal variations. Women of childbearing potential should use effective contraception during treatment with mirabegron.
It is not known whether mirabegron or its metabolites are excreted in human breast milk. In animal studies, mirabegron was excreted in the milk of lactating rats. A decision must be made whether to discontinue breastfeeding or to discontinue Mirabegron STADA therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother. Discuss your options with your doctor.
Driving and Operating Machinery
Mirabegron STADA has no known effect on the ability to drive and use machines. However, if you experience side effects such as dizziness or blurred vision, you should not drive or operate machinery until these symptoms have resolved.
How Does Mirabegron STADA Interact with Other Drugs?
Mirabegron undergoes metabolism through multiple pathways, including CYP3A4, CYP2D6, and several non-CYP enzyme systems. Importantly, mirabegron is itself a moderate inhibitor of the CYP2D6 enzyme and an inhibitor of the P-glycoprotein (P-gp) drug transporter. These properties create the potential for clinically meaningful drug interactions when mirabegron is taken concurrently with certain other medications.
Major Interactions
| Interacting Drug | Mechanism | Clinical Effect | Action Required |
|---|---|---|---|
| Digoxin | P-gp inhibition | Increased digoxin plasma concentrations (approximately 27% increase in AUC) | Start digoxin at lowest dose. Monitor digoxin levels and adjust dose accordingly. |
| Dabigatran | P-gp inhibition | Potential increase in dabigatran plasma concentrations | Monitor for signs of bleeding. Consider dose adjustment of dabigatran. |
| Thioridazine | CYP2D6 inhibition | Increased thioridazine exposure; risk of QT prolongation and cardiac arrhythmias | Avoid concomitant use. If combination is necessary, close cardiac monitoring is required. |
| Flecainide | CYP2D6 inhibition | Increased flecainide plasma concentrations; risk of cardiac toxicity | Monitor ECG and flecainide levels. Dose adjustment may be needed. |
| Propafenone | CYP2D6 inhibition | Increased propafenone plasma concentrations; risk of pro-arrhythmic effects | Monitor ECG. Dose reduction of propafenone may be necessary. |
Other Notable Interactions
| Interacting Drug | Mechanism | Clinical Effect | Action Required |
|---|---|---|---|
| Metoprolol | CYP2D6 inhibition | Increased metoprolol Cmax by 90% and AUC by 229% when co-administered | Dose reduction of metoprolol may be appropriate. Monitor heart rate and blood pressure. |
| Desipramine | CYP2D6 inhibition | Increased desipramine AUC by approximately 141% | Dose reduction of desipramine may be needed. Monitor for tricyclic antidepressant side effects. |
| Warfarin | CYP2C9 (minor pathway) | No significant change in warfarin pharmacokinetics in clinical studies | No dose adjustment needed. Standard INR monitoring should continue. |
| Ketoconazole | CYP3A4 inhibition (affects mirabegron) | Increased mirabegron AUC by approximately 45% | No dose adjustment needed at standard doses. Caution with potent CYP3A4 inhibitors in patients with hepatic or renal impairment. |
| Solifenacin | Pharmacodynamic + CYP3A4/CYP2D6 | Combination therapy may offer additive efficacy for OAB; slightly increased exposure to both drugs | Approved combination (mirabegron 50 mg + solifenacin 5 mg) in some regions. Monitor for anticholinergic and cardiovascular effects. |
The interaction between mirabegron and metoprolol is of particular clinical importance. When mirabegron 160 mg (a supratherapeutic dose) was co-administered with a single dose of metoprolol 100 mg in a pharmacokinetic study, the Cmax and AUC of metoprolol were increased by approximately 90% and 229%, respectively. At the therapeutic dose of mirabegron 50 mg, the increase in metoprolol exposure is expected to be smaller but still clinically relevant. This interaction has implications for patients taking metoprolol for hypertension, heart failure, or rate control, as increased metoprolol levels could lead to excessive beta-1 blockade, resulting in symptomatic bradycardia or hypotension.
Similarly, the increase in desipramine exposure (approximately 141% increase in AUC) when co-administered with mirabegron highlights the need for caution when prescribing mirabegron alongside CYP2D6 substrates with a narrow therapeutic index. The clinical significance of this interaction extends to other CYP2D6 substrates, including many antidepressants (paroxetine, fluoxetine, venlafaxine), antipsychotics (haloperidol, risperidone), opioids (codeine, tramadol, oxycodone), and beta-blockers (metoprolol, nebivolol, propafenone).
If you are taking any over-the-counter medications, herbal supplements, or vitamins, inform your doctor or pharmacist before starting Mirabegron STADA. While specific studies with herbal products have not been conducted, supplements that affect hepatic enzyme activity or blood pressure could theoretically interact with mirabegron.
What Is the Correct Dosage of Mirabegron STADA?
Always take Mirabegron STADA exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The tablet is a prolonged-release formulation, which means that the active substance is released gradually over time from the tablet matrix. This provides a steady supply of mirabegron to the body over 24 hours, supporting once-daily dosing and minimizing fluctuations in blood levels.
Adults
Standard Dosage – Adults
The recommended dose is 50 mg once daily, taken by mouth with a glass of water, with or without food. The tablet must be swallowed whole and must not be chewed, crushed, or divided, as this would destroy the prolonged-release mechanism and could result in an uncontrolled release of the drug.
Treatment response should be assessed after approximately 8 weeks of continuous therapy. If adequate improvement in symptoms has not been achieved after 8–12 weeks, your doctor may reconsider the treatment approach and explore alternative therapeutic options. Conversely, if mirabegron is effective, treatment can be continued long-term. In the CAPRICORN study, efficacy was sustained over 12 months of treatment without evidence of tolerance (loss of effect over time).
Special Populations
| Patient Group | Recommended Dose | Notes |
|---|---|---|
| Adults (standard) | 50 mg once daily | Swallow whole; with or without food |
| Severe renal impairment (eGFR 15–29) | 25 mg once daily | Not studied on dialysis; not recommended if eGFR <15 |
| Moderate hepatic impairment (Child-Pugh B) | 25 mg once daily | Not studied in severe impairment (Child-Pugh C); not recommended |
| Mild renal/hepatic impairment | 50 mg once daily | No dose adjustment required |
| Elderly (≥65 years) | 50 mg once daily | No dose adjustment required based on age alone |
| With potent CYP3A4 inhibitors + renal/hepatic impairment | 25 mg once daily | Caution; mirabegron exposure may be further increased |
Children and Adolescents
The safety and efficacy of Mirabegron STADA in children and adolescents under 18 years of age have not been established. This medicine should not be used in this age group. Studies in paediatric patients with neurogenic detrusor overactivity have been conducted with the originator product, but the results have not led to approval for paediatric use of mirabegron for OAB.
Elderly Patients
No dose adjustment is required in elderly patients based on age alone. In the phase III clinical trial programme, approximately 50% of the enrolled patients were aged 65 years or older, and approximately 15% were 75 years or older. The efficacy and tolerability of mirabegron in these older subgroups were comparable to those observed in the overall study population. However, elderly patients should be monitored for blood pressure changes and potential drug interactions, as polypharmacy is common in this age group and the likelihood of concomitant CYP2D6 substrate use is higher.
Missed Dose
If you forget to take your daily dose of Mirabegron STADA, take it as soon as you remember on the same day. However, if it is almost time for your next scheduled dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten one. If you miss several consecutive doses, inform your doctor at your next visit.
Overdose
If you have taken more Mirabegron STADA than you should, tell your doctor or pharmacist immediately. Symptoms of overdose may include palpitations (awareness of the heartbeat), increased heart rate, and elevated blood pressure. In clinical pharmacology studies, single doses of up to 400 mg were administered to healthy volunteers. At these supratherapeutic doses, the most common findings were increases in heart rate and pulse pressure. There is no specific antidote for mirabegron. Treatment should be symptomatic and supportive, with monitoring of heart rate, blood pressure, and ECG as appropriate.
What Are the Side Effects of Mirabegron STADA?
Like all medicines, Mirabegron STADA can cause side effects, although not everybody gets them. The side effects reported in clinical trials and post-marketing surveillance are listed below according to their frequency. The safety profile of mirabegron has been well characterized through clinical trials involving more than 10,000 patients and through extensive post-marketing experience since the originator product was first approved in 2012.
In the pivotal phase III trials (SCORPIO, ARIES, and CAPRICORN), the overall incidence of adverse events with mirabegron 50 mg was similar to that observed with placebo, and the discontinuation rate due to adverse events was low (approximately 3.5% for mirabegron 50 mg versus 3.1% for placebo). The most commonly reported treatment-emergent adverse events were hypertension, urinary tract infection, headache, and nasopharyngitis, with incidence rates broadly similar between mirabegron and placebo groups in most categories.
Common
May affect up to 1 in 10 people
- Urinary tract infection
- Tachycardia (rapid heart rate)
- Palpitations (awareness of heartbeat)
- Nasopharyngitis (common cold)
- Headache
- Constipation
- Nausea
- Diarrhoea
Uncommon
May affect up to 1 in 100 people
- Cystitis (bladder infection)
- Urticaria (hives)
- Rash, skin itching (pruritus)
- Elevated blood pressure
- Dizziness
- Joint pain (arthralgia)
- Vaginal infection
- Dyspepsia (indigestion)
- Elevated liver enzymes (GGT, AST, ALT)
Rare
May affect up to 1 in 1,000 people
- Lip oedema (swelling of the lips)
- Eyelid oedema (swelling of the eyelids)
- Leukocytoclastic vasculitis (inflammation of small blood vessels)
- Purpura (purple spots on skin from bleeding under the skin)
- Urinary retention (inability to empty the bladder)
Not Known
Frequency cannot be estimated from available data
- Hypertensive crisis (dangerously high blood pressure)
- Angioedema (severe swelling of deeper skin layers, including face and throat)
- Insomnia
- Glaucoma (increased eye pressure) – reported in post-marketing surveillance
The cardiovascular effects of mirabegron deserve specific attention. Tachycardia and palpitations are known pharmacological effects related to beta-3 adrenergic receptor stimulation. In clinical trials, the mean increase in resting pulse rate with mirabegron 50 mg was approximately 1 beat per minute compared with placebo. The mean increase in blood pressure was approximately 0.5–1 mmHg systolic and diastolic. While these changes are small on a population level, individual patients may experience more pronounced effects. Your doctor should measure your blood pressure before initiating treatment and should monitor it periodically, particularly during the first months of therapy.
Urinary tract infections (UTIs) were among the most commonly reported adverse events in clinical trials, but the incidence was similar between mirabegron and placebo groups. This is expected, as UTIs are inherently common in the OAB population, particularly in postmenopausal women. There is no convincing evidence that mirabegron directly increases the risk of UTI.
Hepatic effects have been reported uncommonly. Small increases in liver enzymes (gamma-glutamyltransferase, aspartate aminotransferase, alanine aminotransferase) have been observed in some patients. These elevations were generally mild, asymptomatic, and reversible upon discontinuation. Monitoring of liver function tests is not routinely required but should be considered if symptoms suggestive of liver dysfunction develop (unexplained nausea, fatigue, jaundice, dark urine, or right upper abdominal pain).
Post-marketing surveillance has identified rare cases of severe hypersensitivity reactions, including angioedema and anaphylaxis. If you experience sudden swelling of the face, lips, tongue, or throat, or difficulty breathing or swallowing after taking Mirabegron STADA, seek emergency medical care immediately and do not take further doses.
Contact your doctor immediately if you experience: a sudden severe increase in blood pressure with symptoms such as intense headache, visual disturbances, or chest pain; signs of a severe allergic reaction (swelling of face, lips, or throat, difficulty breathing); inability to urinate; or unexplained skin rash with purplish spots. If any side effect becomes severe or bothersome, or if you notice any effect not listed above, tell your doctor or pharmacist.
How Should You Store Mirabegron STADA?
Proper storage of your medication is important to ensure its effectiveness and safety throughout the treatment period. Mirabegron STADA prolonged-release tablets are formulated to be stable under standard storage conditions, but certain environmental factors can affect the quality of the product.
- Temperature: Store below 30 °C (86 °F). Do not expose the tablets to excessive heat. Avoid storing in locations that may become very warm, such as a car dashboard in summer or near radiators.
- Moisture: Keep the tablets in the original blister packaging or container to protect them from moisture. Do not store in a bathroom or kitchen where humidity levels are high. If using a pill organizer, transfer only the tablets you will use within a short period.
- Light: While the tablets are not highly light-sensitive, it is good practice to keep them in the original packaging.
- Expiry date: Do not use Mirabegron STADA after the expiry date stated on the blister and carton after “EXP.” The expiry date refers to the last day of that month. Expired medications may not work as intended and could potentially be harmful.
- Keep out of reach of children: Store the medication in a safe place where children cannot see or reach it.
- Disposal: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
When traveling, keep your medication in your carry-on luggage to avoid temperature extremes in the cargo hold of an aircraft. Carry a copy of your prescription or a letter from your doctor if traveling internationally, as some countries require documentation for prescription medications.
What Does Mirabegron STADA Contain?
Understanding the composition of your medication can be important, particularly if you have known allergies or dietary restrictions. Below is a detailed breakdown of the ingredients in Mirabegron STADA.
Active Ingredient
The active substance is mirabegron. Each prolonged-release tablet contains 50 mg of mirabegron. Mirabegron is a synthetic small molecule with the chemical name 2-(2-amino-1,3-thiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide. It has a molecular weight of 396.51 g/mol and appears as a white to off-white crystalline powder.
Inactive Ingredients (Excipients)
| Ingredient | Role | Notes |
|---|---|---|
| Mirabegron | Active substance (beta-3 agonist) | 50 mg per tablet |
| Sucrose | Filler / excipient | Patients with rare sugar intolerances should consult their doctor |
| Hypromellose (HPMC) | Matrix former for prolonged release | Controls drug release rate |
| Hydroxypropylcellulose | Binder | Helps tablet cohesion |
| Butylhydroxytoluene (E321) | Antioxidant | Prevents degradation of the active substance |
| Magnesium stearate | Lubricant | Facilitates tablet manufacturing |
| Polyethylene glycol / Titanium dioxide / Iron oxide yellow | Film coating agents | Provides colour and protects tablet |
Important Information About Excipients
Mirabegron STADA contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars (such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency), contact your doctor before taking this medicine.
The tablet also contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g., contact dermatitis), or irritation to the eyes and mucous membranes in sensitive individuals.
Appearance and Pack Sizes
Mirabegron STADA 50 mg prolonged-release tablets are yellow, oval, film-coated tablets. They are available in blister packs of various sizes (commonly 30, 60, or 90 tablets). Not all pack sizes may be marketed in every country.
Marketing Authorization Holder
STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany. Mirabegron STADA is a generic medicinal product, bioequivalent to the reference product Betmiga / Myrbetriq (Astellas Pharma). Generic medicines undergo rigorous regulatory review to ensure they meet the same standards of quality, safety, and efficacy as the originator product.
Frequently Asked Questions About Mirabegron STADA
Mirabegron STADA is used to treat the symptoms of overactive bladder (OAB) in adults. These symptoms include urgency (a sudden, compelling desire to urinate that is difficult to postpone), increased urinary frequency (going to the toilet more often than usual), and urge urinary incontinence (involuntary leakage of urine associated with urgency). It works by relaxing the bladder muscle during the filling phase, allowing the bladder to hold more urine and reducing the frequency and intensity of urgency episodes.
Mirabegron STADA works through a fundamentally different mechanism compared with older OAB medications. Traditional treatments (anticholinergics such as oxybutynin, tolterodine, solifenacin, and fesoterodine) block muscarinic acetylcholine receptors to reduce involuntary bladder contractions. Mirabegron instead activates beta-3 adrenergic receptors, which relaxes the bladder muscle during filling without blocking cholinergic pathways. This means mirabegron avoids the classic anticholinergic side effects of dry mouth, constipation, blurred vision, drowsiness, and cognitive impairment, making it particularly suitable for elderly patients and those who cannot tolerate anticholinergics.
Some patients may notice improvement in OAB symptoms within the first 2–4 weeks of treatment, but the full therapeutic benefit is typically observed after approximately 8 weeks of continuous daily use. In clinical trials, statistically significant improvements in incontinence episodes and micturition frequency were documented at the 8-week and 12-week time points. Your doctor will usually evaluate whether mirabegron is working after 8 to 12 weeks. Do not stop taking the medication prematurely, as the full effect may not yet have been reached.
Yes, Mirabegron STADA can be taken with or without food. Food does not significantly affect the overall systemic exposure (AUC) of mirabegron, although it may slightly delay the time to peak concentration. This delay does not affect the clinical efficacy of the medication. You can take it at whatever time of day is most convenient for you, as long as you take it at approximately the same time each day to maintain consistent blood levels.
Yes, Mirabegron STADA has been shown to be well tolerated in elderly patients. In the phase III clinical trials, approximately half of all participants were aged 65 or older, and no dose adjustment is necessary based on age alone. Importantly, because mirabegron does not block muscarinic receptors, it does not carry the risk of anticholinergic cognitive side effects (such as confusion, memory impairment, or delirium) that can be particularly problematic in older adults. Blood pressure monitoring is recommended, and drug interactions with concomitant medications should be reviewed, as polypharmacy is common in the elderly population.
No. Mirabegron STADA is a prolonged-release tablet that must be swallowed whole with water. Crushing, chewing, or splitting the tablet would destroy the prolonged-release matrix, causing the entire dose to be released at once rather than gradually over 24 hours. This could lead to higher peak blood levels, increasing the risk of side effects, and would also reduce the duration of the therapeutic effect. If you have difficulty swallowing tablets, discuss alternative options with your doctor.
References
- European Medicines Agency (EMA). Betmiga (mirabegron) – Summary of Product Characteristics. Last updated 2025. Available at: EMA Betmiga EPAR.
- U.S. Food and Drug Administration (FDA). Myrbetriq (mirabegron) – Prescribing Information. Astellas Pharma. Revised 2024.
- Khullar V, Amarenco G, Angulo JC, et al. Efficacy and Tolerability of Mirabegron, a β3-Adrenoceptor Agonist, in Patients with Overactive Bladder: Results from a Randomised European-Australian Phase 3 Trial (SCORPIO). Eur Urol. 2013;63(2):283–295. doi:10.1016/j.eururo.2012.10.016.
- Nitti VW, Auerbach S, Martin N, et al. Results of a Randomized Phase III Trial of Mirabegron in Patients with Overactive Bladder (ARIES). J Urol. 2013;189(4):1388–1395. doi:10.1016/j.juro.2012.10.017.
- Chapple CR, Kaplan SA, Mitcheson D, et al. Randomized Double-Blind, Active-Controlled Phase 3 Study to Assess 12-Month Safety and Efficacy of Mirabegron, a β3-Adrenoceptor Agonist, in Overactive Bladder (CAPRICORN). Eur Urol. 2013;63(2):296–305. doi:10.1016/j.eururo.2012.10.048.
- Chapple CR, Cardozo L, Nitti VW, Siddiqui E, Michel MC. Mirabegron in Overactive Bladder: A Review of Efficacy, Safety, and Tolerability. Neurourol Urodyn. 2014;33(1):17–30. doi:10.1002/nau.22505.
- European Association of Urology (EAU). Guidelines on the Management of Non-Neurogenic Male and Female Lower Urinary Tract Symptoms. 2024. Available at: EAU Guidelines.
- Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019;202(3):558–563. doi:10.1097/JU.0000000000000309.
- World Health Organization (WHO). ATC/DDD Index: Mirabegron G04BD12. WHO Collaborating Centre for Drug Statistics Methodology. 2025.
- British National Formulary (BNF). Mirabegron. National Institute for Health and Care Excellence (NICE). 2025.
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