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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Mirabegron
Generic Name
Mirabegron
Active Ingredient
MirabegronCategory
beta3-Adrenergic Agonist [EPC]
Variants
12
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 50 mg/1 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | 68180-152 |
| 50 mg/1 | TABLET, EXTENDED RELEASE | ORAL | 70710-1160 |
| 25 mg/1 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL |
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Mirabegron, you must consult a qualified healthcare professional.
| 25 mg/1 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | 67184-0571 |
| 25 mg/1 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | 71335-2809 |
| 50 mg/1 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | 71335-2810 |
| 50 mg/1 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | 71335-2808 |
| 25 mg/1 | TABLET, EXTENDED RELEASE | ORAL | 70771-1752 |
| 25 mg/1 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | 68180-151 |
| 50 mg/1 | TABLET, EXTENDED RELEASE | ORAL | 70518-4304 |
| 25 mg/1 | TABLET, EXTENDED RELEASE | ORAL | 70710-1159 |
| 50 mg/1 | TABLET, EXTENDED RELEASE | ORAL | 70771-1753 |
Detailed information about Mirabegron
Mirabegron is a first-in-class beta-3 adrenergic agonist used to treat overactive bladder (OAB) and pediatric neurogenic detrusor overactivity. It works by relaxing the bladder muscle to increase storage capacity.
For the treatment of overactive bladder (OAB) in adults, the standard starting dose of Mirabegron is 25 mg taken once daily. This dose is effective for many patients and allows the body to adjust to the medication. If the 25 mg dose is well-tolerated but symptoms persist after 4 to 8 weeks, your healthcare provider may increase the dose to 50 mg once daily, which is the maximum recommended dose for adults.
When used in combination with solifenacin (an anticholinergic), the typical starting dose is also 25 mg of Mirabegron daily. Clinical trials have shown that the combination therapy can provide superior symptom relief for some patients compared to using either drug alone. However, your doctor will monitor you closely for increased side effects when using two medications for bladder control.
Mirabegron is approved for pediatric patients aged 3 years and older for the treatment of neurogenic detrusor overactivity (NDO). The dosage in children is strictly based on body weight to ensure safety and efficacy.
Mirabegron has not been established as safe or effective for children under the age of 3 years.
The kidneys are responsible for clearing about half of the Mirabegron dose from the body. If kidney function is reduced, the drug can build up to toxic levels.
The liver metabolizes Mirabegron through various enzyme pathways.
No specific dose adjustments are required based solely on age. However, because older adults are more likely to have decreased renal or hepatic function, healthcare providers often start at the lowest effective dose and monitor blood pressure closely.
To get the most benefit from Mirabegron, follow these specific administration guidelines:
If you miss a dose of Mirabegron, take it as soon as you remember. If it has been more than 12 hours since your scheduled dose, skip the missed dose and take your next dose at the regular time. Do not take two doses at once to make up for a missed one, as this increases the risk of cardiovascular complications.
Signs of a Mirabegron overdose may include an abnormally fast heartbeat (tachycardia), palpitations, and a significant increase in blood pressure. In clinical trials, doses up to 300 mg (six times the max dose) resulted in increased pulse rates and elevated systolic blood pressure. If an overdose is suspected, contact your local poison control center or seek emergency medical attention immediately. Treatment is generally supportive, focusing on monitoring heart rate and blood pressure.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, as your symptoms may return quickly.
Mirabegron is generally well-tolerated, but like all medications, it can cause side effects. The most frequently reported side effect in clinical trials is increased blood pressure (hypertension). This occurs because, while Mirabegron is selective for beta-3 receptors in the bladder, at therapeutic doses, it may have minor effects on beta-receptors in the heart and blood vessels. Patients may not 'feel' high blood pressure, which is why regular monitoring is essential. Other very common effects include:
Mirabegron is a powerful medication that interacts with the autonomic nervous system. Before starting this drug, it is vital to understand that it is not suitable for everyone. The most critical safety point is the risk of elevated blood pressure. Mirabegron can increase blood pressure significantly, even in patients who previously had normal readings. If you have a history of hypertension, your condition must be well-controlled before you begin Mirabegron. Your healthcare provider should measure your blood pressure at the start of therapy and periodically thereafter.
Another key safety consideration is the risk of urinary retention. Because Mirabegron relaxes the bladder muscle, it may make it harder for the bladder to contract when it is actually time to urinate. This is particularly risky for patients with a physical blockage in the urinary tract, such as an enlarged prostate (Benign Prostatic Hyperplasia) or those taking other medications that also relax the bladder. If you find that you are straining to urinate or cannot empty your bladder, seek medical help immediately.
No FDA black box warnings for Mirabegron. While the drug carries significant warnings for hypertension and angioedema, it has not met the FDA criteria for a boxed warning as of 2026.
While there are few absolute contraindications for Mirabegron, it should never be used in patients with severe, uncontrolled hypertension (defined as systolic BP ≥180 mmHg and/or diastolic BP ≥110 mmHg). Using Mirabegron in this state can trigger a hypertensive crisis, potentially leading to stroke or organ damage.
Additionally, Mirabegron should not be used in combination with other potent Beta-3 agonists or medications that significantly increase heart rate if the patient has an underlying cardiac condition, as the additive effects on the heart can be dangerous.
Mirabegron is a moderate inhibitor of the CYP2D6 enzyme. This is a critical interaction because many common medications are broken down by this enzyme. When Mirabegron inhibits CYP2D6, the levels of these other drugs can rise to toxic levels in the blood. Examples include:
There are specific scenarios where Mirabegron must NEVER be used because the risks far outweigh any potential benefits:
Mirabegron is currently classified as a medication where the risks during pregnancy are not fully known. In animal studies (rats and rabbits), very high doses of Mirabegron were associated with lower fetal body weights and increased fetal mortality. There are no adequate and well-controlled studies in pregnant women.
Healthcare providers typically only prescribe Mirabegron during pregnancy if the potential benefit to the mother justifies the potential risk to the fetus. If you become pregnant while taking this drug, notify your doctor immediately.
It is not known whether Mirabegron is excreted in human breast milk. However, animal studies have shown that the drug is present in the milk of lactating rats. Because many drugs are excreted in human milk and the potential for serious adverse reactions in a nursing infant (such as increased heart rate or blood pressure) exists, a decision must be made whether to discontinue nursing or discontinue the drug. Most clinicians recommend avoiding Mirabegron while breastfeeding if possible.
Mirabegron is a selective beta-3 adrenergic receptor agonist. To understand its action, one must look at the autonomic control of the bladder. During the storage phase, the sympathetic nervous system releases norepinephrine, which binds to beta-3 receptors on the detrusor muscle. This binding activates the Gs-protein/adenylyl cyclase pathway, increasing intracellular cyclic AMP (cAMP). High cAMP levels lead to a reduction in intracellular calcium and the activation of potassium channels, resulting in smooth muscle relaxation.
By pharmacologically stimulating these receptors, Mirabegron enhances this natural relaxation process. This increases the 'voiding threshold'—the amount of urine the bladder can hold before the urge to urinate becomes uncontrollable. Unlike anticholinergics, Mirabegron does not inhibit the voiding contraction (which is mediated by muscarinic M3 receptors), meaning it is less likely to cause a total inability to urinate in healthy individuals.
The primary pharmacodynamic effect of Mirabegron is an increase in bladder capacity and a decrease in the frequency of involuntary detrusor contractions. In clinical urodynamic studies, Mirabegron has been shown to increase the volume at first contraction and increase the total bladder capacity. The onset of action is not immediate; while some patients notice improvement within 1-2 weeks, the full therapeutic effect usually takes 4 to 8 weeks of consistent daily use. There is no evidence of 'tachyphylaxis' (tolerance), meaning the drug remains effective over long periods of use.
Common questions about Mirabegron
Mirabegron is primarily used to treat the symptoms of an overactive bladder (OAB) in adults, including sudden urges to urinate, frequent urination, and urge incontinence (leaking urine). It is also approved for children aged 3 and older to treat neurogenic detrusor overactivity, a bladder condition caused by nerve issues. Unlike older medications that block nerve signals, Mirabegron works by stimulating specific receptors to relax the bladder muscle. This allows the bladder to hold more urine and reduces the frequency of bathroom trips. It is often prescribed when other medications have failed or caused too many side effects like dry mouth.
The most common side effect of Mirabegron is an increase in blood pressure, which is why regular monitoring is required. Other frequent side effects include headaches, symptoms of the common cold (nasopharyngitis), and urinary tract infections. Some patients also report constipation, dizziness, or a fast heart rate. While it is less likely to cause dry mouth than older bladder drugs, a small percentage of people may still experience it. Most of these side effects are mild, but you should always report any new or worsening symptoms to your healthcare provider.
There is no known direct chemical interaction between Mirabegron and alcohol, but caution is still advised. Alcohol is a natural diuretic and bladder irritant, which means it can make overactive bladder symptoms like urgency and frequency much worse. Drinking alcohol may essentially 'undo' the benefits you are getting from the medication. Additionally, both alcohol and Mirabegron can influence your blood pressure and heart rate. It is best to limit alcohol intake and discuss your habits with your doctor to ensure you are getting the most out of your treatment.
The safety of Mirabegron during pregnancy has not been established in human clinical trials. Animal studies have suggested that very high doses could potentially harm a developing fetus or lead to lower birth weights. Because of this uncertainty, Mirabegron is generally only used during pregnancy if the doctor decides the benefits clearly outweigh the potential risks. If you are pregnant or planning to become pregnant, you should discuss alternative bladder management strategies with your obstetrician. It is also unknown if the drug passes into breast milk, so caution is advised for nursing mothers.
Mirabegron does not provide instant relief for bladder symptoms; it requires consistent daily use to build up in your system. Some patients may notice a slight improvement in their symptoms within the first 1 to 2 weeks of treatment. However, it typically takes 4 to 8 weeks to reach the full therapeutic effect of the medication. Your doctor will likely wait at least 4 weeks before deciding if your dose needs to be increased from 25 mg to 50 mg. It is important to keep taking the medication every day, even if you do not feel a difference immediately.
You can safely stop taking Mirabegron without experiencing a physical withdrawal syndrome or the need for a tapering schedule. However, because Mirabegron treats a chronic condition, your overactive bladder symptoms will likely return shortly after you stop. You may notice an increase in urinary urgency, frequency, and leakage within a few days. You should always consult your healthcare provider before stopping the drug. They can help determine if your symptoms have improved enough to stop or if you should switch to a different type of treatment.
If you miss a dose of Mirabegron, you should take it as soon as you remember, provided it is within 12 hours of your scheduled time. If more than 12 hours have passed since you were supposed to take your dose, you should skip the missed dose entirely and wait until your next scheduled time. Never take two doses at once to 'catch up,' as this can lead to a dangerous increase in blood pressure or heart rate. To help remember your dose, try taking it at the same time every day, such as with breakfast or when you first wake up.
Weight gain is not a commonly reported side effect of Mirabegron in clinical trials. Most patients taking the medication do not experience significant changes in their body weight. If you notice rapid weight gain or swelling in your ankles and feet while taking this medication, it could be a sign of a different medical issue, such as heart or kidney problems, rather than a direct side effect of the drug itself. You should report any unusual weight changes or fluid retention to your doctor for a thorough evaluation.
Mirabegron can interact with several other drugs, particularly those broken down by the CYP2D6 enzyme. It can increase the levels of certain heart medications (like metoprolol), antipsychotics, and some antidepressants in your blood. It can also increase the levels of Digoxin, requiring a dose adjustment of the Digoxin. While it is often safely used in combination with solifenacin for bladder control, this should only be done under strict medical supervision. Always provide your doctor and pharmacist with a full list of your current medications, including over-the-counter supplements, to avoid dangerous interactions.
As of 2024 and 2025, generic versions of Mirabegron (the generic name for Myrbetriq) have become available in many markets following the expiration of certain patent protections. Generic Mirabegron is required by the FDA to have the same active ingredient, strength, dosage form, and route of administration as the brand-name version. It must also prove 'bioequivalence,' meaning it works the same way in the body. Choosing the generic version can significantly lower your out-of-pocket costs. Check with your pharmacist or insurance provider to see if the generic version is available and covered by your plan.
Other drugs with the same active ingredient (Mirabegron)
These side effects occur in a smaller percentage of the population but are still documented in clinical literature:
Rare but documented side effects include:
> Warning: Stop taking Mirabegron and call your doctor immediately or seek emergency care if you experience any of the following:
The long-term safety of Mirabegron has been studied for up to one year in clinical trials. The primary concern with prolonged use is the cumulative effect on cardiovascular health. Because Mirabegron can cause sustained increases in blood pressure, long-term users must have their blood pressure checked at every doctor's visit. There is currently no evidence that Mirabegron causes cognitive decline (dementia), which is a significant advantage over long-term use of older anticholinergic OAB medications.
No FDA black box warnings for Mirabegron. Unlike some other urological or cardiovascular medications, the FDA has not required a boxed warning for Mirabegron. However, the warnings regarding high blood pressure and angioedema are considered 'Major Warnings' within the prescribing information and should be treated with the highest level of caution.
Report any unusual symptoms, especially those affecting your heart rate or ability to urinate, to your healthcare provider promptly. Keeping a 'bladder diary' can help you and your doctor track both the effectiveness of the drug and any potential side effects.
To ensure your safety while taking Mirabegron, your healthcare provider will likely implement the following monitoring schedule:
Mirabegron generally does not cause drowsiness or significant cognitive impairment. However, because it can cause dizziness or blurred vision in some individuals, you should observe how the medication affects you before driving a car or operating heavy machinery. If you feel lightheaded, avoid these activities and consult your doctor.
There is no direct chemical interaction between Mirabegron and alcohol. However, alcohol is a known bladder irritant and a diuretic (it increases urine production). Consuming alcohol while treating OAB may counteract the benefits of Mirabegron and worsen symptoms of urgency and frequency. Additionally, both alcohol and Mirabegron can affect blood pressure; combining them may lead to unpredictable changes in your readings.
Mirabegron does not require a tapering schedule. You can generally stop taking it without experiencing a withdrawal syndrome. However, because the drug treats a chronic condition, your overactive bladder symptoms (urgency, frequency, leakage) will likely return within a few days of stopping the medication. Always discuss your decision to stop the medication with your doctor to explore alternative treatments.
> Important: Discuss all your medical conditions, especially heart disease, high blood pressure, and kidney or liver problems, with your healthcare provider before starting Mirabegron.
Mirabegron is not known to interfere with common laboratory tests, such as urinalysis, blood glucose, or cholesterol panels. However, it is always important to inform the laboratory and your doctor of all medications you are taking before any diagnostic testing.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. A complete medication review is the only way to prevent dangerous drug-drug interactions.
These are conditions where the drug may be used, but only with extreme caution and frequent medical oversight:
There is no known cross-sensitivity between Mirabegron and antimuscarinic OAB drugs (like oxybutynin). However, patients who have experienced angioedema with other drugs—especially ACE inhibitors used for blood pressure—should be monitored very closely, as they may be more predisposed to swelling of the airway.
> Important: Your healthcare provider will evaluate your complete medical history, including your current blood pressure and organ function, before prescribing Mirabegron to ensure it is safe for you.
Mirabegron is FDA-approved for the treatment of Neurogenic Detrusor Overactivity (NDO) in children aged 3 years and older. It is not approved for 'standard' overactive bladder in children; its use is limited to those with neurological conditions.
Clinical trials included a significant number of patients aged 65 and over. Data suggests that there are no overall differences in safety or effectiveness between older and younger patients. However, the elderly are more likely to have:
Mirabegron is often preferred in the elderly over anticholinergics because it does not cross the blood-brain barrier significantly and therefore does not cause the confusion or memory loss associated with drugs like oxybutynin.
For patients with a GFR between 15 and 29 mL/min, the dose must not exceed 25 mg. Mirabegron is not removed by hemodialysis; therefore, patients on dialysis should not use this medication. Regular monitoring of serum creatinine is recommended for all patients with known kidney disease.
For patients with moderate hepatic impairment (Child-Pugh Class B), the dose is capped at 25 mg. The drug has not been studied in patients with severe hepatic impairment (Class C), and its use is contraindicated in that group due to the risk of extreme drug accumulation.
> Important: Special populations require individualized medical assessment. Always inform your doctor if you are pregnant, planning to become pregnant, or have any degree of kidney or liver disease.
| Parameter | Value |
|---|---|
| Bioavailability | 29% (25 mg) to 35% (50 mg) |
| Protein Binding | ~71% (Albumin and Alpha-1 acid glycoprotein) |
| Half-life | Approximately 50 hours |
| Tmax | 3.5 to 5 hours |
| Metabolism | CYP3A4, CYP2D6, Glucuronidation, Amide Hydrolysis |
| Excretion | Renal 55% (25% unchanged), Fecal 34% |
Mirabegron belongs to the therapeutic class of Beta-3 Adrenergic Agonists. It is currently the primary medication in this class for urological use. Other medications for OAB, such as oxybutynin, tolterodine, and solifenacin, belong to the Antimuscarinic (Anticholinergic) class. Vibegron (Gemtesa) is another newer member of the beta-3 agonist class that works similarly to Mirabegron.