mirabegron
Brand names: Myrbetriq
Mirabegron is a medicine that helps control an overactive bladder. It relaxes the bladder muscle, allowing it to hold more urine.
Drug Pricing (NADAC)
Generic Price
$9.89/unit
Generic Available
Yes (3 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Mirabegron treats overactive bladder (OAB) in adults.
Common side effects
High blood pressure, Common cold symptoms (nasopharyngitis), Urinary tract infection
Key warnings
Mirabegron can raise your blood pressure.
How It Works
Mirabegron is a beta-3 adrenergic agonist. It works by relaxing the bladder muscle. This helps increase the bladder's capacity to store urine and reduces the urge to go.
How to Take It
Take mirabegron tablets once a day, by mouth. You can take it with or without food. Swallow the tablet whole with water; do not chew, crush, or divide it. The usual starting dose is 25 mg daily, which may be increased to 50 mg daily after 4 to 8 weeks if needed.
Pregnancy & Breastfeeding
It is not known if mirabegron can harm an unborn baby. Talk to your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store mirabegron tablets at room temperature (between 59°F and 86°F).
Side Effects (from patient reports)
Based on 23,615 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 36,931 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2010–2025.
Total Reports
36,931
Death-Related Reports
2,913
Hospitalization Reports
7,208
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 5,738 |
| 2 | OFF LABEL USE | 2,683 |
| 3 | FATIGUE | 2,215 |
| 4 | HEADACHE | 2,162 |
| 5 | DIZZINESS | 2,093 |
| 6 | FALL | 1,892 |
| 7 | DIARRHOEA | 1,861 |
| 8 | PAIN | 1,742 |
| 9 | NAUSEA | 1,705 |
| 10 | INTENTIONAL PRODUCT MISUSE | 1,524 |
| 11 | HYPERTENSION | 1,490 |
| 12 | BLOOD PRESSURE INCREASED | 1,474 |
| 13 | ASTHENIA | 1,468 |
| 14 | ARTHRALGIA | 1,391 |
| 15 | RASH | 1,350 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Mirabegron can raise your blood pressure. Your doctor should check your blood pressure regularly, especially if you have high blood pressure. Mirabegron is not recommended if you have severe, uncontrolled high blood pressure (180/110 mm Hg or higher). Use caution if you have bladder outlet obstruction or are taking other medicines for overactive bladder, as it can increase the risk of urinary retention. Angioedema (swelling of the face, lips, tongue, or throat) has been reported.
Known 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 )] .
Mechanism: Studies show that these two drugs do not significantly change how the body handles either medication.
What to do: You can usually take these together, but always keep your doctor informed of all your medications.
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...
Mechanism: Mirabegron can slightly increase the levels of warfarin in your body.
What to do: Your doctor should monitor your blood clotting levels closely to ensure your dose is safe.
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 )] .
Mechanism: Ketoconazole can change how your body processes mirabegron, which may lead to higher levels of the medicine in your blood.
What to do: Your doctor may monitor you more closely for side effects, though a dose change is usually not required.
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 )] .
Mechanism: Rifampin can speed up how your body breaks down mirabegron, which might lower the amount of medicine available to work in your system.
What to do: Tell your doctor if you feel your bladder symptoms are not being controlled as well while taking these drugs together.
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 )] .
Mechanism: Taking these two bladder medicines together can slightly change how your body absorbs or handles each drug.
What to do: These medicines can be used together, but you should let your healthcare provider know if you experience any new symptoms.
Common Questions
Can I cut the tablet in half?
Can I take this with other overactive bladder medicines?
What if I have kidney problems?
Will this medicine cure my overactive bladder?
How long does it take to work?
Can this medicine cause weight gain?
Can I drink alcohol while taking this medicine?
What should I do if I have swelling of my face or tongue?
Does this medication interact with any other medications?
Can I stop taking mirabegron if my symptoms improve?
What are the common side effects of mirabegron?
Does mirabegron interact with other medications?
What drug class is mirabegron?
Is mirabegron safe during pregnancy?
Related Medications in Beta-3 Agonist (Overactive Bladder)
Other drugs grouped near mirabegron — same-class peers and common alternatives.
alfuzosin
Uroxatral
Alfuzosin is a medicine that helps men with enlarged prostate glands.
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bethanechol
Urecholine
Bethanechol helps you to urinate if you have trouble emptying your bladder.
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darifenacin
Enablex
Darifenacin (Enablex) is a medicine that helps control an overactive bladder.
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dutasteride
Avodart
Dutasteride and tamsulosin hydrochloride capsules contain two medicines to treat enlarged prostate in men.
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dutasteride/tamsulosin
Jalyn
This medicine combines two drugs to treat enlarged prostate in men.
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Medication Guides
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What the FDA Data Shows for mirabegron
The FDA label for mirabegron (sold under brand names such as Myrbetriq) classifies it as a prescription-only medication in the Beta-3 Agonist (Overactive Bladder) class. Mirabegron treats overactive bladder (OAB) in adults. Official labeling lists 4 commonly reported side effects, including High blood pressure, Common cold symptoms (nasopharyngitis), Urinary tract infection.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 23,615 voluntary reports. The database also lists 6 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $9.89.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: September 26, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages