Prescription medication · Beta-3 Agonist (Overactive Bladder)
mirabegron
Also sold as Myrbetriq. Mirabegron treats overactive bladder (OAB) in adults.
Data updated 2026-05-15
- 36,931
- FDA reportsModerately reported
- 6
- InteractionsFew interactions
- $9.89
- Generic price (NADAC)
What the data shows
mirabegron (Myrbetriq) is a prescription Beta-3 Agonist (Overactive Bladder), reported at a middle-of-the-pack volume (36,931 FDA reports), with 6 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
mirabegron (Myrbetriq) is a prescription Beta-3 Agonist (Overactive Bladder). Mirabegron treats overactive bladder (OAB) in adults.
Mirabegron is a medicine that helps control an overactive bladder. It relaxes the bladder muscle, allowing it to hold more urine.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from mirabegron's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of mirabegron's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of mirabegron's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of mirabegron's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store mirabegron tablets at room temperature (between 59°F and 86°F).
Side Effects (from patient reports)
Based on 36,931 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for mirabegron, by number of reports
- Feeling tired
Feeling tired
2,215 reports
- Head pain
Head pain
2,162 reports
- Feeling lightheaded
Feeling lightheaded
2,093 reports
- Accidentally falling down
Accidentally falling down
1,892 reports
- Loose, watery stools
Loose, watery stools
1,861 reports
- General pain
General pain
1,742 reports
- Feeling sick to your stomach
Feeling sick to your stomach
1,705 reports
- Purposely using the medicine incorrectly
Purposely using the medicine incorrectly
1,524 reports
- High blood pressure
High blood pressure
1,490 reports
- Blood pressure went up
Blood pressure went up
1,474 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for mirabegron each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where mirabegron sits
mirabegron has more FDA adverse-event reports than 68% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is mirabegron; the line is the median (50th percentile).
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
Reports Mentioning Death
2,913
7.9% of reports — not proof of cause
Hospitalization Reports
7,208
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 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 |
| 16 | DRY MOUTH | 1,319 |
| 17 | CONFUSIONAL STATE | 1,308 |
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 (...
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
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darifenacin
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dutasteride
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dutasteride/tamsulosin
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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 36,931 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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