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.
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
- Fatigue
Fatigue
2,215 reports
- Headache
Headache
2,162 reports
- Dizziness
Dizziness
2,093 reports
- Fall
Fall
1,892 reports
- Diarrhoea
Diarrhoea
1,861 reports
- Pain
Pain
1,742 reports
- Nausea
Nausea
1,705 reports
- Intentional Product Misuse
Intentional Product Misuse
1,524 reports
- Hypertension
Hypertension
1,490 reports
- Blood Pressure Increased
Blood Pressure Increased
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) 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for mirabegron?
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.
Compare with mirabegron →
bethanechol
Urecholine
Bethanechol helps you to urinate if you have trouble emptying your bladder.
Compare with mirabegron →
darifenacin
Enablex
Darifenacin (Enablex) is a medicine that helps control an overactive bladder.
Compare with mirabegron →
dutasteride
Avodart
Dutasteride and tamsulosin hydrochloride capsules contain two medicines to treat enlarged prostate in men.
Compare with mirabegron →
dutasteride/tamsulosin
Jalyn
This medicine combines two drugs to treat enlarged prostate in men.
Compare with mirabegron →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for mirabegron: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 36,931.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 7.89%.
- methotrexate Δ 0.04 pts · 410,053 reports · Disease-Modifying Antirheumatic Drug (DMARD) 7.93%death share
- ranitidine Δ 0.07 pts · 197,405 reports · H2 Receptor Antagonist 7.82%death share
- saxagliptin Δ 0.07 pts · 8,141 reports · DPP-4 Inhibitor 7.96%death share
- etodolac Δ 0.08 pts · 5,880 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 7.81%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: September 26, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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