What the label lists and what reports show
Mirabegron side effects
Mirabegron's FDA label: “Most commonly reported adverse reactions with mirabegron monotherapy in adult patients with OAB (> 2% and > placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache.” FAERS holds 38,466 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (2,325 reports).
- Generic listed
Check it at the source: the mirabegron FDA label on DailyMed (effective December 24, 2025, Lupin Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of mirabegron extended-release tablets?Mirabegron extended-release tablets may cause serious side effects, including: increased blood pressure. Mirabegron extended-release tablets may cause your blood pressure to increase or make your blood pressure worse if you have a history of high blood pressure. You and your doctor should check your blood pressure while you are taking mirabegron extended-release tablets. Call your doctor if you have increased blood pressure. inability to empty your bladder (urinary retention). Mirabegron extended-release tablets may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction or if you are taking other medicines to treat overactive bladder. Tell your doctor right away if you are unable to empty your bladder. angioedema. […]
Source: FDA drug label, Lupin Pharmaceuticals, Inc., effective December 24, 2025 (SPL set d22d3d12-8466-46db-bc19-d13e87c6115c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost commonly reported adverse reactions with mirabegron monotherapy in adult patients with OAB (> 2% and > placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache.
Table 9: Percentages of Patients with Adverse Reactions, Derived from All Adverse Events, Reported in > 2% of OAB Patients Treated with MYRBETRIQ 50 mg Once Daily in Study 4
This table is printed in the Myrbetriq label published by Astellas Pharma US, Inc. of August 1, 2024; the label quoted above does not print one.
| Adverse Reaction | MYRBETRIQ 50 mg (%) | Active Control (%) |
|---|---|---|
| Number of Patients | 812 | 812 |
| Hypertension | 9.2 | 9.6 |
| Urinary Tract Infection | 5.9 | 6.4 |
| Headache | 4.1 | 2.5 |
| Nasopharyngitis | 3.9 | 3.1 |
| Back Pain | 2.8 | 1.6 |
| Constipation | 2.8 | 2.7 |
| Dry Mouth | 2.8 | 8.6 |
| Dizziness | 2.7 | 2.6 |
| Sinusitis | 2.7 | 1.5 |
| Influenza | 2.6 | 3.4 |
| Arthralgia | 2.1 | 2.0 |
| Cystitis | 2.1 | 2.3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost commonly reported adverse reactions with mirabegron monotherapy in adult patients with OAB (> 2% and > placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are discussed in more detail in other sections of the labeling. Hypertension [see Warnings and Precautions ( 5.1 )] Urinary Retention [see Warnings and Precautions ( 5.2 )] Angioedema [see Warnings and Precautions ( 5.3 )] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Mirabegron Extended-Release Tablets Monotherapy for Adult OAB In three, 12-week, double-blind, placebo-controlled, safety and efficacy studies in patients with OAB (Studies 1, 2, and 3), mirabegron extended-release tablets were evaluated for safety in 2736 patients [see Clinical Studies ( 14.1 )]. Study 1 also included an active control. …
Source: FDA drug label, Lupin Pharmaceuticals, Inc., effective December 24, 2025 (SPL set d22d3d12-8466-46db-bc19-d13e87c6115c), via openFDA; the full label on DailyMed
What do FAERS reports show?
38,466 reports list mirabegron among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,197 are coded as a death and 7,785 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Mirabegron: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions