Mirabegron, a beta-3 adrenergic receptor agonist, is used to treat overactive bladder (OAB) by relaxing the bladder muscle during the filling phase, increasing its capacity. Unlike antimuscarinic drugs, it offers a unique mechanism with fewer side effects like dry mouth or constipation.

The FDA approved Mirabegron on June 28, 2012, for OAB treatment, and it has since gained approval in multiple countries, including the European Union and Japan.

Its approval was based on robust Phase II and III clinical trials, which demonstrated significant reductions in incontinence episodes and urinary frequency, along with improved quality of life. Long-term studies confirmed sustained efficacy and safety. While generally well-tolerated, slight increases in blood pressure were noted in some patients. Mirabegron has become a key option for patients who do not respond well to or tolerate traditional OAB therapies.

Mirabegron treats symptoms associated with an overactive bladder, such as urgency incontinence (inability to control bladder emptying), sudden urination urges, and increased urinary frequency.

Take the Mirabegron as your physician advises. Do not crush, chew, or open the medicine. Your physician will decide the correct dosage and duration based on age, body weight, and disease condition. Only stop taking the tablet if your doctor advises you to stop.

The most common side effects of Mirabegron are increased heart rate, nausea, constipation, diarrhea, dizziness, and urinary tract infection Serious side effects while taking Mirabegron are irregular heartbeat, sudden or throbbing headache, angioedema (swelling of the face, mouth, or throat), elevated blood pressure.

Mirabegron should not be taken if you have allergies to Mirabegron or if you have high uncontrolled blood pressure. Before starting the treatment, inform your doctor if you have trouble emptying your bladder (urinary retention) or if you are taking specific medications for HIV, fungal or bacterial infections, or anticholinergic medicine. Don't consume this medicine if you are pregnant or planning to get pregnant or breastfeeding.

Notify your doctor if you have liver or kidney problems. Your doctor may adjust your dose in such conditions. Also, inform your doctor if you have any heart conditions, such as abnormal ECG (QT prolongation) or taking medications that may cause it. This medicine is not advised to use in children under 18 years old. Inform your doctor if you are pregnant, planning to get pregnant, or think you may be pregnant or breastfeeding.

Liver, heart, and kidney patients should take Mirabegron cautiously and inform the doctor about all the underlying medical conditions and medications they consume. Do not stop the medicine until your doctor advises. Do not double-dose the medicine to make up for a forgotten dose. Notify your doctor if you experience any serious side effects. 

Your medical professional will inform you if you need any dose adjustments. Contact your doctor for more information. Keep out of sight and reach of pets and children. Do not freeze the medicine. Do not store above 30°C. Always check the expiry date before consuming it.

1. Astellas Pharma Ltd, Electronic Medicines Compendium (EMC), [Revised on December 2022] [Accessed on 6th June 2023], MIRABEGRON-TAB PL-Patient United Kingdom (Great Britain) en - TW366830 (medicines.org.uk)
2. Astellas Pharma US, Inc; [Revised on March 2021] [Accessed on 6th June 2023],label (fda.gov)
3. J. Goddard, A.N. Turner, Kidney and urinary tract disease, Davidson’s Principles and Practice of Medicine, 22nd Edition, 2014, 461-523

The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you are eligible to receive this treatment.