Can Mirabegron Be Crushed?
No, mirabegron extended-release tablets must not be crushed, chewed, or divided—they must be swallowed whole with water. 1
Administration Requirements
The FDA labeling explicitly states that mirabegron extended-release tablets should be:
- Swallowed whole with water 1
- Never chewed, divided, or crushed 1
- Taken with or without food in adults 1
- Taken with food in pediatric patients 1
Why Crushing Is Contraindicated
Mirabegron is formulated using oral controlled-absorption system (OCAS) technology, which is an extended-release delivery system. 2 This specialized formulation is designed to:
- Control the rate of drug release over 24 hours 2
- Maintain therapeutic plasma concentrations 2
- Minimize peak-related adverse effects 2
Crushing the tablet would destroy the extended-release mechanism, potentially causing:
- Immediate release of the entire 25 mg or 50 mg dose 1
- Dangerously high peak plasma concentrations 2
- Increased risk of dose-related adverse effects including hypertension (7.5-11.3% incidence), tachycardia, and cardiovascular complications 3, 4
- Loss of 24-hour therapeutic coverage 2
Alternative Options for Patients with Swallowing Difficulties
For patients who cannot swallow tablets whole, the FDA labeling indicates that mirabegron granules are available as an alternative formulation for certain patient populations. 1 However, the labeling explicitly states that:
- Mirabegron extended-release tablets and mirabegron granules are NOT substitutable on a milligram-per-milligram basis 1
- Product selection should be based on indication and patient weight 1
Clinical Pitfalls to Avoid
- Never attempt to crush, split, or dissolve mirabegron tablets to facilitate administration, as this compromises the extended-release formulation and patient safety 1
- Do not assume bioequivalence between different mirabegron formulations—they require different dosing 1
- Be aware that food significantly affects mirabegron absorption (low-fat meals reduce exposure by 47-51%), though this does not warrant dose adjustment in clinical practice 2
Practical Recommendation
If a patient cannot swallow mirabegron extended-release tablets whole, consult with the prescriber about switching to mirabegron granules (if appropriate for the indication and patient weight) or consider alternative therapies such as behavioral interventions (pelvic floor muscle training, bladder training) which are first-line treatments for overactive bladder and have minimal adverse effects. 5