Mirabegron: risk of severe hypertension

Mirabegron (Betmiga) is associated with a risk of severe hypertension, cerebrovascular and cardiac events, and is now contraindicated in patients with severe uncontrolled hypertension, the MHRA has advised.

Mirabegron is used in the management of urinary frequency, urgency and incontinence in overactive bladder syndrome.

Mirabegron is contraindicated in patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg) and should be used with caution in patients with stage 2 hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).

Further information
View Betmiga drug record
MHRA Drug Safety Update
Manufacturer: Astellas Pharma

Cases of severe hypertension, including hypertensive crisis associated with reports of transient ischaemia attack or stroke, have been reported in patients treated with mirabegron. Healthcare professionals should measure blood pressure before and throughout treatment, especially in patients with pre-existing hypertension. 

All suspected adverse reactions associated with mirabegron should be reported in accordance with the MHRA Yellow Card Scheme.

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