Mirabegron is a beta-3 adrenergic agonist that is used for treatment of overactive bladder syndrome. Mirabegron has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.


Mirabegron (mir" a beg' ron) is a synthetic beta-3 adrenergic agonist which binds to receptors in the bladder that causes relaxation of the detrusor smooth muscle and results in an increase in the bladder capacity. Mirabegron has been evaluated as therapy of the overactive bladder syndrome, a condition marked by urgency, frequency, nocturia and incontinence that occurs most commonly in older women. Other therapies of overactive bladder include anticholinergics, but these are only partially effective and can have troublesome side effects, particularly in the elderly. In several short term clinical trials, mirabegron was found to increase voided volume and decrease episodes of incontinence and urinary frequency modestly. Mirabegron was approved for use in the United States in 2012 as treatment of overactive bladder with symptoms of urgency, incontinence, and frequency. In 2021, the indications were expanded to include treatment of children with neurogenic detrusor muscle instability using formulations of mirabegron granules. Mirabegron is available as 25 and 50 mg extended-release tablets under the brand name Myrbetriq. The typical dose in adults is 25 to 50 mg orally once daily. Mirabegron is also available as granules in solution of 8 mg/mL, and the typical dose in children is 48 or 80 mg daily. Side effects are not common, but can include nausea, diarrhea, constipation, dizziness, tachycardia, palpitations, hypertension, and headache. Rare, but potentially severe side effects include hypertension, urinary retention, and hypersensitivity reactions, angioedema, and rash.


In preregistration clinical trials, serum aminotransferase elevations were uncommon and mild in patients treated with mirabegron and rates of serum enzyme elevations were similar to those with placebo treatment. Among several thousands of patients treated, there were no episodes of clinically apparent liver injury. Since its approval and more widescale use, there have not been any published reports of hepatotoxicity attributed to mirabegron. However, the product label for mirabegron mentions occasional elevations in ALT and AST associated with treatment as well as a case of Stevens Johnson syndrome with aminotransferase elevations. Thus, mirabegron may cause hepatic injury as a part of a generalized hypersensitivity reactions.

Likelihood score: E* (unproven but suspected rare cause of clinically apparent liver injury).

Mechanism of Injury

The possible cause of liver injury due to mirabegron is not known but might result from a generalized hypersensitivity reaction. Mirabegron is metabolized in part by CYP 2D6, but drug-drug interactions with agents that inhibit or induce this enzyme are uncommon.

Drug Class: Urologic Agents, Overactive Bladder Syndrome Agents

Other Drugs in the Subclass, Overactive Bladder Syndrome Agents: Darifenacin, Fesoterodine, Flavoxate, Hyoscyamine, Oxybutynin, Solifenacin, Tolterodine, Trospium, Vibegron



Mirabegron – Myrbetriq®


Urologic Agents


Product labeling at DailyMed, National Library of Medicine, NIH



References updated: 14 July 2023

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    (Among 199 adult women with overactive bladder syndrome treated with 50 mg of either mirabegron or vibegron daily for 12 weeks, response rates were similar in both groups as were overall rates of adverse events [17.5% vs 15.7%], discontinuations [6.2% vs 6.8%], constipation [10.3% vs 11.8%], dry mouth [both 1%], and rash [2% vs 1%]; no mention of ALT elevations or hepatotoxicity).
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