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Mirabegron Side Effects

Medically reviewed by Last updated on Oct 2, 2023.

Applies to mirabegron: oral powder for suspension extended release, oral tablet extended release.

Serious side effects of Mirabegron

Along with its needed effects, mirabegron may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking mirabegron:

More common


Incidence not known

Other side effects of Mirabegron

Some side effects of mirabegron may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common


For Healthcare Professionals

Applies to mirabegron: oral granule for reconstitution extended release, oral tablet extended release.


The more commonly reported adverse reactions have included hypertension, nasopharyngitis, urinary tract infection, and headache.


In 2 randomized controlled studies, dose-related increases in supine blood pressure occurred. At the maximum recommended dose of 50 mg per day, the mean maximum increase in systolic/diastolic blood pressure was approximately 3.5/1.5 mm Hg.[Ref]

Very common (10% or more): Hypertension (up to 11.3%)

Common (1% to 10%): Tachycardia

Uncommon (0.1% to 1%): Atrial fibrillation, palpitations, worsening of preexisting hypertension[Ref]


Angioedema of the face, lips, tongue, and/or larynx has been reported. In some case, this occurred after the first dose or after multiple doses.[Ref]

Uncommon (0.1% to 1%): Urticaria, rash, pruritus, lip edema, macular rash, papular rash

Rare (less than 0.1%): Leukocytoclastic vasculitis, purpura, angioedema[Ref]


Common (1% to 10%): Nausea, constipation, diarrhea, abdominal pain

Uncommon (0.1% to 1%): Dyspepsia, gastritis, abdominal distension

Rare (less than 0.1%): Lip edema[Ref]


Urinary retention has been reported in patients with bladder outlet obstruction (BOO) and in patients taking muscarinic antagonists for the treatment of overactive bladder. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patient taking this drug.[Ref]

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Nephrolithiasis, bladder pain, cystitis, vaginal infection, vulvovaginal pruritus

Postmarketing reports: Urinary retention[Ref]


Common (1% to 10%): Arthralgia

Uncommon (0.1% to 1%): Joint swelling[Ref]

Nervous system

Common (1% to 10%): Headache, fatigue, dizziness[Ref]


Uncommon (0.1% to 1%): Glaucoma, blurred vision, dry eyes

Rare (less than 0.1%): Eyelid edema[Ref]


Rare (less than 0.1%): Prostate cancer[Ref]


Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, sinusitis, rhinitis[Ref]


Uncommon (0.1% to 1%): Increased ALT, AST, and GGT[Ref]


Postmarketing reports: Confusion, hallucinations, insomnia, anxiety

The majority of patients reporting confusion, hallucinations, insomnia, and anxiety had preexisting conditions or were using concomitant medications that may have contributed to these events.


1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Pharmaceutical Society of Australia. APPGuide online. Australian prescription products guide online. 2006.

3. Product Information. Myrbetriq (mirabegron). Astellas Pharma US, Inc. 2012.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.