Summary

Commonly reported side effects of mirabegron include: hypertension. Other side effects include: urinary tract infection. Continue reading for a comprehensive list of adverse effects.

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

• Bladder pain
• bloody or cloudy urine
• blurred vision
• difficult, burning, or painful urination
• dizziness
• frequent urge to urinate
• headache
• lower back or side pain
• nervousness
• pounding in the ears
• slow, fast, or irregular heartbeat

Rare

• Blindness
• decrease in vision
• eye pain
• lower abdominal or stomach pain
• nausea
• pain in the groin or genitals
• tearing or eyes
• vomiting

Incidence not known

• Blistering, peeling, or loosening of the skin
• chills
• confusion
• cough
• decrease in the frequency of urination
• decrease in urine volume
• diarrhea
• difficulty in passing urine (dribbling)
• itching
• joint or muscle pain
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• red skin lesions, often with a purple center
• red, irritated eyes
• seeing, hearing, or feeling things that are not there
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• trouble sleeping
• unusual tiredness or weakness

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

• Back pain
• body aches or pain
• constipation
• difficulty having a bowel movement
• difficulty with breathing
• difficulty with moving
• dry mouth
• ear congestion
• fever
• general feeling of discomfort or illness
• loss of voice
• muscle ache or stiffness
• shivering
• sneezing
• stomach pain
• stuffy or runny nose
• sweating

Rare

• Belching
• burning feeling in the chest or stomach
• full or bloated feeling
• heartburn
• hives or welts, skin rash
• indigestion
• itching or pain of the vagina or genital area
• pain or tenderness around the eyes and cheekbones
• pressure in the stomach
• redness of the skin
• stomach discomfort, upset, or tenderness
• swelling of the lips
• thick, white vaginal discharge with mild or no odor

For Healthcare Professionals

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

General

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

Cardiovascular

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]

Dermatologic

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]

Gastrointestinal

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]

Genitourinary

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]

Musculoskeletal

Common (1% to 10%): Arthralgia

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

Nervous system

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

Ocular

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

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

Oncologic

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

Respiratory

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

Hepatic

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

Psychiatric

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.