Myrbetriq

Note: This document contains side effect information about mirabegron. Some of the dosage forms listed on this page may not apply to the brand name Myrbetriq.

Common side effects of Myrbetriq include: hypertension. Other side effects include: urinary tract infection. See below for a comprehensive list of adverse effects.

Applies to mirabegron: oral tablet extended release

Along with its needed effects, mirabegron (the active ingredient contained in Myrbetriq) 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
• 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
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• unusual tiredness or weakness

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
• difficulty having a bowel movement
• difficulty with breathing
• difficulty with moving
• dry mouth
• ear congestion
• fever
• loss of voice
• muscle ache or stiffness
• sneezing
• stomach pain
• stuffy or runny nose

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

Applies to mirabegron: oral tablet extended release

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

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

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.

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

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

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.

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

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

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

Postmarketing reports: Urinary retention

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.

Common (1% to 10%): Arthralgia

Uncommon (0.1% to 1%): Joint swelling

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

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

Rare (less than 0.1%): Eyelid edema

Rare (less than 0.1%): Prostate cancer

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

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

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.

Postmarketing reports: Confusion, hallucinations, insomnia, anxiety