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Mirabegron Side Effects

In Summary

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

For the Consumer

Applies to mirabegron: oral tablet extended release

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 or vomiting
  • pain in the groin or genitals
  • tearing or eyes

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
  • 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

  • Abdominal or stomach pain
  • back pain
  • body aches or pain
  • difficulty having a bowel movement (stool)
  • difficulty with breathing
  • difficulty with moving
  • dry mouth
  • ear congestion
  • fever
  • loss of voice
  • muscle aches
  • muscle stiffness
  • sneezing
  • stuffy or runny nose

Rare

  • Acid or sour stomach
  • belching
  • burning feeling in the chest or stomach
  • full or bloated feeling
  • heartburn
  • hives or welts
  • indigestion
  • itching
  • 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
  • shortness of breath or troubled breathing
  • skin rash
  • stomach discomfort or upset
  • swelling of the lips
  • tenderness in the stomach area
  • thick, white vaginal discharge with mild or no odor

For Healthcare Professionals

Applies to mirabegron: oral tablet extended release

General

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

Cardiovascular

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]

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]

Dermatologic

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

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

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

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]

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]

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

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

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

3. "Product Information. Myrbetriq (mirabegron)." Astellas Pharma US, Inc, Deerfield, IL.

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.

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