Mirabegron Side Effects

It is possible that some side effects of mirabegron may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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
  • 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
  • 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


Cardiovascular side effects have included atrial fibrillation (0.2%), hypertension (up to 11.3%), tachycardia (up to 1.6%), and palpitations (less than 1%).


Dermatologic side effects occurring in less than 1% of patients have included urticaria, leukocytoclastic vasculitis, rash, pruritus, purpura, and lip edema.


Gastrointestinal side effects have included constipation (up to 1.6%), diarrhea (up to 1.5%), abdominal pain (up to 1.4%), nausea (less than 1%), dyspepsia (less than 1%), gastritis (less than 1%), and abdominal distension (less than 1%).


Genitourinary side effects have included urinary tract infection (up to 4.2%), nephrolithiasis (less than 1%), and bladder pain (less than 1%). Genitourinary side effects reported postmarketing have included urinary retention.


Musculoskeletal side effects have included arthralgia (up to 1.6%),

Nervous system

Nervous system side effects have included headache (up to 3.2%), fatigue (up to 1.4%), and dizziness (less than 1%).


Ocular side effects have included glaucoma (less than 1%), blurred vision (0.4%), and dry eyes (0.4%).


Oncologic side effects have included prostate cancer (0.1%).


Other side effects occurring in less than 1% of patients have included GGT increased, AST increased, ALT increased, LDH increased, vulvovaginal pruritus, and vaginal infection.


Respiratory side effects have included nasopharyngitis (up to 3.9%), upper respiratory tract infection (up to 2.1%), sinusitis (less than 1%), and rhinitis (less than 1%).

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