Myrbetriq Side Effects
Generic name: mirabegron
Medically reviewed by Drugs.com. Last updated on Aug 27, 2024.
Note: This document provides detailed information about Myrbetriq Side Effects associated with mirabegron. Some dosage forms listed on this page may not apply specifically to the brand name Myrbetriq.
Applies to mirabegron: oral powder for suspension extended release, oral tablet extended release.
Serious side effects of Myrbetriq
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 side effects
- 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 side effects
- 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 Myrbetriq
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 side effects
- 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 side effects
- 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 granule for reconstitution extended release, oral tablet extended release.
General adverse events
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
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.
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Pharmaceutical Society of Australia (2006) APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp
3. (2012) "Product Information. Myrbetriq (mirabegron)." Astellas Pharma US, Inc
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Further information
Myrbetriq side effects can vary depending on the individual. 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.