Myrbetriq Side Effects

Generic name: mirabegron

Medically reviewed by Drugs.com. Last updated on Jun 12, 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:

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:

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase your blood pressure. You will need to have your blood pressure measured while you are using this medicine. If you notice any change in your blood pressure, call your doctor right away.

This medicine may increase your risk of having urinary retention (trouble passing urine or not fully emptying the bladder), especially when using another medicine (eg, solifenacin succinate). Check with your doctor if you have a decrease in urine volume, decrease in the frequency of urination, difficulty in passing urine (dribbling), or painful urination.

This medicine may cause a serious allergic reaction, called angioedema, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, rouble breathing, or trouble swallowing after using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

• 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.

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer