Mirabegron is used alone or together with other medicines (eg, solifenacin succinate) to treat the symptoms of an overactive bladder. It helps control incontinence (loss of bladder control), the need to urinate right away, and the need to urinate often. Mirabegron works on the muscles of the bladder to prevent them from causing incontinence.

This medicine is available only with your doctor's prescription.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the extended-release tablet whole and with water. Do not crush, break, or chew it. You may take this medicine with or without food.

Along with its needed effects, a medicine 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:

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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.