The U.S. Food and Drug Administration has approved Myrbetriq (mirabegron) to treat adults with overactive bladder, a condition in which the bladder muscle cannot be controlled, squeezes too often or squeezes without warning.
An extended-release tablet taken once daily, Myrbetriq improves the storage capacity of the bladder by relaxing the bladder muscle during filling. Symptoms of overactive bladder include the need to urinate too often (urinary frequency), the need to urinate immediately (urinary urgency), and the involuntary leakage of urine as a result of the need to urinate immediately (urge urinary incontinence).
Myrbetriq is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:
- Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
- Urgency: a strong need to urinate right away
- Frequency: urinating often
It is not known if Myrbetriq is safe and effective in children.
Before you take Myrbetriq, tell your doctor if you:
- have liver problems
- have kidney problems
- have very high uncontrolled blood pressure
- have trouble emptying your bladder or you have a weak urine stream
- are pregnant or plan to become pregnant. It is not known if Myrbetriq will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if Myrbetriq passes into your breast milk. You and your doctor should decide if you will take Myrbetriq or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Myrbetriq may affect the way other medicines work, and other medicines may affect how Myrbetriq works.
Tell your doctor if you take:
- thioridazine (Mellaril or Mellaril-S)
- flecainide (Tambocor)
- propafenone (Rythmol)
- digoxin (Lanoxin)
Myrbetriq may cause serious side effects including:
- increased blood pressure. Myrbetriq may cause your blood pressure to increase or make your blood pressure worse if you have a history of high blood pressure. It is recommended that your doctor check your blood pressure while you are taking Myrbetriq.
- inability to empty your bladder (urinary retention). Myrbetriq may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction or if you are taking other medicines to treat overactive bladder. Tell your doctor right away if you are unable to empty your bladder.
The most common side effects of Myrbetriq include:
- increased blood pressure
- common cold symptoms (nasopharyngitis)
- urinary tract infection
Tell your doctor if you have any side effect that bothers you or that does not go away or if you have hives, skin rash or itching while taking Myrbetriq.
These are not all the possible side effects of Myrbetriq. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.