GEMTESA SIDE EFFECTS AND ESTABLISHED SAFETY IN A CLINICAL STUDY AT 12 WEEKS

What are the most common side effects of GEMTESA?

In a 12-week clinical study of GEMTESA:

The most common side effects of GEMTESA at 12 weeks in a clinical trial were headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infection.

GEMTESA had no significant impact on blood pressure. At 12 weeks, people taking GEMTESA and those taking placebo had similar rates of hypertension (1.7 vs 1.7, respectively), and increased blood pressure (0.7 vs 0.9, respectively).

Less than 2% of people stopped taking GEMTESA because of side effects.

What is GEMTESA?

GEMTESA 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: the need to urinate right away
frequency: urinating often

It is not known if GEMTESA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA 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 GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. 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.

Please see full Prescribing Information.

GEMTESA SIDE EFFECTS AND ESTABLISHED SAFETY IN A CLINICAL STUDY AT 12 WEEKS

What are the most common side effects of GEMTESA?

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