FDA label
What is Gemtesa used for?
Gemtesa contains vibegron. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Gemtesa lists 2 uses: Overactive Bladder in Adults; Overactive Bladder in Adult Males with Benign Prostatic Hyperplasia (BPH).
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Gemtesa, tablet, film coated
Indications and Usage, quoted from the label by Sumitomo Pharma America, Inc. (NDA213006). Cross-references to other label sections are left out.
Overactive Bladder in Adults
GEMTESA® is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Overactive Bladder in Adult Males with Benign Prostatic Hyperplasia (BPH)
GEMTESA is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).
Source: DailyMed label, set id 25f21d25-14f8-4fda-91f6-7aa8b68aa1c8, version 12, effective April 1, 2025. NDC 73336-075, one of 1 listing for this product.
Questions
What is Gemtesa used for?
The FDA label for Gemtesa lists 2 uses: Overactive Bladder in Adults; Overactive Bladder in Adult Males with Benign Prostatic Hyperplasia (BPH).
What drug class is Gemtesa?
FDA lists vibegron in the beta3-Adrenergic Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.