What are the most common side effects of VIBEGRON?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for VIBEGRON. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is VIBEGRON the same as GEMTESA?

GEMTESA is a brand name for VIBEGRON. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

VIBEGRON

Q: What is VIBEGRON used for?

VIBEGRON (brand name GEMTESA) is a Beta-3 Agonist indicated for 1 INDICATIONS AND USAGE GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of: overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. ( 1.1 ) overactive bladder (OAB) with symptoms of urge urinary incontinence.

Q: How does VIBEGRON work?

VIBEGRON works through the following mechanism: 12.1 Mechanism of Action Vibegron is a selective human beta-3 adrenergic receptor agonist. Activation of the beta-3 adrenergic receptor increases bladder capacity by relaxing the detrusor smooth muscle during bladder filling..

Beta-3 Agonist

Brand names: GEMTESA, Gems

Oral

Mechanism of Action

12.1 Mechanism of Action Vibegron is a selective human beta-3 adrenergic receptor agonist. Activation of the beta-3 adrenergic receptor increases bladder capacity by relaxing the detrusor smooth muscle during bladder filling.

Indications

1 INDICATIONS AND USAGE GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of: overactive bladder (OAB) with symptoms of urge urinary incontinence

urgency

and urinary frequency in adults. ( 1.1 ) overactive bladder (OAB) with symptoms of urge urinary incontinence

urgency

Contraindications

• 4 CONTRAINDICATIONS GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions
• such as angioedema
• have occurred [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] . Do not use if prior hypersensitivity reaction to vibegron or any components of the product. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Urinary Retention : Monitor for urinary retention, especially in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for OAB, in whom the risk of urinary retention may be greater
The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB
GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any component of GEMTESA [see Contraindications ( 4 ) and Adverse Reactions ( 6

Known Side Effects

8 documented side effects by frequency

Drug Not Working

>10%

Diarrhea

1-10%

Headache

1-10%

UTI

1-10%

Fatigue

1-10%

Nausea

1-10%

Constipation

0.1-1%

Dizziness

0.1-1%

Community Discussions

No community discussions found for VIBEGRON yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → VIBEGRON openFDA label JSON → VIBEGRON FAERS adverse-event reports → VIBEGRON ClinicalTrials.gov → completed Phase 2+ trials of VIBEGRON

Compare With

4 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral