Medical Editor: John P. Cunha, DO, FACOEP
What Is Gemtesa?
What Are Side Effects of Gemtesa?
Side effects of Gemtesa include:
- urinary tract infection (UTI),
- runny or stuffy nose,
- nausea, and
- upper respiratory tract infection
Dosage for Gemtesa
The recommended dose of Gemtesa is one 75 mg tablet once daily.
TGemtesa In Children
Safety and effectiveness of Gemtesa in pediatric patients have not been established.
What Drugs, Substances, or Supplements Interact with Gemtesa?
Gemtesa may interact with other medicines such as:
Tell your doctor all medications and supplements you use.
Gemtesa During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Gemtesa; it is unknown how it would affect a fetus. It is unknown if Gemtesa passes into breast milk. Consult your doctor before breastfeeding.
Our Gemtesa (vibegron) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following clinically significant adverse reaction is described elsewhere in the labeling:
- Urinary retention [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of GEMTESA was evaluated in a 12-week, double-blind, placebo-and active-controlled study (Study 3003) in patients with OAB [see Clinical Studies]. A total of 545 patients received GEMTESA. The majority of the patients were Caucasian (78%) and female (85%) with a mean age of 60 years (range 18 to 93 years).
Adverse reactions that were reported in Study 3003 at an incidence greater than placebo and in ≥2% of patients treated with GEMTESA are listed in Table 1.
Table 1: Adverse Reactions, Exceeding Placebo Rate, Reported in ≥2% of Patients Treated with GEMTESA 75 mg for up to 12 Weeks in Study 3003
|GEMTESA 75 mg|
|Number of Patients||545||540|
|Headache||22 (4.0)||13 (2.4)|
|Nasopharyngitis||15 (2.8)||9 (1.7)|
|Diarrhea||12 (2.2)||6 (1.1)|
|Nausea||12 (2.2)||6 (1.1)|
|Upper respiratory tract infection||11 (2.0)||4 (0.7)|
Other adverse reactions reported in <2% of patients treated with GEMTESA included:
Gastrointestinal disorders: dry mouth, constipation
Investigations: residual urine volume increased
Renal and urinary disorders: urinary retention
Vascular disorders: hot flush
GEMTESA was also evaluated for long-term safety in an extension study (Study 3004) in 505 patients who completed the 12-week study (Study 3003). Of the 273 patients who received GEMTESA 75 mg once daily in the extension study, 181 patients were treated for a total of one year.
Adverse reactions reported in ≥2% of patients treated with GEMTESA 75 mg for up to 52 weeks in the longterm extension study, and not already listed above, were urinary tract infection (6.6%) and bronchitis (2.9%).
The following adverse reactions have been identified during post-approval use of vibegron. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse events have been reported in association with vibegron use in worldwide postmarketing experience:
Urologic disorders: urinary retention
Skin and subcutaneous tissue disorders: pruritus, rash, drug eruption, eczema
Gastrointestinal disorders: constipation
Read the entire FDA prescribing information for Gemtesa (Vibegron Tablets)
© Gemtesa Patient Information is supplied by Cerner Multum, Inc. and Gemtesa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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