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Gemtesa Side Effects

Generic name: vibegron

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 8, 2025.

Note: This document provides detailed information about Gemtesa.

Applies to vibegron: oral tablet Side Effects associated with vibegron. Some dosage forms listed on this page may not apply specifically to the brand name Gemtesa.

Applies to vibegron: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Urine tests may be needed to check for unwanted effects.

This medicine may increase your risk of having urinary retention (trouble passing urine or not fully emptying the bladder), especially if you have bladder blockage or when using another medicine. Check with your doctor right away if you have a decrease in urine volume, decrease in the frequency of urination, difficulty in passing urine (dribbling), or painful urination.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Gemtesa

Along with its needed effects, vibegron (the active ingredient contained in Gemtesa) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking vibegron:

More common side effects

  • bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • lower back or side pain

Incidence not known

  • decrease in the frequency of urination
  • decrease in urine volume
  • difficulty in passing urine (dribbling)
  • itching, skin rash, encrusted, scaly and oozing

Other side effects of Gemtesa

Some side effects of vibegron may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common side effects

  • body aches or pain
  • chills
  • constipation
  • cough or cough producing mucus
  • diarrhea
  • difficulty in breathing
  • dry mouth
  • ear congestion
  • headache
  • feeling of warmth
  • fever
  • loss of voice
  • muscle aches
  • nausea
  • redness of the face, neck, arms and occasionally, the upper chest
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tightness in the chest
  • unusual tiredness or weakness

For healthcare professionals

Applies to vibegron: oral tablet.

General adverse events

The most common adverse reactions were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.[Ref]

Cardiovascular

In nonhypertensive patients, hypertension was defined as an average systolic blood pressure (SBP) at least 140 mmHg or diastolic BP (DBP) at least 90 mmHg on 3 assessments at 2 consecutive visits. In hypertensive patients, hypertension was defined as an average increased SBP at least 20 mmHg or DBP at least 10 mmHg on 3 assessments at 2 consecutive visits, or the start or increase in dose of antihypertensive therapy at any visit.

Dermatologic

Rash included pruritic rash and erythematous rash.

Gastrointestinal

Genitourinary

Urinary retention included urinary straining.

Hypersensitivity

Hypersensitivity reactions included urticaria, pruritus, rash, and drug eruption.

Nervous system

Respiratory

See also:

References

1. (2025) "Product Information. Obgemsa (vibegron)." Pierre Fabre Ltd

2. (2024) "Product Information. Gemtesa (vibegron)." Urovant Sciences, Inc, SUPPL-11

Frequently asked questions

Further information

Gemtesa side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.