Based on the clinical trials for Gemtesa (vibegron), patients who were exposed to Gemtesa with at least a 75mg dose and 12-weeks of use experienced a greater than 2% increase in side effects such as constipation. In addition, patients have also experienced issues related to diarrhea, which can later cause constipation due to the irregular bowel movements.
Key Takeaways
Gemtesa does cause constipation in patients. However, it’s usually a less common side effect than some of the others like headache and nausea.
According to the clinical trials where 545 people took 75mg of Gemtesa (vibegron) for 12 weeks, only around 2% of patients experienced gastrointestinal issues such as constipation.
Avoiding spicy foods and acidic foods can be a simple way to avoid issues with constipation while on Gemtesa (vibegron).
Does Gemtesa Cause Constipation?
Constipation is one of the common side effects of Gemtesa (vibegron). However, it’s important to note that according to the clinical trials, constipation is still only experienced in a relatively low number of patients. According to the trial, “The following adverse reactions (like constipation) 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.”
In the trial the number of placebo patients that had diarrhea or other gastrointestinal disorders from the 75mg dose went from 6% to 12%. The total number of patients in the trial was around 545. Making it still a relatively low number of patients that experienced an increase in gastrointestinal issues due to the medication.
How Long Do Side Effects Last
Gemtesa (vibegron) side effects can vary depending on the person. However, on average, side effects can last anywhere from a few days to a few weeks. The best course of action whenever any side effect is causing discomfort in your life is to speak with your PCP (primary care physician) about your medication and consider adjusting your dosage or considering an alternative medication.
How to Avoid Constipation While on Gemtesa (vibegron)
Easy methods to avoid constipation while on Gemtesa (vibegron) usually come from controlling your diet while on the medication. Here are our top tips:
1. Avoid spicy foods
Spicy foods may cause general gastrointestinal discomfort on their own, depending on who you are. When taken in combination with Gemtesa (vibegron), you could increase your chances of experiencing discomfort, along with the other side effects such as diarrhea. Avoid spicy foods that may cause general discomfort.
2. Avoid acidic foods
Acidic foods such as citrus fruits, red meats, and other non-alkaline foods can cause discomfort and difficulty with digestion. In order to keep your digestive system from having to struggle to digest highly acidic foods, avoid foods with low alkalinity.
3. Keep diet to whole foods
A whole food diet can be the best course of action to help with general digestion. This would be your basic meals such as chicken and rice. Or chicken and broccoli. Foods that have a higher pH level are going to be easier for your stomach acids to naturally break down, causing more regular bowel movements.
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Sources
U.S. Food and Drug Administration. (n.d.). Drug trials snapshot: Gemtesa. Retrieved November 15, 2024, from https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-gemtesa
Urovant Sciences. (2020). Gemtesa prescribing information. Retrieved November 15, 2024, from https://www.gemtesa.com/files/gemtesa-prescribing-information.pdf
The Medical Letter. (2023). Vibegron (Gemtesa) for overactive bladder. The Medical Letter on Drugs and Therapeutics, 62(1623). Retrieved November 12, 2024, from https://secure.medicalletter.org/system/files/private/TML-article-1623c.pdf
U.S. Food and Drug Administration. (2020). Original NDA approval for Gemtesa (NDA 213006). Retrieved November 15, 2024, from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213006Orig1s000Approv.pdf
Sumitomo Pharma. (2023). Notice regarding approval of vibegron (generic name) in China for overactive bladder treatment. Retrieved November 13, 2024, from https://www.sumitomo-pharma.com/news/assets/pdf/ene20230912.pdf
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