About IBSRELA
How IBSRELA works
IBSRELA works differently than other IBS-C medications:
IBSRELA works differently than other IBS-C medications:
Helps stool move more easily
IBSRELA keeps water in your gut to create softer, well-formed stools that move more comfortably
Helps support the gut’s protective lining
IBSRELA helps restore the gut lining, which may reduce irritation linked to belly pain*
Helps calm pain-sensing nerves
IBSRELA helps calm pain-sensing nerves in the intestine,* which can reduce sensitivity to belly pain
*This was seen in animal studies, and the relevance to humans is not known.
IBSRELA works exclusively in the intestine to help address the symptoms of IBS‑C.
Create a personalized guide to discuss your symptoms with your healthcare provider, and ask them if IBSRELA could be right for you.
IBSRELA delivers rapid and lasting relief of IBS-C symptoms
More people taking IBSRELA had an overall response (improved bowel movements and reduced belly pain together) than placebo-treated patients (those not taking IBSRELA) in a 26-week study. People taking IBSRELA typically began to experience constipation and belly pain improvement as early as 1 week and continued to experience improvement in belly pain during the first 3 months of treatment.†‡
More Bowel Movements
3.2 vs 1.5 per week in placebo-treated patients (those not taking IBSRELA), on average from start of treatment, with a feeling of complete emptying‡
Less Belly Pain
from start of treatment vs 39% in placebo-treated patients (those not taking IBSRELA), on average with people continuing to experience improvement during the first 3 months of treatment‡
Less Bloating
from start of treatment vs 32% in placebo-treated patients (those not taking IBSRELA), on average‡
These were observed data. While these endpoints were evaluated in a separate 12-week clinical trial, an earlier endpoint in the testing sequence was not met. As a result, the outcomes were not consistent enough across studies to draw conclusions and may have occurred by chance.
With continued use, IBSRELA typically provides lasting symptom relief...
so that you can get back to doing what you enjoy!‡
The goal of the study was to measure relief from constipation and belly pain together. People had to experience these improvements consistently during at least half of the 12 weeks of treatment. 37% of people taking IBSRELA achieved this goal compared with 24% of people not taking IBSRELA.
Common side effects and long-term safety data
Diarrhea is the most common side effect experienced by those taking IBSRELA. If diarrhea occurs with IBSRELA, it tends to be mild-to-moderate and typically goes away within 1 week.
Stop taking IBSRELA and call your healthcare provider if you experience severe diarrhea while taking IBSRELA.Other common side effects of IBSRELA may include swelling—or a feeling of fullness or pressure in your belly—gas, and dizziness.
IBSRELA was studied in people for more than 52 weeks in clinical trials.§
Includes only patients who remained in studies for ≥1 year.
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Frequently asked questions
What is IBSRELA?
IBSRELA is a prescription medication for adults with Irritable Bowel Syndrome with Constipation (IBS‑C) that works differently to relieve the constipation and belly pain of IBS‑C.
What is the most important information I should know about IBSRELA?
- Do not give IBSRELA to children who are less than 6 years of age. It may harm them.
- You should not give IBSRELA to children 6 years to less than 18 years of age. It may harm them. IBSRELA can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
See “What are the common side effects of IBSRELA?” below for more information about side effects.
Who is IBSRELA for?
IBSRELA is a prescription medicine used in adults to treat IBS-C. It is not known if IBSRELA is safe and effective in children less than 18 years of age.
Who should not take IBSRELA?
- Do not give IBSRELA to children who are less than 6 years of age. IBSRELA can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
- Do not take IBSRELA if a doctor has told you that you have a bowel blockage (intestinal obstruction).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
How is IBSRELA different from other IBS‑C prescription medications?
IBSRELA treats IBS‑C symptoms, like constipation and belly pain, in three ways:
- Helps stool move more easily
IBSRELA keeps water in your gut to create softer, well-formed stools that move more comfortably - Helps support the gut’s protective lining
IBSRELA helps restore the gut lining, which may reduce irritation and inflammation linked to belly pain* - Helps calm pain-sensing nerves
IBSRELA helps calm pain-sensing nerves in the intestine,* which can reduce sensitivity to belly pain
IBSRELA works exclusively in the intestine to help address the symptoms of IBS‑C.
*This was seen in animal studies, and the relevance to humans is not known.
What symptoms does IBSRELA help with?
More people taking IBSRELA had an overall response (improved bowel movements and reduced belly pain together) than placebo-treated patients (those not taking IBSRELA) in a 26-week study. People taking IBSRELA typically began to experience constipation and belly pain improvement as early as 1 week.*
- Constipation: People treated with IBSRELA experienced more bowel movements per week, with a feeling of complete emptying†
- Belly pain: People continued to experience improvement in belly pain during the first 3 months of treatment†
- Bloating: Improvements were usually maintained with continued use of IBSRELA†
†These were observed data. While these endpoints were evaluated in a separate 12-week clinical trial, an earlier endpoint in the testing sequence was not met. As a result, the outcomes were not consistent enough across studies to draw conclusions and may have occurred by chance.
*The goal of the study was to measure relief from constipation and belly pain together. People had to experience these improvements consistently during at least half of the 12 weeks of treatment. 37% of people taking IBSRELA achieved this goal compared with 24% of people not taking IBSRELA.
What are the IBSRELA dosing instructions?
IBSRELA is a 50-mg tablet taken twice a day, just before breakfast and just before dinner.
How long does it take for IBSRELA to work?
Most people taking IBSRELA start to see rapid relief from constipation and belly pain within 1 week of treatment.
What are the common side effects of IBSRELA?
IBSRELA can cause serious side effects, including:
- See “What is the most important information I should know about IBSRELA?”
- Diarrhea is the most common side effect of IBSRELA, and it can sometimes be severe. Stop taking IBSRELA and call your doctor if you develop severe diarrhea.
The other most common side effects of IBSRELA include:
- swelling, or a feeling of fullness or pressure in your abdomen (distension).
- gas (flatulence).
- dizziness.
These are not all the possible side effects of IBSRELA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to www.fda.gov/medwatch.
IMPORTANT RISK INFORMATION
- Do not give IBSRELA to children who are less than 6 years of age. It may harm them.
- You should not give IBSRELA to children 6 years to less than 18 years of age. It may harm them. IBSRELA can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
- Do not take IBSRELA if a doctor has told you that you have a bowel blockage (intestinal obstruction).
Before you take IBSRELA, tell your doctor about your medical conditions, including if you are:
- Pregnant or plan to become pregnant. It is not known if IBSRELA will harm your unborn baby.
- Breastfeeding or plan to breastfeed, although IBSRELA is not expected to pass into your breast milk and to harm your baby. Talk with your doctor about the best way to feed your baby if you take IBSRELA.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Side Effects
Diarrhea is the most common side effect of IBSRELA, and it can sometimes be severe. Stop taking IBSRELA and call your doctor if you develop severe diarrhea.
Other common side effects of IBSRELA include swelling, or a feeling of fullness or pressure in your abdomen (distension), gas (flatulence), or dizziness.
These are not all the possible side effects of IBSRELA. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to www.fda.gov/medwatch.
What is IBSRELA?
IBSRELA (tenapanor) is a prescription medicine used in adults to treat irritable bowel syndrome with constipation (IBS-C). It is not known if IBSRELA is safe and effective in children less than 18 years of age.
Please see full Prescribing Information and Medication Guide, including Boxed Warning.
What is IBSRELA?
IBSRELA (tenapanor) is a prescription medicine used in adults to treat irritable bowel syndrome with constipation (IBS-C). It is not known if IBSRELA is safe and effective in children less than 18 years of age.
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IMPORTANT RISK INFORMATION
- Do not give IBSRELA to children who are less than 6 years of age. It may harm them.
- You should not give IBSRELA to children 6 years to less than 18 years of age. It may harm them. IBSRELA can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
- Do not take IBSRELA if a doctor has told you that you have a bowel blockage (intestinal obstruction).
Before you take IBSRELA, tell your doctor about your medical conditions, including if you are:
- Pregnant or plan to become pregnant. It is not known if IBSRELA will harm your unborn baby.
- Breastfeeding or plan to breastfeed, although IBSRELA is not expected to pass into your breast milk and to harm your baby. Talk with your doctor about the best way to feed your baby if you take IBSRELA.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Side Effects
Diarrhea is the most common side effect of IBSRELA, and it can sometimes be severe. Stop taking IBSRELA and call your doctor if you develop severe diarrhea.
Other common side effects of IBSRELA include swelling, or a feeling of fullness or pressure in your abdomen (distension), gas (flatulence), or dizziness.
These are not all the possible side effects of IBSRELA. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to www.fda.gov/medwatch.
What is IBSRELA?
IBSRELA (tenapanor) is a prescription medicine used in adults to treat irritable bowel syndrome with constipation (IBS-C). It is not known if IBSRELA is safe and effective in children less than 18 years of age.
Please see full Prescribing Information and Medication Guide, including Boxed Warning.
What is IBSRELA?
IBSRELA (tenapanor) is a prescription medicine used in adults to treat irritable bowel syndrome with constipation (IBS-C). It is not known if IBSRELA is safe and effective in children less than 18 years of age.