Meds & supplements › Tenapanor
Medicine
IBSRELA is indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
Selected manufacturer label information, organised into consistent sections by Sofidex. Read the full label at DailyMed ↗
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS IBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS See full prescribing information for complete boxed warning. IBSRELA is contraindicated in patients less than 6 years of age; in young juvenile rats, tenapanor caused death presumed to be due to dehydration. The safety and effectiveness of IBSRELA have not been established in pediatric patients less than 18 years of age.
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 "
Take IBSRELA exactly as your doctor tells you to take it. Take 1 IBSRELA tablet by mouth, 2 times each day. Take IBSRELA immediately before breakfast or the first meal of the day and immediately before dinner. If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take 2 doses at the same time.
What are the possible side effects of IBSRELA? IBSRELA can cause serious side effects, including: 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.
" for more information about side effects. What is IBSRELA? IBSRELA 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.
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). Before you take IBSRELA, tell your doctor about all your medical conditions, including if you: are pregnant or plan to become pregnant.
It is not known if IBSRELA will harm your unborn baby. are 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.
Store IBSRELA at room temperature between 68°F to 77°F (20°C to 25°C). Keep IBSRELA in the original container and protect from moisture. Keep the container of IBSRELA tightly closed and in a dry place. Do not put IBSRELA in another container (repackage). The IBSRELA bottle contains a desiccant canister to help keep your medicine dry (protect it from moisture).
Do not remove the desiccant from the bottle. Keep IBSRELA and all medicines out of the reach of children.
sofidex [Internet]. Daloreum; c2026. Tenapanor; [reviewed 2026 Aug 3; cited 2026 Nov 10]. Available from: https://sofidex.com/patients/medicines/tenapanor
sofidex. (2026, August 3). Tenapanor. Daloreum. Retrieved November 10, 2026, from https://sofidex.com/patients/medicines/tenapanor
Tenapanor. sofidex. Reviewed August 3, 2026. Accessed November 10, 2026. https://sofidex.com/patients/medicines/tenapanor
The cited date is today’s, because a citation records when you read the page. The reviewed date is when a clinician last checked it.