Ibsrela is a prescription medication used to treat irritable bowel syndrome with constipation (IBS-C). Ibsrela belongs to a group of drugs called sodium/hydrogen exchanger 3 (NHE3) inhibitors. By inhibiting NHE3 on the surface of certain intestinal cells, Ibsrela reduces absorption of sodium from the small intestine and colon, resulting in an increase in water secretion into the intestines, which accelerates the movement of food through the intestines and results in a softer stool consistency. 

This medication comes in tablet form and is taken twice daily, immediately before breakfast or the first meal of the day and immediately before dinner.

Common side effects include swelling, or a feeling of fullness or pressure in your abdomen (distension), gas (flatulence) and dizziness.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects may occur. See "Ibsrela Precautions" section.

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.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

• Do not give Ibsrela to children who are less than 6 years of age. It may harm them.
• You should not give Ibsrela to patients 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). 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.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Ibsrela, there are no specific foods that you must exclude from your diet when receiving this medication.

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. It is not known if Ibsrela passes into your breast milk. 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.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans taking Ibsrela and the manufacturer makes no recommendation regarding use during pregnancy. Because Ibsrela is taken orally and only very small amounts are absorbed systemically, maternal use is not expected to result in fetal exposure to the drug. In animal studies with Ibsrela in pregnant rats and rabbits, no adverse fetal effects were observed. This medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. Talk to your doctor if you become pregnant while taking this medication.

Tell your doctor if you are breastfeeding or planning to breastfeed.

It is not known if Ibsrela crosses into human milk.

Talk with your doctor about the best way to feed your baby if you take Ibsrela.

• 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.

Take this medication exactly as prescibed by your doctor. Follow the directions on your prescription label carefully. 

The recommended dosage of Ibsrela in adults is 50 mg orally twice daily. 

If you take too much Ibsrela, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• Store Ibsrela at room temperature, between 68°F and 77°F (20°C and 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.

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.