Ibsrela is a brand-name medication that’s prescribed for irritable bowel syndrome with constipation. Ibsrela contains the active drug tenapanor. It comes as an oral tablet.

Ibsrela is FDA-approved to treat irritable bowel syndrome (IBS) with constipation in adults.

Drug details

You’ll find key information about Ibsrela below.

  • Drug class: sodium/hydrogen exchanger 3 inhibitor
  • Drug form: oral tablet
  • Generic available? no
  • Prescription required? yes
  • Controlled substance? no
  • Year of FDA approval: 2019

Ibsrela is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics typically cost less than brand-name drugs.

The following information describes dosages that are commonly prescribed or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Ibsrela comes as an oral tablet. It’s available in one strength: 50 milligrams (mg).

Dosage for irritable bowel syndrome with constipation

Ibsrela is prescribed to treat irritable bowel syndrome with constipation (IBS-C) in adults. The typical dosage is 50 mg taken by mouth twice per day.

About taking Ibsrela

Below you’ll find information about key dosage issues:

  • When to take. You should take Ibsrela twice per day. You’ll take the first dose right before breakfast or your first meal of the day. You’ll take the second dose right before dinner. This timing helps Ibsrela work effectively.
  • If you miss a dose. If you miss a dose, skip the missed dose and take the next dose at the regular time. Do not take two doses at the same time to make up for the missed dose.
  • Taking Ibsrela with food. You should take each dose of Ibsrela right before you eat. Typically, the drug is taken right before breakfast (or your first meal of the day) and again right before dinner. Taking Ibsrela with food may help the drug work effectively.
  • Crushing, splitting, or chewing Ibsrela. Ibsrela’s manufacturer hasn’t provided guidance about whether the drug can be safely crushed, split, or chewed. So it’s best to swallow the Ibsrela tablet whole.
  • Length of treatment. Ibsrela is meant to be a long-term treatment. If you and your doctor determine that Ibsrela is safe and effective for you, you’ll likely take it long term.
  • Length of time to work. Ibsrela starts working soon after you take your first dose. In clinical trials, people who took Ibsrela had reduced symptoms of IBS-C within the first week of treatment.

Overdose

Taking more than the recommended dosage of Ibsrela can lead to harmful effects. Do not take more Ibsrela than your doctor recommends. To learn about side effects of Ibsrela, see the “Ibsrela side effects” section below.

Overdose symptoms

Symptoms of an overdose can include severe diarrhea, which may lead to dehydration.

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

Ibsrela can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Ibsrela. These lists do not include all possible side effects.

For more information about the possible side effects of Ibsrela, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Ibsrela, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Ibsrela. To learn about other mild side effects, talk with your doctor or pharmacist, or view Ibsrela’s prescribing information.

Mild side effects of Ibsrela can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Ibsrela, see “Allergic reaction” below.

Serious side effects

Serious side effects from Ibsrela aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects of Ibsrela can include:

  • Severe diarrhea, which may lead to dehydration. Symptoms can include:
  • Risk of serious dehydration in certain children.* (Note: Ibsrela is not approved for use in children of any age.)
  • Severe allergic reaction.†

* Ibsrela has a boxed warning for this risk. A boxed warning is the most serious warning from the FDA. To learn more, see the “Ibsrela precautions” section below.
† For details about allergic reaction and Ibsrela, see “Allergic reaction” just below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Ibsrela. This side effect wasn’t reported in clinical trials of this drug but can still occur.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Ibsrela, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

As with all medications, the cost of Ibsrela can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Drug coupons. You can visit Optum Perks* for price estimates of Ibsrela. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.

Financial and insurance assistance. If you need financial support to pay for Ibsrela, or if you need help understanding your insurance coverage, help is available.

A program called ArdelyxAssist is available for Ibsrela. For more information and to find out whether you’re eligible for support, call 844-427-7352 or visit the program website.

To learn more about saving money on prescriptions, check out this article.

Generic version. Ibsrela isn’t available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

* Optum Perks is a sister site of Medical News Today.

Here are answers to some frequently asked questions about Ibsrela.

Does Ibsrela cause weight loss?

No, not directly. Weight loss wasn’t a reported side effect in clinical trials of Ibsrela.

However, diarrhea is a common side effect of the drug. Rarely, this side effect can be severe. If you have diarrhea that lasts a long time or is severe, your body loses a lot of fluid. This may lead to dehydration and weight loss. For more information about the potential negative effects of Ibsrela, see the “Ibsrela side effects” section above.

If you experience severe diarrhea and weight loss while taking Ibsrela, contact your doctor right away. They may have you stop taking the drug. They may also recommend drinking extra fluids or seeking medical attention, depending on the severity of your dehydration.

Children, especially young children, can become dehydrated very quickly.* Due to this risk, Ibsrela is not recommended for children.* The drug is only approved for use in adults.

If you have questions about Ibsrela and weight loss, talk with your doctor or pharmacist.

* Ibsrela has a boxed warning for the risk of serious dehydration in certain children. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Ibsrela precautions” section below.

How does Ibsrela work?

Ibsrela is prescribed to treat irritable bowel syndrome (IBS) with constipation in adults.

Ibsrela works locally in the digestive tract. (“Locally” means the drug acts on a specific area of your body and doesn’t travel to other areas outside of the digestive tract.)

Specifically, Ibsrela works by blocking a receptor (a type of protein) called sodium/hydrogen exchanger 3 (NHE3). NHE3 is located on the surface of cells in the small intestine and colon. This receptor regulates how much sodium (salt) your body absorbs from your diet.

When Ibsrela blocks NHE3, your body absorbs less sodium than is typical. This results in more water entering the digestive tract, which softens stool and promotes bowel movements.

Ibsrela may also work in other ways. People with IBS can have digestive tracts that are more sensitive than is typical. Ibsrela may work by making the digestive tract less sensitive, reducing abdominal pain.

In addition, the lining of the digestive tract in people with IBS may be more permeable. A more permeable digestive tract, also called “leaky gut,” allows more bacteria and toxins into your bloodstream. Ibsrela may work by making the digestive tract lining less permeable. This may help to reduce leaky gut, which is thought to play a role in causing IBS.

If you’d like to know more about this, talk with your doctor or pharmacist for more information.

Can Ibsrela cause long-term side effects?

Ibsrela isn’t known to cause any long-term side effects.

Ibsrela was approved by the FDA in 2019. Before its approval, the drug’s safety and effectiveness were tested in clinical trials. In these trials, participants took the drug for 4–26 weeks. No long-term side effects were reported during or after these trials.

As with any drug, it’s possible that long-term side effects or new risks could be identified in the future. If you have questions about Ibsrela’s side effects, talk with your doctor or pharmacist. For more information about the potential negative effects of Ibsrela, see the “Ibsrela side effects” section above.

Other drugs are available that can treat irritable bowel syndrome with constipation (IBS-C). Some may be a better fit for you than others. If you’re interested in finding an alternative to Ibsrela, talk with your doctor. They can tell you about other medications that may work well for you.

Other drugs that may be prescribed to treat IBS-C include:

If you have questions about drugs similar to Ibsrela, talk with your doctor for more information.

The Food and Drug Administration (FDA) approves prescription drugs such as Ibsrela to treat certain conditions. Ibsrela may also be prescribed off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Ibsrela for irritable bowel syndrome with constipation

Ibsrela is FDA-approved to treat irritable bowel syndrome (IBS) with constipation in adults.

IBS is a group of digestive symptoms that keep coming back. People with IBS typically either have diarrhea or constipation as their main symptom. Other related symptoms may occur, such as abdominal pain.

To learn more about IBS and ways to manage it, visit our IBS hub.

Ibsrela and children

Ibsrela is not FDA-approved for use in children. It’s only approved for use in people ages 18 years and older. The drug hasn’t been tested for effectiveness or safety in children of any age.

Note: Ibsrela has a boxed warning for the risk of serious dehydration in certain children. A boxed warning is the most serious warning from the FDA. To learn more, see the “Ibsrela precautions” section below.

Ibsrela can interact with several other medications.

Before taking Ibsrela, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications

Below is a list of medications that can interact with Ibsrela. This list does not contain all drugs that may interact with Ibsrela. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Medications that can interact with Ibsrela include:

Ibsrela isn’t known to interact with specific herbs, supplements, or foods.

Alcohol interaction

Alcohol isn’t known to interact with Ibsrela. It’s likely safe to consume alcohol while taking Ibsrela.

If you have questions about how much alcohol is safe to drink while taking Ibsrela, talk with your doctor or pharmacist.

This drug comes with several precautions.

FDA warning: Risk of serious dehydration in children

This drug has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

In animal studies of Ibsrela, some of the young rats died after receiving the drug. The deaths were likely due to serious dehydration. (In people, Ibsrela may cause diarrhea as a side effect. If diarrhea is severe or lasts a long time, it can lead to severe dehydration.)

Keep in mind that animal studies don’t always accurately predict what will happen in people. Still, due to this risk, doctors typically won’t prescribe Ibsrela for children.

Ibsrela is not FDA-approved for use in children of any age. It’s only approved for use in people ages 18 years and older. The drug hasn’t been tested for effectiveness or safety in children. To learn more about Ibsrela’s approved use, see the “Ibsrela uses” section above.

Talk with your doctor if you have questions about this warning.

Other precautions

Before taking Ibsrela, discuss your health history with your doctor. Ibsrela may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

Note: For more information about the potential negative effects of Ibsrela, see the “Ibsrela side effects” section above.

If you can become pregnant, consider the following information about pregnancy and breastfeeding.

Ibsrela and pregnancy

In general, Ibsrela is considered safe to take during pregnancy. However, you should still ask your doctor whether they feel it’s safe for you.

Ibsrela and breastfeeding

In general, Ibsrela is considered safe to take while breastfeeding. However, you should still ask your doctor whether they feel it’s safe for you.

If you’d like to learn about other aspects of Ibsrela, talk with your doctor or pharmacist.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.