Key takeaways

  • Ibsrela is a prescription drug used to treat irritable bowel syndrome in adults. It carries a boxed warning about the risk of serious dehydration in children under 6 years old and is not approved for use in children of any age.
  • Common side effects of Ibsrela include diarrhea, dizziness, gas, and abdominal bloating, with severe diarrhea posing a risk of dehydration, especially for those with low kidney function.
  • While Ibsrela is generally considered safe during pregnancy and breastfeeding, it’s important to consult with a doctor before starting this drug and promptly report any significant changes in weight or severe allergic reactions.

Specifically, Ibsrela (tenapanor) is used in adults to treat irritable bowel syndrome with constipation (IBS-C), a chronic (long-term) gastrointestinal (GI) disorder.

Ibsrela comes as an oral tablet and contains the active ingredient tenapanor.

Keep reading to learn about the common, mild, and serious side effects Ibsrela can cause.

This drug 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). It alerts doctors and patients about drug effects that may be dangerous. For details, see the “Side effects explained” section.

Some people may experience mild to serious side effects during Ibsrela treatment. Examples of the drug’s commonly reported side effects include:

Mild side effects have been reported with Ibsrela. These include:

  • dizziness
  • diarrhea
  • gas
  • abdominal bloating
  • unusual stomach noises
  • rectal bleeding

In most cases, these side effects should be temporary. And some may be easily managed with diet changes, over-the-counter medications, or home remedies. But if you have ongoing or bothersome symptoms, talk with your doctor or pharmacist. And do not stop taking Ibsrela unless your doctor recommends it.

Ibsrela may cause mild side effects other than those listed here. See the drug’s prescribing information for details.

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Serious side effects have been reported with Ibsrela. These include:

  • severe diarrhea with dehydration, especially in people with low kidney function
  • boxed warning: risk of serious dehydration in certain children

To learn more about these side effects, see the “Side effects explained” section.

If you develop serious side effects while taking Ibsrela, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medication safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect while taking Ibsrela and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

Get answers to some frequently asked questions about Ibsrela’s side effects.

Does Ibsrela cause weight gain or weight loss?

Weight gain and weight loss weren’t side effects reported in studies of Ibsrela. However, fluid gain or loss caused by Ibsrela or irritable bowel syndrome may cause weight to temporarily increase or decrease.

If you notice a significant change in your weight, talk with your pharmacist or doctor right away.

How do the side effects of Ibsrela compare with those of Trulance?

Ibsrela and Trulance (plecanatide) both treat IBS-C but work differently. Side effects they have in common include diarrhea, dizziness, bloating, and gas.

Other side effects differ by drug. For example, Ibsrela can cause rectal bleeding. And Trulance can cause nausea, cold symptoms, upper respiratory tract infection, and urinary tract infection (UTI). Elevated liver enzymes were also a rare side effect reported in studies of Trulance.

For more information on how the side effects of Ibsrela and Trulance compare, talk with your doctor or pharmacist.

Does Ibsrela cause long-term side effects?

Long-term side effects weren’t reported in studies of Ibsrela. However, studies were only conducted for 26 weeks.

If you’re concerned about possible long-term side effects from this medication, talk with your doctor or pharmacist.

Learn more about some of the side effects Ibsrela may cause.

Risk of serious dehydration in certain children

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.

Ibsrela is not approved for use in children of any age. The safety and effectiveness of Ibsrela use in children under 18 years old haven’t been confirmed in studies. And because of the risk of life threatening diarrhea and dehydration, children less than 6 years old should not take this medication.

Severe diarrhea and dehydration in children may cause symptoms such as:

What might help

If a child accidentally takes Ibsrela, immediately call a pediatrician and get medical care. Giving them fluids by mouth may not be enough to prevent life threatening dehydration.

If you think they’re having a medical emergency, immediately call 911 or your local emergency number.

Severe diarrhea

Severe diarrhea was a common side effect reported in studies of Ibsrela. It may cause symptoms such as:

  • cramping
  • nausea
  • abdominal pain and bloating
  • loose, watery stool
  • excessive bowel movements

Diarrhea can quickly lead to fluid loss and increase the risk of dehydration. Without treatment, diarrhea can cause serious side effects. Symptoms of dehydration include:

  • dry mouth and increased thirst
  • dizziness
  • increased heart rate
  • headache
  • little to no urine output
  • confusion
  • lethargy or unresponsiveness

People with low kidney function have an increased risk of severe diarrhea and dehydration. Additional factors that can increase the risk of diarrhea when taking this drug include:

  • food sensitivities
  • eating or drinking items high in sugar
  • taking magnesium supplements or laxatives
  • intestinal infection

What might help

If you have diarrhea during Ibsrela treatment, consider following the BRAT diet to help temporarily relieve your symptoms. Make sure to drink plenty of water and supplement it with low sugar electrolyte drinks. If your diarrhea continues or worsens, talk with your doctor. They’ll likely recommend a medical evaluation.

Allergic reaction

Like most drugs, Ibsrela can cause an allergic reaction in some people. But this side effect wasn’t reported in studies. Symptoms can be mild to serious and can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)
  • swelling under your skin (usually in your eyelids, lips, hands, or feet)
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:

  • an oral antihistamine, such as diphenhydramine (Benadryl)
  • a product you apply to your skin, such as hydrocortisone cream

If your doctor confirms you’ve had a mild allergic reaction to Ibsrela, they’ll decide whether you should continue taking it.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Ibsrela, they may have you switch to a different treatment.

The following is important information you should consider before taking Ibsrela.

Boxed warning: Risk of serious dehydration in some children

Ibsrela has a boxed warning for the risk of serious dehydration in some children. A boxed warning is the most serious warning from the FDA. Ibsrela is not approved for use in children of any age. Studies haven’t confirmed the safety and effectiveness of Ibsrela in children under 18 years old. And because of the potential danger of life threatening diarrhea and dehydration, Ibsrela should not be given to children under 6 years old.

To learn more, see the “Side effects explained” section.

Other warnings

Ibsrela can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Ibsrela is a good treatment option for you.

Talk with your doctor about your health history before starting this medication. Be sure to tell them if any of the following factors apply to you:

Alcohol and Ibsrela

There are no known interactions between alcohol and Ibsrela. If you have questions about consuming alcohol while taking this drug, talk with your doctor or pharmacist.

Disclaimer: Healthline 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.