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Ibsrela Side Effects

Generic name: tenapanor

Medically reviewed by Drugs.com. Last updated on May 1, 2022.

Note: This document contains side effect information about tenapanor. Some of the dosage forms listed on this page may not apply to the brand name Ibsrela.

For the Consumer

Applies to tenapanor: oral tablet

Warning

Oral route (Tablet)

Tenapanor 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 tenapanor in patients 6 years to less than 12 years of age.The safety and effectiveness of tenapanor have not been established in patients less than 18 years of age.

Side effects requiring immediate medical attention

Along with its needed effects, tenapanor (the active ingredient contained in Ibsrela) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tenapanor:

More common

Less common or rare

  • Bleeding in the rectum

Rare

Side effects not requiring immediate medical attention

Some side effects of tenapanor may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Dizziness
  • excess air or gas in the stomach or intestines
  • full or bloated feeling
  • passing gas
  • pressure in the stomach
  • swelling of abdominal or stomach area

For Healthcare Professionals

Applies to tenapanor: oral tablet

General

The most commonly reported side effects included diarrhea, abdominal distention, flatulence, and dizziness.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 20%)

Common (1% to 10%): Abdominal distention, flatulence, severe diarrhea

Frequency not reported: Abnormal gastrointestinal sounds, rectal bleeding[Ref]

Diarrhea occurred in 20% of patients with renal dysfunction (estimated glomerular function rate [eGFR] less than 90 mL/min/1.73 m2), compared to 16% of patients without renal dysfunction.[Ref]

Metabolic

Frequency not reported: Hyperkalemia resulting in hospitalization[Ref]

In a clinical trial with patients with type 2 diabetes mellitus and chronic kidney disease (eGFR 25 to 70 mL/min/1.73 m2), hyperkalemia resulting in hospitalization was reported in 2 patients given this drug and 1 patient given placebo.[Ref]

Nervous system

Common (1% to 10%): Dizziness[Ref]

References

1. "Product Information. Ibsrela (tenapanor)." Ardelyx, Inc (2019):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.