Note: This document contains side effect information about tenapanor. Some dosage forms listed on this page may not apply to the brand name Ibsrela.
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.
Serious side effects of Ibsrela
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
- Diarrhea
Less common or rare
- Bleeding in the rectum
Rare
- Abdominal or stomach pain
- confusion
- difficult breathing
- irregular heartbeat
- nausea or vomiting
- nervousness
- numbness or tingling in the hands, feet, or lips
- weakness or heaviness of the legs
Other side effects of Ibsrela
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]
