Ibsrela Side Effects Center

Last updated on RxList: 5/28/2021
Ibsrela Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Ibsrela?

Ibsrela (tenapanor) is a sodium/hydrogen exchanger 3 (NHE3) inhibitor indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

What Are Side Effects of Ibsrela?

Common side effects of Ibsrela include:

  • diarrhea,
  • abdominal distension,
  • gas (flatulence), and
  • dizziness.

Dosage for Ibsrela

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

What Drugs, Substances, or Supplements Interact with Ibsrela?

Ibsrela may interact with other drugs. Tell your doctor all medications and supplements you use.

Ibsrela During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Ibsrela; maternal use is not expected to result in fetal exposure to the drug. It is unknown if Ibsrela passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Ibsrela (tenapanor) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Ibsrela Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect data from 1203 adult patients with IBS-C in two randomized, double-blind, placebo-controlled clinical trials (Trial 1 and Trial 2). Patients were randomized to receive placebo or IBSRELA 50 mg twice daily for up to 52 weeks. Demographic characteristics were comparable between treatment groups in the two trials [see Clinical Studies].

Most Common Adverse Reactions

The most common adverse reactions reported in at least 2% of patients in IBSRELA-treated patients and at an incidence greater than placebo during the 26-week double-blind placebo-controlled treatment period of Trial 1 are shown in Table 1.

Table 1: Most Common Adverse Reactions* in Patients with IBS-C in Trial 1 (26 Weeks)

Adverse Reactions IBSRELA
N=293
%
Placebo
N=300
%
Diarrhea 16 4
Abdominal Distension 3 <1
Flatulence 3 1
Dizziness 2 <1
* Reported in at least 2% of patients in IBSRELA-treated patients and at an incidence greater than placebo

The adverse reaction profile was similar during the 12-week double-blind placebo-controlled treatment period of Trial 2 (610 patients: 309 IBSRELA-treated and 301 placebo-treated) with diarrhea (15% with IBSRELA vs 2% with placebo) and abdominal distension (2% with IBSRELA vs 0% with placebo) as the most common adverse reactions.

Adverse Reaction Of Special Interest - Severe Diarrhea

Severe diarrhea was reported in 2.5% of IBSRELA-treated patients compared to 0.2% of placebo-treated patients during the 26 weeks of Trial 1 and the 12 weeks of Trial 2 [see WARNINGS AND PRECAUTIONS].

Patients With Renal Impairment

In Trials 1 and 2, there were 368 patients (31%) with baseline renal impairment (defined as eGFR less than 90 mL/min/1.73m²). In patients with renal impairment, diarrhea, including severe diarrhea, was reported in 20% (39/194) of IBSRELA-treated patients and 0.6% (1/174) of placebo-treated patients. In patients with normal renal function at baseline, diarrhea, including severe diarrhea, was reported in 13% (53/407) of IBSRELA-treated patients and 3.5% (15/426) of placebo-treated patients. No other differences in the safety profile were reported in the renally impaired subgroup. The incidence of diarrhea and severe diarrhea in IBSRELA-treated patients did not correspond to the severity of renal impairment.

Adverse Reactions Leading To Discontinuation

Discontinuations due to adverse reactions occurred in 7.6% of IBSRELA-treated patients and 0.8% of placebo-treated patients during the 26 weeks of Trial 1 and the 12 weeks of Trial 2. The most common adverse reaction leading to discontinuation was diarrhea: 6.5% of IBSRELA-treated patients compared to 0.7% of placebo-treated patients.

Less Common Adverse Reactions

Adverse reactions reported in less than 2% of IBSRELA-treated patients and at an incidence greater than placebo during the 26 weeks of Trial 1 and the 12 weeks of Trial 2 were: rectal bleeding and abnormal gastrointestinal sounds.

Hyperkalemia

In a trial of another patient population with chronic kidney disease (defined by eGFR from 25 to 70 mL/min/1.73m²) and Type 2 diabetes mellitus, three serious adverse reactions of hyperkalemia resulting in hospitalization were reported in 3 patients (2 IBSRELA-treated patients and 1 placebo-treated patient).

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Ibsrela (Tenapanor Tablets)

QUESTION

What is irritable bowel syndrome or IBS? See Answer

© Ibsrela Patient Information is supplied by Cerner Multum, Inc. and Ibsrela Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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