Prescription medicine
Tenapanor Brand names: Xphozah, Ibsrela
Tenapanor (Ibsrela) is a prescription medicine with an FDA approval on record since 2019. No generic is listed; pharmacies paid $32.54 per Ibsrela 50 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the tenapanor FDA label on DailyMed (effective June 27, 2025, Ardelyx, Inc.); the NDA 211801 record on Drugs@FDA; every tenapanor label on DailyMed.
Highlights of the record
FDA label of June 27, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageXPHOZAH is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
Forms and strengths
- 10 mg
- 20 mg
- 30 mg
- 53.2 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- September 12, 2019 Ibsrela, Ardelyx Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 26, 2042 Ibsrela tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $32.54 per tablet Ibsrela 50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,543 through July 30, 2026
What is tenapanor used for?
From the label: indications and usageXPHOZAH is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH is a sodium hydrogen exchanger 3 (NHE3) inhibitor indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy ( 1 ).
Conditions named in the indications of tenapanor's FDA labels, with every medicine labeled for each:
From other tenapanor labelsIrritable bowel syndrome and Constipation: IBSRELA is indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
FDA pharmacologic class: Sodium-Hydrogen Exchanger 3 Inhibitor.
Source: FDA drug label (XPHOZAH 10 mg), Ardelyx, Inc., effective June 27, 2025 (SPL set c57e279c-0f1b-4238-81b7-4e0dc0cc60c5), via openFDA; the full label on DailyMed
What does the patient leaflet for tenapanor say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about IBSRELA?Do not give IBSRELA to children who are less than 6 years of age. It may harm them. You should not give IBSRELA to children 6 years to less than 18 years of age. It may harm them. IBSRELA can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt). See " What are the possible side effects of IBSRELA? " for more information about side effects.
From the patient leaflet: How should I store IBSRELA?Store IBSRELA at room temperature between 68°F to 77°F (20°C to 25°C). Keep IBSRELA in the original container and protect from moisture. Keep the container of IBSRELA tightly closed and in a dry place. Do not put IBSRELA in another container (repackage). The IBSRELA bottle contains a desiccant canister to help keep your medicine dry (protect it from moisture). Do not remove the desiccant from the bottle. Keep IBSRELA and all medicines out of the reach of children.
Source: FDA drug label (IBSRELA), Ardelyx, Inc., effective May 28, 2025 (SPL set 2102da5f-a1a0-4ac7-a1f6-38698cf7273a), via openFDA; the full label on DailyMed
Is there a generic for tenapanor (Ibsrela)?
No generic tenapanor is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Ibsrela tablets: the compound patent runs to August 1, 2033, and the last listed entry to November 26, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tenapanor (Ibsrela)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $32.54 per Ibsrela 50 mg tablet, up 9% from $29.93 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ibsrela 50 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ibsrela 50 mg tablet | Brand | $32.54 per tablet | $976.34 | +9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the tenapanor label say about other medicines?
The tenapanor label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Enalapril | drug interactions | DRUG INTERACTIONS OATP2B1 Substrates: Potential for reduced exposure of the concomitant drug (e.g., enalapril). |
| Enalaprilat | drug interactions | When enalapril was coadministered with XPHOZAH (30 mg twice daily for five days), the peak exposure (C max ) of enalapril and its active metabolite, enalaprilat, decreased by approximately 70% and total systemic exposures (AUC) decreased by 50 to 65% compared to when enalapril was administered alone [see Clinical … |
| Sodium polystyrene sulfonate | drug interactions | Sodium Polystyrene Sulfonate (SPS): Separate administration by at least three hours ( 7.2 ). |
Source: FDA drug label (XPHOZAH 10 mg), Ardelyx, Inc., effective June 27, 2025 (SPL set c57e279c-0f1b-4238-81b7-4e0dc0cc60c5), via openFDA; the full label on DailyMed
What do FAERS reports show for tenapanor?
The FDA Adverse Event Reporting System holds 3,543 reports that list tenapanor among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 104 are coded as a death and 558 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tenapanor?
5 other medicines are given the same way (oral) and in the same FDA class as tenapanor or labeled mainly for the same use (irritable bowel syndrome), the same class first. Irritable bowel syndrome lists all 7 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dicyclomine | Irritable bowel syndrome | 37 labelers | $0.059 per tablet 20 mg tablet | No current entry |
| Lubiprostone | Irritable bowel syndrome, Constipation | 10 labelers | $0.651 per capsule 24 mcg capsule | No current entry |
| Chlordiazepoxide and clidinium | Irritable bowel syndrome | 12 labelers | $0.256 per capsule Chlordiazepoxide-clidinium capsule | No current entry |
| Linaclotide | Irritable bowel syndrome, Constipation | none listed | $9.02 per capsule 145 mcg capsule | No current entry |
| Eluxadoline | Irritable bowel syndrome | none listed | $28.09 per tablet 100 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to tenapanor
- 5 medicines for the same use
- Tenapanor side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other