FDA-filed SPL labeling · retrieved through openFDA

Tenapanor

Tenapanor is a gut-acting tablet used to treat irritable bowel syndrome with constipation (IBS-C) in adults and to lower high phosphorus levels in adults with chronic kidney disease on dialysis.

Brand names IbsrelaXphozahXPHOZAH 10 mgXPHOZAH 20 mgXPHOZAH 30 mg
Drug class ⓘ Sodium-hydrogen Exchanger 3 Inhibitor
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJun 27, 2025
Clinical labels in scope ⓘ2
AvailabilityRx
Earliest approval/marketing year ⓘ2019
FDA-listed product records ⓘ16
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
⭐ Tenapanor at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Tenapanor comes in two branded products with different uses: Ibsrela treats IBS-C in adults, and XPHOZAH lowers phosphorus in adults with chronic kidney disease on dialysis. Both are taken twice daily before meals and work mainly in the gut with very little absorption into the bloodstream. Diarrhea is the most common side effect — if it becomes severe, stop the medication and hydrate, and call your doctor.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Important safety warning for children: Ibsrela (tenapanor) must not be given to children under 6 years old. In animal studies, young animals given tenapanor died, likely from severe dehydration caused by diarrhea. Use in children ages 6 to under 12 should also be avoided. Tenapanor has not been shown to be safe or effective in anyone under 18 years of age. If a child accidentally takes this medication, seek emergency medical help immediately.

Read the full warning on DailyMed →

📖 Tenapanor: Patient Information Guide

A plain-language walkthrough of Tenapanor — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Tenapanor is the active ingredient in two separate branded products approved for different conditions:

  • Ibsrela (tenapanor tablet) — treats irritable bowel syndrome with constipation (IBS-C) in adults
  • XPHOZAH (tenapanor tablet, film coated) — reduces high serum phosphorus in adults with chronic kidney disease (CKD) who are on dialysis, used as an add-on when phosphate binder therapy has not produced an adequate response or is not tolerated at any dose
⚙️How it works▾

Tenapanor blocks a protein called NHE3 (sodium/hydrogen exchanger 3) that sits on the inner surface of the small intestine and colon. NHE3 normally absorbs sodium — and pulls water along with it — from the gut into the body. By blocking NHE3, tenapanor keeps more water inside the intestine, softening stool and speeding up bowel movement. In IBS-C, it also reduces abdominal pain by calming oversensitive gut nerves and decreasing intestinal permeability (leakiness). In CKD, blocking NHE3 reduces how much phosphorus the gut absorbs, helping to lower phosphorus levels in the blood.

Tenapanor is minimally absorbed into the bloodstream — it works almost entirely inside the gut — which means its effects are mainly local.

💊How it's taken▾

Tenapanor tablets are taken twice daily by mouth, before meals. Timing before meals matters — taking it just before eating increases its effectiveness.

  • Ibsrela: take immediately before breakfast (or your first meal) and immediately before dinner. Skip any missed dose; do not take two at once.
  • XPHOZAH: take just before the first and last meals of the day. If you are on hemodialysis, do not take your dose right before your dialysis session — take it before your next meal after dialysis. Skip any missed dose and resume your regular schedule.
🤒Side effects — in detail▾

The most commonly reported side effects with tenapanor include:

  • Diarrhea (most frequent — reported in about 1 in 6 Ibsrela-treated patients in trials)
  • Abdominal bloating (distension)
  • Gas (flatulence)
  • Dizziness

Severe diarrhea occurred in about 2.5% of Ibsrela-treated patients in clinical trials. If diarrhea becomes severe, stop taking the medication, drink plenty of fluids to stay hydrated, and contact your doctor right away — prolonged diarrhea can cause dangerous dehydration.

⚠️Warnings & precautions▾
  • Serious dehydration in children: Tenapanor must not be given to children under 6 — animal studies showed deaths from dehydration. Use in children 6 to under 12 should also be avoided. Safety and effectiveness have not been established in anyone under 18.
  • Severe diarrhea: This is the most common serious risk in adults. If you experience severe diarrhea, stop the medication and rehydrate. Seek medical care if it does not improve quickly.
  • Bowel obstruction: XPHOZAH is contraindicated (must not be used) in anyone with a known or suspected mechanical blockage in the digestive tract.
🔀What it interacts with▾

Tenapanor can affect how certain other medications are absorbed in the gut. Key interactions to know:

  • OATP2B1 substrate drugs (e.g., enalapril): Tenapanor inhibits an intestinal transporter called OATP2B1, which can significantly reduce the absorption of drugs that rely on it. Enalapril levels dropped by roughly 50–70% in studies with XPHOZAH. Monitor for reduced effectiveness of these medications.
  • Sodium polystyrene sulfonate (SPS): Separate XPHOZAH and SPS by at least 3 hours — SPS can bind to many oral drugs and reduce their absorption.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Children under 6: Contraindicated — serious risk of dehydration and death
  • Children 6 to under 12: Avoid use of Ibsrela; safety not established
  • Anyone under 18: Safety and effectiveness not established for either product
  • Bowel blockage: XPHOZAH is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction
  • Pregnancy: Tenapanor is minimally absorbed systemically, so fetal exposure is not expected; discuss with your doctor
  • Breastfeeding: Tenapanor and its major metabolite were not detected in breast milk; discuss benefits and risks with your provider
  • Liver impairment: Moderate liver impairment reduced levels of the metabolite M1, but this is not considered clinically significant
  • Taking enalapril or SPS: Tell your doctor before starting tenapanor
🚑If you take too much▾

There is no specific overdose data in patients. Based on how tenapanor works, taking too much would likely cause gastrointestinal effects — especially diarrhea — which could lead to significant dehydration if severe or prolonged. If you suspect an overdose, seek medical attention right away and stay well hydrated.

📡Pharmacodynamics — effects in the body▾

Tenapanor's main measurable effect is in the gut: it increases water secretion into the intestinal lumen (the inside of the bowel), softens stool, and speeds up intestinal transit. For XPHOZAH, it increases phosphorus excretion in stool by reducing gut absorption of phosphorus. Taking tenapanor 5–10 minutes before a meal produces the greatest effect on stool sodium or phosphorus excretion compared to taking it while eating or fasting. At recommended doses, tenapanor does not have a meaningful effect on heart rhythm (QTc interval).

🔬Pharmacokinetics — how your body processes it▾

Tenapanor is barely absorbed into the bloodstream after oral dosing — blood levels are below detectable limits in most people, which is why it acts locally in the gut rather than throughout the body. It is processed primarily by liver enzymes (CYP3A4/5), and most of the drug leaves the body through the stool (about 70–79% within five to ten days), largely unchanged. A small amount exits via urine as metabolites. Its minimal systemic absorption means that liver or kidney impairment does not meaningfully change how the body handles the drug overall.

📦How to store it▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) . protect from moisture. Store and dispense in original bottle with the desiccant.

📄 Written from Tenapanor’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

138

Supplements & herbs that interact with Tenapanor

138 supplements and herbal products have documented interactions with Tenapanor in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 94
  • Minor · 41
Every supplement checked against Tenapanor — ranked by severity The full interaction hub: 3 major · 94 moderate · 41 minor · every one linked to its full report. Check Tenapanor against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Tenapanor — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is tenapanor used for? ▾
It depends on which brand you have. Ibsrela is prescribed for irritable bowel syndrome with constipation — that means belly pain and not being able to go regularly. XPHOZAH is a completely different use: it helps lower phosphorus levels in the blood for adults with chronic kidney disease who are on dialysis, when other phosphorus-lowering medications haven't been enough. Both products contain the same active ingredient but are approved for very different conditions.
Why do I need to take it right before eating — does timing really matter? ▾
Yes, timing genuinely matters here. Studies showed that taking tenapanor 5 to 10 minutes before a meal — rather than during or after — produces the best effect. For Ibsrela, take it immediately before breakfast and immediately before dinner. For XPHOZAH, take it just before your first and last meals of the day. If you're on dialysis, skip the dose before your dialysis session and take it before the next meal after you're done.
What side effects should I expect, and when should I actually call my doctor? ▾
Diarrhea is by far the most common side effect — it happened in about 1 in 6 people taking Ibsrela in clinical trials. You may also notice bloating, gas, or some dizziness. Mild diarrhea is common and often settles down. But if the diarrhea becomes severe — frequent, watery, or making you feel faint or very thirsty — stop taking the medication and call your doctor right away. Severe diarrhea can cause dangerous dehydration if it goes on too long.
Is this medication safe if I'm pregnant or breastfeeding? ▾
Tenapanor is barely absorbed into your bloodstream — it works almost entirely in your gut — so very little is expected to reach your baby during pregnancy. In a small study, it was not detected in breast milk. That said, this medication is not recommended for everyone, and the evidence in pregnant or breastfeeding women is limited. Always let your doctor know before starting or continuing it during pregnancy or while nursing so you can make the best decision together.
Can I give this to my child if they have the same problem? ▾
No — and this is a serious safety point. Tenapanor must never be given to children under 6 years old. In animal studies, very young animals died from dehydration after taking it. For children between 6 and 12, use of Ibsrela should also be avoided. The medication has not been proven safe or effective in anyone under 18. If a child accidentally takes it, call Poison Control or go to the emergency room right away.
Does tenapanor interact with any of my other medications? ▾
Yes, there are a couple of important ones to know about. Tenapanor can reduce how well certain medications are absorbed in your gut — particularly drugs that use a transporter called OATP2B1, like the blood pressure medication enalapril. Your doctor may need to keep an eye on how well those drugs are working. If you take sodium polystyrene sulfonate (a potassium binder, sometimes called SPS), separate it from your XPHOZAH dose by at least 3 hours. Always bring a full list of your medications to your appointments.
Is Tenapanor available over the counter? ▾
Tenapanor is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Tenapanor first available? ▾
Tenapanor has been available in the United States since at least 2019, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Tenapanor? ▾
Tenapanor is supplied by 5 manufacturers listed in the FDA NDC Directory, including Ardelyx, Inc., Patheon Pharmaceuticals Inc., Valdepharm.

💬 Answers drafted from Tenapanor’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Tenapanor comes

Tenapanor is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Ibsrela XPHOZAH 10 mg XPHOZAH 20 mg XPHOZAH 30 mg
How this form is used
What it may be used for
  • Ibsrela is used to treat irritable bowel syndrome with constipation (IBS-C) in adults
  • XPHOZAH is used to reduce high phosphorus levels in adults with chronic kidney disease on dialysis, when phosphate binders have not worked well enough or are not tolerated
Important instructions
  • Ibsrela: take immediately before breakfast or your first meal of the day, and immediately before dinner; if you miss a dose, skip it and take the next one at the regular time — do not take two doses at once
  • XPHOZAH: take just before the first and last meals of the day; do not take right before a hemodialysis session — instead, take it before the next meal after dialysis
  • XPHOZAH: if you miss a dose, skip it and take your next dose at the regular time
Available strengths 7 strengths
Show 1 more strength Show fewer strengths
12 FDA-listed product records ⓘ

📊 Tenapanor across the U.S. market

How Tenapanor appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
5
Manufacturers
4
Brand names
16
FDA-listed product records ⓘ
2019
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Ardelyx, Inc.50%
Patheon Pharmaceuticals Inc.25%
Valdepharm13%
Chunghwa Chemical Synthesis & Biotech Co., Ltd.6%
Hovione FarmaCiencia SA6%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Tenapanor is used

A general measure of how commonly Tenapanor is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Tenapanor is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

43,479
Medicaid prescriptions filled (Q1–Q4 2025)
$99.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tenapanor prescribed? Of the 1,597 medications we measure, Tenapanor ranks #658 by Medicaid prescriptions — more than 59% of them.

Where Tenapanor ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Tenapanor product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 50 mg oral tablet is the most-dispensed Tenapanor product — about 75% of these Medicaid prescriptions.

tenapanor 50 MG Oral Tablet Most dispensed

32,815 Medicaid prescriptions (Q1–Q4 2025) 75% of Tenapanor prescriptions shown $64.8M gross reimbursement (before rebates) ≈ $1,976 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2199679

tenapanor 30 MG Oral Tablet

9,016 Medicaid prescriptions (Q1–Q4 2025) 21% of Tenapanor prescriptions shown $29.1M gross reimbursement (before rebates) ≈ $3,225 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2669452

tenapanor 20 MG Oral Tablet

1,648 Medicaid prescriptions (Q1–Q4 2025) 4% of Tenapanor prescriptions shown $5.3M gross reimbursement (before rebates) ≈ $3,233 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2669448

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tenapanor, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 8 listed Tenapanor NDCs with Medicaid activity.

🔍 Compare Tenapanor products

A representative set of FDA-listed product records for Tenapanor — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Tenapanor NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Tenapanor RxCUI 2199674 1 dose form · 4 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 2199678 In current FDA listings
    Clinical drug / strength (SCD) 10 MG RxCUI 2669440 20 MG RxCUI 2669448 30 MG RxCUI 2669452 50 MG RxCUI 2199679

Look up RxCUI 2199674 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Ibsrela Xphozah XPHOZAH 10 mg XPHOZAH 20 mg XPHOZAH 30 mg

🏭 Manufacturers & labelers

Ardelyx, Inc. 8 Patheon Pharmaceuticals Inc. 4 Valdepharm 2 Chunghwa Chemical Synthesis & Biotech Co., Ltd. 1 Hovione FarmaCiencia SA 1

RxNorm drug class

Tenapanor belongs to the Sodium-Hydrogen Exchanger 3 Inhibitor class.

Pharmacologic class Sodium-Hydrogen Exchanger 3 Inhibitor
Drug family (ATC) Other drugs for constipation
How it works Organic Anion Transporting Polypeptide 2B1 Inhibitors, Sodium-Hydrogen Exchanger 3 Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 27, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tenapanor.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Tenapanor after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
NDC products indexed
16
Distinct labelers/manufacturers represented
5
Linked representative label ⓘ
Ardelyx, Inc.
Linked label effective
Jun 27, 2025
Composite sections available
23
Linked SPL Set ID
c57e279c-0f1b-4238-81b7-4e0dc0cc60c5
Linked SPL Document ID
4555be24-05c0-4145-80c4-2fbd64d08e52
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Ardelyx, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.