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IBSRELA tenapanor hydrochloride 53.2 mg Tablet, 6-count — NDC 73154-0050-06 package photo

IBSRELA tenapanor hydrochloride 53.2 mg Tablet, 6-count

by Ardelyx, Inc. · 6 TABLET in 1 BOTTLE (73154-050-06)
NDC 73154-0050-06
🏷️ FDA NDC (as labeled) 73154-050-06 billing pads the product segment with a zero
This package
Contains6-count Pack sizes2 compare ↓
Also comes in: 60 tablets 73154-0050-60
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 73154-050-06
Product NDC 73154-050
11-digit billing NDC 73154005006
RxCUI 2199679, 2199685
UNII 50605O2ZNS
UPC 0373154050604, 0373154050062
Application # NDA211801
SPL Set ID 2102da5f-a1a0-4ac7-a1f6-38698cf7273a
Established class (EPC) Sodium-Hydrogen Exchanger 3 Inhibitor
Mechanism of action Organic Anion Transporting Polypeptide 2B1 Inhibitors; Sodium-Hydrogen Exchanger 3 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-09-12
Route ORAL
Dosage form TABLET
Substance TENAPANOR HYDROCHLORIDE
GPI-14 52558580100320
GPI class Ibsrela
GCN Seq No 080204
GCN 46915
HICL code 046009
Ingredient (HICL) Tenapanor Hcl
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6N
Therapeutic class — specific (HIC3) Ibs Agents,Sodium-Hydrogen Exchanger 3(Nhe3) Inhib
AHFS code 56:92.00.00
AHFS class Gi Drugs, Miscellaneous
FDB label name IBSRELA 50 MG TABLET
FDB brand name Ibsrela
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 73154-050-06 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 73154-0050-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine 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
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerArdelyx, Inc.
Application holderARDELYX INC
FDA applicationNDA211801 (NDA)
Labeler code73154
First marketedSep 2019
Product typeHuman Prescription Drug
Portfolio4 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name IBSRELA 50 MG TABLET Ingredient Tenapanor Hcl
📖 What it is MedlinePlus · NLM

Tenapanor is used to treat irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and infrequent or difficult passage of stools) in adults. Tenapanor is in a class of medications called sodium/hydrogen exchanger (NHE3) inhibitors. It works by increasing the movement of food and waste through the stomach and intestines.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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 co...
  • 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 i...
  • Why do I need to take it right before eating — does timing really matter?
  • 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 di...
📖 Read our full Tenapanor guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 60 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ibsrela 53.2 mgthis 73154-0050-06 Ardelyx, 6 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2019
First FDA approval
Sep 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2042
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2042. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 12, 2019 RLD RS ⏳ ~16.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9006281 — method of use (U-2626)
US 9408840 — method of use (U-2626)
US 8969377 — drug substance
US 12539299 — drug product
US 12016856 — drug substance
US 8541448 — drug substance
2019 2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041 2043
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (6)
PatentTypeUse codeExpires
US 9006281 ↗ Method of use U-2626 May 2, 2030
US 9408840 ↗ Method of use U-2626 Dec 30, 2029
US 8969377 ↗ Drug substance — Dec 30, 2029
US 12539299 ↗ Drug product — Nov 26, 2042
US 12016856 ↗ Drug substance — Dec 30, 2029
US 8541448 ↗ Drug substance — Aug 1, 2033
Common questions
Is there a generic version of IBSRELA 50 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for IBSRELA 50 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2042 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
60 tablets73154-0050-60 32,815 Rx · $64,842,294
6 tablets this page73154-0050-06 No Medicaid data
Drug total (last 4 qtrs): 32,815 Rx · 2,154,742 units · $64,842,294 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ibsrela — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ibsrela. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$38.04M
Claims incl. refills
16.9K
Beneficiaries
9K
Spend / beneficiary
$4,207.55
Spend / claim
$2,248.14
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for IBSRELA (this brand).

Top reported reactions

Diarrhoea1,239
Therapy Interrupted292
Abdominal Distension234
Insurance Issue184
Intentional Underdose167
Abdominal Pain Upper159
Nausea140

Age at onset

Adult61
Elderly37

Reporter sex

3,525 reports
Male · 21%
Female · 78%
Unknown · 0%

Serious outcomes

Hospitalization551
Life-threatening16
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 42 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
73154-0050-06 You're viewing this 6 TABLET in 1 BOTTLE (73154-050-06) — — 2019-09-12 Active
73154-0050-60 60 TABLET in 1 BOTTLE (73154-050-60) $32.55 / ea $1,953.11 2019-09-12 Active

You're viewing the smallest of 2 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 60 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 73154-0050-06?
NDC 73154-0050-06 is a 6-count package — 6 tablet in 1 bottle.
What is the difference between NDC 73154-0050-06 and NDC 73154-0050-60?
Both are IBSRELA tenapanor hydrochloride 53.2 mg Tablet — the drug itself is identical. NDC 73154-0050-06 is the 6-count package, while NDC 73154-0050-60 is the 60 tablets package.
What NDC number is used to bill for this package of IBSRELA tenapanor hydrochloride 53.2 mg Tablet?
Bill NDC 73154-0050-06 — the 11-digit billing format is 73154005006. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 73154-050-06, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 73154-0050-06, written without dashes as 73154005006. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 73154-0050-06, the first segment (73154) is the labeler code FDA assigned to Ardelyx, Inc.; the middle segment (0050) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Ardelyx, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 60 tablets (73154-0050-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Ardelyx, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 187 words ▾

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS IBSRELA 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 [see Contraindications (4) , Use in Specific Populations (8.4) ]. Avoid use of IBSRELA in patients 6 years to less than 12 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ]. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age [see Use in Specific Populations (8.4) ] .

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS See full prescribing information for complete boxed warning. IBSRELA is contraindicated in patients less than 6 years of age; in young juvenile rats, tenapanor caused death presumed to be due to dehydration. ( 4 , 8.4 ) Avoid use of IBSRELA in patients 6 years to less than 12 years of age.

( 5.1 , 8.4 ) The safety and effectiveness of IBSRELA have not been established in pediatric patients less than 18 years of age. ( 8.4 )

🎯 Indications and Usage 41 words ▾

1 INDICATIONS AND USAGE IBSRELA is indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults. IBSRELA is a sodium/hydrogen exchanger 3 (NHE3) inhibitor indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults. ( 1 )

⏱️ Dosage and Administration 104 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of IBSRELA in adults is 50 mg orally twice daily. The recommended dosage in adults is 50 mg, orally twice daily. ( 2 ) Take immediately prior to breakfast or the first meal of the day and immediately prior to dinner.

( 2 ) Administration Instructions Take IBSRELA immediately prior to breakfast or the first meal of the day and immediately prior to dinner [see Clinical Pharmacology (12.2) ] . If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take 2 doses at the same time.

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 50 mg tenapanor supplied as an oval, white to off-white tablet debossed with " 50" on one side and "5791" on the other side. Tablets: 50 mg tenapanor. ( 3 ) Image

⛔ Contraindications 67 words ▾

4 CONTRAINDICATIONS IBSRELA is contraindicated in: Patients less than 6 years of age due to the risk of serious dehydration [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ]. Patients with known or suspected mechanical gastrointestinal obstruction . Pediatric patients less than 6 years of age. ( 4 , 5.1 , 8.4 ) Patients with known or suspected mechanical gastrointestinal obstruction. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Diarrhea: Patients may experience severe diarrhea. If severe diarrhea occurs, suspend dosing and rehydrate patient. ( 5.2 )

5.1Risk of Serious Dehydration in Pediatric Patients IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor.

There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years). Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age [see Contraindications (4) , Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] .

5.2Diarrhea Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients [see Adverse Reactions (6.1) ] . If severe diarrhea occurs, suspend dosing and rehydrate patient.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (≥2%) are diarrhea, abdominal distension, flatulence and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ardelyx at 1-844-427-7352 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 (14) ] . 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 Reported in at least 2% of patients in IBSRELA-treated patients and at an incidence greater than placebo 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 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 (5.2) ] . 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/1.73m 2 ). 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/1.73m 2 ) 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).

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of IBSRELA. Because these reactions are reported voluntarily from a popul…

🔄 Drug Interactions 172 words ▾

7 DRUG INTERACTIONS OATP2B1 Substrates: Potential for reduced exposure of the concomitant drug (e.g., enalapril). Monitor for signs related to loss of efficacy and adjust the dosage of the concomitantly administered drug as needed. ( 7.1 )

7.1OATP2B1 Substrates Tenapanor is an inhibitor of intestinal uptake transporter, OATP2B1 [see Clinical Pharmacology (12.3) ] . Drugs which are substrates of OATP2B1 may have reduced exposures when concomitantly taken with IBSRELA. Monitor for signs related to loss of efficacy and adjust the dosage of concomitantly administered drug as needed.

Enalapril is a substrate of OATP2B1. When enalapril was coadministered with tenapanor (30 mg twice daily for five days, a dosage 0.6 times the recommended dosage), the peak exposure (C max ) of enalapril and its active metabolite, enalaprilat, decreased by approximately 70% and total systemic exposures (AUC) decreased by approximately 50% to 65% compared to when enalapril was administered alone [see Clinical Pharmacology (12.3) ] . Monitor blood pressure and increase the dosage of enalapril, if needed, when IBSRELA is coadministered with enalapril.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Tenapanor is minimally absorbed systemically, with plasma concentrations below the limit of quantification (less than 0.5 ng/mL) following oral administration [see Clinical Pharmacology (12.3) ]. Therefore, maternal use is not expected to result in fetal exposure to the drug. The available data on IBSRELA exposure from a small number of pregnant women have not identified any drug associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In reproduction studies with tenapanor in pregnant rats and rabbits, no adverse fetal effects were observed in rats at 0.1 times the maximum recommended human dose and in rabbits at doses up to 8.8 times the maximum recommended human dose (based on body surface area). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryofetal development study in rats, tenapanor was administered orally to pregnant rats during the period of organogenesis at dose levels of 1, 10 and 30 mg/kg/day. Tenapanor doses of 10 and 30 mg/kg/day were not tolerated by the pregnant rats and was associated with mortality and moribundity with body weight loss.

The 10 and 30 mg/kg dose group animals were sacrificed early, and the fetuses were not examined for intrauterine parameters and fetal morphology. No adverse fetal effects were observed in rats at 1 mg/kg/day (approximately 0.1 times the maximum recommended human dose) and in rabbits at doses up to 45 mg/kg/day (approximately 8.8 times the maximum recommended human dose, based on body surface area). In a pre- and post-natal developmental study in mice, tenapanor at doses up to 200 mg/kg/day (approximately 9.7 times the maximum recommended human dose, based on body surface area) had no effect on pre- and post-natal development.

8.2Lactation Risk Summary Tenapanor and its major metabolite, M1, were not detected in the breast milk of lactating women (see Data ) . In adults, concentrations of tenapanor were below the limit of quantitation in plasma following multiple doses of IBSRELA [see Clinical Pharmacology (12.3) ] . Maternal use of IBSRELA is not expected to result in exposure to tenapanor or its major metabolite in breastfed infants.

There is no information on the effects of tenapanor or its major metabolite on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for IBSRELA and any potential adverse effects on the breastfed infant from IBSRELA or from the underlying maternal condition. Data A clinical lactation study was conducted in seven healthy adult women who were 22 to 37 years of age.

Following oral administration of IBSRELA 50 mg twice daily for 3 days, the concentrations of tenapanor and its major metabolite were below the limit of quantitation (<1 ng/mL and <1 ng/mL) in all breast milk samples collected over 24 hours post-dosing.

8.4Pediatric Use IBSRELA is contraindicated in patients less than 6 years of age. Avoid IBSRELA in patients 6 years to less than 12 years of age [see Contraindications (4) , Warnings and Precautions (5.1) ]. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established.

In nonclinical studies, deaths occurred in young juvenile rats (less than 1 week-old-rats approximate human age equivalent of less than 2 years of age) following oral administration of tenapanor, as described below in Juvenile Animal Toxicity Data. Juvenile Animal Toxicity Data In a 21-day oral dose range finding toxicity study in juvenile rats, tenapanor was administered to neonatal rats (post-natal da…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Tenapanor is minimally absorbed systemically, with plasma concentrations below the limit of quantification (less than 0.5 ng/mL) following oral administration [see Clinical Pharmacology (12.3) ]. Therefore, maternal use is not expected to result in fetal exposure to the drug. The available data on IBSRELA exposure from a small number of pregnant women have not identified any drug associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In reproduction studies with tenapanor in pregnant rats and rabbits, no adverse fetal effects were observed in rats at 0.1 times the maximum recommended human dose and in rabbits at doses up to 8.8 times the maximum recommended human dose (based on body surface area). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryofetal development study in rats, tenapanor was administered orally to pregnant rats during the period of organogenesis at dose levels of 1, 10 and 30 mg/kg/day. Tenapanor doses of 10 and 30 mg/kg/day were not tolerated by the pregnant rats and was associated with mortality and moribundity with body weight loss.

The 10 and 30 mg/kg dose group animals were sacrificed early, and the fetuses were not examined for intrauterine parameters and fetal morphology. No adverse fetal effects were observed in rats at 1 mg/kg/day (approximately 0.1 times the maximum recommended human dose) and in rabbits at doses up to 45 mg/kg/day (approximately 8.8 times the maximum recommended human dose, based on body surface area). In a pre- and post-natal developmental study in mice, tenapanor at doses up to 200 mg/kg/day (approximately 9.7 times the maximum recommended human dose, based on body surface area) had no effect on pre- and post-natal development.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use IBSRELA is contraindicated in patients less than 6 years of age. Avoid IBSRELA in patients 6 years to less than 12 years of age [see Contraindications (4) , Warnings and Precautions (5.1) ]. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established.

In nonclinical studies, deaths occurred in young juvenile rats (less than 1 week-old-rats approximate human age equivalent of less than 2 years of age) following oral administration of tenapanor, as described below in Juvenile Animal Toxicity Data. Juvenile Animal Toxicity Data In a 21-day oral dose range finding toxicity study in juvenile rats, tenapanor was administered to neonatal rats (post-natal day (PND) 5) at doses of 5 and 10 mg/kg/day. Tenapanor was not tolerated in male and female pups and the study was terminated on PND 16 due to mortalities and decreased body weight (24% to 29% reduction in females at the respective dose groups and 33% reduction in males in the 10 mg/kg/day group, compared to control).

In a second dose range finding study, tenapanor doses of 0.1, 0.5, 2.5, or 5 mg/kg/day were administered to neonatal rats from PND 5 through PND 24. Treatment-related mortalities were observed at 0.5, 2.5, and 5 mg/kg/day doses. These premature deaths were observed as early as PND 8, with majority of deaths occurring between PND 15 and 25.

In the 5 mg/kg/day group, mean body weights were 47% lower for males on PND 23 and 35% lower for females on PND 22 when compared to the controls. Slightly lower mean tibial lengths (5% to 11%) were noted in males and females in the 0.5, 2.5, and 5 mg/kg/day dose groups on PND 25 and correlated with the decrements in body weight noted in these groups. Lower spleen, thymus, and/or ovarian weights were noted at the 0.5, 2.5 and 5 mg/kg/day doses.

Tenapanor-related gastrointestinal distension and microscopic bone findings of increased osteoclasts, eroded bone, and/or decreased bone in sternum and/or femorotibial joint were noted in males and females in the 0.5, 2.5 and 5 mg/kg/day dose groups [see Contraindications (4) , Warnings and Precautions (5.1) ].

🧓 Geriatric Use 47 words ▾

8.5Geriatric Use Of the 1203 patients in placebo-controlled clinical trials of IBSRELA, 100 (8%) were 65 years of age and older. No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 41 words ▾

10 OVERDOSAGE Based on nonclinical data, overdose of IBSRELA may result in gastrointestinal adverse effects such as diarrhea as a result of exaggerated pharmacology with a risk for dehydration if diarrhea is severe or prolonged [see Warnings and Precautions (5.1) ].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tenapanor is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. In vitro and animal studies indicate its major metabolite, M1, is not active against NHE3. By inhibiting NHE3 on the apical surface of the enterocytes, tenapanor reduces absorption of sodium from the small intestine and colon, resulting in an increase in water secretion into the intestinal lumen, which accelerates intestinal transit time and results in a softer stool consistency.

Tenapanor has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models. In rat model of colonic hypersensitivity, tenapanor reduced visceral hyperalgesia and normalized colonic sensory neuronal excitability.

12.2Pharmacodynamics Cardiac Electrophysiology At 3 times the mean maximum exposure of M1 at the recommended dosage, there were no clinically relevant effects on the QTc interval. Food Effect Administration of IBSRELA 5 to 10 minutes before a meal increased the 24-hour stool sodium excretion compared to taking IBSRELA in the fed or fasting condition [see Dosage and Administration (2) ] . In clinical trials, IBSRELA was administered immediately prior to the first meal of the day and immediately prior to dinner.

12.3Pharmacokinetics Absorption Tenapanor is minimally absorbed following repeated twice daily oral administration. Plasma concentrations of tenapanor were below the limit of quantitation (less than 0.5 ng/mL) in the majority of samples from healthy subjects following single and repeated oral administration of IBSRELA 50 mg twice daily. Therefore, standard pharmacokinetic parameters such as area under the curve (AUC), maximum concentration (C max ), and half-life (t 1/2 ) could not be determined.

Distribution Plasma protein binding of tenapanor and its major metabolite, M1, is approximately 99% and 97%, respectively, in vitro. Elimination Metabolism Tenapanor is metabolized primarily by CYP3A4/5 and low levels of its major metabolite, M1, are detected in plasma. The C max of M1 is approximately 13 ng/mL after single dose of IBSRELA 50 mg and 15 ng/mL at steady state following repeated dosing of IBSRELA 50 mg twice daily in healthy subjects.

Excretion Following administration of a single 15 mg radiolabeled 14 C-tenapanor dose to healthy subjects, approximately 70% of the radioactivity was excreted in feces within 120 hours post-dose and 79% within 240 hours post-dose, mostly as the parent drug accounting for 65% of dose within 144 hours post-dose. Approximately 9% of the administered dose was recovered in urine, primarily as metabolites. M1 is excreted in urine unchanged accounting for 1.5% of dose within 144 hours post-dose.

Specific Populations Patients with Hepatic Impairment Following a single dose of tenapanor 100 mg in patients with moderate hepatic impairment (Child-Pugh B), plasma concentrations of tenapanor were mostly below the limit of quantitation (< 0.5 ng/mL) and the pharmacokinetic parameters for tenapanor could not be determined. The geometric mean AUC and C max of the major metabolite, M1, were approximately 33% and 27% lower, respectively, in patients with moderate hepatic impairment compared to those of healthy subjects.

The decrease in M1 systemic exposure is not clinically relevant. Patients with Renal Impairment Based on a cross-study comparison, plasma concentrations of M1 in end-stage renal disease patients on hemodialysis (eGFR less than 15 mL/min/1.73m 2 ) was not notably different from those of healthy subjects given comparable doses of IBSRELA. Drug Interaction Studies CYP Metabolism Mediated Drug Interactions Tenapanor and M1 did not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 in vitro.

Tenapanor and M1 did not induce CYP1A2 and CYP2B6 in vitro. No…

🧬 Mechanism of Action 133 words ▾

12.1Mechanism of Action Tenapanor is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. In vitro and animal studies indicate its major metabolite, M1, is not active against NHE3. By inhibiting NHE3 on the apical surface of the enterocytes, tenapanor reduces absorption of sodium from the small intestine and colon, resulting in an increase in water secretion into the intestinal lumen, which accelerates intestinal transit time and results in a softer stool consistency.

Tenapanor has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models. In rat model of colonic hypersensitivity, tenapanor reduced visceral hyperalgesia and normalized colonic sensory neuronal excitability.

📦 How Supplied / Storage and Handling 109 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING IBSRELA tablets contain 50 mg tenapanor and are oval, white to off-white, debossed with " 50" on one side and "5791" on the other side. IBSRELA is supplied in a white, opaque, high-density polyethylene bottle containing 60 tablets with a silica gel canister (as the desiccant) and screw-top polypropylene child-resistant cap lined and induction-activated aluminum foil liner (NDC 73154-050-60). Storage Store at room temperature, between 68°F to 77°F (20°C to 25°C).

Keep in original container and protect from moisture. Keep the container of IBSRELA tightly closed and in a dry place. Do not remove desiccant from the bottle.

Do not subdivide or repackage. Image

📦 Storage and Handling 45 words ▾

Storage Store at room temperature, between 68°F to 77°F (20°C to 25°C). Keep in original container and protect from moisture. Keep the container of IBSRELA tightly closed and in a dry place. Do not remove desiccant from the bottle. Do not subdivide or repackage. Image

📋 Description 136 words ▾

11 DESCRIPTION IBSRELA (tenapanor) tablets contain tenapanor hydrochloride as an active ingredient. Tenapanor hydrochloride is a sodium/hydrogen exchanger 3 (NHE3) inhibitor for oral use. The chemical name for tenapanor hydrochloride is 12,15-Dioxa-2,7,9-triazaheptadecanamide, 17-[[[3-[(4S)-6,8-dichloro-1,2,3,4-tetrahydro-2-methyl-4-isoquinolinyl]phenyl]sulphonyl]amino]-N-[2-[2-[2-[[[3-[(4S)-6,8-dichloro-1,2,3,4-tetrahydro-2-methyl-4-isoquinolinyl]phenyl]sulphonyl]amino]ethoxy]ethoxy]ethyl]-8-oxo-, hydrochloride (1:2).

Tenapanor hydrochloride has the molecular formula of C 50 H 68 Cl 6 N 8 O 10 S 2 , the molecular weight of 1218 Daltons, and the chemical structure below: Tenapanor hydrochloride is a white to off-white to light brown hygroscopic amorphous solid. It is practically insoluble in water. IBSRELA tablets contain 50 mg of tenapanor (equivalent to 53.2 mg of tenapanor hydrochloride).

Inactive ingredients in the tablet are colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, propyl gallate, stearic acid, tartaric acid, and the coating agent OPADRY ® , which consists of hypromellose, titanium dioxide and triacetin. Chemical Structure

💬 Information for Patients 185 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patients to read the FDA-approved patient labeling (Medication Guide). Diarrhea Instruct patients to stop IBSRELA and contact their healthcare provider if they experience severe diarrhea [see Warnings and Precautions (5.2) ] . Accidental Ingestion Accidental ingestion of IBSRELA in children, especially children less than 6 years of age, may result in severe diarrhea and dehydration.

Instruct patients to store IBSRELA securely and out of reach of children [see Contraindications (4) , Warnings and Precautions (5.1) ]. Administration and Handling Instructions Instruct Patients: To take IBSRELA immediately prior to breakfast or the first meal of the day and immediately before dinner [see Dosage and Administration (2) ] . If a dose is missed, skip the missed dose and take the next dose at the regular time.

Do not take 2 doses at the same time [see Dosage and Administration (2) ] . To keep IBSRELA in a dry place. Protect from moisture.

Keep in the original bottle. Do not remove desiccant from the bottle. Do not subdivide or repackage.

Keep bottles tightly closed [see How Supplied/Storage and Handling (16) ].

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: May 2025 Medication Guide IBSRELA ® (ibs rel`a) (tenapanor) tablets, for oral use 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.

What is IBSRELA? IBSRELA is a prescription medicine used in adults to treat: Irritable bowel syndrome with constipation (IBS-C). It is not known if IBSRELA is safe and effective in children less than 18 years of age.

Who should not take IBSRELA? Do not give IBSRELA to children who are less than 6 years of age . IBSRELA can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).

Do not take IBSRELA if a doctor has told you that you have a bowel blockage (intestinal obstruction). Before you take IBSRELA, tell your doctor about all your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if IBSRELA will harm your unborn baby. are breastfeeding or plan to breastfeed, although IBSRELA is not expected to pass into your breast milk and to harm your baby.

Talk with your doctor about the best way to feed your baby if you take IBSRELA. Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins and herbal supplements. How should I take IBSRELA?

Take IBSRELA exactly as your doctor tells you to take it. Take 1 IBSRELA tablet by mouth, 2 times each day. Take IBSRELA immediately before breakfast or the first meal of the day and immediately before dinner.

If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take 2 doses at the same time. What are the possible side effects of IBSRELA?

IBSRELA can cause serious side effects, including: See " What is the most important information I should know about IBSRELA? " Diarrhea is the most common side effect of IBSRELA, and it can sometimes be severe . Stop taking IBSRELA and call your doctor if you develop severe diarrhea. The other most common side effects of IBSRELA include: swelling, or a feeling of fullness or pressure in your abdomen (distension). gas (flatulence). dizziness.

These are not all the possible side effects of IBSRELA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to www.fda.gov/medwatch. 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.

General information about the safe and effective use of IBSRELA. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use IBSRELA for a condition for which it was not prescribed.

Do not give IBSRELA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about IBSRELA that is written for health professionals.

What are the ingredients in IBSRELA? Active ingredient: tenapanor hydrochloride Inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, propyl gallate, stearic acid, ta…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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