Molecule
Tenapanor is a sodium-hydrogen exchanger 3 inhibitor indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults. It is available as tablets for oral use. MedsAcross supplies Tenapanor for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
The recommended dosage of IBSRELA in adults is 50 mg orally twice daily. The recommended dosage in adults is 50 mg, orally twice daily. Take immediately prior to breakfast or the first meal of the day and immediately prior to dinner. Administration Instructions Take IBSRELA immediately prior to breakfast or the first meal of the day and immediately prior to 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.
Source: US FDA prescribing information
IBSRELA is contraindicated in: Patients less than 6 years of age due to the risk of serious dehydration. Patients with known or suspected mechanical gastrointestinal obstruction. Pediatric patients less than 6 years of age.
Source: US FDA prescribing information
Boxed 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. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. Diarrhea: Patients may experience severe diarrhea. If severe diarrhea occurs, suspend dosing and rehydrate patient. Risk 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.
Source: US FDA prescribing information
Most common adverse reactions (≥2%) are diarrhea, abdominal distension, flatulence and dizziness.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
Store at room temperature, between 68°F to 77°F (20°C to 25°C). Keep in original container and protect from moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Tenapanor, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ibsrela 53.2 mg tabletOral | Ardelyx | US FDA | Available on request |
| XPHOZAH 10 mg 10 mg tabletOral | Ardelyx | US FDA | Available on request |
| XPHOZAH 20 mg 20 mg tabletOral | Ardelyx | US FDA | Available on request |
| XPHOZAH 30 mg 30 mg tabletOral | Ardelyx | US FDA | Available on request |
4 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 12 September 2019 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 4 presentations of Tenapanor and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 4 brand names for Tenapanor, including Ibsrela, XPHOZAH 10 mg, XPHOZAH 20 mg, XPHOZAH 30 mg.
Yes. The US FDA first approved Tenapanor on 12 September 2019, according to Drugs@FDA.
No listed presentation of Tenapanor is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.