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Molecule

Dexlansoprazole

Also known as dexlansoprazole sesquihydrate
Available on requestGastroenterology
Presentations
4
Brands
1
Manufacturers
1
Available from stock
0

Dexlansoprazole is a proton pump inhibitor indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE), among other approved uses. It is available as delayed-release capsules for oral use. MedsAcross supplies Dexlansoprazole 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

Key facts

Pharmacological class
Proton Pump Inhibitor, Proton Pump Inhibitors
ATC classification
A02BC06 Dexlansoprazole · Medicines for acid-related stomach conditions, subgroup A02B, subgroup A02BC
US FDA first approval
30 January 2009
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Delayed-release capsule
Identifiers
UNII UYE4T5I70XRxCUI 816346CAS 138530-94-6DrugBank DB05351Q5268339

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

DEXILANT is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). Maintenance of healed EE and relief of heartburn. Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD).

Source: US FDA prescribing information

How it works

Dexlansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H +, K + )-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, dexlansoprazole has been characterized as a gastric proton-pump inhibitor, in that it blocks the final step of acid production.

Source: US FDA prescribing information

Dosing overview

Recommended dosage in patients 12 years of age and older: See full prescribing information for complete dosing information for DEXILANT by indication and age group and dosage adjustment in patients with hepatic impairment. Administration Instructions: Take without regard to food. Swallow whole, do not chew. See full prescribing information for alternative administration options.

Source: US FDA prescribing information

Contraindications

DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis and urticaria. PPIs, including DEXILANT, are contraindicated with rilpivirine-containing products. Patients with known hypersensitivity to any component of the formulation. Patients receiving rilpivirine-containing products.

Source: US FDA prescribing information

Warnings and precautions

Gastric Malignancy: In adults, symptomatic response with DEXILANT does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. Clostridium difficile -Associated Diarrhea: PPI therapy may be associated with increased risk. Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous, new onset or exacerbation of existing disease, discontinue DEXILANT and refer to specialist for evaluation.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis Clostridium difficile -Associated Diarrhea Bone Fracture Severe Cutaneous Adverse Reactions Cutaneous and Systemic Lupus Erythematosus Cyanocobalamin (Vitamin B12) Deficiency Hypomagnesemia and Mineral Metabolism Fundic Gland Polyps Risk of Heart Valve Thickening in Pediatric Patients Less than Two Years of Age The most common adverse reactions are: Adults (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. Patients 12 to 17 years of age (≥5%): headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain.

Source: US FDA prescribing information

Interactions

Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with DEXILANT and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 3. Clinically Relevant Interactions Affecting Drugs Coadministered with DEXILANT and Interactions with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with dexlansoprazole may reduce antiviral effect and promote the development of drug resistance.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Dexlansoprazole, sorted by availability.

MedicineManufacturerRegisterAvailability
Dexlansoprazole 60 mg delayed-release capsuleOralGeneric name—US FDAAvailable on request
Dexlansoprazole 30 mg delayed-release capsuleOralGeneric name—US FDAAvailable on request
Dexilant 30 mg delayed-release capsuleOralTakeda PharmaceuticalsUS FDAAvailable on request
Dexilant 60 mg delayed-release capsuleOralTakeda PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 30 January 2009Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Dexlansoprazole in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Dexlansoprazole available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Dexlansoprazole and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Dexlansoprazole have?

The catalogue lists 1 brand names for Dexlansoprazole, including Dexilant.

Is Dexlansoprazole approved by the US FDA?

Yes. The US FDA first approved Dexlansoprazole on 30 January 2009, according to Drugs@FDA.

Does Dexlansoprazole need cold chain shipping?

No listed presentation of Dexlansoprazole is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Dexlansoprazole in?

Dexlansoprazole is classified under ATC code A02BC06 (Dexlansoprazole).

References

  1. Dexilant prescribing information (Takeda Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 17 February 2025

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