Prescription medicine
Dexlansoprazole Brand names: Dexilant
Dexlansoprazole (Dexilant) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $3.71 per dexlansoprazole DR 60 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the dexlansoprazole FDA label on DailyMed (effective February 17, 2025, Takeda Pharmaceuticals America, Inc.); the NDA 22287 record on Drugs@FDA; every dexlansoprazole label on DailyMed.
Highlights of the record
FDA label of February 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDEXILANT is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE).
Forms and strengths
- 30 mg
- 60 mg
Delayed-release capsule; capsule (delayed release pellets).
On the market
- Earliest approval on file
- January 30, 2009 Dexilant, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first April 19, 2017; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 5, 2032 Dexilant capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $3.71 per capsule Dexlansoprazole DR 60 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 41,466 through July 30, 2026
What is dexlansoprazole used for?
From the label: indications and usageDEXILANT is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). ( 1.1 ) Maintenance of healed EE and relief of heartburn. ( 1.2 ) Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). […]
Conditions named in the indications of dexlansoprazole's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Proton Pump Inhibitor.
Source: FDA drug label (Dexilant), Takeda Pharmaceuticals America, Inc., effective February 17, 2025 (SPL set 9819f033-3bbe-442e-8e92-45fec77b237d), via openFDA; the full label on DailyMed
What does the patient leaflet for dexlansoprazole say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information that I should know about DEXILANT?DEXILANT may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. DEXILANT can cause serious side effects, including: A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including DEXILANT, may develop a kidney problem called acute tubulointerstitial nephritis, that can happen at any time during treatment with PPI medicines. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. Diarrhea. DEXILANT may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection ( Clostridium difficile ) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. Bone fractures. People who take multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take DEXILANT exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take DEXILANT. Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body's immune cells attack other cells or organs in the body). Some people who take PPI medicines may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. DEXILANT can have other serious side effects. See " What are the possible side effects of DEXILANT? ".
From the patient leaflet: How should I store DEXILANT?Store DEXILANT at room temperature between 68°F to 77°F (20°C to 25°C). Keep DEXILANT and all medicines out of the reach of children.
Source: FDA drug label (Dexilant), Takeda Pharmaceuticals America, Inc., effective February 17, 2025 (SPL set 9819f033-3bbe-442e-8e92-45fec77b237d), via openFDA; the full label on DailyMed
Is there a generic for dexlansoprazole (Dexilant)?
The FDA approved the first generic dexlansoprazole on April 19, 2017. 4 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dexlansoprazole from 9 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 8 patents for Dexilant capsules, the last expiring on March 5, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2009 earliest approval on file
- 2017 first generic approved
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dexlansoprazole (Dexilant)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $3.71 per Dexlansoprazole DR 60 mg capsule, down 18% from $4.52 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dexlansoprazole DR 60 mg capsule (generic)
- Dexilant DR 60 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dexlansoprazole DR 30 mg capsule | Generic | $3.77 per capsule | $113.18 | -10% |
| Dexlansoprazole DR 60 mg capsule | Generic | $3.71 per capsule | $111.21 | -18% |
| Dexilant DR 30 mg capsule | Brand | $9.85 per capsule | $295.58 | +0.1% |
| Dexilant DR 60 mg capsule | Brand | $9.84 per capsule | $295.18 | -0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the dexlansoprazole label say about other medicines?
The dexlansoprazole label names 18 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name dexlansoprazole. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions | 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. … Intervention: Rilpivirine-containing products: Concomitant use with DEXILANT is contraindicated [see ]. See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. … |
| Cyanocobalamin | warnings and precautions | Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.7 ) Hypomagnesemia and Mineral Metabolism: |
| Dasatinib | drug interactions | Clinical Impact: Dexlansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid … |
| Digoxin | drug interactions | Clinical Impact: Potential for increased exposure of digoxin. Intervention: Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. See prescribing information for digoxin. |
| Erlotinib | drug interactions | Clinical Impact: Dexlansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid … |
| Itraconazole | drug interactions | Clinical Impact: Dexlansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid … |
| Ketoconazole | drug interactions | Clinical Impact: Dexlansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid … |
| Lansoprazole | warnings and precautions | Nonclinical studies in juvenile rats with lansoprazole have demonstrated an adverse effect of heart valve thickening. |
| Methotrexate | drug interactions | Methotrexate Clinical Impact: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. … Intervention: A temporary withdrawal of DEXILANT may be considered in some patients receiving high-dose methotrexate. |
| Mycophenolate mofetil | drug interactions | Clinical Impact: Dexlansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid … |
| Mycophenolic acid | drug interactions | Clinical Impact: Dexlansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. … receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. … |
| Nelfinavir | drug interactions | 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. … Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with DEXILANT. See prescribing information for nelfinavir. … |
| Nilotinib | drug interactions | Clinical Impact: Dexlansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid … |
| Rifampin | drug interactions | Clinical Impact: Decreased exposure of dexlansoprazole when used concomitantly with strong inducers. Intervention: St. John's Wort, rifampin: Avoid concomitant use with DEXILANT. Ritonavir-containing products: See prescribing information. CYP2C19 or CYP3A4 Inhibitors |
Every other medicine the dexlansoprazole label names
| Medicine named | Section | What the label says |
|---|---|---|
| Rilpivirine | drug interactions | 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. … Intervention: Rilpivirine-containing products: Concomitant use with DEXILANT is contraindicated [see ]. See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. … |
| Tacrolimus | drug interactions | Tacrolimus Clinical Impact: Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19. Intervention: Monitor tacrolimus whole blood trough concentrations. Dose adjustment of tacrolimus may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus. |
| Voriconazole | drug interactions | CYP2C19 or CYP3A4 Inhibitors Clinical Impact: Increased exposure of dexlansoprazole is expected when used concomitantly with strong inhibitors. Intervention: Voriconazole: See prescribing information. |
| Warfarin | drug interactions | Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin. |
Source: FDA drug label (Dexilant), Takeda Pharmaceuticals America, Inc., effective February 17, 2025 (SPL set 9819f033-3bbe-442e-8e92-45fec77b237d), via openFDA; the full label on DailyMed
What do FAERS reports show for dexlansoprazole?
The FDA Adverse Event Reporting System holds 41,466 reports that list dexlansoprazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,710 are coded as a death and 7,224 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (13,440, against a median of 1,914 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dexlansoprazole?
21 other medicines are given the same way (oral) and in the same FDA class as dexlansoprazole or labeled mainly for the same use (acid reflux and ulcers), the same class first. Acid reflux and ulcers lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Omeprazole | Acid reflux and ulcers | 121 labelers | $0.0295 per capsule 20 mg capsule | A presentation being discontinued |
| Esomeprazole | Acid reflux and ulcers | 117 labelers | $0.145 per capsule 20 mg capsule | No current entry |
| Pantoprazole | Acid reflux and ulcers | 52 labelers | $0.0358 per tablet 40 mg tablet | No current entry |
| Lansoprazole | Acid reflux and ulcers | 59 labelers | $0.106 per capsule 30 mg capsule | No current entry |
| Rabeprazole | Acid reflux and ulcers | 20 labelers | $0.224 per tablet 20 mg tablet | No current entry |
| Omeprazole and sodium bicarbonate | Acid reflux and ulcers | 20 labelers | $7.90 per packet 40-1,680 packet | No current entry |
| Esomeprazole and naproxen | Acid reflux and ulcers | 10 labelers | $1.96 per unit 500-20 mg | No current entry |
| Calcium carbonate | Acid reflux and ulcers | none listed | $0.0315 per tablet 750 mg tablet chewable | No current entry |
Every medicine labeled for the same conditions as dexlansoprazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does dexlansoprazole compare with medicines for the same use?
5 side-by-side pages set dexlansoprazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to dexlansoprazole
- 21 medicines for the same use
- Other proton pump inhibitors
- the pharmacologic class, with prices and generics
- Dexlansoprazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other