Prescription medication · Proton Pump Inhibitor (PPI)
dexlansoprazole
Also sold as Dexilant. This medicine can help heal damage to your esophagus (the tube connecting your mouth to your stomach).
Data updated 2026-05-15
- 40,790
- FDA reportsModerately reported
- 8
- InteractionsFew interactions
- $5.02
- Generic price (NADAC)
What the data shows
dexlansoprazole (Dexilant) is a prescription Proton Pump Inhibitor (PPI), reported at a middle-of-the-pack volume (40,790 FDA reports), with 8 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
dexlansoprazole (Dexilant) is a prescription Proton Pump Inhibitor (PPI). This medicine can help heal damage to your esophagus (the tube connecting your mouth to your stomach).
Dexlansoprazole (Dexilant) is a medicine that lowers stomach acid. It belongs to a class of drugs called proton pump inhibitors (PPIs).
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$5.02/unit
Generic Available
Yes (4 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine can help heal damage to your esophagus (the tube connecting your mouth to your stomach).
Common side effects
Diarrhea, Abdominal pain, Nausea
Key warnings
Dexlansoprazole may hide signs of stomach cancer, so tell your doctor if your symptoms don't improve.
The sections below are summarized in plain English from dexlansoprazole's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Dexlansoprazole works by reducing the amount of acid your stomach makes. It does this by blocking a specific system in your stomach cells. This helps to heal damage caused by stomach acid.
How to Take It
Take dexlansoprazole capsules once a day. You can take it with or without food. Swallow the capsule whole; do not chew it. If you have trouble swallowing, you can open the capsule and mix the pellets with applesauce or water.
This is a plain-language summary of dexlansoprazole's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Based on animal studies, this medicine may harm a developing baby's bones. Talk to your doctor if you are pregnant or plan to become pregnant.
This is a plain-language summary of dexlansoprazole's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of dexlansoprazole's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature, away from heat and moisture.
Side Effects (from patient reports)
Based on 40,790 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for dexlansoprazole, by number of reports
- Long-term kidney disease
Long-term kidney disease
16,100 reports
- Sudden kidney damage
Sudden kidney damage
7,791 reports
- Kidney failure
Kidney failure
6,721 reports
- Kidney failure requiring dialysis 4,842
Kidney failure requiring dialysis
4,842 reports
- Kidney damage 4,339
Kidney damage
4,339 reports
- Tiredness 2,337
Tiredness
2,337 reports
- Kidney inflammation 2,190
Kidney inflammation
2,190 reports
- Feeling sick to your stomach 2,138
Feeling sick to your stomach
2,138 reports
- Loose, watery stools 1,947
Loose, watery stools
1,947 reports
- Pain in your head 1,902
Pain in your head
1,902 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for dexlansoprazole each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where dexlansoprazole sits
dexlansoprazole has more FDA adverse-event reports than 69% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is dexlansoprazole; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 40,790 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2008–2025.
Total Reports
40,790
Reports Mentioning Death
3,607
8.8% of reports — not proof of cause
Hospitalization Reports
6,956
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | CHRONIC KIDNEY DISEASE | 16,100 |
| 2 | ACUTE KIDNEY INJURY | 7,791 |
| 3 | RENAL FAILURE | 6,721 |
| 4 | END STAGE RENAL DISEASE | 4,842 |
| 5 | RENAL INJURY | 4,339 |
| 7 | FATIGUE | 2,337 |
| 9 | TUBULOINTERSTITIAL NEPHRITIS | 2,190 |
| 10 | NAUSEA | 2,138 |
| 11 | DIARRHOEA | 1,947 |
| 12 | HEADACHE | 1,902 |
| 13 | PAIN | 1,902 |
| 14 | DEATH | 1,831 |
| 15 | DYSPNOEA | 1,542 |
| 16 | GASTROOESOPHAGEAL REFLUX DISEASE | 1,424 |
| 17 | ARTHRALGIA | 1,402 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Dexlansoprazole may hide signs of stomach cancer, so tell your doctor if your symptoms don't improve. It can also cause kidney problems, severe diarrhea from a Clostridium difficile infection, and bone fractures with long-term use. Some people may have severe skin reactions or lupus. Long-term use may also lead to low vitamin B12 or magnesium levels.
Known Drug Interactions
John’s Wort, rifampin : Avoid concomitant use with dexlansoprazole.
Mechanism: Rifampin can cause your body to clear dexlansoprazole much faster than normal, making the stomach medicine less effective. This prevents the drug from working well to treat your symptoms.
What to do: You should avoid taking these two medications together. Talk to your doctor about finding a different treatment option.
Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin.
Mechanism: Dexlansoprazole can increase the blood-thinning effects of warfarin. This makes your blood take longer to clot and increases the risk of bleeding.
What to do: Your doctor may need to adjust your warfarin dose and will likely check your blood clotting levels more often.
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. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warnings and Precautions (5.10)] . Intervention: A temporary withdrawal of dexlansoprazole may be considered in some patients receiving high-dose methotrexate.
Mechanism: Dexlansoprazole can cause methotrexate to stay in your body longer and reach higher levels than normal. This can increase the risk of harmful side effects from the methotrexate.
What to do: Your doctor may have you stop taking dexlansoprazole for a short time while you are getting high doses of methotrexate.
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Dexlansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
Mechanism: This medicine lowers stomach acid, which ketoconazole needs to dissolve and get into your bloodstream. Without enough acid, your body may not absorb enough of the antifungal medicine to work properly.
What to do: Talk to your doctor about this combination, as the antifungal medicine may not be as effective.
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Dexlansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
Mechanism: Dexlansoprazole reduces the amount of acid in your stomach, which is necessary for itraconazole to be absorbed into your body. This can make the antifungal drug less effective at treating infections.
What to do: Consult your healthcare provider, as they may need to adjust your treatment to ensure the antifungal medicine works.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take this with other medications?
How long does it take for this medicine to work?
Can I crush or chew the capsule?
What should I do if I experience side effects?
Can I take this medicine long-term?
Is it safe to drink alcohol while taking this medication?
Will this medication interact with any of my supplements?
Can I drive or operate machinery while taking this medication?
How often should I see my doctor while taking this medication?
What do the numbers on the capsule mean?
What are the common side effects of dexlansoprazole?
Does dexlansoprazole interact with other medications?
What drug class is dexlansoprazole?
Is dexlansoprazole safe during pregnancy?
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What the FDA Data Shows for dexlansoprazole
The FDA label for dexlansoprazole (sold under brand names such as Dexilant) classifies it as a prescription-only medication in the Proton Pump Inhibitor (PPI) class. This medicine can help heal damage to your esophagus (the tube connecting your mouth to your stomach). Official labeling lists 8 commonly reported side effects, including Diarrhea, Abdominal pain, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 40,790 voluntary reports. The database also lists 8 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $5.02.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: November 19, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages