Over-the-counter medication · Proton Pump Inhibitor (PPI)
esomeprazole
Also sold as Nexium. This medicine treats frequent heartburn.
Data updated 2026-05-15
- 58,495
- FDA reportsOften reported
- 4
- InteractionsFew interactions
- 2
- Recall records
What the data shows
esomeprazole (Nexium) is an over-the-counter Proton Pump Inhibitor (PPI), more reported than most tracked drugs (58,495 FDA reports), with 4 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.
esomeprazole (Nexium) is an over-the-counter Proton Pump Inhibitor (PPI). This medicine treats frequent heartburn.
Esomeprazole (Nexium) is a drug that reduces 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
$6.71/unit
Generic Available
Yes (39 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats frequent heartburn.
Common side effects
Nausea, Diarrhea, Headache
Key warnings
Do not take this medicine for more than 14 days, or more often than every 4 months, unless your doctor tells you to.
The sections below are summarized in plain English from esomeprazole's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Esomeprazole works by reducing the amount of acid your stomach makes. It blocks the proton pump in your stomach lining. This pump is responsible for producing stomach acid.
Side Effects (from patient reports)
Based on 58,495 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for esomeprazole, by number of reports
- Chronic Kidney Disease
Chronic Kidney Disease
5,020 reports
- Acute Kidney Injury
Acute Kidney Injury
4,563 reports
- Nausea
Nausea
4,004 reports
- Diarrhoea
Diarrhoea
3,869 reports
- Fatigue
Fatigue
3,528 reports
- Headache
Headache
3,509 reports
- Dyspnoea
Dyspnoea
3,268 reports
- Pain
Pain
2,752 reports
- Vomiting
Vomiting
2,692 reports
- Arthralgia
Arthralgia
2,587 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 esomeprazole 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 esomeprazole sits
esomeprazole has more FDA adverse-event reports than 76% 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 esomeprazole; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 58,495 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
58,495
Reports Mentioning Death
5,881
10.1% of reports — not proof of cause
Hospitalization Reports
26,381
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | CHRONIC KIDNEY DISEASE | 5,020 |
| 2 | ACUTE KIDNEY INJURY | 4,563 |
| 3 | NAUSEA | 4,004 |
| 4 | DIARRHOEA | 3,869 |
| 5 | FATIGUE | 3,528 |
| 6 | HEADACHE | 3,509 |
| 8 | DYSPNOEA | 3,268 |
| 10 | PAIN | 2,752 |
| 11 | VOMITING | 2,692 |
| 12 | ARTHRALGIA | 2,587 |
| 13 | PYREXIA | 2,476 |
| 14 | MALAISE | 2,472 |
| 15 | DIZZINESS | 2,099 |
| 16 | ASTHENIA | 2,085 |
| 17 | FALL | 2,056 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Do not take this medicine for more than 14 days, or more often than every 4 months, unless your doctor tells you to.
Known Drug Interactions
Interaction Drug Interaction Rifabutin, phenytoin, efavirenz, cimetidine, esomeprazole* Avoid coadministration unless the benefit outweighs the risks ( 7.6 , 7.7 , 7.8 , 7.9 ) Other drugs metabolized by CYP3A4 Consider dosage adjustment and monitor for adverse effects and toxicity ( 7.1 , 7.10 , 7.11 ) Digoxin Monitor digoxin plasma concentrations ( 7.12 ) Fosamprenavir, metoclopramide* Monitor for breakthrough fungal infections ( 7.6 , 7.13 ) *The drug interactions with esomeprazole and metoclopramide do not apply to posaconazole tablets.
Mechanism: Esomeprazole changes the acid levels in the stomach, which can prevent certain forms of posaconazole from being absorbed into the body. This may make the antifungal treatment less effective.
Omeprazole or Esomeprazole Avoid concomitant use of clopidogrel with omeprazole or esomeprazole. A similar reduction in antiplatelet activity was observed with esomeprazole when given concomitantly with clopidogrel. Dexlansoprazole, lansoprazole, and pantoprazole had less effect on the antiplatelet activity of clopidogrel than did omeprazole or esomeprazole [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].
Mechanism: Esomeprazole keeps clopidogrel from being activated in your body. This prevents the blood thinner from doing its job of protecting your heart and blood vessels.
Conivaptan 33% 43% Diltiazem 20% NA Indomethacin 40% NA Mirabegron 29% 27% Nefazodone 27% 15% Nifedipine 45% NA Propantheline 24% 24% Quinine NA 33% Rabeprazole 29% 19% Saquinavir 27% 49% Spironolactone 25% NA Telmisartan 20 to 49% NA Tricagrelor 31% 28% Tolvaptan 30% 20% Trimethoprim 22 to 28% NA Digoxin concentrations increased, but magnitude is unclear Alprazolam, azithromycin, cyclosporine, diclofenac, diphenoxylate, epoprostenol, esomeprazole, ibuprofen, ketoconazole, lansoprazole, metformin, omeprazole Measure serum digoxin concentrations before initiating concomitant drugs.
Mechanism: Taking esomeprazole can raise the levels of digoxin in your body. It likely changes how much of the drug is absorbed or handled by your system.
Co-administration of risedronate sodium with the PPI, esomeprazole, increased risedronate bioavailability.
Mechanism: This acid-reducing medicine can cause your body to absorb a larger amount of the bone medication than it normally would.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
How long does it take for esomeprazole to work?
Can I take esomeprazole with food?
Can I crush or chew the tablet?
How often can I repeat a 14-day course of treatment?
Can children take this medicine?
What should I do if my heartburn doesn't improve?
Can I take this medicine for immediate heartburn relief?
What if I accidentally take more than one tablet a day?
Does this medicine interact with other drugs?
Is it safe to take esomeprazole long-term?
What are the common side effects of esomeprazole?
Does esomeprazole interact with other medications?
What drug class is esomeprazole?
What pregnancy or breastfeeding source fields are listed for esomeprazole?
Has esomeprazole been recalled?
Active Recalls
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Zydus Pharmaceuticals (USA) Inc
Labeling: Not Elsewhere Classified - Wrong NDC number
Zydus Pharmaceuticals (USA) Inc
Related Medications in Proton Pump Inhibitor (PPI)
Other drugs grouped near esomeprazole - same-class peers and common alternatives.
alosetron
Lotronex
Alosetron (Lotronex) is a medicine for women with severe diarrhea-predominant irritable bowel syndrome (IBS).
Compare with esomeprazole →
aprepitant
Emend
Aprepitant (Emend) is a medicine that helps prevent nausea and vomiting.
Compare with esomeprazole →
bisacodyl
Dulcolax
Bisacodyl is a medicine that helps you have a bowel movement.
Compare with esomeprazole →
bismuth subsalicylate
Pepto-Bismol
Bismuth subsalicylate (Pepto-Bismol) is a medicine that can treat diarrhea and upset stomach.
Compare with esomeprazole →
cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
Compare with esomeprazole →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for esomeprazole: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 58,495.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 10.05%.
- propranolol Δ 0.05 pts · 68,257 reports · Non-Selective Beta-Blocker 10.10%death share
- pioglitazone Δ 0.05 pts · 42,504 reports · Thiazolidinedione 10.11%death share
- trazodone Δ 0.12 pts · 15,113 reports · Serotonin Antagonist and Reuptake Inhibitor (SARI) 10.18%death share
- darunavir Δ 0.13 pts · 14,896 reports · HIV Protease Inhibitor 9.93%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
What the FDA Data Shows for esomeprazole
The FDA label for esomeprazole (sold under brand names such as Nexium) classifies it as an over-the-counter product in the Proton Pump Inhibitor (PPI) class. This medicine treats frequent heartburn. Official labeling lists 3 commonly reported side effects, including Nausea, Diarrhea, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 58,495 voluntary reports. The database also lists 4 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $6.71.
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 (currently 2 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: January 21, 2026
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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