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esomeprazole

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Brand names: Nexium

Proton Pump Inhibitor (PPI) OTC

Esomeprazole (Nexium) is a drug that reduces stomach acid. It belongs to a class of drugs called proton pump inhibitors (PPIs).

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.

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.

How to Take It

Adults 18 and older should take 1 tablet daily for 14 days. Swallow 1 tablet with a glass of water before you eat in the morning. Take it every day for 14 days. Do not take more than 1 tablet a day. Swallow the tablet whole; do not crush or chew it.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. Also, tell your doctor if you are breastfeeding or plan to breastfeed.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store at room temperature away from moisture and heat.

Side Effects (from patient reports)

Based on 37,071 FDA adverse event reports.

Long-term kidney disease
5,020
Sudden kidney damage
4,563
Feeling sick to your stomach
4,005
Loose or watery stools
3,869
Feeling very tired
3,528
Pain in your head
3,509
The medicine is not working
3,304
Difficulty breathing
3,267
Using the medicine for something it's not approved for
3,254
Discomfort
2,752

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

Death-Related Reports

5,881

Hospitalization Reports

26,381

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 29,679 (58%)
Male 21,623 (42%)

Age Distribution

0–17 1,223
18–44 5,202
45–64 15,355
65–74 10,458
75+ 9,735

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
7 DRUG INEFFECTIVE 3,304
8 DYSPNOEA 3,268
9 OFF LABEL USE 3,254
10 PAIN 2,752
11 VOMITING 2,692
12 ARTHRALGIA 2,587
13 PYREXIA 2,476
14 MALAISE 2,472
15 DIZZINESS 2,099

Reactions in Death Reports

DEATH 1,191
ACUTE KIDNEY INJURY 567
CHRONIC KIDNEY DISEASE 522
SEPSIS 464
DYSPNOEA 457
DIARRHOEA 428
ASTHENIA 368
FALL 367
CARDIO-RESPIRATORY ARREST 364
NAUSEA 351

Reactions in Hospitalization Reports

DIARRHOEA 1,933
NAUSEA 1,873
ACUTE KIDNEY INJURY 1,745
DYSPNOEA 1,673
VOMITING 1,583
HEADACHE 1,518
PYREXIA 1,467
FATIGUE 1,428
PNEUMONIA 1,416
FALL 1,348

Source: FDA FAERS (Adverse Event Reporting System) 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.

What to do: Avoid taking these together unless your doctor determines the benefits are greater than the risks. Note that this warning may not apply if you are taking the tablet form of posaconazole.

moderate clopidogrel

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.

What to do: You should avoid this combination. Talk to your doctor about using a different stomach medicine that does not interfere with your treatment.

minor digoxin

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.

What to do: Have your digoxin blood levels tested before starting esomeprazole. Your healthcare provider will decide if your dose needs to be changed to keep you safe.

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.

What to do: Your doctor may need to monitor you more closely for side effects since more of the drug is entering your system.

Common Questions

How long does it take for esomeprazole to work?
It may take 1 to 4 days for this medicine to fully work.
Can I take esomeprazole with food?
Take this medicine before eating in the morning.
Can I crush or chew the tablet?
No, swallow the tablet whole. Do not crush or chew it.
How often can I repeat a 14-day course of treatment?
You may repeat a 14-day course every 4 months if needed.
Can children take this medicine?
Children under 18 should ask a doctor before use.
What should I do if my heartburn doesn't improve?
Talk to your doctor if your heartburn does not improve after 14 days.
Can I take this medicine for immediate heartburn relief?
No, this medicine is not for immediate relief of heartburn.
What if I accidentally take more than one tablet a day?
Do not take more than 1 tablet a day.
Does this medicine interact with other drugs?
Tell your doctor about all the medicines you take.
Is it safe to take esomeprazole long-term?
Do not take for more than 14 days or more often than every 4 months unless a doctor tells you to.
What are the common side effects of esomeprazole?
The most commonly reported side effects of esomeprazole include Nausea, Diarrhea, Headache. Based on 37,071 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does esomeprazole interact with other medications?
Yes, esomeprazole has 4 known drug interactions. Notable interactions include posaconazole, clopidogrel, digoxin. Always inform your doctor about all medications you are taking.
What drug class is esomeprazole?
esomeprazole belongs to the Proton Pump Inhibitor (PPI) drug class. It is available over the counter (OTC). This medicine treats frequent heartburn.
Is esomeprazole safe during pregnancy?
Tell your doctor if you are pregnant or plan to become pregnant. Also, tell your doctor if you are breastfeeding or plan to breastfeed. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has esomeprazole been recalled?
There are 2 recalls associated with esomeprazole products. Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. Check the recalls section below for full details and affected products.

Active Recalls

Class II May 13, 2025

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

Class III November 14, 2024

Labeling: Not Elsewhere Classified - Wrong NDC number

Zydus Pharmaceuticals (USA) Inc

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Medication Guides

Related Health & Safety Data

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 37,071 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 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: January 21, 2026

All federal data sources used on this page