Prescription and over-the-counter medicine
Esomeprazole Brand names: Nexium
Esomeprazole (Nexium) is a prescription and over-the-counter medicine with an FDA approval on record since 2001. FDA's NDC Directory lists it from 116 generic labelers, and pharmacies paid $0.145 per esomeprazole mag DR 20 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the esomeprazole FDA label on DailyMed (effective March 19, 2024, Haleon US Holdings LLC); the NDA 21153 record on Drugs@FDA; every esomeprazole label on DailyMed.
Highlights of the record
FDA label of March 19, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagetreats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn;
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
- 20 mg
- 40 mg
- 20 mg/5ml
- 40 mg/5ml
Delayed-release capsule; delayed-release granule; capsule (delayed release pellets); delayed-release tablet; capsule (coated pellets).
On the market
- Earliest approval on file
- February 20, 2001 Nexium, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 58 first March 18, 2013; 41 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 119 of which 116 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- December 8, 2036 Esomeprazole Magnesium tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.145 per capsule Esomeprazole mag DR 20 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 12 since 2012 0 Class I among all firms' recalls; latest November 14, 2024; 2 more by firms not listed as its makers
- FAERS reports
- 235,202 through July 30, 2026
What is esomeprazole used for?
From the label: indications and usagetreats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Conditions named in the indications of esomeprazole's FDA labels, with every medicine labeled for each:
From other esomeprazole labelsAcid reflux and ulcers: Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
FDA pharmacologic class: Proton Pump Inhibitor.
Source: FDA drug label (Nexium 24HR), NDA204655 (Astrazeneca Lp), as published by Haleon US Holdings LLC, effective March 19, 2024 (SPL set 4513934d-0cf0-40fc-a348-b4e75a33b094), via openFDA; the full label on DailyMed
What does the patient leaflet for esomeprazole 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 I should know about NEXIUM?NEXIUM may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. NEXIUM can cause serious side effects, including: • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including NEXIUM, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with NEXIUM. 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 caused by an infection ( Clostridium difficile ) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. • Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine. • 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, including NEXIUM, 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. Talk to your doctor about your risk of these serious side effects. NEXIUM can have other serious side effects. See “ What are the possible side effects of NEXIUM? ”
From the patient leaflet: How should I store NEXIUM?Store NEXIUM at room temperature between 68°F to 77°F (20°C to 25°C). • Keep the container of NEXIUM closed tightly. Keep NEXIUM and all medicines out of the reach of children.
Source: FDA drug label (NEXIUM), AstraZeneca Pharmaceuticals LP, effective December 19, 2025 (SPL set f4853677-1622-4037-688b-fdf533a11d96), via openFDA; the full label on DailyMed
Is there a generic for esomeprazole (Nexium)?
The FDA approved the first generic esomeprazole on March 18, 2013. 58 generic applications are approved; 41 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 esomeprazole from 116 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Nexium for oral suspension; a patent listed only for Esomeprazole Magnesium tablets runs to December 8, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2001 earliest approval on file
- 2013 first generic approved
- 2036 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for esomeprazole (Nexium)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.145 per Esomeprazole mag DR 20 mg capsule, down 12% from $0.163 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Esomeprazole mag DR 20 mg capsule (generic)
- Nexium DR 20 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Esomeprazole DR 10 mg packet | Generic | $4.96 per packet many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -27% |
| Esomeprazole DR 2.5 mg packet | Generic | $5.49 per packet many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -24% |
| Esomeprazole DR 20 mg packet | Generic | $4.00 per packet many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -36% |
| Esomeprazole DR 40 mg packet | Generic | $4.17 per packet many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -36% |
| Esomeprazole DR 5 mg packet | Generic | $5.01 per packet many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -32% |
| Esomeprazole mag DR 20 mg capsule | Generic | $0.145 per capsule | $4.34 | -12% |
| Esomeprazole mag DR 40 mg capsule | Generic | $0.122 per capsule | $3.65 | -15% |
| Ft acid reducer DR 20 mg capsule | Generic | $0.346 per capsule | $10.38 | -3% |
| Gnp esomeprazole mag DR 20 mg | Generic | $0.346 per unit | n/a | -3% |
| Gs esomeprazole mag DR 20 mg | Generic | $0.346 per unit | n/a | -3% |
| Nexium DR 10 mg packet | Brand | $9.14 per packet many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -0.3% |
| Nexium DR 2.5 mg packet | Brand | $9.17 per packet many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -0.2% |
| Nexium DR 20 mg capsule | Brand | $8.78 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $263.30 | -0.2% |
| Nexium DR 20 mg packet | Brand | $9.14 per packet many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -0.4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has esomeprazole been recalled?
The FDA's Enforcement Report lists 14 recalls naming esomeprazole since 2012: 0 Class I (the most serious), 7 Class II, 7 Class III; 3 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of esomeprazole and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 13, 2025 | Class II | Zydus Pharmaceuticals (USA) Inc not a listed maker | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related … |
| November 14, 2024 | Class III | Zydus Pharmaceuticals (USA) Inc | Labeling: Not Elsewhere Classified - Wrong NDC number |
| October 23, 2023 | Class III | Glenmark Pharmaceuticals Inc., USA | Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time … |
| June 21, 2022 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Superpotent Drug: Out of specification for assay at the 12-month timepoint. |
| April 1, 2022 | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point. |
| December 17, 2020 | Class II | CIPLA | Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline |
| April 24, 2020 | Class III | Dr. Reddy's Laboratories, Inc. | Discoloration: product contains brown pellets |
| February 6, 2019 | Class III | Dr. Reddy's Laboratories, Inc. | Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the esomeprazole label say about other medicines?
The esomeprazole label names 27 other medicines in its interaction, contraindication or warning sections. The labels of 15 other medicines name esomeprazole. 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 |
|---|---|---|
| Amoxicillin | contraindications (prescription label) | For information about contraindications of amoxicillin and clarithromycin, indicated in combination with NEXIUM for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, refer to the Contraindications section of the respective prescribing information. |
| Atazanavir | drug interactions (prescription label) | 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 NEXIUM is contraindicated [see ]. Atazanavir: See prescribing information for atazanavir for dosing information. … |
| Cilostazol | drug interactions (prescription label) | Cilostazol Clinical Impact: Increased exposure of cilostazol and one of its active metabolites (3,4-dihydro-cilostazol). Intervention: Consider reducing the dose of cilostazol to 50 mg twice daily. See prescribing information for cilostazol. |
| Citalopram | drug interactions (prescription label) | Citalopram Clinical Impact: Increased exposure of citalopram leading to an increased risk of QT prolongation. Intervention: Limit the dose of citalopram to a maximum of 20 mg per day. See prescribing information for citalopram. |
| Clarithromycin | contraindications (prescription label) | For information about contraindications of amoxicillin and clarithromycin, indicated in combination with NEXIUM for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, refer to the Contraindications section of the respective prescribing information. |
| Clopidogrel | drug interactions (prescription label) | Clopidogrel Clinical Impact: Concomitant use of esomeprazole 40 mg resulted in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition. … Intervention: Avoid concomitant use with NEXIUM Consider use of alternative anti-platelet therapy [see ]. |
| Cyanocobalamin | warnings and precautions (prescription label) | Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. |
| Dasatinib | drug interactions (prescription label) | Clinical Impact: Esomeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which esomeprazole is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure … |
| Diazepam | drug interactions | Coadministration of esomeprazole 30 mg and diazepam, a CYP2C19 substrate, resulted in a 45% decrease in clearance of diazepam. |
| Digoxin | drug interactions (prescription label) | Digoxin Clinical Impact: Potential for increased exposure of digoxin. Intervention: Monitor digoxin concentrations and adjust the dose, if needed, to maintain therapeutic drug concentrations. See prescribing information for digoxin. |
| Erlotinib | drug interactions (prescription label) | Clinical Impact: Esomeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which esomeprazole is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure … |
| Itraconazole | drug interactions (prescription label) | Clinical Impact: Esomeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which esomeprazole is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure … |
| Ketoconazole | drug interactions (prescription label) | Clinical Impact: Esomeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which esomeprazole is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure … |
| Methotrexate | drug interactions (prescription label) | Methotrexate Clinical Impact: Concomitant use of esomeprazole 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 NEXIUM may be considered in some patients receiving high-dose methotrexate. |
Every other medicine the esomeprazole label names
| Medicine named | Section | What the label says |
|---|---|---|
| Mycophenolate mofetil | drug interactions (prescription label) | Clinical Impact: Esomeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which esomeprazole is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure … |
| Mycophenolic acid | drug interactions (prescription label) | Clinical Impact: Esomeprazole 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 (prescription label) | 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 NEXIUM. See prescribing information for nelfinavir. … |
| Nilotinib | drug interactions (prescription label) | Clinical Impact: Esomeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which esomeprazole is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure … |
| Omeprazole | drug interactions (prescription label) | Clinical Impact: Esomeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which esomeprazole is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure … |
| Phenytoin | drug interactions | Drug interaction studies have shown that esomeprazole does not have any clinically significant interactions with phenytoin, quinidine, clarithromycin, or amoxicillin. |
| Quinidine | drug interactions | Drug interaction studies have shown that esomeprazole does not have any clinically significant interactions with phenytoin, quinidine, clarithromycin, or amoxicillin. |
| Rifampin | drug interactions (prescription label) | Clinical Impact: Decreased exposure of esomeprazole when used concomitantly with strong inducers. Intervention: St. John’s Wort, rifampin: Avoid concomitant use with [see Warnings and Precautions (5.10) ]. Ritonavir-containing products: see prescribing information for specific drugs Voriconazole |
| Rilpivirine | drug interactions (prescription label) | 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 NEXIUM is contraindicated [see ]. Atazanavir: See prescribing information for atazanavir for dosing information. … |
| Ritonavir | drug interactions | … 75%, and in C min by 106%, following multiple dosing of saquinavir/ritonavir (1000/100 mg) twice daily for 15 days with omeprazole 40 mg daily coadministered days 11 to 15. |
| Tacrolimus | drug interactions (prescription label) | 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 concentrations and consider reducing the dose, if needed, to maintain therapeutic drug concentrations. See prescribing information for tacrolimus. |
| Voriconazole | drug interactions (prescription label) | Clinical Impact: Decreased exposure of esomeprazole when used concomitantly with strong inducers. Intervention: St. John’s Wort, rifampin: Avoid concomitant use with [see Warnings and Precautions (5.10) ]. Ritonavir-containing products: see prescribing information for specific drugs Voriconazole |
| Warfarin | drug interactions (prescription label) | Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including esomeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain the target INR range. |
Other labels that name esomeprazole
Source: FDA drug label (Nexium 24HR), NDA204655 (Astrazeneca Lp), as published by Haleon US Holdings LLC, effective March 19, 2024 (SPL set 4513934d-0cf0-40fc-a348-b4e75a33b094), via openFDA; the full label on DailyMed
What do FAERS reports show for esomeprazole?
The FDA Adverse Event Reporting System holds 235,202 reports that list esomeprazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 19,686 are coded as a death and 73,131 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 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 esomeprazole?
20 other medicines are given the same way (oral) and in the same FDA class as esomeprazole 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 |
| 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 |
| Dexlansoprazole | Acid reflux and ulcers | 9 labelers | $3.71 per capsule 60 mg capsule | No current entry |
| Calcium carbonate | Acid reflux and ulcers | none listed | $0.0315 per tablet 750 mg tablet chewable | No current entry |
| Famotidine | Acid reflux and ulcers | 144 labelers | $0.0289 per tablet 20 mg tablet | No current entry |
Every medicine labeled for the same conditions as esomeprazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does esomeprazole compare with medicines for the same use?
7 side-by-side pages set esomeprazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to esomeprazole
- 20 medicines for the same use
- Other proton pump inhibitors
- the pharmacologic class, with prices and generics
- Esomeprazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other