Esomeprazole
Esomeprazole is a proton pump inhibitor (PPI) that lowers stomach acid to treat GERD, erosive esophagitis, and related conditions, and the same ingredient is sold over the counter for frequent heartburn.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 225 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Esomeprazole (Nexium) is a proton pump inhibitor, or PPI, that blocks the final step in making stomach acid, used for GERD (acid reflux), erosive esophagitis and certain ulcer problems; on the U.S. market since about 2001, it is one of the most familiar first-choice acid reducers and is available as a generic and over the counter. Most people tolerate it well, and any side effects, usually headache, diarrhea or nausea, tend to be mild. Use the lowest dose for the shortest time that works, because long-term use is linked to fractures, low magnesium and low vitamin B12, and see your doctor if heartburn keeps coming back.
Clinical pearls
- Swallow delayed-release tablets whole before breakfast, since crushing or chewing ruins the coating that shields the drug from acid.
- Avoid it with clopidogrel (Plavix), which it weakens, and never combine it with rilpivirine-containing HIV medicines.
- The over-the-counter version is a 14-day course, repeated no more often than every 4 months unless a doctor says otherwise.
- If you take warfarin, expect closer INR checks while on esomeprazole, because bleeding risk can rise.
Patient information guide A plain-language walkthrough of Esomeprazole, written from its FDA label.
What Esomeprazole is used for
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Esomeprazole is used for several acid-related conditions, depending on the product.
- Prescription oral esomeprazole magnesium products: short-term healing of erosive esophagitis in adults and in children 12 to 17 years old (some suspension products include younger children)
- Maintenance of healing of erosive esophagitis in adults
- Short-term treatment of heartburn and other symptoms of GERD
- Reducing the risk of NSAID-associated stomach ulcers in adults 60 and older and/or with a history of stomach ulcers
- H. pylori eradication in adults to reduce the risk of duodenal ulcer recurrence, together with amoxicillin and clarithromycin
- Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome, in adults
- Esomeprazole strontium delayed-release capsules: GERD in adults, including healing and maintenance of erosive esophagitis and symptomatic GERD, and reducing NSAID-associated gastric ulcers
- Esomeprazole sodium for injection (intravenous): short-term treatment of GERD with erosive esophagitis when oral treatment is not possible or appropriate, and reducing the risk of ulcer rebleeding after endoscopy in adults
- Over-the-counter esomeprazole products: frequent heartburn (2 or more days a week), not for immediate relief
How Esomeprazole works
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Esomeprazole blocks the acid pump (the H+/K+ ATPase enzyme) on the surface of the stomach’s acid-making cells. This is the final step in acid production. The effect is dose-related and reduces acid made both at rest and when stimulated.
Esomeprazole dosage
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Oral esomeprazole is generally taken once daily, with timing depending on the condition and product. The over-the-counter tablet is swallowed whole with water before eating in the morning, for a 14-day course. The injection is given into a vein by a healthcare professional.
- Esomeprazole strontium capsules should be taken at least one hour before meals.
- Food can reduce how much esomeprazole is absorbed from the capsules.
- Follow your prescriber’s directions and the product label.
Dosing details from the FDA-approved label
From the Esomeprazole prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Healing of EE, adults
- 20 mg or 40 mg once daily for 4 to 8 weeks
- Some patients may require an additional 4 to 8 weeks
- Maximum: 20 mg once daily for patients with severe liver impairment (Child-Pugh Class C)
- Most patients are healed within 4 to 8 weeks
- Healing of EE, 12 years to 17 years
- 20 mg or 40 mg once daily for 4 to 8 weeks
- Healing of EE, 1 year to 11 years
- Less than 20 kg: 10 mg once daily
- 20 kg and greater: 10 mg or 20 mg once daily
- For 8 weeks
- Maximum: Dosages over 1 mg/kg/day have not been studied
- weight-based
- EE due to Acid-Mediated GERD, 1 month to less than 1 year
- 3 kg to 5 kg: 2.5 mg once daily
- Greater than 5 kg to 7.5 kg: 5 mg once daily
- Greater than 7.5 kg to 12 kg: 10 mg once daily
- Up to 6 weeks
- Maximum: Dosages over 1.33 mg/kg/day have not been studied
- weight-based
- Maintenance of Healing of EE, adults
- 20 mg once daily
- Controlled studies do not extend beyond 6 months
- Treatment of Symptomatic GERD, adults
- 20 mg once daily for 4 weeks
- If symptoms do not resolve completely, consider an additional 4 weeks
- Treatment of Symptomatic GERD, 12 years to 17 years
- 20 mg once daily for 4 weeks
- Treatment of Symptomatic GERD, 1 year to 11 years
- 10 mg once daily for up to 8 weeks
- Maximum: Dosages over 1 mg/kg/day have not been studied
- Risk Reduction of NSAID-Associated Gastric Ulcer, adults
- 20 mg or 40 mg once daily for up to 6 months
- Maximum: 20 mg once daily for patients with severe liver impairment (Child-Pugh Class C)
- Controlled studies do not extend beyond 6 months
- H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence, adults (triple therapy)
- Esomeprazole magnesium 40 mg once daily, amoxicillin 1000 mg twice daily, clarithromycin 500 mg twice daily, each for 10 days
- Refer to amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Population Recommended Adult ( 2.1 ) and Pediatric Dosage ( 2.2 ) Healing of EE (1 year and older) Adults 20 mg or 40 mg 1 once daily for 4 to 8 weeks; some patients may require an additional 4 to 8 weeks 12 years to 17 years 20 mg or 40 mg 1 once daily for 4 to 8 weeks 1 year to 11 years see full prescribing information for weight-based dosing and duration of treatment ( 2.2 ) Maintenance of Healing of EE Adults 20 mg once daily. Controlled studies do not extend beyond 6 months Treatment of Symptomatic GERD Adults 20 mg once daily for 4 weeks some patients may require an additional 4 weeks 12 years to 17 years 20 mg once daily for 4 weeks 1 year to 11 years 10 mg once daily for up to 8 weeks Risk Reduction of NSAID-Associated Gastric Ulcer Adults 20 mg or 40 mg 1 once daily for up to 6 months 2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Adults Esomeprazole Magnesium Delayed-release Capsules 40 mg 1 once daily for 10 days Amoxicillin 1000 mg twice daily for 10 days 3 Clarithromycin 500 mg twice daily for 10 days 3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults Starting dosage is 40 mg twice daily 4 (varies with the individual patient) as long as clinically indicated. 1 A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C). 2 Controlled studies do not extend beyond 6 months. 3 Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients. 4 A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child-Pugh Class C). Preparation and Administration Information Swallow capsules whole; do not crush or chew. For patients who cannot swallow intact capsule, the capsule can be opened, and the contents mixed with applesauce. ( 2.3 ) Opened capsules can be administered through a nasogastric tube. ( 2.3 ) 2.1 Recommended Dosage in Adults by Indication Table 1 shows the recommended adult dosage of Esomeprazole Magnesium Delayed-release Capsules by indication. The duration of Esomeprazole Magnesium Delayed-release Capsules treatment should be based on available safety and efficacy data specific to the defined indication and dosing frequency and individual patient medical needs.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Esomeprazole side effects
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The most common side effects in adults include:
Common side effects
- Headache
- Diarrhea
- Nausea
- Gas (flatulence)
- Abdominal pain
- Constipation
- Dry mouth
- Sleepiness in children
When to get medical help
- Severe or lasting diarrhea that doesn’t improve, which can signal a Clostridium difficile infection
- Severe skin reactions, such as blistering, peeling, or a spreading rash, or signs of an allergic reaction like swelling or trouble breathing. Stop the medicine and get help right away.
- New or worsening rash, especially on sun-exposed skin, or joint pain, which can signal lupus
- Signs of kidney problems, such as feeling unwell, nausea, or loss of appetite
- Muscle spasms, irregular heartbeat, or seizures, which can signal low magnesium
- Heartburn symptoms that come back quickly or respond poorly to treatment, especially in older adults
- Broken bones of the hip, wrist, or spine with long-term, high-dose use
Esomeprazole warnings and precautions
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- Symptom relief does not rule out stomach cancer in adults.
- Kidney inflammation (acute tubulointerstitial nephritis) can occur at any time during treatment.
- C. difficile-associated diarrhea risk may be higher with PPIs.
- Long-term or high-dose use is linked to bone fractures.
- Severe skin reactions and lupus have been reported, so stop the drug and get evaluated if they occur.
- Long-term use may cause vitamin B12 deficiency, low magnesium, and fundic gland polyps.
- Esomeprazole can interfere with tests for neuroendocrine tumors and with a urine THC screen.
Esomeprazole interactions
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Esomeprazole can change how other drugs work, and some drugs can change esomeprazole levels.
- Rilpivirine-containing products: contraindicated
- Clopidogrel: reduced effect, so avoid
- St. John’s wort and rifampin: lower esomeprazole levels, so avoid
- Warfarin: higher INR and bleeding risk, so monitoring is needed
- Methotrexate: higher levels, possible toxicity
- Nelfinavir: avoid; atazanavir and saquinavir: follow their prescribing information
- Citalopram, cilostazol, digoxin, tacrolimus: may need dose changes or monitoring
- Iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, and itraconazole: absorption may drop because of lower stomach acid
- Voriconazole: raises esomeprazole levels
Interactions listed in the FDA-approved label
From the Esomeprazole prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Rilpivirine-containing products: Decreased exposure of rilpivirine may reduce antiviral effect and promote drug resistance. Concomitant use is contraindicated.
- Atazanavir: Decreased exposure of atazanavir may reduce antiviral effect and promote drug resistance. See prescribing information for atazanavir for dosing information.
- Nelfinavir: Decreased exposure of nelfinavir may reduce antiviral effect and promote drug resistance. Avoid concomitant use.
- Saquinavir: Increased exposure of saquinavir may increase toxicity. See prescribing information for saquinavir for monitoring of potential toxicities.
- Warfarin: Increased INR and prothrombin time, which may lead to abnormal bleeding and even death. Monitor INR and prothrombin time and adjust warfarin dose, if needed, to maintain the target INR range.
- Methotrexate: May elevate and prolong serum concentrations of methotrexate and/or hydroxymethotrexate, possibly leading to methotrexate toxicities. A temporary withdrawal of esomeprazole may be considered in some patients receiving high-dose methotrexate.
- Clopidogrel: Esomeprazole 40 mg reduced plasma concentrations of clopidogrel's active metabolite and reduced platelet inhibition. Avoid concomitant use; consider alternative anti-platelet therapy.
- Citalopram: Increased exposure of citalopram leading to an increased risk of QT prolongation. Limit the dose of citalopram to a maximum of 20 mg per day.
- Cilostazol: Increased exposure of cilostazol and one of its active metabolites. Consider reducing the dose of cilostazol to 50 mg twice daily.
- St. John's Wort, rifampin: Decreased exposure of esomeprazole with strong CYP2C19 or CYP3A4 inducers. Avoid concomitant use.
Read the label’s full interactions text
7 DRUG INTERACTIONS Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with esomeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 3: Clinically Relevant Interactions Affecting Drugs Co-Administered with Esomeprazole and Interaction with Diagnostics 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. • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with esomeprazole may reduce antiviral effect and promote the development of drug resistance [see Clinical Pharmacology (12.3) ] . • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with esomeprazole may increase toxicity [see Clinical Pharmacology (12.3) ] . • There are other antiretroviral drugs which do not result in clinically relevant interactions with esomeprazole. Intervention: Rilpivirine-containing products: Concomitant use with esomeprazole magnesium delayed-release capsules is contraindicated [see Contraindications (4) ] . Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with esomeprazole magnesium delayed-release capsules. See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities. Other antiretrovirals: See prescribing information for specific antiretroviral drugs. 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.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Esomeprazole
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- Do not take if allergic to substituted benzimidazoles or any ingredient in the product.
- Do not take with rilpivirine-containing medicines.
- Tell your doctor if you are pregnant or breastfeeding.
- Children under 18 should see a doctor before using over-the-counter products for heartburn.
- Prescription use is not recommended for symptomatic GERD in infants under 1 year.
- Severe liver impairment may require a lower dose.
- People at risk of osteoporosis, low magnesium, or low calcium should discuss this with their doctor.
Esomeprazole overdose
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Overdose with omeprazole (a related form) caused confusion, drowsiness, blurred vision, fast heartbeat, nausea, sweating, flushing, headache, and dry mouth. There is no specific antidote, and dialysis is not expected to help. Treatment is symptomatic and supportive. Call Poison Control at 1-800-222-1222.
What Esomeprazole does in the body
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Esomeprazole raises stomach pH, keeping the stomach less acidic for much of the day. In adults with GERD, a higher dose kept acid levels lower for more hours than a lower dose. It also raises gastrin (a hormone that signals acid production), which returns to baseline within about four weeks after stopping. In studies, it had no effect on thyroid function.
How your body processes Esomeprazole
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After oral dosing, esomeprazole peaks in the blood at about 1.5 hours. Food can lower absorption considerably. It is heavily processed by the liver, mainly through CYP2C19 and CYP3A4. Its half-life is about 1 to 1.5 hours. About 80% leaves as inactive metabolites in the urine, and the rest in the feces.
How to store Esomeprazole
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Store at 20° to 25°C (68° to 77°F). Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure if the esomeprazole magnesium delayed-release capsules product package is subdivided.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Esomeprazole
154 supplements and herbal products have documented interactions with Esomeprazole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 102
- Minor · 49
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Esomeprazole has been associated with lower levels of 9 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 5
- Moderate · 1
- Unrated · 3
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Esomeprazole: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Esomeprazole — the kind of thing our pharmacy team would talk through with you at the counter.
What is esomeprazole for?
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How should I take it?
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Will it relieve my heartburn right away?
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What side effects should I expect?
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Can I take it with my other medicines?
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Is it safe to take for a long time?
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Is Esomeprazole available over the counter?
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When was Esomeprazole first available?
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Who makes Esomeprazole?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Esomeprazole on HelloPharmacist
Esomeprazole forms and strengths (how it comes)
Esomeprazole is available in 8 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Esomeprazole inactive ingredients by manufacturer.
Delayed-release capsule
How this form is used
- These over-the-counter delayed-release capsule products treat frequent heartburn (2 or more days a week).
- They are not intended for immediate relief of heartburn and may take 1 to 4 days for full effect.
Oral powder
Capsule
Delayed-release tablet
How this form is used
- Acid Reducer and Esomeprazole Magnesium delayed-release tablets treat frequent heartburn (2 or more days a week) and are not for immediate relief.
- Esomeprazole Magnesium delayed-release tablets are for adults 18 and older: swallow 1 tablet whole with water before eating in the morning, every day for 14 days.
- Do not crush or chew Esomeprazole Magnesium delayed-release tablets.
- Do not use for more than 14 days, or repeat the course more often than every 4 months, unless directed by a doctor.
Injection
How this form is used
- Esomeprazole Sodium for injection is used for short-term treatment of GERD with erosive esophagitis in adults and children 1 month to 17 years when oral treatment is not possible or appropriate.
- Esomeprazole Sodium for injection is used in adults to reduce the risk of rebleeding of gastric or duodenal ulcers after therapeutic endoscopy for acute bleeding.
- Esomeprazole Sodium for injection is given into a vein, either as an injection or an infusion.
- For GERD with erosive esophagitis, Esomeprazole Sodium for injection is given once daily for up to 10 days in adults.
- For rebleeding risk, Esomeprazole Sodium for injection is given as an infusion over 72 hours.
Oral suspension
Tablet
Extended-release oral suspension
Esomeprazole on the U.S. market: products, makers and brands
How Esomeprazole appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
107 companies list 252 Esomeprazole product records with the FDA, mostly as delayed-release capsule, oral powder, capsule; the earliest marketing or approval year on record is 2001. Brand names on the directory include Nexium, Nexium 24HR, Acid Reducer and 13 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (49) · Pellet (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Esomeprazole is used (Medicaid data)
A general measure of how commonly Esomeprazole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Esomeprazole is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Esomeprazole prescribed? Of the 1,601 medications we measure, Esomeprazole ranks #226 by Medicaid prescriptions — more than 86% of them.
Utilization by Esomeprazole product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
esomeprazole 40 MG Delayed Release Oral Capsule Most dispensed
Summed across the 38 of 215 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 606730
esomeprazole 20 MG Delayed Release Oral Capsule
Summed across the 34 of 483 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 606726
esomeprazole 20 MG Granules for Oral Suspension
Summed across the 4 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 692576
esomeprazole 10 MG Granules for Oral Suspension
Summed across the 3 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861568
esomeprazole 40 MG Granules for Oral Suspension
Summed across the 4 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 692578
esomeprazole 5 MG Granules for Oral Suspension
Summed across the 3 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1297761
esomeprazole 2.5 MG Granules for Oral Suspension
Summed across the 3 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1297658
esomeprazole 40 MG Injection
Summed across the 1 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 486501
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Esomeprazole, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 90 of 736 listed Esomeprazole NDCs with Medicaid activity.
Compare Esomeprazole products
A representative set of FDA-listed product records for Esomeprazole — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 20 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 40 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 20 mg | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 20 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 20 mg | Oral | Yyba Corp | ANDA | View NDC → |
| 💊Delayed-release capsule | ||||
| 20 mg | Oral | A-S Medication Solutions | NDA | View NDC → |
| 20 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | A-S Medication Solutions × 7 listings | ANDA | View NDC → |
| 20 mg | Oral | Advanced Rx of Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Advanced Rx of Tennessee, LLC | ANDA | View NDC → |
| 20 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | View NDC → |
| 40 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | View NDC → |
| 20 mg | Oral | Ahold U.S.A., Inc, | ANDA | View NDC → |
| 20 mg | Oral | Amazon.com Services LLC × 6 listings | ANDA | View NDC → |
| 20 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 20 mg | Oral | American Sales Company | ANDA | View NDC → |
| 20 mg | Oral | Amerisource Bergen × 3 listings | ANDA | View NDC → |
| 20 mg | Oral | Army & Air Force Exchange Service | ANDA | View NDC → |
| 20 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 40 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 20 mg | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| 20 mg | Oral | AstraZeneca Pharmaceuticals LP | NDA | View NDC → |
| 40 mg | Oral | AstraZeneca Pharmaceuticals LP | NDA | View NDC → |
| 20 mg | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Aurohealth LLC × 5 listings | ANDA | View NDC → |
| 40 mg | Oral | AvPAK | ANDA | View NDC → |
| 20 mg | Oral | Best Choice | ANDA | View NDC → |
| 20 mg | Oral | Better Living Brands, Llc | ANDA | View NDC → |
| 20 mg | Oral | Better Living Brands LLC | ANDA | View NDC → |
| 20 mg | Oral | Better Living Brands Llc. | ANDA | View NDC → |
| 20 mg | Oral | Biocon Pharma Inc., | ANDA | View NDC → |
| 40 mg | Oral | Biocon Pharma Inc., | ANDA | View NDC → |
| 20 mg | Oral | Bjwc | ANDA | View NDC → |
| 20 mg | Oral | Bryant Ranch Prepack × 5 listings | ANDA | View NDC → |
| 40 mg | Oral | Bryant Ranch Prepack × 5 listings | ANDA | View NDC → |
| 20 mg | Oral | Cabinet Health P.B.C. | ANDA | View NDC → |
| 20 mg | Oral | Camber Consumer Care Inc | ANDA | View NDC → |
| 20 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Cardinal Health 110, LLC. dba Leader | ANDA | View NDC → |
| 20 mg | Oral | Chain Drug Marketing Association, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Chain Drug Marketing Association Inc | ANDA | View NDC → |
| 20 mg | Oral | Costco Wholesale Company | ANDA | View NDC → |
| 20 mg | Oral | Cvs | ANDA | View NDC → |
| 20 mg | Oral | CVS Pharmacy × 3 listings | ANDA | View NDC → |
| 20 mg | Oral | CVS Pharmacy, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Cvs Woonsocket Prescription Center, Incorporated × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Direct Rx | ANDA | View NDC → |
| 20 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 20 mg | Oral | Discount Drug Mart, Inc | ANDA | View NDC → |
| 20 mg | Oral | Discount Drug Mart, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Dolgencorp, LLC | ANDA | View NDC → |
| 20 mg | Oral | Dolgencorp Inc × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Dr. Reddy's Laboratories Inc × 5 listings | ANDA | View NDC → |
| 40 mg | Oral | Dr. Reddy's Laboratories Inc | ANDA | View NDC → |
| 20 mg | Oral | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 20 mg | Oral | Family Dollar Stores, LLC | ANDA | View NDC → |
| 20 mg | Oral | Geri-care Pharmaceuticals, Corp | ANDA | View NDC → |
| 20 mg | Oral | Glenmark Therapeutics Inc., Usa × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 40 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 20 mg | Oral | Grocery Outlet, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Guardian Drug Company | ANDA | View NDC → |
| 20 mg | Oral | H-e-b | ANDA | View NDC → |
| 20 mg | Oral | Haleon US Holdings LLC × 2 listings | NDA | View NDC → |
| 20 mg | Oral | H E B × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Heb | ANDA | View NDC → |
Showing 113 of 252 products — FDA National Drug Code Directory. See every product, package size and price: browse all 252 Esomeprazole NDCs →
Esomeprazole side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Esomeprazole — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Esomeprazole are chronic kidney disease, acute kidney injury, renal failure; about 72% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Esomeprazole in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Esomeprazole FDA approval history
How Esomeprazole went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Esomeprazole was first approved by the FDA in 2001 (Brand: NEXIUM · Astrazeneca); the first generic version was approved in 2013. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Esomeprazole recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 4 Esomeprazole recalls since July 2021, covering 6 product listings. Two of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus P… Lots: Lot #:M402147, Exp 10/2025; M311637, Exp 07/2025; M402495, Exp 02/2026; M407997, Exp 05/2026; M502246, Exp11/2026. FDA record D-0443-2025 →
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus P… Lots: Lot # M311638, Exp 07/2025, M400374, Exp 10/2025, M402496, Exp 02/2026, M407998, Exp 05/2026, M502247, Exp 11/2026, M414770, M414512, Exp 09/2026. FDA record D-0442-2025 →
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (US… Lots: Lot#: M408002, Exp 05/31/2026 FDA record D-0102-2025 →
- Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuti… Lots: Lot # 17220002, Exp Date 11/30/2023 FDA record D-0112-2024 →
- Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industr… Lots: Lot AC14304, Exp 12/2022. FDA record D-0005-2023 →
- Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industri… Lots: Lot AC14299, Exp 12/2022 FDA record D-0004-2023 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 283742 6 dose forms · 17 strengths
-
Dose form (SCDF) Delayed Release Oral Capsule RxCUI 606725In current FDA listingsClinical drug / strength (SCD) strontium 24.65 MGRxCUI 1810789strontium 49.3 MGRxCUI 181078720 MGRxCUI 60672640 MGRxCUI 606730 -
Dose form (SCDF) Delayed Release Oral Tablet RxCUI 439356In current FDA listings -
Dose form (SCDF) Granules for Oral Suspension RxCUI 1855312In current FDA listings -
Dose form (SCDF) Injection RxCUI 1728037In current FDA listings -
Dose form (SCDF) Oral Capsule RxCUI 393463In current FDA listingsClinical drug / strength (SCD) 20 MGRxCUI 39187340 MGRxCUI 391874 -
Dose form (SCDF) Oral Tablet RxCUI 393436In current FDA listingsClinical drug / strength (SCD) 20 MGRxCUI 38917540 MGRxCUI 389174
Look up RxCUI 283742 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Esomeprazole supply and shortage status
Whether Esomeprazole is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Esomeprazole costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule, Delayed Release · Oral | 40 mg | $0.122 per capsule | NDC details & price history |
| Granule, Delayed Release · Oral | 20 mg | $9.14 each | NDC details & price history |
| Granule, Delayed Release · Oral | 40 mg | $9.13 each | NDC details & price history |
| Granule, Delayed Release · Oral | 2.5 mg | $9.17 each | NDC details & price history |
| Granule, Delayed Release · Oral | 10 mg | $9.14 each | NDC details & price history |
| Granule, Delayed Release · Oral | 5 mg | $9.16 each | NDC details & price history |
| Capsule, Delayed Release Pellets · Oral | 20 mg | $0.145 per capsule | NDC details & price history |
| Capsule, Delayed Release Pellets · Oral | 40 mg | $0.122 per capsule | NDC details & price history |
| Capsule, Coated Pellets · Oral | 20 mg | $0.145 per capsule | NDC details & price history |
| Capsule, Coated Pellets · Oral | 40 mg | $0.122 per capsule | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Esomeprazole brand names
Esomeprazole is sold under 16 brand names in the FDA directory — Nexium, Nexium 24HR, Acid Reducer, good sense esomeprazole magnesium and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Esomeprazole: manufacturers and labelers
107 companies list Esomeprazole products with the FDA. By number of product records, the largest are A-S Medication Solutions, Bryant Ranch Prepack, Dr. Reddy's Laboratories Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 83 more on the FDA NDC directory.
Esomeprazole drug class (RxNorm)
Esomeprazole belongs to the Proton Pump Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Esomeprazole page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Macleods Pharmaceuticals Limited is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →