Prescription medicine
Esomeprazole and naproxen First approved as Vimovo
Esomeprazole and naproxen (Vimovo) is a prescription medicine with an FDA approval on record since 2010. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $1.96 per unit (Naproxen-esomepraz DR 500-20 mg) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the esomeprazole and naproxen FDA label on DailyMed (effective December 23, 2025, Ajanta Pharma USA Inc.); the NDA 22511 record on Drugs@FDA; every esomeprazole and naproxen label on DailyMed.
Highlights of the record
FDA label of December 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS.
Cardiovascular Thrombotic Events Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of naproxen and esomeprazole magnesium delayed-release tablets, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions ( 5.1 )]. Naproxen and esomeprazole magnesium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications ( 4 ), and Warnings and Precautions ( 5.1 )]. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, a component of naproxen and esomeprazole magnesium delayed-release tablets cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions ( 5.2 )]. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageNaproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers.
Forms and strengths
- 375 mg / 20 mg
- 500 mg / 20 mg
Delayed-release tablet.
On the market
- Earliest approval on file
- April 30, 2010 Vimovo, Horizon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first February 18, 2020; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 10 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.96 per unit Naproxen-esomepraz DR 500-20 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 12 through July 30, 2026
What is esomeprazole and naproxen used for?
From the label: indications and usageNaproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of: osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. juvenile idiopathic arthritis (JIA) in adolescent patients. […]
Conditions named in the indications of esomeprazole and naproxen's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug and Proton Pump Inhibitor.
Source: FDA drug label (Naproxen and esomeprazole magnesium), Ajanta Pharma USA Inc., effective December 23, 2025 (SPL set 7ca657dc-4376-4693-8568-99351fac8186), via openFDA; the full label on DailyMed
What does the patient leaflet for esomeprazole and naproxen 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 naproxen and esomeprazole magnesium delayed-release tablets?You should take naproxen and esomeprazole magnesium delayed-release tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed. Naproxen and esomeprazole magnesium delayed-release tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your healthcare provider. Naproxen and esomeprazole magnesium delayed-release tablets contain naproxen, a nonsteroidal anti-inflammatory drug (NSAID) and esomeprazole magnesium, a proton pump inhibitor (PPI) medicine. Naproxen and esomeprazole magnesium delayed-release tablets can cause serious side effects including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take naproxen and esomeprazole magnesium delayed-release tablets right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking naproxen and esomeprazole magnesium delayed-release tablets after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. […]
From the patient leaflet: How should I store naproxen and esomeprazole magnesium delayed-release tablets?Store naproxen and esomeprazole magnesium delayed-release tablets at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Store naproxen and esomeprazole magnesium delayed-release tablets in the original container. Keep the bottle of naproxen and esomeprazole magnesium delayed-release tablets tightly closed to protect from moisture. Keep naproxen and esomeprazole magnesium delayed-release tablets and all medicines out of the reach of children.
Source: FDA drug label (Naproxen and esomeprazole magnesium), Ajanta Pharma USA Inc., effective December 23, 2025 (SPL set 7ca657dc-4376-4693-8568-99351fac8186), via openFDA; the full label on DailyMed
Is there a generic for esomeprazole and naproxen (Vimovo)?
The FDA approved the first generic esomeprazole and naproxen on February 18, 2020. 5 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists esomeprazole and naproxen from 10 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2010 earliest approval on file
- 2020 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for esomeprazole and naproxen (Vimovo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.96 per unit (Naproxen-esomepraz DR 500-20 mg), down 20% from $2.46 on October 8, 2025. 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.
- Naproxen-esomepraz DR 500-20 mg (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Naproxen-esomepraz DR 375-20 mg | Generic | $2.90 per unit | n/a | -32% |
| Naproxen-esomepraz DR 500-20 mg | Generic | $1.96 per unit | n/a | -20% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the esomeprazole and naproxen label say about other medicines?
The esomeprazole and naproxen label names 25 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Aspirin | contraindications | History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. |
| Atazanavir | drug interactions | Antiretrovirals Clinical Impact: The effect of esomeprazole magnesium on antiretroviral drugs is variable. The clinical importance and mechanisms behind these interactions are not always known. … contraindicated [see Contraindications ( 4 )]. See prescribing information for atazanavir for dosing information. Avoid concomitant use with naproxen and esomeprazole magnesium delayed-release tablets. … |
| Cilostazol | drug interactions | Cilostazol Clinical Impact: Increased exposure of cilostazol and one of its active metabolites (3,4-dihydro-cilostazol) when coadministered with omeprazole magnesium, the racemate of esomeprazole. Intervention: Consider reducing the dose of cilostazol to 50 mg twice daily. |
| Clopidogrel | drug interactions | Clinical Impact: Naproxen Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants have increased the risk of serious bleeding compared to the use of either drug alone. … Intervention: Monitor patients with concomitant use of naproxen and esomeprazole magnesium delayed-release tablets with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake … |
| Cyanocobalamin | warnings and precautions | Avoid concomitant use. ( 5.22 , 7 ) Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.23 ) Hypomagnesemia and Mineral Metabolism: |
| Cyclosporine | drug interactions | Clinical Impact: Concomitant use of naproxen and cyclosporine may increase cyclosporine’s nephrotoxicity. Intervention: During concomitant use of naproxen and esomeprazole magnesium delayed-release tablets and cyclosporine, monitor patients for signs of worsening renal function. |
| Diazepam | drug interactions | Diazepam Clinical Impact: Increased exposure of diazepam. Intervention: Monitor patients for increased sedation and adjust the dose of diazepam as needed. |
| Diflunisal | drug interactions | NSAIDs and Salicylates Clinical Impact: Concomitant use of naproxen with other NSAIDs or salicylates (…) increases the risk of GI toxicity, with little or no increase in efficacy. Intervention: The concomitant use of naproxen and esomeprazole magnesium delayed-release tablets with other NSAIDs or salicylates is not recommended. |
| Digoxin | drug interactions | Digoxin Clinical Impact: Naproxen The concomitant use of naproxen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Esomeprazole Magnesium Potential for increased exposure of digoxin. Intervention: Monitor digoxin concentrations during concomitant use of naproxen and esomeprazole magnesium delayed-release tablets. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. |
| Erlotinib | drug interactions | Clinical Impact: Esomeprazole magnesium 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 magnesium is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the … |
| Furosemide | drug interactions | Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. … Intervention: During concomitant use of naproxen and esomeprazole magnesium delayed-release tablets with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy … |
| Ketoconazole | drug interactions | Clinical Impact: Esomeprazole magnesium 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 magnesium is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the … |
| Lithium | drug interactions | Clinical Impact: NSAIDs have produced elevations of plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. … Intervention: During concomitant use of naproxen and esomeprazole magnesium delayed-release tablets and lithium, monitor patients for signs of lithium toxicity. |
| Methotrexate | drug interactions | Methotrexate Clinical Impact: Naproxen • Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (…). Esomeprazole Magnesium • Concomitant use of esomeprazole magnesium with methotrexate (primarily at high dose) may elevate and prolong … Intervention: During concomitant use of naproxen and esomeprazole magnesium delayed-release tablets and methotrexate, monitor patients for methotrexate toxicity. … |
Every other medicine the esomeprazole and naproxen label names
| Medicine named | Section | What the label says |
|---|---|---|
| Mycophenolate mofetil | drug interactions | Clinical Impact: Esomeprazole magnesium 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 magnesium is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the … |
| Mycophenolic acid | drug interactions | Clinical Impact: Esomeprazole magnesium 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 | Antiretrovirals Clinical Impact: The effect of esomeprazole magnesium on antiretroviral drugs is variable. The clinical importance and mechanisms behind these interactions are not always known. … Intervention: Rilpivirine-containing products: Concomitant use with naproxen and esomeprazole magnesium delayed-release tablets is contraindicated [see Contraindications ( 4 )]. … |
| Omeprazole | contraindications | Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen, esomeprazole magnesium, substituted benzimidazoles, or to any components of the drug product, including … |
| Pemetrexed | drug interactions | Pemetrexed Clinical Impact: Concomitant use of naproxen and esomeprazole magnesium delayed-release tablets and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). Intervention: During concomitant use of naproxen and esomeprazole magnesium delayed-release tablets and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 mL/min to 79 mL/min … |
| Propranolol | drug interactions | ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). … Intervention: During concomitant use of naproxen and esomeprazole magnesium delayed-release tablets and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is … |
| Rifampin | drug interactions | Clinical Impact: Decreased exposure of esomeprazole when used concomitantly with strong inducers. Intervention: St. John’s Wort, rifampin: Avoid concomitant use with naproxen and esomeprazole magnesium delayed-release tablets [see Warnings and Precautions ( 5.25 )]. CYP2C19 or CYP3A4 Inhibitors |
| Rilpivirine | drug interactions | Antiretrovirals Clinical Impact: The effect of esomeprazole magnesium on antiretroviral drugs is variable. The clinical importance and mechanisms behind these interactions are not always known. … Intervention: Rilpivirine-containing products: Concomitant use with naproxen and esomeprazole magnesium delayed-release tablets is contraindicated [see Contraindications ( 4 )]. … |
| Tacrolimus | drug interactions | Tacrolimus Clinical Impact: Concomitant use of esomeprazole magnesium and tacrolimus may increase exposure of tacrolimus Intervention: During concomitant use of naproxen and esomeprazole magnesium delayed-release tablets and tacrolimus, monitor tacrolimus whole blood concentrations. |
| Voriconazole | drug interactions | CYP2C19 or CYP3A4 Inhibitors Clinical Impact: Increased exposure of esomeprazole. Intervention: Voriconazole: Avoid concomitant use with naproxen and esomeprazole magnesium delayed-release tablets. |
| Warfarin | drug interactions | Clinical Impact: Naproxen Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants have increased the risk of serious bleeding compared to the use of either drug alone. … Intervention: Monitor patients with concomitant use of naproxen and esomeprazole magnesium delayed-release tablets with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake … |
Source: FDA drug label (Naproxen and esomeprazole magnesium), Ajanta Pharma USA Inc., effective December 23, 2025 (SPL set 7ca657dc-4376-4693-8568-99351fac8186), via openFDA; the full label on DailyMed
What do FAERS reports show for esomeprazole and naproxen?
The FDA Adverse Event Reporting System holds 12 reports that list esomeprazole and naproxen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 7 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.
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 and naproxen?
20 other medicines are given the same way (oral) and in the same FDA class as esomeprazole and naproxen 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 and naproxen
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to esomeprazole and naproxen
- 20 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Esomeprazole and naproxen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other