Prescription and over-the-counter medicine
Omeprazole Brand names: Prilosec
Omeprazole (Prilosec) is a prescription and over-the-counter medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 118 generic labelers, and pharmacies paid $0.0295 per omeprazole DR 20 mg capsule in the October 7, 2026 NADAC survey; its other strengths are brand-only, $14.75 per pen (Prilosec DR 2.5 mg suspension).
- Generic listed
- A presentation discontinued
Check it at the source: the omeprazole FDA label on DailyMed (effective April 22, 2024, Apotex Corp); the NDA 19810 record on Drugs@FDA; every omeprazole label on DailyMed.
Highlights of the record
FDA label of April 22, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageOmeprazole is a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults ( 1.1 ) Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) Treatment of active benign gastric ulcer in adults ( 1.3 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older ( 1.4 ) Treatment of erosive esophagitis (EE
Forms and strengths
- 2.5 mg
- 10 mg
- 20 mg
- 20.6 mg
- 40 mg
Delayed-release capsule; delayed-release tablet; orally disintegrating delayed-release tablet; capsule (delayed release pellets); delayed-release granule.
On the market
- Earliest approval on file
- September 14, 1989 Prilosec, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 31 first November 1, 2002; 24 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 138 of which 118 under generic applications, 32 under brand applications, repackagers included; 1 more under the over-the-counter monograph, without an application
- Last listed patent
- December 8, 2036 Omeprazole tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0295 per capsule Omeprazole DR 20 mg capsule
- Shortage (FDA)
- None current 10 past records
- Recalls by its makers (FDA)
- 7 since 2013 0 Class I among all firms' recalls; latest June 30, 2025
- FAERS reports
- 446,179 through July 30, 2026
What is omeprazole used for?
From the label: indications and usageOmeprazole is a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults ( 1.1 ) Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) Treatment of active benign gastric ulcer in adults ( 1.3 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older ( 1.4 ) Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older ( 1.5 ) Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older ( 1.6 ) Pathologic hypersecretory conditions in adults ( 1.7 ) 1.1 Treatment of Active Duodenal Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. […]
Conditions named in the indications of omeprazole's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Proton Pump Inhibitor.
Source: FDA drug label (Omeprazole), Apotex Corp, effective April 22, 2024 (SPL set b83329ac-a65e-b3af-a3fb-c5a6c740e5e7), via openFDA; the full label on DailyMed
What does the patient leaflet for omeprazole 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 omeprazole delayed-release capsules?You should take omeprazole delayed-release capsules exactly as prescribed, at the lowest dose possible and for the shortest time needed. Omeprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Omeprazole delayed-release capsules can cause serious side effects, including: A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including omeprazole delayed-release capsules, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with omeprazole delayed-release capsules. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine. Diarrhea. Omeprazole may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection ( Clostridium difficile ) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. Bone fractures. People who take multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take omeprazole delayed-release capsules exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take omeprazole delayed-release capsules. Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). […]
From the patient leaflet: How should I store omeprazole delayed-release capsules?Store omeprazole delayed-release capsules at room temperature between 68°F to 77°F (20°C to 25°C). Keep the container of omeprazole delayed-release capsules dry and away from light. Keep omeprazole delayed-release capsules and all medicines out of the reach of children.
Source: FDA drug label (Omeprazole), Apotex Corp, effective April 22, 2024 (SPL set b83329ac-a65e-b3af-a3fb-c5a6c740e5e7), via openFDA; the full label on DailyMed
Is there a generic for omeprazole (Prilosec)?
The FDA approved the first generic omeprazole on November 1, 2002. 31 generic applications are approved; 24 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 omeprazole from 118 labelers under a generic (ANDA) application and from 32 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 Prilosec Otc tablets; a patent listed only for Omeprazole 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.
- 1989 earliest approval on file
- 2002 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 omeprazole (Prilosec)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0295 per Omeprazole DR 20 mg capsule, down 7% from $0.0316 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.
- Omeprazole DR 20 mg capsule (generic)
- Prilosec DR 2.5 mg suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Acid reducer DR 20 mg capsule | Generic | $0.395 per capsule | $11.85 | -2% |
| Ft omeprazole DR 20 mg tablet | Generic | $0.383 per tablet | $11.50 | -4% |
| Gnp omeprazole DR 20 mg tablet | Generic | $0.383 per tablet | $11.50 | -4% |
| Gs omeprazole DR 20 mg ODT | Generic | $0.468 per unit | n/a | -0.4% |
| Gs omeprazole DR 20 mg tablet | Generic | $0.383 per tablet | $11.50 | -4% |
| Omeprazole DR 10 mg capsule | Generic | $0.0766 per capsule | $2.30 | -1% |
| Omeprazole DR 20 mg capsule | Generic | $0.0295 per capsule | $0.884 | -7% |
| Omeprazole DR 20 mg ODT | Generic | $0.468 per unit | n/a | -0.4% |
| Omeprazole DR 20 mg tablet | Generic | $0.383 per tablet | $11.50 | -4% |
| Omeprazole DR 40 mg capsule | Generic | $0.0498 per capsule | $1.49 | -6% |
| Omeprazole mag DR 20 mg capsule | Generic | $0.395 per capsule | $11.85 | -2% |
| Omeprazole mag DR 20 mg tablet | Generic | $0.473 per tablet | $14.19 | +30% |
| Omeprazole mag DR 20.6 mg capsule | Generic | $0.395 per capsule | $11.85 | -2% |
| Prilosec DR 10 mg suspension | Brand | $14.76 per pen many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is omeprazole in shortage?
No omeprazole presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 10 records are all marked to be discontinued, the latest updated October 9, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Omeprazole, Delayed Release Capsule, 10 mg (NDC 0781-2859-01) | Sandoz Inc. | To Be Discontinued | October 9, 2025 |
| Omeprazole, Delayed Release Capsule, 10 mg (NDC 0781-2859-10) | Sandoz Inc. | To Be Discontinued | October 9, 2025 |
| Omeprazole, Delayed Release Capsule, 10 mg (NDC 0781-2859-31) | Sandoz Inc. | To Be Discontinued | October 9, 2025 |
| Omeprazole, Delayed Release Capsule, 20 mg (NDC 0781-2868-01) | Sandoz Inc. | To Be Discontinued | October 9, 2025 |
| Omeprazole, Delayed Release Capsule, 20 mg (NDC 0781-2868-10) | Sandoz Inc. | To Be Discontinued | October 9, 2025 |
| Omeprazole, Delayed Release Capsule, 20 mg (NDC 0781-2868-31) | Sandoz Inc. | To Be Discontinued | October 9, 2025 |
| Omeprazole, Delayed Release Capsule, 20 mg (NDC 0781-2868-92) | Sandoz Inc. | To Be Discontinued | October 9, 2025 |
| Omeprazole, Delayed Release Capsule, 40 mg (NDC 0781-2234-01) | Sandoz Inc. | To Be Discontinued | October 9, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has omeprazole been recalled?
The FDA's Enforcement Report lists 7 recalls naming omeprazole since 2013: 0 Class I (the most serious), 7 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 30, 2025 | Class II | Dr. Reddy's Laboratories, Inc. | Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. |
| October 5, 2021 | Class II | Dr. Reddy's Laboratories, Inc. | CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle. |
| March 19, 2021 | Class II | Golden State Medical Supply Inc. | Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| March 11, 2021 | Class II | Breckenridge Pharmaceutical, Inc | Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing. |
| December 17, 2018 | Class II | Duren Health Mart Pharmacy | Lack of Processing Controls. |
| September 16, 2013 | Class II | Kremers Urban Pharmaceuticals, Inc. | Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the omeprazole label say about other medicines?
The omeprazole label names 26 other medicines in its interaction, contraindication or warning sections. The labels of 45 other medicines name omeprazole. 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 | For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole, refer to the CONTRAINDICATIONS section of their package inserts. |
| Atazanavir | drug interactions | 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 omeprazole is contraindicated [see Contraindications ()]. Atazanavir: Avoid concomitant use with omeprazole. … |
| Cilostazol | drug interactions | Cilostazol Clinical Impact: Increased exposure of one of the active metabolites of cilostazol (3,4-dihydro-cilostazol). Intervention: Reduce the dose of cilostazol to 50 mg twice daily. See prescribing information for cilostazol. |
| Citalopram | drug interactions | 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 | For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole, refer to the CONTRAINDICATIONS section of their package inserts. |
| Clopidogrel | drug interactions | Clopidogrel Clinical Impact: Concomitant use of omeprazole 80 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition. … Intervention: Avoid concomitant use with omeprazole. Consider use of alternative anti-platelet therapy [see Warnings and Precautions ()]. |
| Cyanocobalamin | warnings and precautions | Avoid concomitant use of omeprazole. ( 5.7 , 7 ) Cyanocobalamin (Vitamin B-12) Deficiency: |
| Cyclosporine | drug interactions | Clinical Impact: There have been clinical reports of interactions with other drugs metabolized via the cytochrome P450 system (…). Intervention: Monitor patients to determine if it is necessary to adjust the dosage of these other drugs when taken concomitantly with omeprazole. … |
| Dasatinib | drug interactions | Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic … |
| Diazepam | drug interactions | Diazepam Clinical Impact: Increased exposure of diazepam. Intervention: Monitor patients for increased sedation and reduce the dose of diazepam as needed. |
| Digoxin | drug interactions | Clinical Impact: Potential for increased exposure of digoxin. Intervention: Monitor digoxin concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See digoxin prescribing information. |
| Disulfiram | drug interactions | Clinical Impact: There have been clinical reports of interactions with other drugs metabolized via the cytochrome P450 system (…). Intervention: Monitor patients to determine if it is necessary to adjust the dosage of these other drugs when taken concomitantly with omeprazole. … |
| Erlotinib | drug interactions | Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic … |
| Itraconazole | drug interactions | Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic … |
Every other medicine the omeprazole label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ketoconazole | drug interactions | Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic … |
| Methotrexate | drug interactions | Methotrexate Clinical Impact: Concomitant use of omeprazole 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 omeprazole may be considered in some patients receiving high-dose methotrexate. |
| Mycophenolate mofetil | drug interactions | Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic … |
| Mycophenolic acid | drug interactions | Clinical Impact: Omeprazole 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 PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. … omeprazole. See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with omeprazole. See prescribing information for nelfinavir. … |
| Nilotinib | drug interactions | Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic … |
| Phenytoin | drug interactions | Phenytoin Clinical Impact: Potential for increased exposure of phenytoin. Intervention: Monitor phenytoin serum concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for phenytoin. |
| Rifampin | drug interactions | Clinical Impact: Decreased exposure of omeprazole when used concomitantly with strong inducers. Intervention: St. John’s Wort, rifampin: Avoid concomitant use with omeprazole [see Warnings and Precautions ( 5.10 )]. Ritonavir-containing products: see prescribing information for specific drugs. … |
| Rilpivirine | drug interactions | 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 omeprazole is contraindicated [see Contraindications ()]. Atazanavir: Avoid concomitant use with omeprazole. … |
| Tacrolimus | drug interactions | Tacrolimus Clinical Impact: Potential for increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19. Intervention: Monitor tacrolimus whole blood concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus. |
| Voriconazole | drug interactions | CYP2C19 or CYP3A4 Inhibitors Clinical Impact: Increased exposure of omeprazole. Intervention: Voriconazole: Dose adjustment of omeprazole is not normally required. However, in patients with Zollinger-Ellison syndrome, who may require higher doses, dose adjustment may be considered. … |
| Warfarin | drug interactions | Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including omeprazole, 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 target INR range. |
Other labels that name omeprazole
- Aminophylline
- Anagrelide
- Armodafinil
- Carbamazepine
- Carisoprodol
- Clobazam
- Darunavir
- Drospirenone and ethinyl estradiol
- Drospirenone and ethinyl estradiol and levomefolate
- Enzalutamide
- Eslicarbazepine
- Esomeprazole
- Ferric oxyhydroxide
- Fosamprenavir
- Ivacaftor and lumacaftor
- Ledipasvir and sofosbuvir
- Letermovir
- Modafinil
- Olanzapine
- Sofosbuvir and velpatasvir
- Tocilizumab
Source: FDA drug label (Omeprazole), Apotex Corp, effective April 22, 2024 (SPL set b83329ac-a65e-b3af-a3fb-c5a6c740e5e7), via openFDA; the full label on DailyMed
What do FAERS reports show for omeprazole?
The FDA Adverse Event Reporting System holds 446,179 reports that list omeprazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 39,203 are coded as a death and 150,196 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 omeprazole?
20 other medicines are given the same way (oral) and in the same FDA class as omeprazole 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 |
|---|---|---|---|---|
| Esomeprazole | Acid reflux and ulcers | 117 labelers | $0.145 per capsule 20 mg capsule | No current entry |
| 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 |
| Dexlansoprazole | Acid reflux and ulcers | 9 labelers | $3.71 per capsule 60 mg capsule | No current entry |
| Esomeprazole and naproxen | Acid reflux and ulcers | 10 labelers | $1.96 per unit 500-20 mg | 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 omeprazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does omeprazole compare with medicines for the same use?
12 side-by-side pages set omeprazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to omeprazole
- 20 medicines for the same use
- Other proton pump inhibitors
- the pharmacologic class, with prices and generics
- Omeprazole side effects
- the label's list beside FAERS reports
- Omeprazole shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other