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Omeprazole

Omeprazole is a proton pump inhibitor that lowers stomach acid. It treats ulcers, acid reflux disease (GERD), erosive esophagitis and H. pylori infection with prescription products, and frequent heartburn with over-the-counter products.

Brand names PrilosecPrilosec OTCPrimeguardGastrobimUlcerGard +11 more
Drug class Proton Pump Inhibitor
Rx/OTC Forms 5
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 335 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 →

Omeprazole at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Omeprazole is a proton pump inhibitor (PPI) that shuts down the stomach's acid pumps, and it is a standard first choice for ulcers, GERD (acid reflux), erosive esophagitis (acid damage to the food pipe), frequent heartburn and, with antibiotics, H. pylori infection; it has been on the market since about 1989 and is available as a generic and over the counter. Most people tolerate it well, apart from occasional headache or diarrhea. Watch how long you stay on it, since long-term use is linked to fractures and low vitamin B12 and magnesium, and heartburn that keeps returning, trouble swallowing or black stools need a doctor.

Clinical pearls

  • Take it shortly before breakfast, not after, because it works best on acid pumps that a meal is switching on.
  • Swallow the delayed-release capsules and tablets whole, because crushing or chewing exposes the drug to the stomach acid that destroys it.
  • Avoid pairing it with clopidogrel, the anti-clotting drug used after stents and heart attacks, because omeprazole can weaken its effect.
  • Over-the-counter omeprazole is a 14-day course, used no more than once every 4 months unless a doctor directs otherwise.
How we write & review this content — our editorial policy →
How you get itPrescription and over the counter
Comes asDelayed-release capsule, Delayed-release tablet, Delayed-release orally disintegrating tablet +2
Earliest FDA record1989
Companies listing it with the FDA129
FDA label last updatedJan 22, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Omeprazole, written from its FDA label.

What Omeprazole is used for

▾

Omeprazole is used for a range of acid-related conditions, depending on the product.

  • Prescription Prilosec and omeprazole delayed-release capsules: short-term treatment of active duodenal ulcer in adults.
  • Active benign gastric ulcer in adults.
  • Symptomatic GERD in adults and children 1 year and older.
  • Erosive esophagitis due to acid-mediated GERD in patients 1 month and older, and maintaining healing in patients 1 year and older.
  • Pathologic hypersecretory conditions in adults.
  • H. pylori eradication with clarithromycin, with or without amoxicillin, in adults with duodenal ulcer disease, to lower the risk of ulcer recurrence.
  • Over-the-counter tablets and capsules: treating frequent heartburn (2 or more days a week). They are not for immediate relief.

How Omeprazole works

▾

Omeprazole blocks the acid pump (H+/K+ ATPase enzyme) on stomach lining cells. This pump does the last step in making stomach acid. Blocking it lowers acid made both at rest and after stimulation.

Omeprazole is acid-sensitive, so the capsules contain coated granules that release it only after leaving the stomach.

Omeprazole dosage

▾

Omeprazole is taken by mouth, usually once daily before eating.

  • Prescription capsules are swallowed whole. Your pharmacist can explain alternatives if you cannot swallow them.
  • Over-the-counter products are taken once a day in the morning for a 14-day course, and the course may be repeated every 4 months if needed.
  • Orally disintegrating tablets dissolve on the tongue, with or without water. Do not crush or chew them.
  • Do not use over-the-counter products longer than 14 days unless a doctor directs it, and do not take them with alcohol where the product label says so.

Follow your prescriber’s directions and the label.

Dosing details from the FDA-approved label

From the Omeprazole 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.

  • Treatment of Active Duodenal Ulcer
    • 20 mg once daily for 4 weeks
    • Some patients may require an additional 4 weeks
    • Most patients heal within 4 weeks
  • H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence - Triple Therapy
    • Omeprazole 20 mg plus amoxicillin 1000 mg plus clarithromycin 500 mg, all three drugs twice daily for 10 days
    • If an ulcer is present at start of therapy, continue omeprazole 20 mg once daily for an additional 18 days
  • H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence - Dual Therapy
    • Omeprazole 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days
    • If an ulcer is present at start of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended
  • Active Benign Gastric Ulcer
    • 40 mg once daily for 4 to 8 weeks
  • Treatment of Symptomatic GERD (adults)
    • 20 mg once daily for up to 4 weeks
  • Treatment of Symptomatic GERD (pediatric, 1 to 16 years)
    • 5 to less than 10 kg: 5 mg
    • 10 to less than 20 kg: 10 mg
    • 20 kg and greater: 20 mg
    • Once daily for up to 4 weeks
    • Weight-based dose
  • Treatment of EE due to Acid-Mediated GERD (adults)
    • 20 mg once daily for 4 to 8 weeks
    • If no response after 8 weeks, an additional 4 weeks may be given; for recurrence, additional 4 to 8 week courses may be considered
  • Treatment of EE due to Acid-Mediated GERD (pediatric, 1 month to less than 1 year)
    • 3 to less than 5 kg: 2.5 mg
    • 5 to less than 10 kg: 5 mg
    • 10 kg and greater: 10 mg
    • Once daily up to 6 weeks
    • Weight-based dose
  • Maintenance of Healing of EE due to Acid-Mediated GERD (adults)
    • 20 mg once daily
    • Reduce to 10 mg once daily for hepatic impairment (Child-Pugh Class A, B or C) and Asian patients; controlled studies do not extend beyond 12 months
  • Pathological Hypersecretory Conditions
    • Starting dose is 60 mg once daily
    • Adjust to patient needs, as long as clinically indicated
    • Maximum: Doses up to 120 mg three times daily have been administered
    • Daily dosages greater than 80 mg should be given in divided doses
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Indications Recommended Adult ( Error! Hyperlink reference not valid.) and Pediatric Dosage ( Error! Hyperlink reference not valid.) Treatment of Active Duodenal Ulcer 20 mg once daily for 4 weeks; some patients may require an additional 4 weeks ( Error! Hyperlink reference not valid. ) H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Omeprazole Delayed-Release Capsules 20 mg Each drug twice daily for 10 days ( Error! Hyperlink reference not valid. )* Amoxicillin 1000 mg Clarithromycin 500 mg Dual Therapy: Omeprazole Delayed-Release Capsules 40 mg once daily for 14 days** Clarithromycin 500 mg three times daily for 14 days ( Error! Hyperlink reference not valid. ) Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks ( Error! Hyperlink reference not valid. ) Symptomatic GERD 20 mg once daily for up to 4 weeks ( Error! Hyperlink reference not valid. ) See full prescribing information for weight based dosing in pediatric patients 1 year of age and older ( Error! Hyperlink reference not valid. ) EE due to Acid-Mediated GERD 20 mg once daily for 4 to 8 weeks ( Error! Hyperlink reference not valid. )*** See full prescribing information for weight based dosing in pediatric patients 1 year of age and older ( Error! Hyperlink reference not valid. ) Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily ( Error! Hyperlink reference not valid. )**** See full prescribing information for weight based dosing in pediatric patients 1 year of age and older ( Error! Hyperlink reference not valid. ) Pathological Hypersecretory Conditions Starting dose is 60 mg once daily (varies with individual patient, see full prescribing information) as long as clinically indicated ( Error! Hyperlink reference not valid. ) * if ulcer present, continue Omeprazole Delayed-Release Capsules 20 mg once daily for an additional 18 days. ** if ulcer present, continue Omeprazole Delayed-Release Capsules 20 mg once daily for an additional 14 days. *** an additional 4 weeks of treatment may be given if no response; if recurrence additional 4 to 8 week courses may be considered. **** studied for 12 months. Reduce the dosage to 10 mg once daily for patients with hepatic impairment (Child Pugh Class A, B, or C) and Asian patients ( Error! Hyperlink reference not valid.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Omeprazole side effects

▾

Most people tolerate omeprazole well. Common side effects include:

Common side effects

  • Headache
  • Stomach pain
  • Nausea
  • Diarrhea
  • Vomiting
  • Gas (flatulence)

When to get medical help

  • Severe skin reactions such as reddening, blisters or rash: stop the medicine and get medical help right away.
  • Diarrhea that does not improve: call your doctor, as it can be a sign of a C. difficile infection.
  • New rash or joint pain: stop use and ask a doctor, since it could signal lupus.
  • Signs of an allergic reaction such as swelling, trouble breathing or hives: get emergency help.
  • Symptoms of low magnesium, such as muscle spasms, a racing or irregular heartbeat, or seizures: contact your doctor.
  • Trouble or pain swallowing, vomiting blood, or bloody or black stools: do not use the over-the-counter product and see a doctor.
  • Chest pain, shortness of breath, or pain spreading to the arm, neck or shoulder: seek medical care.
  • Heartburn that continues or worsens: stop use and ask a doctor.

In children, respiratory problems and fever were reported most often. Seek help for severe skin reactions, diarrhea that does not improve, new rash or joint pain, or signs of an allergic reaction.

Omeprazole warnings and precautions

▾
  • Severe allergic and skin reactions can occur. Stop the medicine and get medical help right away.
  • Stomach cancer is not ruled out by symptom relief. Poor response or early relapse needs follow-up.
  • Kidney inflammation (acute tubulointerstitial nephritis) can occur at any time during treatment.
  • C. difficile diarrhea risk may rise, especially in hospitalized patients.
  • Long-term use may raise the risk of bone fractures, low vitamin B-12, low magnesium and fundic gland polyps (stomach growths).
  • Lupus has been reported, as a new case or a flare.

Omeprazole interactions

▾

Omeprazole can change how other medicines work, and some medicines can change omeprazole levels.

  • Rilpivirine: must not be combined.
  • Clopidogrel: avoid, since its effect may be reduced.
  • St. John’s Wort and rifampin: avoid, as they lower omeprazole levels.
  • Atazanavir and nelfinavir: avoid combining.
  • Warfarin: INR needs monitoring.
  • Methotrexate: levels may rise at high doses.
  • Citalopram, cilostazol, phenytoin, diazepam, digoxin, tacrolimus: levels may rise, so doses or blood levels may need adjusting.
  • Iron salts, ketoconazole, itraconazole, mycophenolate: may be absorbed less well.
  • Tests: it can affect neuroendocrine tumor tests and cause false-positive urine THC screens.

Interactions listed in the FDA-approved label

From the Omeprazole 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 may reduce antiviral effect and promote development of drug resistance. Avoid concomitant use. See prescribing information for atazanavir for dosing information.
  • Nelfinavir: Decreased exposure may reduce antiviral effect and promote development of drug resistance. Avoid concomitant use. See prescribing information for nelfinavir.
  • Saquinavir: Increased exposure of saquinavir may increase toxicity. See the 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 the warfarin dose, if needed, to maintain target INR range.
  • Methotrexate: May elevate and prolong serum concentrations of methotrexate and/or hydroxymethotrexate, possibly leading to toxicities. A temporary withdrawal of omeprazole may be considered in some patients receiving high-dose methotrexate.
  • Clopidogrel: Omeprazole 80 mg reduces plasma concentrations of the active metabolite of clopidogrel and reduces 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 an active metabolite of cilostazol (3,4-dihydro-cilostazol). Reduce the dose of cilostazol to 50 mg twice daily.
  • Phenytoin: Potential for increased exposure of phenytoin. Monitor phenytoin serum concentrations; dose adjustment may be needed.
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 Omeprazole Delayed-Release Capsules 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 Omeprazole Delayed-Release Capsules 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 omeprazole may reduce antiviral effect and promote the development of drug resistance [see C li n i cal P harmacology ( 12.3 )] . Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with omeprazole may increase toxicity [see C l i n i cal P harmacology ( 12.3 )] . There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole. Intervention: R il p i v i rine-containing products : Concomitant use with Omeprazole Delayed-Release Capsules is contraindicated [see C o ntraindications ( 4 )] . A t azanavir : Avoid concomitant use with Omeprazole Delayed-Release Capsules. See prescribing information for atazanavir for dosing information. Nelfinavir : Avoid concomitant use with Omeprazole Delayed-Release Capsules. See prescribing information for nelfinavir. S aquinavir : See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities. Other antiretrovirals : See prescribing information for specific antiretroviral drugs.

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.

🌿174 supplements and herbs with documented Omeprazole interactions, ranked by severity Check Omeprazole against a supplement or herb →

Before taking Omeprazole

▾
  • Do not use if you are allergic to omeprazole or similar medicines.
  • Do not use with rilpivirine-containing products.
  • Ask a doctor first about heartburn lasting over 3 months, wheezing, unexplained weight loss, nausea, vomiting or stomach pain.
  • Ask a health professional first if pregnant or breastfeeding.
  • Children under 18 should ask a doctor before using over-the-counter products.
  • Tell your doctor about all prescription medicines you take.

Omeprazole overdose

▾

Overdose can cause confusion, drowsiness, blurred vision, fast heartbeat, nausea, vomiting, sweating, flushing, headache and dry mouth. Symptoms were temporary in reports. There is no specific antidote. Contact Poison Control at 1-800-222-1222 or seek medical help right away.

What Omeprazole does in the body

▾

Omeprazole starts reducing acid within one hour, with a peak effect within two hours. The effect can last up to 72 hours, and acid production returns gradually over 3 to 5 days after stopping. The effect builds with daily dosing and levels off after about four days. Gastrin levels rise during the first 1 to 2 weeks and return to normal after stopping.

How your body processes Omeprazole

▾

Absorption is quick, with peak blood levels within 0.5 to 3.5 hours. About 30 to 40% of a dose reaches the bloodstream. The blood half-life is short, 0.5 to 1 hour, though the acid-lowering effect lasts much longer. The liver breaks omeprazole down mainly using the CYP2C19 and CYP3A4 enzymes. About 77% of a dose leaves in urine as metabolites, and the rest leaves in feces.

How to store Omeprazole

▾

store at 20-25°C (68-77°F); keep product out of high heat and moisture • take the tablet immediately after opening individual blister. store the tablet outside the blister pack for future use.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

174

Supplements & herbs that interact with Omeprazole

174 supplements and herbal products have documented interactions with Omeprazole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 121
  • Minor · 50
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate AMERICAN ELDER Moderate ARTICHOKE Moderate +166 more
Every supplement checked against Omeprazole — ranked by severity The full interaction hub: 3 major · 121 moderate · 50 minor · every one linked to its full report. Check Omeprazole against your exact supplements

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.

9

Nutrient depletion considerations

Omeprazole 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.

Evidence & significance mix
  • Higher significance · 5
  • Moderate · 1
  • Unrated · 3
CALCIUM Insignificant Depletion FOLIC ACID Insignificant Depletion IRON Insignificant Depletion MAGNESIUM Major Depletion ZINC Insignificant Depletion VITAMIN B12 Moderate Depletion BETA-CAROTENE Insufficient Evidence CHROMIUM Insufficient Evidence +1 more
See the full Omeprazole nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Omeprazole: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Omeprazole — the kind of thing our pharmacy team would talk through with you at the counter.

What is omeprazole for?

▾
It lowers stomach acid. Prescription versions treat ulcers, GERD, erosive esophagitis and H. pylori infection. Over-the-counter versions treat frequent heartburn, which is heartburn 2 or more days a week.

How should I take it?

▾
Take it by mouth once a day, before eating. For over-the-counter use, that means the morning, with water, for a 14-day course. Swallow capsules and regular tablets whole. Dissolving tablets go on your tongue. Never crush or chew them.

How quickly will it work?

▾
It is not for immediate relief. The over-the-counter label says full effect can take 1 to 4 days. Some people feel complete relief within 24 hours.

What side effects should I expect?

▾
The most common are headache, stomach pain, nausea, diarrhea, vomiting and gas. Call your doctor for diarrhea that does not go away, new rash or joint pain, or signs of an allergic reaction. Get help right away for blisters or a severe skin rash.

Can I take it with my other medicines?

▾
Not always. Avoid it with clopidogrel, St. John’s Wort and rifampin, and never take it with rilpivirine. Warfarin, methotrexate, digoxin and others may need monitoring. Tell me about every medicine you use.

When should I see a doctor instead of self-treating?

▾
See a doctor if you have trouble swallowing, bloody or black stools, vomiting blood, or chest pain. Also see one if heartburn lasts over 3 months or you need more than 14 days of treatment. Do not use more than one course every 4 months without medical advice.

Is Omeprazole available over the counter?

▾
Both. Some Omeprazole products are sold over the counter and others need a prescription. According to their FDA listings, the delayed-release capsule form is sold both ways, at different strengths or package sizes, the delayed-release tablet, delayed-release orally disintegrating tablet and capsule forms are sold over the counter and the oral powder form needs a prescription. The package says which kind you have. Your pharmacist can tell you which product is right for you.

When was Omeprazole first available?

▾
The earliest FDA record we hold for Omeprazole is from 1989: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Omeprazole was first used.

Who makes Omeprazole?

▾
129 companies currently list Omeprazole products in the FDA's NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack, Proficient Rx LP. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Omeprazole on HelloPharmacist

📊Omeprazole supplement interactions174 checked — ranked by severity 🌿Drug & Supplement CheckerOmeprazole vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Omeprazole NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Omeprazole Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Omeprazole forms and strengths (how it comes)

Omeprazole is available in 5 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.

Delayed-release capsule

By mouth
Brands Acid Reducer Basic Care Omeprazole Equate Omeprazole Good Sense Omeprazole
How this form is used
What it may be used for
  • Omeprazole Dr delayed-release capsules (prescription) treat active duodenal ulcer, active benign gastric ulcer, and GERD in adults and children.
  • Equate Omeprazole, Basic Care Omeprazole and Good Sense Omeprazole capsules treat frequent heartburn (2 or more days a week).
Important instructions
  • Omeprazole Dr capsules should be taken before eating and swallowed whole.
  • Equate Omeprazole, Basic Care Omeprazole and Good Sense Omeprazole: swallow 1 capsule with water before eating in the morning, for 14 days.
  • These over-the-counter capsules should not be chewed or crushed, and are for adults 18 and older.
Available strengths 4 strengths
10 mg 20 mg 20.6 mg 40 mg
424 FDA-listed product records ⓘ

Delayed-release tablet

By mouth
Brands Acid Reducer Basic Care Omeprazole Berkley and Jensen Omeprazole Careone Omeprazole Dg Health Omeprazole Equate Omeprazole Good Neighbor Pharmacy Omeprazole Good Sense Omeprazole Prilosec OTC Signature Care Omeprazole TopCare Omeprazole Up And Up Omeprazole
How this form is used
What it may be used for
  • 24 HOUR Omeprazole, Basic Care Omeprazole and Careone Omeprazole treat frequent heartburn (2 or more days a week).
  • These products are not meant for immediate relief and may take 1 to 4 days for full effect.
Important instructions
  • Careone Omeprazole and Berkley and Jensen Omeprazole: swallow 1 tablet with water before eating in the morning, for 14 days.
  • Do not chew, crush or suck these tablets.
  • A 14-day course may be repeated every 4 months if needed.
Available strengths 4 strengths
20 mg 20.6 mg 25 mg 1 kg/kg
260 FDA-listed product records ⓘ

Delayed-release orally disintegrating tablet

By mouth
Brands Basic Care Omeprazole Berkley And Jensen Omeprazole Careone Omeprazole Good Neighbor Pharmacy Omeprazole Good Sense Omeprazole Signature Care Omeprazole Topcare Omeprazole Up And Up Omeprazole
How this form is used
What it may be used for
  • Over-the-counter products such as Basic Care Omeprazole and Berkley And Jensen Omeprazole treat frequent heartburn (2 or more days a week).
Important instructions
  • Basic Care Omeprazole and Berkley And Jensen Omeprazole: take 1 tablet before eating in the morning, once a day for 14 days.
  • Place the tablet on the tongue, where it dissolves with or without water. It can also be swallowed whole with water.
  • Do not crush or chew these tablets.
Available strengths 1 strength
20 mg
39 FDA-listed product records ⓘ

Oral powder

By mouth
Brands Prilosec
How this form is used
What it may be used for
  • Prilosec delayed-release granules treat active duodenal ulcer, active benign gastric ulcer and symptomatic GERD.
  • Prilosec also treats erosive esophagitis due to acid-mediated GERD, helps maintain its healing, and is used for pathologic hypersecretory conditions.
Important instructions
  • Prilosec is also used with clarithromycin, with or without amoxicillin, to eradicate H. pylori in adults with duodenal ulcer disease.
  • Follow your prescriber’s directions for how to take Prilosec.
Available strengths 3 strengths
2.5 mg 10 mg 100 mg
5 FDA-listed product records ⓘ

Capsule

By mouth
Available strengths 1 strength
20.6 mg
1 FDA-listed product record ⓘ

Omeprazole on the U.S. market: products, makers and brands

How Omeprazole 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.

129 companies list 355 Omeprazole product records with the FDA, mostly as delayed-release capsule, delayed-release tablet, delayed-release orally disintegrating tablet; the earliest marketing or approval year on record is 1989. Brand names on the directory include Prilosec, Prilosec OTC, Primeguard and 13 more; the rest are generics.

5
Dose forms ⓘ
129
Labelers (makers, repackagers, distributors)
37
Brand names
355
FDA-listed product records ⓘ
1989
Earliest FDA record ⓘ

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 (42) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions6%
Bryant Ranch Prepack4%
Proficient Rx LP4%
Aphena Pharma Solutions - Tennessee, LLC3%
NuCare Pharmaceuticals,Inc.3%
Amazon.com Services LLC3%
Other makers78%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Omeprazole is used (Medicaid data)

A general measure of how commonly Omeprazole 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 Omeprazole 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.

8,598,486
Medicaid prescriptions filled (Q1–Q4 2025)
$91.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Omeprazole prescribed? Of the 1,601 medications we measure, Omeprazole ranks #14 by Medicaid prescriptions — more than 99% of them.

Where Omeprazole ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #14 of 1,601
#9 Ondansetron 10,434,600 Rx #10 Fluticasone Nasal Spra... 9,154,113 Rx #11 Metformin 9,119,008 Rx #12 Hydroxyzine 9,012,994 Rx #13 Sertraline 8,868,838 Rx #14 Omeprazole 8,598,486 Rx #15 Amphetamine / Amphetam... 8,570,176 Rx #16 Amlodipine 8,001,920 Rx #17 Ergocalciferol 7,906,448 Rx #18 Trazodone 7,898,849 Rx #19 Levothyroxine 7,786,593 Rx

Utilization by Omeprazole 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.

The 20 mg delayed release oral capsule is the most-dispensed Omeprazole product — about 50% of these Medicaid prescriptions.

omeprazole 20 MG Delayed Release Oral Capsule Most dispensed

4,300,125 Medicaid prescriptions (Q1–Q4 2025) 50% of Omeprazole prescriptions shown $42.2M gross reimbursement (before rebates) ≈ $9.82 per prescription (gross)

Summed across the 45 of 639 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198051

omeprazole 40 MG Delayed Release Oral Capsule

4,106,276 Medicaid prescriptions (Q1–Q4 2025) 48% of Omeprazole prescriptions shown $42.9M gross reimbursement (before rebates) ≈ $10 per prescription (gross)

Summed across the 35 of 308 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 200329

omeprazole 20 MG Delayed Release Oral Tablet

109,412 Medicaid prescriptions (Q1–Q4 2025) 1% of Omeprazole prescriptions shown $2.4M gross reimbursement (before rebates) ≈ $22 per prescription (gross)

Summed across the 29 of 354 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 402014

omeprazole 10 MG Delayed Release Oral Capsule

77,429 Medicaid prescriptions (Q1–Q4 2025) <1% of Omeprazole prescriptions shown $868,880 gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 12 of 87 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199119

omeprazole 10 MG Granules for Oral Suspension

2,343 Medicaid prescriptions (Q1–Q4 2025) <1% of Omeprazole prescriptions shown $2M gross reimbursement (before rebates) ≈ $839 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 797058

omeprazole 20 MG Disintegrating Oral Tablet

1,174 Medicaid prescriptions (Q1–Q4 2025) <1% of Omeprazole prescriptions shown $29,624 gross reimbursement (before rebates) ≈ $25 per prescription (gross)

Summed across the 4 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2003656

omeprazole 2.5 MG Granules for Oral Suspension

713 Medicaid prescriptions (Q1–Q4 2025) <1% of Omeprazole prescriptions shown $571,638 gross reimbursement (before rebates) ≈ $802 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 797063

Other Omeprazole products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

1,014 Medicaid prescriptions (Q1–Q4 2025) <1% of Omeprazole prescriptions shown $157,607 gross reimbursement (before rebates) ≈ $155 per prescription (gross)

Summed across the 3 of 230 listed NDC products with Medicaid activity.

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 Omeprazole, 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 130 of 1,654 listed Omeprazole NDCs with Medicaid activity.

Compare Omeprazole products

A representative set of FDA-listed product records for Omeprazole — 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.)

Showing 104 of 355 products — FDA National Drug Code Directory. See every product, package size and price: browse all 355 Omeprazole NDCs →

Omeprazole 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 Omeprazole — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Omeprazole are chronic kidney disease, nausea, fatigue; about 72% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

448,269
Reports mentioning it
72%
Reported as serious
12
Distinct effects shown
Most reported effects
Chronic Kidney Disease
36,807
Nausea
27,096
Fatigue
26,259
Diarrhoea
25,669
Acute Kidney Injury
23,964
Dyspnoea
21,146
Pain
20,500
Headache
19,502
Renal Failure
18,226
Vomiting
17,423
Age groups
Adult · 32,838Elderly · 30,558Adolescent · 877Child · 706Neonate · 292Infant · 271

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 Omeprazole 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.

Omeprazole FDA approval history

How Omeprazole went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Omeprazole was first approved by the FDA in 1989 (Brand: PRILOSEC · Astrazeneca); the first generic version was approved in 2002. It remains available in U.S. pharmacies today.

1989
Brand approved
Brand: PRILOSEC · Astrazeneca
2002
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Omeprazole 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 2 Omeprazole recalls since July 2021. One of them is still ongoing and is 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.

Ongoing Class II Jun 30, 2025 · 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.
  • Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals H… Lots: Lot: C2403017, Exp 12/31/2026 FDA record D-0525-2025 →
Class II Oct 5, 2021 · Terminated · Dr. Reddy's Laboratories, Inc.
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
  • Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC… Lots: BT001594C FDA record D-0026-2022 →

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.

Ingredient (IN) Omeprazole RxCUI 7646 6 dose forms · 13 strengths
  1. Dose form (SCDF) Delayed Release Oral Capsule RxCUI 378236 In current FDA listings
    Clinical drug / strength (SCD) 10 MG RxCUI 199119 20 MG RxCUI 198051 40 MG RxCUI 200329
  2. Dose form (SCDF) Delayed Release Oral Tablet RxCUI 402424 In current FDA listings
    Clinical drug / strength (SCD) 10 MG RxCUI 402013 20 MG RxCUI 402014 40 MG RxCUI 402015
  3. Dose form (SCDF) Disintegrating Oral Tablet RxCUI 2003655 No current FDA listing
    Clinical drug / strength (SCD) 20 MG RxCUI 2003656
  4. Dose form (SCDF) Granules for Oral Suspension RxCUI 1855328 No current FDA listing
    Clinical drug / strength (SCD) 2.5 MG RxCUI 797063 10 MG RxCUI 797058
  5. Dose form (SCDF) Oral Paste RxCUI 1796429 No current FDA listing
    Clinical drug / strength (SCD) 0.37 MG/MG RxCUI 994510
  6. Dose form (SCDF) Oral Tablet RxCUI 393435 No current FDA listing
    Clinical drug / strength (SCD) 10 MG RxCUI 389171 20 MG RxCUI 389172 40 MG RxCUI 389173

Look up RxCUI 7646 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.

Omeprazole supply and shortage status

Whether Omeprazole 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.

Omeprazole is not in shortage right now; the FDA has 10 past shortage records for it.

✅No current shortage of Omeprazole on record
To be discontinued Omeprazole, Delayed Release Capsule, 20 mg (NDC 0781-2868-10)
Sandoz Inc. · Since 10/09/2025 · Updated 10/09/2025
To be discontinued Omeprazole, Delayed Release Capsule, 20 mg (NDC 0781-2868-92)
Sandoz Inc. · Since 10/09/2025 · Updated 10/09/2025
To be discontinued Omeprazole, Delayed Release Capsule, 20 mg (NDC 0781-2868-31)
Sandoz Inc. · Since 10/09/2025 · Updated 10/09/2025
To be discontinued Omeprazole, Delayed Release Capsule, 40 mg (NDC 0781-2234-01)
Sandoz Inc. · Since 10/09/2025 · Updated 10/09/2025
To be discontinued Omeprazole, Delayed Release Capsule, 40 mg (NDC 0781-2234-31)
Sandoz Inc. · Since 10/09/2025 · Updated 10/09/2025
To be discontinued Omeprazole, Delayed Release Capsule, 10 mg (NDC 0781-2859-10)
Sandoz Inc. · Since 10/09/2025 · Updated 10/09/2025
To be discontinued Omeprazole, Delayed Release Capsule, 10 mg (NDC 0781-2859-01)
Sandoz Inc. · Since 10/09/2025 · Updated 10/09/2025
To be discontinued Omeprazole, Delayed Release Capsule, 20 mg (NDC 0781-2868-01)
Sandoz Inc. · Since 10/09/2025 · Updated 10/09/2025
To be discontinued Omeprazole, Delayed Release Capsule, 40 mg (NDC 0781-2234-10)
Sandoz Inc. · Since 10/09/2025 · Updated 10/09/2025
To be discontinued Omeprazole, Delayed Release Capsule, 10 mg (NDC 0781-2859-31)
Sandoz Inc. · Since 10/09/2025 · Updated 10/09/2025

Source: openFDA, from the FDA Drug Shortages database.

💵 What Omeprazole 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.

FormStrengthPharmacy acquisition benchmark
Tablet, Delayed Release · Oral 20 mg $0.383 per tablet NDC details & price history
Tablet, Orally Disintegrating, Delayed Release · Oral 20 mg $0.468 per tablet NDC details & price history
Capsule, Delayed Release 40 mg $0.050 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full 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.

Omeprazole brand names

Omeprazole is sold under 16 brand names in the FDA directory — Prilosec, Prilosec OTC, Primeguard, Gastrobim and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Prilosec Prilosec OTC Primeguard Gastrobim UlcerGard Acid Reducer basic care omeprazole up and up omeprazole good sense omeprazole careone omeprazole berkley and jensen omeprazole Signature Care Omeprazole dg health omeprazole topcare omeprazole equate omeprazole good neighbor pharmacy omeprazole

Who makes Omeprazole: manufacturers and labelers

129 companies list Omeprazole products with the FDA. By number of product records, the largest are A-S Medication Solutions, Bryant Ranch Prepack, Proficient Rx LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

A-S Medication Solutions 21 Bryant Ranch Prepack 13 Proficient Rx LP 13 Aphena Pharma Solutions - Tennessee, LLC 11 NuCare Pharmaceuticals,Inc. 10 Amazon.com Services LLC 9 Dr. Reddy's Laboratories Limited 7 H E B 7 Walgreen Company 7 Golden State Medical Supply, Inc. 6 Kroger Company 5 L. Perrigo Company 5 Northwind Health Company, LLC 5 Preferred Pharmaceuticals Inc. 5 Safeway 5 Sandoz Inc 5 Advanced Rx of Tennessee, LLC 4 Apotex Corp 4 Aurohealth LLC 4 CVS Pharmacy 4 Meijer Distribution Inc 4 NorthStar Rx LLC 4 PD-Rx Pharmaceuticals, Inc. 4 PLD Acquisitions LLC DBA Avma Pharma Solutions 4

…and 105 more on the FDA NDC directory.

Omeprazole drug class (RxNorm)

Omeprazole belongs to the Proton Pump Inhibitor class.

Pharmacologic class Proton Pump Inhibitor
Drug family (ATC) Proton pump inhibitors
How it works Proton Pump Inhibitors, Cytochrome P450 2C19 Inhibitors

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 Omeprazole 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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 22, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Omeprazole.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Omeprazole after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
335
Finished products in the current FDA directory
355
Companies listing them (makers, repackagers, distributors)
129
FDA labeler codes behind them ⓘ
115
Linked representative label ⓘ
Walgreen Company
Linked label effective
Jan 22, 2025
Composite sections available
28
Linked SPL Set ID
064f048c-eddd-4370-9ee4-706f9f00c8d2
Linked SPL Document ID
d56182bb-d424-4890-93c6-bca29194af8c
Open the linked representative label on DailyMed ↗

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. Walgreen Company 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 →