FDA label
What is omeprazole used for?
The FDA-approved uses of omeprazole, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for omeprazole (capsule, delayed release) lists 7 uses: Treatment of Active Duodenal Ulcer; Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence; Treatment of Active Benign Gastric Ulcer; Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD); and 3 more.
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Omeprazole, capsule, delayed release
Indications and Usage, quoted from the label by Sandoz Inc (ANDA076515). Cross-references to other label sections are left out.
Treatment of Active Duodenal Ulcer
Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Triple Therapy
Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.
Dual Therapy
Omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.
Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
Treatment of Active Benign Gastric Ulcer
Omeprazole delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.
Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
Omeprazole delayed-release capsules are indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 2 years of age and older.
Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD
Omeprazole delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD that has been diagnosed by endoscopy in patients 2 years of age and older.
The efficacy of omeprazole delayed-release capsules are used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole delayed-release capsules may be considered.
Maintenance of Healing of EE Due to Acid-Mediated GERD
Omeprazole delayed-release capsules are indicated for the maintenance healing of EE due to acid-mediated GERD in patients 2 years of age and older.
Controlled studies do not extend beyond 12 months.
Pathological Hypersecretory Conditions
Omeprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
Source: DailyMed label, set id 5a09ce48-7139-4fc7-9b6e-439459c8e866, version 26, effective December 31, 2024. NDC 0781-2234, one of 171 listings for this product.
Omeprazole, capsule, delayed release pellets
Indications and Usage, quoted from the label by Golden State Medical Supply, Inc. (ANDA203481). Cross-references to other label sections are left out.
Treatment of Active Duodenal Ulcer
Omeprazole delayed-release capsules, USP, are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Triple Therapy
Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.
Dual Therapy
Omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.
Among patients who fail therapy, Omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
Treatment of Active Benign Gastric Ulcer
Omeprazole delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.
Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
Omeprazole is indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 2 years of age and older.
Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD
Pediatric Patients 2 Years of Age to Adults
Omeprazole is indicated for the short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD that has been diagnosed by endoscopy in patients 2 years of age and older.
The efficacy of omeprazole used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of Omeprazole may be considered.
Maintenance of Healing of EE Due to Acid-Mediated GERD
Omeprazole is indicated for the maintenance healing of EE due to acid-mediated GERD in patients 2 years of age and older. Controlled studies do not extend beyond 12 months.
Pathological Hypersecretory Conditions
Omeprazole is indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
Source: DailyMed label, set id f27b3518-d5c1-1229-e053-2a95a90ab56f, version 5, effective April 14, 2026. NDC 51407-664, one of 3 listings for this product.
Questions
What is omeprazole used for?
The FDA label for omeprazole (capsule, delayed release) lists 7 uses: Treatment of Active Duodenal Ulcer; Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence; Treatment of Active Benign Gastric Ulcer; Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD); and 3 more.
What drug class is omeprazole?
FDA lists omeprazole in the Proton Pump Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.