What is esomeprazole used for?

Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc (ANDA209735). Cross-references to other label sections are left out.

Healing of Erosive Esophagitis (EE)

Adults

Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered.

Pediatric Patients 12 Years to 17 Years of Age

Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age.

Maintenance of Healing of EE

Esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months.

Treatment of Symptomatic GERD

Adults

Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults.

Pediatric Patients 12 Years to 17 Years of Age

Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 12 years to 17 years of age.

Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Associated Gastric Ulcer

Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in adult patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.

Helicobacter pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence

Eradication of H. pylorihas been shown to reduce the risk of duodenal ulcer recurrence.

Triple Therapy

Esomeprazole magnesium delayed-release capsules in combination with amoxicillin and clarithromycin is indicated for the treatment of adult patients with H. pyloriinfection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.

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.

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Esomeprazole magnesium delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome, in adults.

Source: DailyMed label, set id dc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf, version 8, effective September 18, 2025. NDC 63304-734, one of 62 listings for this product.

Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA205606). Cross-references to other label sections are left out.

Healing of Erosive Esophagitis (EE)

Adults

Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of esomeprazole magnesium delayed-release capsules may be considered.

Pediatric Patients 12 Years to 17 Years of Age

Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age.

Maintenance of Healing of EE

Esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months.

Treatment of Symptomatic GERD

Adults

Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults.

Pediatric Patients 12 Years to 17 Years of Age

Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 12 years to 17 years of age.

Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Associated Gastric Ulcer

Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in adult patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.

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

Esomeprazole magnesium delayed-release capsules in combination with amoxicillin and clarithromycin is indicated for the treatment of adult patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.

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 [see Clinical Pharmacology and the prescribing information for clarithromycin].

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Esomeprazole magnesium delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome, in adults.

Source: DailyMed label, set id f4ae091d-9b74-4a0e-ac68-057effd91e17, version 15, effective March 26, 2025. NDC 65862-783, one of 11 listings for this product.