FDA label
What is Nexium used for?
Nexium contains esomeprazole. The FDA-approved uses below are 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 Nexium lists 6 uses: Healing of Erosive Esophagitis (EE); Maintenance of Healing of EE; Treatment of Symptomatic GERD; Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Associated Gastric Ulcer; and 2 more.
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Nexium, granule, delayed release
Indications and Usage, quoted from the label by AstraZeneca Pharmaceuticals LP (NDA022101). Cross-references to other label sections are left out.
Healing of Erosive Esophagitis (EE)
Adults
NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension 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 NEXIUM may be considered.
Pediatric Patients 12 Years to 17 Years of Age
NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension 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.
Pediatric Patients 1 Year to 11 Years of Age
NEXIUM for delayed-release oral suspension is indicated for the short-term treatment (8 weeks) for the healing of EE in pediatric patients 1 year to 11 years of age.
Pediatric Patients 1 Month to Less Than 1 Year of Age
NEXIUM for delayed-release oral suspension is indicated for short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age.
Maintenance of Healing of EE
NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months.
Treatment of Symptomatic GERD
Adults
NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension 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
NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension 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.
Pediatric Patients 1 Year to 11 Years of Age
NEXIUM for delayed-release oral suspension is indicated for short-term treatment (up to 8 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 1 year to 11 years of age.
Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Associated Gastric Ulcer
NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension 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
NEXIUM delayed-release capsules or NEXIUM for delayed-release oral suspension 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.
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome, in adults.
Source: DailyMed label, set id f4853677-1622-4037-688b-fdf533a11d96, version 74, effective December 19, 2025. NDC 0186-4010, one of 5 listings for this product.
Questions
What is Nexium used for?
The FDA label for Nexium lists 6 uses: Healing of Erosive Esophagitis (EE); Maintenance of Healing of EE; Treatment of Symptomatic GERD; Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Associated Gastric Ulcer; and 2 more.
What drug class is Nexium?
FDA lists esomeprazole 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.
More on Nexium
- Is Nexium a controlled substance?Federal schedule
- Generic for NexiumFDA Orange Book
- What is Esomeprazole used for?FDA label uses
- Is Esomeprazole a controlled substance?Federal schedule
- Generic for Nexium IVFDA Orange Book
- Proton Pump Inhibitors listFDA drug class
- NDC 0186-4010Nexium NDC record
- NDC 0186-4020Nexium NDC record
- NDC 0186-4025Nexium NDC record