FDA label
What is lansoprazole used for?
The FDA-approved uses of lansoprazole, 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 lansoprazole (capsule, delayed release) lists 10 uses: Treatment of Active Duodenal Ulcer; Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence; Maintenance of Healed Duodenal Ulcers; Treatment of Active Benign Gastric Ulcer; and 6 more.
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Lansoprazole, capsule, delayed release
Indications and Usage, quoted from the label by Ajanta Pharma USA Inc. (ANDA203957). Cross-references to other label sections are left out.
Treatment of Active Duodenal Ulcer
Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer.
Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy: lansoprazole /amoxicillin /clarithromycin
Lansoprazole in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with H.pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H.pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Please refer to the full prescribing information for amoxicillin and clarithromycin.
Dual Therapy: lansoprazole /amoxicillin
Lansoprazole in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin prescribing information, Microbiology section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Please refer to the full prescribing information for amoxicillin.
Maintenance of Healed Duodenal Ulcers
Lansoprazole delayed-release capsules are indicated in adults to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months.
Treatment of Active Benign Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer.
Healing of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond eight weeks.
Risk Reduction of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks.
Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
Lansoprazole delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with GERD.
Treatment of Erosive Esophagitis (EE)
Lansoprazole delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of EE.
For adults who do not heal with lansoprazole delayed-release capsules for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis an additional eight week course of lansoprazole delayed-release capsules may be considered.
Maintenance of Healing of EE
Lansoprazole delayed-release capsules are indicated in adults to maintain healing of EE. Controlled studies did not extend beyond 12 months.
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)
Lansoprazole delayed-release capsules are indicated in adults for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Source: DailyMed label, set id 6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b, version 17, effective November 10, 2025. NDC 27241-019, one of 59 listings for this product.
Lansoprazole, tablet, orally disintegrating, delayed release
Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA207167). Cross-references to other label sections are left out.
Treatment of Active Duodenal Ulcer
Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer.
Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy: Lansoprazole delayed-release orally disintegrating tablets /amoxicillin/clarithromycin
Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Please refer to the full prescribing information for amoxicillin and clarithromycin.
Dual Therapy: Lansoprazole delayed-release orally disintegrating tablets /amoxicillin
Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin prescribing information, Microbiology section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Please refer to the full prescribing information for amoxicillin.
Maintenance of Healed Duodenal Ulcers
Lansoprazole delayed-release orally disintegrating tablets are indicated in adults to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months.
Treatment of Active Benign Gastric Ulcer
Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer.
Healing of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond eight weeks.
Risk Reduction of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks.
Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
Lansoprazole delayed-release orally disintegrating tablets are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with GERD.
Treatment of Erosive Esophagitis (EE)
Lansoprazole delayed-release orally disintegrating tablets are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of EE. For adults who do not heal with lansoprazole delayed-release orally disintegrating tablets for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis an additional eight week course of lansoprazole delayed-release orally disintegrating tablets may be considered.
Maintenance of Healing of EE
Lansoprazole delayed-release orally disintegrating tablets are indicated in adults to maintain healing of EE. Controlled studies did not extend beyond 12 months.
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)
Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Source: DailyMed label, set id 1f2883d8-12db-40b7-9104-22a6690a22a7, version 2, effective April 2, 2024. NDC 65862-895, one of 10 listings for this product.
Lansoprazole, capsule, delayed release pellets
Indications and Usage, quoted from the label by Mylan Institutional Inc. (ANDA090763). Cross-references to other label sections are left out.
Treatment of Active Duodenal Ulcer
Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies].
Eradication of H. pylorito Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy:
Dual Therapy:
Maintenance of Healed Duodenal Ulcers
Lansoprazole delayed-release capsules are indicated in adults to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months [see Clinical Studies].
Treatment of Active Benign Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer [see Clinical Studies].
Healing of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond eight weeks [see Clinical Studies].
Risk Reduction of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks [see Clinical Studies].
Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
Lansoprazole delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with GERD [see Clinical Studies].
Treatment of Erosive Esophagitis (EE)
Lansoprazole delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of EE.
For adults who do not heal with lansoprazole delayed-release capsules for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis an additional eight week course of lansoprazole delayed-release capsules may be considered [see Clinical Studies].
Maintenance of Healing of EE
Lansoprazole delayed-release capsules are indicated in adults to maintain healing of EE. Controlled studies did not extend beyond 12 months [see Clinical Studies].
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)
Lansoprazole delayed-release capsules are indicated in adults for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome [see Clinical Studies].
Source: DailyMed label, set id eea82d0b-6600-4693-a2b8-596a55458f61, version 18, effective November 11, 2025. NDC 51079-121, one of 5 listings for this product.
Questions
What is lansoprazole used for?
The FDA label for lansoprazole (capsule, delayed release) lists 10 uses: Treatment of Active Duodenal Ulcer; Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence; Maintenance of Healed Duodenal Ulcers; Treatment of Active Benign Gastric Ulcer; and 6 more.
What drug class is lansoprazole?
FDA lists lansoprazole 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.