FDA label
What is Protonix used for?
Protonix contains pantoprazole. 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 Protonix lists 3 uses: Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD); Maintenance of Healing of Erosive Esophagitis; Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome.
Run it in Rivvi
Which 2027 plans near you dropped or restricted Protonix?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Protonix, injection, powder, for solution
Indications and Usage, quoted from the label by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. (NDA020988). Cross-references to other label sections are left out.
PROTONIX I.V. is indicated for treatment of:
- gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric patients 3 months and older.
- pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
Limitations of Use
The safety and effectiveness of PROTONIX I.V. for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients.
Source: DailyMed label, set id 51e4144a-489e-436c-609a-39305f8f56ba, version 60, effective December 22, 2025. NDC 0008-0923, one of 4 listings for this product.
Protonix, tablet, delayed release
Indications and Usage, quoted from the label by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. (NDA020987). Cross-references to other label sections are left out.
PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for:
Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
PROTONIX is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
Maintenance of Healing of Erosive Esophagitis
PROTONIX is indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
Source: DailyMed label, set id 08098cb2-c048-4640-f387-6beec4a38936, version 48, effective May 18, 2026. NDC 0008-0841, one of 2 listings for this product.
Questions
What is Protonix used for?
The FDA label for Protonix lists 3 uses: Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD); Maintenance of Healing of Erosive Esophagitis; Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome.
What drug class is Protonix?
FDA lists pantoprazole 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 Protonix
- Is Protonix a controlled substance?Federal schedule
- Generic for ProtonixFDA Orange Book
- What is Pantoprazole used for?FDA label uses
- Is Pantoprazole a controlled substance?Federal schedule
- Generic for Protonix IVFDA Orange Book
- Proton Pump Inhibitors listFDA drug class
- Protonix Medicare Part D coverageBy plan and state
- NDC 0008-0841Protonix NDC record
- NDC 0008-0843Protonix NDC record
- NDC 0008-0844Protonix NDC record