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PROTONIX® (pantoprazole sodium) Highlights


These highlights do not include all the information needed to use PROTONIX safely and effectively. See full prescribing information for PROTONIX.

PROTONIX (pantoprazole sodium) delayed-release tablets, for oral use
PROTONIX (pantoprazole sodium) for delayed-release oral suspension
Initial U.S. approval: 2000


Warnings and Precautions, Fundic Gland Polyps (5.9) 06/2018


PROTONIX is a proton pump inhibitor (PPI) indicated for the following:

  • Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1)
  • Maintenance of Healing of Erosive Esophagitis (1.2)
  • Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (1.3)


Indication Dose Frequency
Controlled studies did not extend beyond 12 months
Short-Term Treatment of Erosive Esophagitis Associated With GERD (2.1)
  Adults 40 mg Once Daily for up to 8 wks
  Children (5 years and older)
    ≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks
    ≥ 40 kg 40 mg
Maintenance of Healing of Erosive Esophagitis (2.1)
  Adults 40 mg Once Daily*
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (2.1)
  Adults 40 mg Twice Daily

See full prescribing information for administration instructions


  • Delayed-Release Tablets: 20 mg and 40 mg pantoprazole (3)
  • For Delayed-Release Oral Suspension: 40 mg pantoprazole (3)


  • Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles (4)
  • Patients receiving rilpivirine-containing products (4,7)


  • Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1)
  • Acute Interstitial Nephritis: Observed in patients taking PPIs. (5.2)
  • Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea. (5.3)
  • Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.4)
  • Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue PROTONIX and refer to specialist for evaluation. (5.5)
  • Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. (5.6)
  • Hypomagnesemia: Reported rarely with prolonged treatment with PPIs. (5.7)
  • Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. (5.9)


Most common adverse reactions are:

  • For adult use (>2%): headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. (6.1)
  • For pediatric use (>4%): URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or


See full prescribing information for a list of clinically important drug interactions (7)


Pregnancy: Based on animal data, may cause fetal harm. (8.1)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 4/2019

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