Description
Pantoprazole 40 mg Enteric Coated Tablets is available by prescription only. Go ahead and place your purchase. After making payment, we will ensure that a valid prescription is received from your prescriber.
Drug Label Highlights
Pantoprazole Sodium Delayed-release Tablets
These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS.
PANTOPRAZOLE SODIUM delayed-release tablets, for oral use
Initial U.S. approval: 2000
Indications And Usage
Pantoprazole sodium 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)
Dosage And Administration
IndicationDoseFrequency
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
≥ 40 kg
20 mg
40 mg
Once Daily for up to 8 wks
Maintenance of Healing of Erosive Esophagitis (2.1)
Adults 40 mg Once Daily
Adults 40 mg Twice Daily
See full prescribing information for administration instructions (2)
Dosage Forms And Strengths
3)
Contraindications
4)
4,
7)
Warnings And Precautions
- Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1)
- Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. ( 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)
- Severe Cutaneous
- Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1)
- Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. ( 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)
- Severe Cutaneous
5.1)
5.2)
: PPI therapy may be associated with increased risk of
Clostridium difficile-associated diarrhea. (
5.3)
5.4)
5.5)
5.6)
5.7)
5.8)
5.10)
Adverse Reactions
Most common adverse reactions are:
6.1)
6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc., at 1-877-770-3183 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Drug Interactions
See full prescribing information for a list of clinically important drug interactions (
7)
Use In Specific Populations
Pregnancy: Based on animal data, may cause fetal harm. (
8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 12/2025
DailyMed highlights last updated: 2026-06-24 22:17:05









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