Pantoprazole is a proton pump inhibitor indicated for pROTONIX is a proton pump inhibitor (PPI) indicated for the following, among other approved uses. MedsAcross supplies Pantoprazole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for: PROTONIX is a proton pump inhibitor (PPI) indicated for the following: • Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD). • Maintenance of Healing of Erosive Esophagitis. • Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome
Source: US FDA prescribing information
Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H +, K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H +, K + )-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested (20 mg to 120 mg).
Source: US FDA prescribing information
Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD. 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. Adults 40 mg Once Daily Controlled studies did not extend beyond 12 months Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome. Adults 40 mg Twice Daily See full prescribing information for administration instructions
Source: US FDA prescribing information
• PROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria. • Proton pump inhibitors (PPIs), including PROTONIX, are contraindicated in patients receiving rilpivirine-containing products. • Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles. • Patients receiving rilpivirine-containing products
Source: US FDA prescribing information
• Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. • Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. • Clostridium difficile- Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile- associated diarrhea. • 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. • Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
Source: US FDA prescribing information
The following serious adverse reactions are described below and elsewhere in labeling: • Acute Tubulointerstitial Nephritis • Clostridium difficile- Associated Diarrhea • Bone Fracture • Severe Cutaneous Adverse Reactions • Cutaneous and Systemic Lupus Erythematosus • Cyanocobalamin (Vitamin B-12) Deficiency • Hypomagnesemia and Mineral Metabolism • Fundic Gland Polyps Most common adverse reactions are: • For adult use (>2%): headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. • For pediatric use (>4%): URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.
Source: US FDA prescribing information
Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PROTONIX and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 4: Clinically Relevant Interactions Affecting Drugs Co-Administered with PROTONIX and Interactions with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with pantoprazole may reduce antiviral effect and promote the development of drug resistance.
Source: US FDA prescribing information
Store PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
18 presentations of Pantoprazole, sorted by availability.
3 brand names across 1 markets.
Indian manufacturers are highlighted.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Pantoprazole in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 18 presentations of Pantoprazole and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Piramal Critical Care.
The catalogue lists 3 brand names for Pantoprazole, including Pantoprazole Sodium I.V., Protonix Delayed-Release, Protonix I.V..
Yes. The US FDA first approved Pantoprazole on 2 February 2000, according to Drugs@FDA.
Yes. Pantoprazole has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Pantoprazole must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Pantoprazole is classified under ATC code A02BC02 (Pantoprazole).
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