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Protonix (pantoprazole)
Irreversibly inhibits the gastric proton pump (H+/K+ ATPase), suppressing stomach acid secretion.
Pantoprazole (Protonix) is a proton pump inhibitor approved in 2000, now available generically. It is notable for fewer drug interactions than other PPIs and is widely used in hospital settings via its IV formulation.
At a glance
| Generic name | pantoprazole |
|---|---|
| Also known as | Protonix, Pantoloc, Controloc |
| Sponsor | Generic (originally Byk Gulden/Altana/Nycomed) |
| Drug class | Proton pump inhibitor (PPI) |
| Target | ATP-binding cassette sub-family G member 2, Fatty acid synthase, Multidrug and toxin extrusion protein 1 |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
| First approval | 2000-02-02 (United States) |
Mechanism of action
Pantoprazole is a proton pump inhibitor that irreversibly blocks the hydrogen-potassium ATPase in gastric parietal cells. It has the advantage of fewer drug interactions compared to omeprazole due to lower affinity for CYP2C19, and is available in both oral and IV formulations making it useful in hospital settings.
Approved indications
- Erosive esophagitis
- Gastric Hypersecretory Conditions
- Gastroesophageal reflux disease
- Maintenance of Healing Erosive Esophagitis
- Multiple endocrine adenomas
- Peptic ulcer
- Zollinger-Ellison syndrome
Common side effects
- Upper Respiratory Infection (URI)
- Headache
- Fever
- Diarrhea
- Vomiting
- Rash
- Abdominal Pain
- Constipation
- Dry Mouth
- Flatulence
- Nausea
- Elevated Triglycerides
Serious adverse events
- 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
- Hepatitis
- Leukopenia
Drug interactions
- Rilpivirine
- Atazanavir
- Nelfinavir
- Saquinavir
- Warfarin
- Clopidogrel
- Methotrexate
Key clinical trials
- A Phase 1 Study of the Effect of Acid-reducing Agents on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects (Phase 1)
- Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer - a Single Arm Phase II Clinical Trial With a Predefined Reference Group (PANDORA) (Phase 2)
- Efficacy of Proton Pump Inhibitors in Cirrhotic Patients With Acute Variceal Bleeding (Phase 4)
- Comparison of Helicobacter Pylori Treatment Between Modified Quadruple Therapy and Tailored Eradication Based on the Presence of Clarithromycin Resistance (N/A)
- Functional Dyspepsia Response to Relaxation Therapy Alone or Combined With Physical Activity (NA)
- A Pilot Study to Determine if Pantoprazole Modifies Steady-State Plasma Concentrations of Orally Administered Psychotropic Medications (Phase 4)
- A Relative Bioavailability Replicated Crossover Study of Pantoprazole Sodium 40 mg DR Tablets Under Non-Fasting Conditions. (Phase 1)
- A Muliticenter, Open Label Safety Study of 2 Doses of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed GERD (Phase 3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |