Pantoprazole

ATC code

A02BC02

Therapeutic class

Proton pump inhibitor · Proton pump inhibitors

Forms

oral tablet, intravenous injection

Brand names

Protonix (US) · Pantoprazole Sodium (US) · NORMOGASTROL (ES) · INIPOMP (FR) · Pantozol Control (EU)

Overall confidence

high

Regulatory sources consulted

openfda-label-48bbc577-3242-4da3-bca3-7a5f89105415
aemps-cima-ft-74483
ansm-bdpm-rcp-68729174
ema-epar-EMEA/H/C/001013
PubMed PMID:38875111 ↗
PubMed PMID:36142643 ↗
PubMed PMID:35787720 ↗
PubMed PMID:38345252 ↗
PubMed PMID:37635269 ↗
OpenFDA · A02BC02
RxNorm rxcui 40790 ↗

Approved indications

Short-term treatment (up to 10 days) of gastroesophageal reflux disease (GERD) with a history of erosive esophagitis in adults (IV formulation).
Treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome in adults.
Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults (oral OTC formulation).
Stress ulcer prophylaxis in critically ill adult patients undergoing invasive mechanical ventilation. · off-label

Contraindications

Absolute

Known hypersensitivity to pantoprazole, substituted benzimidazoles, or any component of the formulation.
Concomitant use with rilpivirine-containing products.

Clinical warnings

PPIs may be associated with an increased risk of Clostridioides difficile-associated diarrhea (CDAD). — FDA
Long-term therapy (>1 year) may be associated with an increased risk for osteoporosis-related bone fractures. — FDA
Hypomagnesemia (symptomatic and asymptomatic) has been reported in patients treated with PPIs for at least three months. — FDA
Major warning · Acute tubulointerstitial nephritis (ATIN) has been observed in patients taking PPIs; may occur at any point during therapy. — FDA

Drug interactions

HighRilpivirineJ05AG05
Mechanism: Increased gastric pH by pantoprazole reduces rilpivirine absorption, decreasing its antiviral efficacy and promoting resistance.
Recommendation: Concomitant use is contraindicated.
FDA label
ModerateMethotrexateL01BA01
Mechanism: Concomitant use of high-dose methotrexate with PPIs may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to toxicity. The exact mechanism is unclear, possibly via inhibition of renal elimination.
Recommendation: Consider temporary withdrawal of pantoprazole in patients receiving high-dose methotrexate.
ANSM RCP
ModerateWarfarinB01AA03
Mechanism: Reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. The mechanism is not well established.
Recommendation: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed.
FDA labelANSM RCP
HighAtazanavirJ05AE08
Mechanism: Increased gastric pH by pantoprazole significantly reduces the absorption and plasma concentrations of atazanavir, which has pH-dependent absorption.
Recommendation: Co-administration is not recommended. If necessary, follow specific atazanavir dosing recommendations.
FDA labelANSM RCP

Adverse events

Common (≥1%)

headache · diarrhea · nausea · abdominal pain · vomiting · flatulence · dizziness · arthralgia

Rare but serious

acute interstitial nephritis · severe hypomagnesemia · severe cutaneous adverse reactions (SJS/TEN/DRESS) · subacute cutaneous lupus erythematosus · bone fracture · pancytopenia

Pregnancy and lactation

Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. Animal reproduction studies have revealed no evidence of harm to the fetus.

Recent literature (PubMed)

Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation.
Cook D, et al. · N Engl J Med · 2024 · Relevance 5/5
Ensayo aleatorizado internacional (REVISE) en 4821 pacientes de UCI con ventilación invasiva. El pantoprazol IV (40 mg/día) redujo significativamente el riesgo de hemorragia gastrointestinal superior clínicamente importante (1.0% vs 3.5% con placebo; HR 0.30) sin afectar la mortalidad a 90 días.
Proton Pump Inhibitors and Bone Health: An Update Narrative Review.
Lespessailles E, et al. · Int J Mol Sci · 2022 · Relevance 4/5
Revisión narrativa que actualiza la evidencia sobre la asociación entre el uso de IBP y la salud ósea. Confirma que existe evidencia sustancial de estudios observacionales que asocian el uso a largo plazo de IBP con un mayor riesgo de fractura, aunque los efectos sobre la densidad mineral ósea no son consistentes y los mecanismos no están completamente elucidados.
An update on drug-drug interactions associated with proton pump inhibitors.
Ben Ghezala I, et al. · Expert Opin Drug Metab Toxicol · 2022 · Relevance 4/5
Revisión sobre interacciones farmacológicas de los IBP. Destaca que no todos los IBP tienen el mismo perfil; pantoprazol, rabeprazol y dexlansoprazol son inhibidores débiles de CYP2C19, a diferencia de omeprazol y esomeprazol (inhibidores fuertes), lo que los convierte en opciones preferibles según los tratamientos concomitantes.
Comparative Efficacy of P-CAB vs Proton Pump Inhibitors for Grade C/D Esophagitis: A Systematic Review and Network Meta-analysis.
Zhuang Q, et al. · Am J Gastroenterol · 2024 · Relevance 4/5
Metaanálisis en red que compara los bloqueadores de ácido competitivos con potasio (P-CAB) con los IBP para la esofagitis grave (grado C/D). Vonoprazan (un P-CAB) demostró una eficacia considerablemente mayor que los IBP, incluido el pantoprazol, en la curación inicial y de mantenimiento, con un perfil de seguridad similar a corto y largo plazo.
Pharmacological treatment of gastro-oesophageal reflux in children.
Tighe MP, et al. · Cochrane Database Syst Rev · 2023 · Relevance 3/5
Revisión sistemática Cochrane sobre el tratamiento farmacológico del reflujo gastroesofágico en niños. Concluye que, debido a la heterogeneidad de los estudios y la falta de datos robustos, no hay evidencia clara para apoyar el uso de IBP como omeprazol sobre placebo en lactantes. Destaca la necesidad de más investigación de alta calidad en esta población.