• Esomeprazole magnesium delayed-release capsules are contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.  Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria.
• Symptomatic response to therapy does not rule out the presence of gastric malignancy.
• Atrophic gastritis has occasionally been noted with long-term therapy with omeprazole, of which esomeprazole is an enantiomer.
• Acute interstitial nephritis has been observed in patients taking Proton Pump Inhibitors including Esomeprazole magnesium. Discontinue Esomeprazole magnesium delayed-release capsules if acute interstitial nephritis develops.
• Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12). Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature.
• PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea.
• Avoid concomitant use of Esomeprazole magnesium delayed-release capsules with clopidogrel, due to a reduction in plasma concentrations of the active metabolite of clopidogrel. When using Esomeprazole magnesium delayed-release capsules consider alternative anti-platelet therapy.
• Long-term and multiple daily dose proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine.
• Hypomagnesemia has been reported rarely with prolonged treatment with PPI therapy and may require discontinuing PPI therapy.
• Interactions with diagnostic investigations for neuroendocrine tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors.
• Concomitant use of Esomeprazole magnesium delayed-release capsules and St. John’s wort or rifampin can substantially decrease Esomeprazole magnesium delayed-release capsules concentrations. Avoid concomitant use.
• Concomitant use of Esomeprazole magnesium delayed-release capsules and atazanavir or nelfinavir is not recommended. Esomeprazole magnesium delayed-release capsules may increase the plasma levels of saquinavir. Dose reduction of saquinavir should be considered.
• Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may interfere with the absorption of drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, erlotinib, digoxin and mycophenolate mofetil). Patients treated with esomeprazole and digoxin may need to be monitored for digoxin toxicity.
• Esomeprazole magnesium delayed-release capsules may increase systemic exposure of cilostazol and one of its active metabolites. Consider dose reduction.
• Esomeprazole magnesium delayed release capsules may increase serum levels of tacrolimus and methotrexate.
• In adults, the most frequently reported adverse reactions (ARs) with Esomeprazole magnesium delayed-release capsules include headache, diarrhea, and abdominal pain, constipation and dry mouth.
• In pediatric patients 1 to 17 years of age, the most frequently reported ARs with Esomeprazole magnesium delayed-release capsules include headache, diarrhea, abdominal pain, nausea, and somnolence.
• Patients with severe liver impairment – do not exceed dose of 20 mg.
• Greater sensitivity of some older individuals cannot be ruled out.
• Esomeprazole is likely present in human milk.  Caution should be exercised when esomeprazole is administered to a nursing woman.
• Esomeprazole, based on animal data, may cause fetal harm.

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