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1000104-2458401 Last Updated 1/14

Important Safety Information

  • NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles
  • 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
  • PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea
  • Avoid concomitant use of NEXIUM with clopidogrel, due to a reduction in plasma concentrations of the active metabolite of clopidogrel. When using NEXIUM 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
  • Concomitant use of NEXIUM and St. John’s wort or rifampin can substantially decrease NEXIUM concentrations. Avoid concomitant use
  • Concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended. NEXIUM 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 (eg, ketoconazole, iron salts, and digoxin)
  • NEXIUM may increase systemic exposure of cilostazol and one of its active metabolites. Consider dose reduction
  • NEXIUM I.V. should be used only when oral therapy with NEXIUM is not possible or appropriate
  • In adults, the most frequently reported adverse reactions (ARs) with NEXIUM include headache, diarrhea, and abdominal pain
  • The ARs reported at a frequency of 1% or greater with NEXIUM I.V. in clinical trials were headache, flatulence, nausea, abdominal pain, injection site reaction, diarrhea, dry mouth, dizziness/vertigo, constipation, and pruritus
  • In pediatric patients 1 to 17 years of age, the most frequently reported ARs with NEXIUM include headache, diarrhea, abdominal pain, nausea, and somnolence
  • In pediatric patients 1 to 11 months the most frequently reported ARs with NEXIUM include abdominal pain, regurgitation, tachypnea, and increased ALT

Approved Uses

NEXIUM 40 mg and 20 mg are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed erosive esophagitis (EE). NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE (controlled studies did not extend beyond 6 months), and for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD.

Prescribing Information with Medication Guide for NEXIUM. (PDF – 303 KB)

Prescribing Information for NEXIUM I.V. (PDF - 72 KB)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.