Safety Profile for NEXIUM

Demonstrated Safety Profile for NEXIUM

Drug Interactions

Demonstrated Safety Profile for NEXIUM1

NEXIUM® has a demonstrated safety and tolerability profile.

  • The safety of NEXIUM was evaluated in over 15,000 patients (aged 18 to 84 years) in clinical trials worldwide, including over 8500 patients in the United States and over 6500 patients in Europe and Canada. NEXIUM has demonstrated a safety and tolerability profile 
  • The safety of NEXIUM was evaluated in 316 pediatric patients and adolescent patients aged 1 to 17 years in 4 clinical trials for the treatment of symptomatic GERD. No new safety concerns were identified in pediatric patients
  • PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea
  • 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



  • Hypomagnesemia has been reported rarely with prolonged treatment with PPI therapy and may require discontinuing PPI therapy



  • In over 1000 patients treated with NEXIUM for up to 6 to 12 months, the prevalence of Enterochromaffin-like (ECL) cell hyperplasia increased with time and dose. No patient developed ECL cell carcinoids, dysplasia, or neoplasia in the gastric mucosa

NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information. Before prescribing NEXIUM, please see the full Prescribing Information (PDF – 303 KB).



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Drug Interactions1

Drug interaction studies have shown that NEXIUM does not have any clinically significant interactions with1:



  • phenytoin
  • warfarin
  • quinidine
  • clarithromycin
  • amoxicillin

Postmarketing reports of changes in prothrombin measures have been received among patients on concomitant warfarin and esomeprazole therapy. Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.

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.

Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts, erlotinib, and digoxin).

Combined inhibitor of CYP 2C19 and 3A4 may raise esomeprazole levels.

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 because the plasma concentrations and therapeutic effects of those antiretroviral drugs may be reduced.

NEXIUM may increase the plasma levels of saquinavir. Dose reduction of saquinavir should be considered.

Concomitant use of NEXIUM and methotrexate may increase and prolong the serum levels of methotrexate and/or its metabolite. In high-dose methotrexate administration, a temporary withdrawal of NEXIUM may be considered in some patients.

For more information, click here to see the full Prescribing Information (PDF – 303 KB).



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Next: Pharmacokinetics

1000104-2067505 Last updated 2/13

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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

Indications

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)

Reference

1.     Prescribing Information for NEXIUM, AstraZeneca Pharmaceuticals LP, Wilmington, DE.

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.