Safety Profile for NEXIUM
Demonstrated Safety Profile for NEXIUM1NEXIUM 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 a demonstrated 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
- Acute interstitial nephritis has been observed in patients taking PPIs including NEXIUM. Discontinue NEXIUM if acute interstitial nephritis develops
- Daily treatment with any acid-suppressing medications over a long period of time (eg, 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
- Proton Pump Inhibitor (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
Drug interaction studies have shown that NEXIUM does not have any clinically significant interactions with1:
Postmarketing reports of changes in prothrombin measures have been received among patients on concomitant warfarin and esomeprazole therapy. Patients treated with PPIs 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 CYP2C19 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.