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IMPORTANT SAFETY INFORMATION FOR NEXIUM® (esomeprazole magnesium)

  • Symptom relief does not rule out the presence of other serious conditions. Talk with your doctor
  • Talk to your doctor about serious side effects, including:

    – Kidney problems (acute interstitial nephritis) may happen at any time during treatment with NEXIUM. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine

    – NEXIUM may increase your risk of getting severe diarrhea. Call your doctor right away if you have watery stool, stomach pain and fever that does not go away

    – Bone fractures if you take multiple daily doses of NEXIUM for a year or longer

    – Some people who take PPIs, including NEXIUM, develop certain types of lupus or have worsening of the lupus they already have. Call your doctor right away if you have joint pain or rash on your cheeks or arms that gets worse in the sun

    – Low vitamin B12 if you have been on NEXIUM for a long time (more than 3 years)

    – Low magnesium levels if you take NEXIUM (for 3 months or more)

  • Tell your doctor about all of the medicines you take, prescription and nonprescription drugs, including clopidogrel, vitamins and herbal supplements. NEXIUM may affect how other medicines work and other medicines may affect how NEXIUM works
  • Do not take NEXIUM if you are allergic to esomeprazole magnesium or any of the ingredients in NEXIUM or are allergic to any other PPI
  • Side effects with NEXIUM may include headache, diarrhea, and abdominal pain
  • In adults 18 and older, side effects with NEXIUM may include headache, diarrhea, and abdominal pain
  • In children 1 to 17 years of age, side effects with NEXIUM may include headache, diarrhea, abdominal pain, nausea, and sleepiness

APPROVED USES FOR NEXIUM® (esomeprazole magnesium)

NEXIUM is prescribed to treat the symptoms of acid reflux disease, which typically include persistent heartburn on 2 or more days per week, despite treatment and change of diet in children 1 year of age and older or adults.

For adults and children as young as 1 month of age, NEXIUM is also prescribed to heal damage to the esophagus called erosive esophagitis. This damage may be caused over time from stomach acid wearing away the lining of the esophagus. Only a doctor can diagnose this condition. With NEXIUM, most erosions heal in 4 to 8 weeks. Results with NEXIUM may vary.

Please read full Prescribing Information, Medication Guide and Instructions for Use for NEXIUM Packets.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.1-800-FDA-1088.