Safety information

What is the most important information to know about NEXIUM Packets?

NEXIUM may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. NEXIUM can cause serious side effects, including:

  • Kidney problems (acute interstitial nephritis). Kidney problems 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
  • Diarrhea. NEXIUM may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines.Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away
  • Bone fractures. People who take multiple daily doses of Proton Pump Inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take NEXIUM exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take NEXIUM
  • Certain types of lupus erythematosus. Some people who take proton pump inhibitors (PPIs), including NEXIUM, develop certain types of lupus erythematosus 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

Who should not take NEXIUM?

NEXIUM should not be taken if one is:

  • Allergic to esomeprazole magnesium or any of the ingredients in NEXIUM. See the Medication Guide for a complete list of ingredients in NEXIUM
  • Allergic to any other proton pump inhibitor (PPI) medicine

What to tell the doctor before NEXIUM is taken

Before taking NEXIUM, tell the doctor if one:

  • Has been told they have low magnesium levels in their blood
  • Has liver problems
  • Is pregnant or plans to become pregnant. It is not known if NEXIUM can harm an unborn baby
  • Is breastfeeding or planning to breastfeed. Talk to the doctor about the best way to feed the baby, if NEXIUM is taken

Tell the doctor about all of the medicines being taken

Tell the doctor about all of the medicines being taken, including prescription and non-prescription drugs, vitamins and herbal supplements. NEXIUM may affect how other medicines work, and other medicines may affect how NEXIUM works. Especially tell the doctor if the following medicines are being taken:

  • warfarin (Coumadin, Jantoven)
  • ketoconazole (Nizoral)
  • voriconazole (Vfend)
  • atazanavir (Reyataz)
  • nelfinavir (Viracept)
  • saquinavir (Fortovase)
  • products that contain iron
  • digoxin (Lanoxin)
  • St. John’s Wort (Hypericum perforatum)
  • rifampin (Rimactane, Rifater, Rifamate)
  • cilostazol (Pletal)
  • diazepam (Valium)
  • tacrolimus (Prograf)
  • erlotinib (Tarceva)
  • methotrexate
  • clopidogrel (Plavix)
  • mycophenolate mofetil (Cellcept)

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What are the possible side effects of NEXIUM?

NEXIUM can cause serious side effects, including:

  • Vitamin B12 deficiency: NEXIUM reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B12 properly. Talk with your doctor about the possibility of vitamin B12 deficiency if you have been on NEXIUM for a long time (more than 3 years).
  • Low magnesium levels in your body. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. One may or may not have symptoms of low magnesium

    Tell the doctor right away if any of these symptoms are seen:

    • seizures
    • dizziness
    • abnormal or fast heartbeat
    • jitteriness
    • jerking movements or shaking (tremors)
    • muscle weakness
    • spasms of the hands and feet
    • cramps or muscle aches
    • spasm of the voice box

    The doctor may check the level of magnesium in the body before starting to take NEXIUM or during treatment if NEXIUM will be taken for a long period of time.

The most common side effects with NEXIUM may include:

  • headache
  • diarrhea
  • nausea
  • gas
  • abdominal pain
  • constipation
  • dry mouth
  • drowsiness

Other side effects

Serious allergic reactions

Tell the doctor if any of the following symptoms are experienced with NEXIUM:

  • rash
  • face swelling
  • throat tightness
  • difficulty breathing

The doctor may stop NEXIUM if these symptoms happen.

Tell the doctor if there are any side effects that are bothersome or do not go away. These are not all the possible side effects with NEXIUM.

Call the doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.1-800-FDA-1088.

Remember, if you have any questions about treatment with NEXIUM, talk with the doctor.
 

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.