SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT NEXIUM?

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 TAKE NEXIUM?
Do not take NEXIUM if you:

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

WHAT SHOULD I TELL MY DOCTOR BEFORE I TAKE NEXIUM?

Before you take NEXIUM, tell your doctor if you:

• have been told that you have low magnesium levels in your blood
• have liver problems
• are pregnant or plan to become pregnant. It is not known if NEXIUM can harm your unborn baby
• are breastfeeding or planning to breastfeed. It is not known if NEXIUM passes into your breastmilk. You and your doctor should decide if you will take NEXIUM or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take NEXIUM

Tell your doctor about all of the medicines you take

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 your doctor if you take:

• 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)

WHAT ARE THE POSSIBLE SIDE EFFECTS OF NEXIUM?

NEXIUM can cause serious side effects, including:

• Low vitamin B12 levels in your body. Low vitamin B12 can happen in some people who take a proton pump inhibitor medicine for at least 3 years. If low vitamin B12 levels happen, it is usually after 3 years of treatment. You may or may not have symptoms of low vitamin B12
• 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. You may or may not have symptoms of low magnesium

Tell your doctor right away if you have any of these symptoms:

• 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

Your doctor may check the level of magnesium in your body before you start taking NEXIUM or during treatment if you will be taking NEXIUM 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 your doctor if you get any of the following symptoms with NEXIUM:

• rash
• face swelling
• throat tightness
• difficulty breathing

Your doctor may stop NEXIUM if these symptoms happen.

Tell your doctor if you have any side effects that bother you or that do not go away. These are not all the possible side effects with NEXIUM.

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