esomeprazole (oral)

What is the most important information I should know about esomeprazole?

Esomeprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Esomeprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

What is esomeprazole?

Esomeprazole is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. Esomeprazole is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).

Esomeprazole may also be given to prevent gastric ulcer caused by infection with Helicobacter pylori (H. pylori), or by the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Esomeprazole is not for immediate relief of heartburn symptoms.

Esomeprazole may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking esomeprazole?

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.

• you had breathing problems, kidney problems, or a severe allergic reaction after taking esomeprazole in the past; or
• you are allergic to esomeprazole or to similar medicines such as lansoprazole, omeprazole, pantoprazole, rabeprazole, Dexilant, Nexium, Prevacid, Protonix, and others.

Tell your doctor if you have ever had:

• severe liver disease;
• lupus;
• osteoporosis or low bone mineral density (osteopenia); or
• low levels of magnesium in your blood.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

How should I take esomeprazole?

Use exactly as directed on the label, or as prescribed by your doctor.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

The esomeprazole capsule can be given through a nasogastric (NG) feeding tube. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Esomeprazole is usually given for 4 to 8 weeks only. Your doctor may recommend a second course of treatment if you need additional healing time.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using esomeprazole.

Some conditions are treated with a combination of esomeprazole and antibiotics. Use all medications as directed.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while taking esomeprazole?

What are the possible side effects of esomeprazole?

• severe stomach pain, diarrhea that is watery or bloody;
• seizure (convulsions);
• kidney problems -- fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;
• low magnesium --dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
• new or worsening symptoms of lupus --joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking esomeprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use esomeprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

• headache;
• diarrhea;
• nausea, stomach pain, gas, constipation; or
• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect esomeprazole?

Tell your doctor about all your current medicines. Many drugs can affect esomeprazole, especially:

• cilostazol;
• clopidogrel;
• diazepam;
• digoxin;
• erlotinib;
• iron-containing medicines (ferrous fumarate, ferrous gluconate, ferrous sulfate, and others);
• methotrexate;
• mycophenolate mofetil;
• rifampin;
• St. John's wort;
• tacrolimus;
• warfarin (Coumadin, Jantoven);
• antifungal medication --ketoconazole, voriconazole; or
• HIV/AIDS medication --atazanavir, nelfinavir, saquinavir.

This list is not complete and many other drugs may affect esomeprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about esomeprazole.