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.

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

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

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.

You may be more likely to have a broken bone while taking esomeprazole long term or more than once per day.

Prescription esomeprazole comes as a delayed-release (releases the medication in the intestine to prevent break-down of the medication by stomach acids) capsule to take by mouth or to open, mix with water, and give through a feeding tube, and as packets of delayed-release (releases the medication in the intestine to prevent break-down of the medication by stomach acids) granules for suspension (to be mixed with water) to take by mouth or give through a feeding tube. Nonprescription (over-the-counter) esomeprazole comes as a delayed-release capsule and tablet to take by mouth. Prescription esomeprazole is usually taken once a day at least 1 hour before a meal. When prescription esomeprazole is used to treat certain conditions in which the stomach makes too much acid, it is taken twice a day. The nonprescription delayed-release capsules and tablets are usually taken once a day in the morning at least 1 hour before eating for 14 days in a row. If needed, additional 14-day treatments may be repeated, not more often than once every 4 months.

Take esomeprazole at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take esomeprazole exactly as directed. Do not take more or less of it or take it more often than or for a longer period of time than prescribed by your doctor or stated on the package.

Swallow the capsules whole; do not split, chew, or crush them. If you cannot swallow the capsule, put 1 tablespoon of cool, soft applesauce in an empty bowl. Open one esomeprazole capsule and carefully sprinkle the pellets onto the applesauce. Mix the pellets with the applesauce and swallow the entire tablespoonful of the applesauce and pellet mixture immediately. Do not crush or chew the pellets in the applesauce. Do not save the pellets and applesauce for later use.

If you are taking the granules for oral suspension, you will need to mix it with water before use. If you are using the 2.5- or 5-mg packet, place 1 teaspoonful (5 mL) of water in a container. If you are using the 10-, 20-, or 40-mg packet, place 1 tablespoonful (15 mL) of water in a container. Add the contents of the powder packet and stir. Wait 2 to 3 minutes to allow the mixture to thicken, and stir the mixture again. Drink the entire mixture within 30 minutes. If any of the mixture is stuck to the container, pour more water into the container, stir and drink all the mixture immediately.

The granules and the contents of the prescription delayed-release capsules can both be given through a feeding tube. If you have a feeding tube, ask your doctor or pharmacist how you should take the medication. Follow those directions carefully.

Do not take nonprescription esomeprazole for immediate relief of heartburn symptoms. It may take 1 to 4 days for you to feel the full benefit of the medication. Call your doctor if your symptoms get worse or do not improve after 14 days or if your symptoms return sooner than 4 months after you finish your treatment. Do not take nonprescription esomeprazole for longer than 14 days or treat yourself with esomeprazole more often than once every 4 months without talking to your doctor.

Continue to take prescription esomeprazole, even if you feel well. Call your doctor if your symptoms worsen or do not improve during this time. Do not stop taking esomeprazole without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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

Take each dose with a full glass (8 ounces) of water.

Esomeprazole should be taken at least one hour before a meal.

Swallow the pill whole and do not crush, chew, break, or open it.

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 esomeprazole for the full prescribed length of time, even if your symptoms quickly improve.

Call your doctor if your symptoms do not improve or if they get worse while you are taking this medicine.

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.

Store at room temperature away from moisture and heat.

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 should not use this medicine if:

• 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.

You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

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

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

esomeprazole can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Esomeprazole may cause serious side effects. Call your doctor at once if you have:

• 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 of esomeprazole 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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests before and during your treatment.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking esomeprazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Vimovo® (containing Esomeprazole, Naproxen)