Medications and Drugs

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Brand Names: Vimovo

Generic Name: esomeprazole and naproxen (Pronunciation: ee soe MEP ra zole and na PROX en)

What is esomeprazole and naproxen (Vimovo)?

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that cause inflammation, pain, and fever.

Esomeprazole is a proton pump inhibitor. It decreases the amount of acid produced in the stomach.

The combination of esomeprazole and naproxen is used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The esomeprazole in this medication helps reduce the risk of stomach ulcers in people who may be at risk for them while receiving treatment with an NSAID.

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

What are the possible side effects of esomeprazole and naproxen (Vimovo)?

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

Stop using esomeprazole and naproxen and call your doctor at once if you have a serious side effect such as:

pale skin, easy bruising, unusual bleeding, or any bleeding that will not stop;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
pain, swelling, warmth, or redness in one or both legs;
low magnesium (dizziness, confusion, fast or uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or choking feeling, seizure);
urinating less than usual or not at all;
swelling, rapid weight gain, feeling short of breath (even with mild exertion);
black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

constipation, diarrhea; or
mild stomach pain.

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 is the most important information I should know about esomeprazole and naproxen (Vimovo)?

The naproxen in this medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Naproxen may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking esomeprazole and naproxen, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Ask a doctor or pharmacist before using any other pain or arthritis medicine. Many medicines available over the counter contain naproxen or similar medicines (such as aspirin, ibuprofen, or ketoprofen).

What should I discuss with my healthcare provider before taking esomeprazole and naproxen (Vimovo)?»

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.