Generic Name: naproxen (na PROX en)
Brand Names: Aleve, Anaprox, Anaprox-DS, EC-Naprosyn, Leader Naproxen Sodium, Midol Extended Relief, Naprelan 375, Naprosyn

What is Aleve?

Aleve (naproxen) is a nonsteroidal anti-inflammatory drug (NSAID). Naproxen works by reducing hormones that cause inflammation and pain in the body.

Aleve is used to temporarily relieve minor aches and pains due to arthritis, muscular aches, backache, menstrual cramps, headache, toothache,and the common cold. Aleve is also used to temporarily reduce fever.

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

Important information

You should not use Aleve if you have a history of allergic reaction to aspirin or other NSAID (nonsteroidal anti-inflammatory drug).

Aleve may increase your risk of heart attack or stroke, especially if you use it long term or have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

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Aleve may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking Aleve.

Before taking this medicine

Aleve may increase your risk of heart attack or stroke, especially if you use it long term or have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Aleve may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking Aleve.

You should not use Aleve if you are allergic to naproxen, or if you have a history of allergic reaction to aspirin or other NSAIDs.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

  • a history of heart attack, stroke, or blood clot;

  • heart disease, congestive heart failure, high blood pressure;

  • a history of stomach ulcers or bleeding;

  • liver or kidney disease;

  • asthma;

  • polyps in your nose;

  • a bleeding or blood clotting disorder; or

  • if you smoke.

FDA pregnancy category C. Before using Aleve, tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking Aleve during the last 3 months of pregnancy may result in birth defects. Do not take Aleve during pregnancy unless your doctor has told you to.

See also: Pregnancy and breastfeeding warnings (in more detail)

Naproxen can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 2 years old without medical advice.

How should I take Aleve?

Use Aleve exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. The smallest effective dose should be used.

Dosage for adults and children 12 years and older: Take 1 Aleve capsule or tablet every 8 to 12 hours while symptoms last. For the first dose you may take 2 capsules or tablets within the first hour. Do not exceed 2 capsules or tablets in any 8 to 12 hour period - do not exceed 3 capsules or tablets in a 24-hour period.

Drink a full glass of water with each dose. If taken with food, Aleve may take longer to work.

Store Aleve at room temperature away from moisture and heat.

What happens if I miss a dose?

Since Aleve is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid?

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to naproxen (such as ibuprofen or ketoprofen). Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains naproxen, aspirin, ibuprofen, or ketoprofen.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid exposure to sunlight or tanning beds. Aleve can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Aleve side effects

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

Stop using Aleve and call your doctor at once if you have:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

  • black, bloody, or tarry stools;

  • coughing up blood or vomit that looks like coffee grounds;

  • swelling or rapid weight gain, little or no urinating;

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • bruising, severe tingling, numbness, pain, muscle weakness;

  • fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions) 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.

Common Aleve side effects may include:

  • upset stomach, mild heartburn or stomach pain, diarrhea, constipation;

  • bloating, gas;

  • dizziness, headache, nervousness;

  • skin itching or rash;

  • blurred vision; or

  • ringing in your ears.

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.

See also: Side effects (in more detail)

What other drugs will affect Aleve?

Ask your doctor before using Aleve if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you are also using any of the following drugs:

  • a blood thinner (warfarin, Coumadin);

  • lithium;

  • methotrexate;

  • a diuretic or "water pill";

  • steroids (prednisone and others);

  • aspirin or other NSAIDs--ibuprofen (Advil, Motrin), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

  • heart or blood pressure medication--benazepril, candesartan, enalapril, lisinopril, losartan, olmesartan, quinapril, ramipril, telmisartan, valsartan, and others.

This list is not complete. Other drugs may interact with Aleve, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Aleve.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Aleve only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 12.01. Revision Date: 2013-04-25, 12:25:12 PM.

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