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Generic Name: naproxen (na-PROX-en)
Brand Name: Aleve

Aleve is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, a heart attack, stroke). The risk may be greater if you already have heart problems or if you take Aleve for a long time. Do not use Aleve right before or after bypass heart surgery.

Aleve may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.


Aleve is used for:

Temporary relief of minor aches and pains. These may include arthritis, muscle aches, backache, menstrual cramps, headache, toothache, and those due to a cold. It is also used to reduce fever. It may also be used for other conditions as determined by your doctor.

Aleve is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use Aleve if:

  • you are allergic to any ingredient in Aleve
  • you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or another NSAID (eg, ibuprofen, celecoxib)
  • you have recently had or will be having bypass heart surgery
  • you are in the last 3 months of pregnancy
  • you are taking another medicine that contains naproxen

Contact your doctor or health care provider right away if any of these apply to you.

Before using Aleve:

Some medical conditions may interact with Aleve. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)
  • if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation
  • if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or a blood vessel disease, or if you are at risk of any of these diseases
  • if you have poor health; dehydration or low fluid volume; low blood sodium levels; are on a low-salt (sodium) diet; or drink alcohol, smoke, or have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Aleve. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel, prasugrel), aspirin, corticosteroids (eg, prednisone), heparin, rivaroxaban, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or other NSAIDs (eg, ibuprofen) because the risk of stomach bleeding may be increased
  • Probenecid because it may increase the risk of Aleve's side effects
  • Bisphosphonates (eg, alendronate), cyclosporine, hydantoins (eg, phenytoin), lithium, methotrexate, quinolones (eg, ciprofloxacin), sulfonamides (eg, sulfamethoxazole), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Aleve
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Aleve

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aleve may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aleve:

Use Aleve as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Aleve comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Aleve refilled.
  • Take Aleve by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
  • Take Aleve with a full glass of water (8 oz/240 mL) as directed by your doctor.
  • If you take antacids, cholestyramine, or sucralfate, ask your doctor or pharmacist how to take them with Aleve.
  • If you miss a dose of Aleve and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aleve.

Important safety information:

  • Aleve may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Aleve with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Serious stomach ulcers or bleeding can occur with the use of Aleve. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Aleve with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
  • Talk to your doctor before you take Aleve if you drink more than 3 drinks with alcohol per day.
  • If you have pain that does not get better within 10 days or fever that does not get better within 3 days, check with your doctor. If your symptoms get worse or if you have new symptoms, check with your doctor.
  • Do NOT take more than the recommended dose or use for longer than directed without checking with your doctor.
  • Contact your doctor if you have trouble swallowing, severe or persistent heartburn, or if it feels like the tablet is stuck in your throat.
  • Aleve has naproxen in it. Before you start any new medicine, check the label to see if it has naproxen or any other NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do not take aspirin while you are using Aleve unless your doctor tells you to.
  • Aleve may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take Aleve.
  • Use Aleve with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
  • Aleve should not be used in CHILDREN younger than 12 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Aleve may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aleve while you are pregnant. Aleve should not be used during labor. Aleve is found in breast milk. If you are or will be breast-feeding while you use Aleve, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Aleve:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; mental or mood changes; numbness of an arm or leg; one-sided weakness; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of Aleve:

Store Aleve at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Avoid temperatures above 104 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aleve out of the reach of children and away from pets.

General information:

  • If you have any questions about Aleve, please talk with your doctor, pharmacist, or other health care provider.
  • Aleve is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Aleve or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Aleve. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aleve. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Aleve.

Issue Date: April 3, 2013
Database Edition 13.2.1.001
Copyright © 2013 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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