Generic Name: naproxen (na-PROX-en)

Brand Names: Naprosyn®, Aleve®

Classification: Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Issue Date: 1986

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

Naproxen 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.

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

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

Do NOT use Naproxen if:

• you are allergic to any ingredient in Naproxen
• have had a severe allergic reaction to aspirin
• had a severe reaction to nonsteroidal anti-inflammatory drug (NSAID)
• you have recently had or will be having bypass heart surgery
• you are in the last 3 months of pregnancy

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

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

Naproxen comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Naproxen refilled.

Take Naproxen by mouth. It may be taken with food if it upsets your stomach. 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 this medicine 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 Naproxen.

Naproxen may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Naproxen 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 Naproxen. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Naproxen 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
• unusual weight gain or swelling.

Talk to your doctor before you take Naproxen 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 10 days 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.

Naproxen 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 Naproxen unless your doctor tells you to. Naproxen may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take Naproxen.

Use Naproxen with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.

Naproxen should not be used in CHILDREN younger than 12 years old without first checking with the child's doctor.

Naproxen 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 Naproxen while you are pregnant. Naproxen should not be used during labor. Naproxen is found in breast milk. Do not breast-feed while taking Naproxen.

Side Effects

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

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

• 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
• persistent sore throat
• mental or mood changes
• numbness of an arm or leg
• one-sided weakness
• 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 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

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

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

Tell your health care provider if you are taking any other medicines, especially any of the following:

• anticoagulants (eg, warfarin®)
• aspirin
• corticosteroids (Prednisone®)
• heparin
• SSRIs (fluoxetine, etc.)
• probenecid
• cyclosporine
• hydantoins (phenytoin)
• lithium
• methotrexate
• quinolones (Ciprofloxacin®)
• sulfonamides (sulfamethoxazole, etc.)
• sulfonylureas (Glipizide®)
• angiotensin-converting enzyme (ACE) inhibitors (Enalapril®)
• beta-blockers (Propranolol®)
• diuretics (furosemide, hydrochlorothiazide)

This may not be a complete list of all interactions that may occur. Ask your health care provider if Naproxen 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.