Aleve

Prescription

Naproxen is used to treat the following:

• pain and redness
• swelling and inflammation from conditions such as different types of arthritis and gout 
• menstrual cramps
• other types of short-term pain

Over-the-counter

Naproxen is used to temporarily reduce fever, as well as treat minor aches and pains due to:

• minor pain of arthritis
• menstrual cramps
• the common cold
• muscular aches
• headache
• backache
• toothache

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

Aleve is part of the drug class:

• Propionic acid derivatives

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of naproxen, there are no specific foods that you must exclude from your diet when receiving naproxen.

Store naproxen tablets and suspension at room temperature and protect from light.

Keep this and all medicines out of the reach of children.

In the U.S.

• Aflaxen
• Aleve
• Aleve Arthritis
• Anaprox
• Anaprox DS
• EC Naprosyn
• Naprelan
• Naprelan 500
• Naprelan Dose Card
• Naprosyn

In Canada

• Naxen

Available Dosage Forms:

• Tablet
• Suspension
• Tablet, Enteric Coated
• Tablet, Extended Release
• Capsule, Liquid Filled
• Capsule

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Belching
• bruising
• difficult or labored breathing
• feeling of indigestion
• headache
• itching skin
• large, flat, blue, or purplish patches in the skin
• pain in the chest below the breastbone
• skin eruptions
• stomach pain
• swelling
• tightness in the chest

• Bloating
• bloody or black, tarry stools
• blurred or loss of vision
• burning upper abdominal or stomach pain
• cloudy urine
• constipation
• decrease in urine output or decrease in urine-concentrating ability
• disturbed color perception
• double vision
• fast, irregular, pounding, or racing heartbeat or pulse
• halos around lights
• indigestion
• loss of appetite
• nausea or vomiting
• night blindness
• overbright appearance of lights
• pale skin
• pinpoint red or purple spots on the skin
• severe and continuing nausea
• severe stomach burning, cramping, or pain
• skin rash
• swelling or inflammation of the mouth
• troubled breathing with exertion
• tunnel vision
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of material that looks like coffee grounds
• weight loss

• Anxiety
• back or leg pains
• bleeding gums
• blindness
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• blue lips and fingernails
• canker sores
• change in the ability to see colors, especially blue or yellow
• chest pain or discomfort
• clay-colored stools
• cold sweats
• coma
• confusion
• cool, pale skin
• cough or hoarseness
• coughing that sometimes produces a pink frothy sputum
• cracks in the skin
• darkened urine
• decreased vision
• depression
• diarrhea
• difficult, burning, or painful urination
• difficult, fast, or noisy breathing
• difficulty with swallowing
• dilated neck veins
• dizziness
• dry cough
• dry mouth
• early appearance of redness, or swelling of the skin
• excess air or gas in the stomach
• extreme fatigue
• eye pain
• fainting
• fever with or without chills
• fluid-filled skin blisters
• flushed, dry skin
• frequent urination
• fruit-like breath odor
• greatly decreased frequency of urination or amount of urine
• hair loss
• high fever
• hives
• increased hunger
• increased sensitivity of the skin to sunlight
• increased sweating
• increased thirst
• increased urination
• increased volume of pale, dilute urine
• irregular breathing
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• late appearance of rash with or without weeping blisters that become crusted, especially in sun-exposed areas of skin, may extend to unexposed areas
• light-colored stools
• lightheadedness
• loss of heat from the body
• lower back or side pain
• nervousness
• nightmares
• no blood pressure
• no breathing
• no pulse
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• pain in the ankles or knees
• pain or burning in the throat
• pain or discomfort in the arms, jaw, back, or neck
• painful, red lumps under the skin, mostly on the legs
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale or blue lips, fingernails, or skin
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid, shallow breathing
• red, irritated eyes
• red skin lesions, often with a purple center
• red-green color blindness
• redness or other discoloration of the skin
• redness, swelling, or soreness of the tongue
• scaly skin
• seizures
• severe sunburn
• shakiness
• skin thinness
• slurred speech
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• sores, welting, or blisters
• spots on your skin resembling a blister or pimple
• stiff neck or back
• stomach cramps or tenderness
• stomach upset
• swelling in the legs and ankles
• swelling of the face, fingers, feet, or lower legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tiny bumps on the inner lining of the eyelid
• unexplained weight loss
• unpleasant breath odor
• watery or bloody diarrhea
• weakness or heaviness of the legs
• weight gain
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Bleeding under the skin
• confusion about identity, place, and time
• muscle tremors
• restlessness
• sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Continuing ringing or buzzing or other unexplained noise in the ears
• hearing loss

• Acid or sour stomach
• change in hearing
• feeling of constant movement of self or surroundings
• passing gas
• sensation of spinning
• stomach soreness or discomfort

• Appetite changes
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• difficulty with moving
• discharge, excessive tearing
• general feeling of discomfort or illness
• lack or loss of strength
• menstrual changes
• muscle aching, cramping, stiffness, or weakness
• not able to concentrate
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• seeing, hearing, or feeling things that are not there
• shakiness in the legs, arms, hands, or feet
• swollen joints
• trembling or shaking of the hands or feet
• trouble getting pregnant
• trouble performing routine tasks
• trouble sleeping
• unusual drowsiness, dullness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Aleve is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Aleve or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 Aleve. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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 Aleve if you are also using any of the following drugs:

• cholestyramine;

• cyclosporine;

• digoxin;

• lithium;

• methotrexate;

• pemetrexed;

• phenytoin or similar seizure medications;

• probenecid;

• warfarin (Coumadin, Jantoven) or similar blood thinners;

• a diuretic or "water pill";

• heart or blood pressure medication; or

• insulin or oral diabetes medicine.

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

Applies to naproxen: compounding powder, oral capsule, oral delayed release tablet, oral suspension, oral tablet, oral tablet extended release, oral and topical kit

Gastrointestinal

Very common (10% or more): Dyspepsia (14%), heartburn, nausea, constipation
Common (1% to 10%): Diarrhea, abdominal pain
Very rare (less than 0.01%): Pancreatitis
Frequency not reported: Flatulence, gastritis, vomiting, dysphagia, stomatitis, abdomen enlarged, eructation, GI hemorrhage, rectal hemorrhage, aphthous, mouth ulcer, stomach ulcer, cardiospasm, colitis, esophagitis, gastroenteritis, GI disorder, rectal disorder, tooth disorder, melena esophageal ulcer, hematemesis, non-peptic GI ulceration, ulcerative stomatitis, sialadenitis, colitis
Postmarketing reports: Inflammation, bleeding, ulceration, perforation, obstruction, exacerbation of inflammatory bowel disease[Ref]

Hepatic

Rare (less than 0.1%): Hepatitis, jaundice
Frequency not reported: Cholecystitis, cholelithiasis, hepatosplenomegaly, liver function abnormality, SGOT increased, SGPT increased, elevated liver enzymes[Ref]

Nervous system

Very common (10% or more): Headache (15%)
Common (1% to 10%): Drowsiness, dizziness
Uncommon (0.1% to 1%): Cognitive dysfunction, poor concentration
Very rare (less than 0.01%): Convulsions, stroke
Frequency not reported: Paresthesia, lightheadedness, migraine, syncope, hypertonia, neuralgia, neuritis, amnesia, paralysis[Ref]

Renal

Very rare (less than 0.01%): Glomerular nephritis, interstitial nephritis, nephrotic syndrome, renal papillary necrosis
Frequency not reported: Kidney function abnormality, pyelonephritis, creatinine increased, glucosuria, albuminuria, BUN increased, renal failure, renal disease, kidney pain, nephrosclerosis, kidney failure, kidney calculus, nephropathy[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Palpitations
Rare (0.01% to 0.1%): Vasculitis
Very rare (less than 0.01%): Arterial thrombotic events, myocardial infarction
Frequency not reported: Hypertension, angina pectoris, coronary artery disease, deep thrombophlebitis, vasodilation, vascular anomaly, arrhythmia, bundle branch block, abnormal ECG, right heart failure, hemorrhage, aortic stenosis, tachycardia, congestive heart failure
Postmarketing reports: Cardiac failure[Ref]

Hematologic

Rare (0.01% to 0.1%): Hemolytic anemia
Very rare (less than 0.01%): Granulocytopenia, thrombocytopenia, agranulocytosis
Frequency not reported: Anemia, aplastic anemia, leukopenia, bleeding time increased, eosinophilia, abnormal RBC, abnormal WBC, neutropenia, pancytopenia[Ref]

Hypersensitivity

Rare (less than 0.1%): Allergic reaction, anaphylactoid/anaphylaxis reaction, hypersensitivity reaction[Ref]

Dermatologic

Common (1% to 10%): Ecchymosis, rash, skin eruptions, pruritus, purpura
Uncommon (0.1% to 1%): Urticaria, photosensitivity
Rare (0.01% to 0.1%): Alopecia, pseudo-porphyria
Very rare (less than 0.01%): Toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, epidermolysis bullosa
Frequency not reported: Angioneurotic edema/angioedema, angiodermatitis, dry skin, sweating, skin ulcer, acne, contact dermatitis, eczema, skin necrosis, subcutaneous nodule, photosensitive dermatitis, porphyria cutaneous tarda, nail disorder, epidermal necrosis, exfoliative dermatoses, bullous dermatoses, lichen planus
Postmarketing reports: Erythema nodosum, fixed drug eruption, pustular reaction, bullous reactions[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, rhinitis, dyspnea
Rare (less than 0.1%): Aggravated asthma, eosinophilic pneumonitis
Frequency not reported: Bronchitis, cough increased, asthma, pulmonary edema, laryngitis, lung disorder, epistaxis, pneumonia, respiratory distress, respiratory disorder, bronchospasm, sore throat[Ref]

Other

Very common (10% or more): Influenza-like syndrome (10%)
Common (1% to 10%): Infection, edema, tinnitus, fatigue
Rare (0.01% to 0.1%): Hearing impairment
Very rare (less than 0.01%): Aseptic meningitis
Frequency not reported: Fever, accidental injury, asthenia, chest pain, peripheral edema, hearing disturbances, thirst, abscess, cellulitis, malaise, mucous membrane disorder, periodontal abscess, necrosis, aseptic meningitis, chills, weight increased, otitis media, deafness, ear disorder, herpes simplex, herpes zoster, vertigo, subdural hematoma, exacerbation of Parkinson's disease[Ref]

Metabolic

Rare (less than 0.1%): Hyperkalemia
Frequency not reported: Hyperglycemia, anorexia, hypoglycemia, hypercholesteremia, alkalosis, dehydration, glucose tolerance increase, hyperuricemia, hypokalemia[Ref]

Endocrine

Postmarketing reports: Infertility[Ref]

General

The most frequently reported adverse events were headache, dyspepsia, nausea, constipation, heartburn, abdominal pain, and influenza-like syndrome.[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Very rare (less than 0.01%): Hematuria
Frequency not reported: Cystitis, monilia, pelvic pain, dysmenorrhea, dysuria, nocturia, prostate disorder, urinary incontinence, menorrhagia, menstrual disorders, vaginitis, uterine spasm, urinary retention, urinary frequency, abnormal urine, pyuria, metrorrhagia[Ref]

Musculoskeletal

Common (1% to 10%): Back pain
Rare (less than 0.1%): Myalgia, muscle weakness
Frequency not reported: Leg cramps, arthralgia, joint disorder, tendon disorder, neck rigid/pain, LE syndrome, myasthenia, bone disorder, spontaneous bone fracture, fibrotendinitis, bone pain, spasm, bursitis
Postmarketing reports: Systemic lupus erythematosus[Ref]

Ocular

Common (1% to 10%): Visual disturbances
Frequency not reported: Ptosis, amblyopia, scleritis, cataract, conjunctivitis, keratoconjunctivitis, lacrimation disorder, eye pain, diplopia, retrobulbar optic neuritis
Postmarketing reports: Corneal opacity, papillitis, papilledema[Ref]

Oncologic

Frequency not reported: Carcinoma, breast carcinoma, breast neoplasm, skin neoplasm[Ref]

Psychiatric

Common (1% to 10%): Confusion
Uncommon (0.1% to 1%): Depression, dream abnormalities, mood alterations
Frequency not reported: Insomnia, anxiety, nervousness, emotional lability, hallucinations[Ref]

Some side effects of Aleve may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using naproxen, especially in older adults.

Use exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Do not crush, chew, or break a naproxen tablet. Swallow it whole.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you change brands, strengths, or forms of naproxen, your dosage needs may change. Ask your pharmacist if you have any questions about the kind of naproxen you are using.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Naproxen doses are based on weight in children, and any changes may affect your child's dose.

If you use naproxen long-term, you may need frequent medical tests.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using naproxen.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.