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Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.
Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps. It can also be used to treat acute pain caused by other conditions not listed in this medication guide.
The delayed-release or extended-release tablets are slower-acting forms of naproxen that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms will not work fast enough to treat acute pain.
You should not use naproxen if you have a history of allergic reaction to aspirin or other NSAID (nonsteroidal anti-inflammatory drug).
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. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.
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 swelling of the face or throat, chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance. Stop taking naproxen and notify your physician if you notice stomach pain, tiredness or weakness, yellow skin or eyes, nausea, vomiting, bloody or black and sticky bowel movements, skin rash, unexplained weight loss or weight gain, or swelling of the hands and feet.
Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.
Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.
You should not use naproxen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:
heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
a history of heart attack, stroke, or blood clot;
a history of stomach ulcers or bleeding;
asthma;
liver or kidney disease; or
fluid retention.
Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. Ask a doctor before using this medicine if you are pregnant. It may interfere with ovulation, causing temporary infertility.
Naproxen can pass into breast milk and may cause side effects in the nursing baby. You should not breast-feed while using this medicine.
Naproxen is not approved for use by anyone younger than 2 years old. Do not give this medicine to a child without medical advice.
Use naproxen 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 this medicine, 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. Doses are based on weight in children, and any changes may affect your child's dose.
If you use this medicine 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.
Since naproxen is sometimes used only 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.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid drinking alcohol. It may increase your risk of stomach bleeding.
Avoid taking aspirin while you are taking naproxen.
Ask your doctor before taking any other medication for pain, arthritis, fever, or swelling. Many medicines available over the counter contain aspirin, salicylates, 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.
Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb naproxen.
Get emergency medical help if you have signs of an allergic reaction to naproxen: wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
Stop using naproxen and call your doctor at once if you have:
shortness of breath (even with mild exertion);
swelling or rapid weight gain;
the first sign of any skin rash, no matter how mild;
signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; 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 naproxen side effects may include:
indigestion, heartburn, stomach pain, nausea;
headache, dizziness, drowsiness;
bruising, itching, rash;
swelling; 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.
Ask your doctor before using naproxen 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:
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Naproxen Sodium (www.drugs.com/naproxen.html).
Applies to naproxen: oral capsule liquid filled, oral suspension, oral tablet, oral tablet enteric coated, oral tablet extended release
Oral route (Tablet; Tablet, Enteric Coated; Suspension)
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen is contraindicated in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Elderly patients and patients with a history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Oral route (Tablet, Extended Release; Tablet)
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen sodium is contraindicated in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Elderly patients and patients with a history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Along with its needed effects, naproxen 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 while taking naproxen:
More common
Less common
Rare
Get emergency help immediately if any of the following symptoms of overdose occur while taking naproxen:
Symptoms of overdose
Some side effects of naproxen 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:
More common
Less common
Rare
Applies to naproxen: compounding powder, oral capsule, oral delayed release tablet, oral suspension, oral tablet, oral tablet extended release, oral and topical kit
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
Rare (less than 0.1%): Hepatitis, jaundice
Frequency not reported: Cholecystitis, cholelithiasis, hepatosplenomegaly, liver function abnormality, SGOT increased, SGPT increased, elevated liver enzymes
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
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
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
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
Rare (less than 0.1%): Allergic reaction, anaphylactoid/anaphylaxis reaction, hypersensitivity reaction
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
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
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
Rare (less than 0.1%): Hyperkalemia
Frequency not reported: Hyperglycemia, anorexia, hypoglycemia, hypercholesteremia, alkalosis, dehydration, glucose tolerance increase, hyperuricemia, hypokalemia
Postmarketing reports: Infertility
The most frequently reported adverse events were headache, dyspepsia, nausea, constipation, heartburn, abdominal pain, and influenza-like syndrome.
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
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
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
Frequency not reported: Carcinoma, breast carcinoma, breast neoplasm, skin neoplasm
Common (1% to 10%): Confusion
Uncommon (0.1% to 1%): Depression, dream abnormalities, mood alterations
Frequency not reported: Insomnia, anxiety, nervousness, emotional lability, hallucinations
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Naproxen Sodium (www.drugs.com/naproxen.html).
March 28, 2020
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