Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Aflaxen
  2. Aleve
  3. Aleve Arthritis
  4. Anaprox
  5. Anaprox DS
  6. EC Naprosyn
  7. Naprelan
  8. Naprelan 500
  9. Naprelan Dose Card
  10. Naprosyn

Canadian Brand Name

  1. Naxen

Descriptions


Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis) such as inflammation, swelling, stiffness, and joint pain. Naproxen also helps relieve symptoms of ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.

This medicine may also be used to treat mild to moderate pain, including acute gout and other painful conditions such as bursitis, tendonitis, or menstrual cramps.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

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

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of naproxen controlled-release tablets in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of naproxen delayed release tablets, suspension, and tablets in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naproxen in the elderly. However, elderly patients may be more sensitive to the effects of naproxen than younger adults, and are more likely to have age-related kidney or stomach problems, which may require caution and an adjustment in the dose for patients receiving naproxen.

Pregnancy

Information about this naproxen-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Breastfeeding

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Apixaban
  • Ardeparin
  • Argatroban
  • Aspirin
  • Beta Glucan
  • Bivalirudin
  • Ceritinib
  • Certoparin
  • Cilostazol
  • Citalopram
  • Clopidogrel
  • Clovoxamine
  • Cyclosporine
  • Dabigatran Etexilate
  • Dabrafenib
  • Dalteparin
  • Danaparoid
  • Desirudin
  • Dipyridamole
  • Duloxetine
  • Enoxaparin
  • Eptifibatide
  • Erlotinib
  • Escitalopram
  • Femoxetine
  • Feverfew
  • Flesinoxan
  • Fluoxetine
  • Fondaparinux
  • Ginkgo
  • Gossypol
  • Heparin
  • Lepirudin
  • Levomilnacipran
  • Meadowsweet
  • Methotrexate
  • Milnacipran
  • Nadroparin
  • Nefazodone
  • Parnaparin
  • Paroxetine
  • Pemetrexed
  • Pentosan Polysulfate Sodium
  • Pentoxifylline
  • Pixantrone
  • Pralatrexate
  • Prasugrel
  • Protein C
  • Reviparin
  • Rivaroxaban
  • Sibutramine
  • Tacrolimus
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Venlafaxine
  • Vilazodone
  • Vortioxetine
  • Warfarin
  • Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Acetohexamide
  • Alacepril
  • Alprenolol
  • Amiloride
  • Amlodipine
  • Arotinolol
  • Atenolol
  • Azilsartan Medoxomil
  • Azosemide
  • Befunolol
  • Bemetizide
  • Benazepril
  • Bendroflumethiazide
  • Benzthiazide
  • Bepridil
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bopindolol
  • Bucindolol
  • Bumetanide
  • Bupranolol
  • Buthiazide
  • Candesartan Cilexetil
  • Canrenoate
  • Captopril
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Chlorothiazide
  • Chlorpropamide
  • Chlorthalidone
  • Cilazapril
  • Clopamide
  • Cyclopenthiazide
  • Delapril
  • Desvenlafaxine
  • Dilevalol
  • Diltiazem
  • Enalaprilat
  • Enalapril Maleate
  • Eprosartan
  • Esmolol
  • Ethacrynic Acid
  • Felodipine
  • Flunarizine
  • Fosinopril
  • Furosemide
  • Gallopamil
  • Gliclazide
  • Glimepiride
  • Glipizide
  • Gliquidone
  • Glyburide
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Imidapril
  • Indapamide
  • Irbesartan
  • Isradipine
  • Labetalol
  • Lacidipine
  • Landiolol
  • Levobunolol
  • Lidoflazine
  • Lisinopril
  • Lithium
  • Losartan
  • Manidipine
  • Mepindolol
  • Methyclothiazide
  • Metipranolol
  • Metolazone
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Nicardipine
  • Nifedipine
  • Nilvadipine
  • Nimodipine
  • Nipradilol
  • Nisoldipine
  • Nitrendipine
  • Olmesartan Medoxomil
  • Oxprenolol
  • Penbutolol
  • Pentopril
  • Perindopril
  • Pindolol
  • Piretanide
  • Polythiazide
  • Pranidipine
  • Propranolol
  • Quinapril
  • Ramipril
  • Sotalol
  • Spirapril
  • Spironolactone
  • Talinolol
  • Tasosartan
  • Telmisartan
  • Temocapril
  • Tertatolol
  • Timolol
  • Tolazamide
  • Tolbutamide
  • Torsemide
  • Trandolapril
  • Triamterene
  • Trichlormethiazide
  • Valsartan
  • Verapamil
  • Xipamide
  • Zofenopril

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Tobacco

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia or
  • Bleeding problems or
  • Blood clots or
  • Edema (fluid retention or body swelling) or
  • Heart attack, history of or
  • Heart disease (e.g., congestive heart failure) or
  • Hypertension (high blood pressure) or
  • Kidney disease or
  • Liver disease (e.g., hepatitis) or
  • Stomach or intestinal ulcers or bleeding, history of or
  • Stroke, history of—Use with caution. May make these conditions worse.
  • Aspirin-sensitive asthma or
  • Aspirin sensitivity, history of—Should not be used in patients with these conditions.
  • Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

Proper Use

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

Check with your doctor first before changing dosage forms (e.g., tablets, suspension). These forms are very different from each other.

Swallow the delayed-release tablet whole. Do not crush, break, or chew it.

If you are using the suspension, shake it gently before using it. Use the marked measuring cup included in the package to measure the dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For naproxen (e.g., Naprosyn®) tablet and oral suspension dosage forms:
    • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
      • Adults—At first, 250 milligrams (mg) (10 milliliters (mL)/2 teaspoonfuls), 375 mg (15 mL/3 teaspoonfuls), or 500 mg (20 mL/4 teaspoonfuls) two times a day, in the morning and evening. Your doctor may increase your dose, as needed, up to a total of 1500 mg per day.
      • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 milligrams (mg) per kilogram (kg) of body weight two times a day.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
      • Adults—500 milligrams (mg) for the first dose, then 250 mg every 6 to 8 hours as needed.
      • Children—Use and dose must be determined by your doctor.
    • For acute gout:
      • Adults—750 milligrams (mg) for the first dose, then 250 mg every 8 hours until the attack is relieved.
      • Children—Use and dose must be determined by your doctor.
  • For naproxen controlled-release tablet (e.g., Naprelan®) dosage form:
    • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
      • Adults—At first, 750 milligrams (mg) (taken as one 750 mg or two 375 mg tablets) or 1000 mg (taken as two 500 mg tablets) once a day. Your doctor may adjust your dose as needed, up to a total of 1500 mg (taken as two 750 mg or three 500 mg tablets) per day.
      • Children—Use and dose must be determined by your doctor.
    • For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
      • Adults—At first, 1000 milligrams (mg) (taken as two 500 mg tablets) once a day. Some patients may need 1500 mg (taken as two 750 mg or three 500 mg tablets) per day, for a limited period. However, the dose is usually not more than 1000 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For acute gout:
      • Adults—1000 to 1500 milligrams (mg) (taken as two to three 500 mg tablets) once a day for the first dose, then 1000 mg (taken as two 500 mg tablets) once a day until the attack is relieved.
      • Children—Use and dose must be determined by your doctor.
  • For naproxen delayed-release tablet (e.g., EC-Naprosyn®) dosage form:
    • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
      • Adults—At first, 375 or 500 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day.
      • Children—Use and dose must be determined by your doctor.
  • For naproxen sodium (e.g., Anaprox®, Anaprox® DS) tablet dosage form:
    • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
      • Adults—At first, 275 or 550 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
      • Adults—550 milligrams (mg) for the first dose, then 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed. Your doctor may increase the dose, if necessary, up to a total of 1375 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For acute gout:
      • Adults—825 milligrams (mg) for the first dose, then 275 mg every 8 hours until the attack is relieved.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs; severe stomach pain, black, tarry stools, or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert. .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

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:

More common

  1. Belching
  2. bruising
  3. difficult or labored breathing
  4. feeling of indigestion
  5. headache
  6. itching skin
  7. large, flat, blue, or purplish patches in the skin
  8. pain in the chest below the breastbone
  9. shortness of breath
  10. skin eruptions
  11. stomach pain
  12. swelling
  13. tightness in the chest
  14. wheezing

Less common

  1. Bloating
  2. bloody or black, tarry stools
  3. blurred or loss of vision
  4. burning upper abdominal or stomach pain
  5. cloudy urine
  6. constipation
  7. decrease in urine output or decrease in urine-concentrating ability
  8. disturbed color perception
  9. double vision
  10. fast, irregular, pounding, or racing heartbeat or pulse
  11. halos around lights
  12. indigestion
  13. loss of appetite
  14. nausea or vomiting
  15. night blindness
  16. overbright appearance of lights
  17. pale skin
  18. pinpoint red or purple spots on the skin
  19. severe and continuing nausea
  20. severe stomach burning, cramping, or pain
  21. skin rash
  22. swelling or inflammation of the mouth
  23. troubled breathing with exertion
  24. tunnel vision
  25. unusual bleeding or bruising
  26. unusual tiredness or weakness
  27. vomiting of material that looks like coffee grounds
  28. weight loss

Rare

  1. Anxiety
  2. back or leg pains
  3. bleeding gums
  4. blindness
  5. blistering, peeling, or loosening of the skin
  6. blood in the urine or stools
  7. blue lips and fingernails
  8. canker sores
  9. change in the ability to see colors, especially blue or yellow
  10. chest pain or discomfort
  11. clay-colored stools
  12. cold sweats
  13. coma
  14. confusion
  15. cool, pale skin
  16. cough or hoarseness
  17. coughing that sometimes produces a pink frothy sputum
  18. cracks in the skin
  19. darkened urine
  20. decreased vision
  21. depression
  22. diarrhea
  23. difficult, burning, or painful urination
  24. difficult, fast, or noisy breathing
  25. difficulty with swallowing
  26. dilated neck veins
  27. dizziness
  28. dry cough
  29. dry mouth
  30. early appearance of redness, or swelling of the skin
  31. excess air or gas in the stomach
  32. extreme fatigue
  33. eye pain
  34. fainting
  35. fever with or without chills
  36. fluid-filled skin blisters
  37. flushed, dry skin
  38. frequent urination
  39. fruit-like breath odor
  40. greatly decreased frequency of urination or amount of urine
  41. hair loss
  42. high fever
  43. hives
  44. increased hunger
  45. increased sensitivity of the skin to sunlight
  46. increased sweating
  47. increased thirst
  48. increased urination
  49. increased volume of pale, dilute urine
  50. irregular breathing
  51. joint or muscle pain
  52. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  53. late appearance of rash with or without weeping blisters that become crusted, especially in sun-exposed areas of skin, may extend to unexposed areas
  54. light-colored stools
  55. lightheadedness
  56. loss of heat from the body
  57. lower back or side pain
  58. nervousness
  59. nightmares
  60. no blood pressure
  61. no breathing
  62. no pulse
  63. nosebleeds
  64. numbness or tingling in the hands, feet, or lips
  65. pain in the ankles or knees
  66. pain or burning in the throat
  67. pain or discomfort in the arms, jaw, back, or neck
  68. painful, red lumps under the skin, mostly on the legs
  69. pains in the stomach, side, or abdomen, possibly radiating to the back
  70. pale or blue lips, fingernails, or skin
  71. pounding in the ears
  72. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  73. rapid, shallow breathing
  74. red, irritated eyes
  75. red skin lesions, often with a purple center
  76. red-green color blindness
  77. redness or other discoloration of the skin
  78. redness, swelling, or soreness of the tongue
  79. scaly skin
  80. seizures
  81. severe sunburn
  82. shakiness
  83. skin thinness
  84. slurred speech
  85. sneezing
  86. sore throat
  87. sores, ulcers, or white spots on the lips or tongue or inside the mouth
  88. sores, welting, or blisters
  89. spots on your skin resembling a blister or pimple
  90. stiff neck or back
  91. stomach cramps or tenderness
  92. stomach upset
  93. swelling in the legs and ankles
  94. swelling of the face, fingers, feet, or lower legs
  95. swollen, painful, or tender lymph glands in the neck, armpit, or groin
  96. tiny bumps on the inner lining of the eyelid
  97. unexplained weight loss
  98. unpleasant breath odor
  99. watery or bloody diarrhea
  100. weakness or heaviness of the legs
  101. weight gain
  102. yellow eyes or skin

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

Symptoms of overdose

  1. Bleeding under the skin
  2. confusion about identity, place, and time
  3. muscle tremors
  4. restlessness
  5. 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:

More common

  1. Continuing ringing or buzzing or other unexplained noise in the ears
  2. hearing loss

Less common

  1. Acid or sour stomach
  2. change in hearing
  3. feeling of constant movement of self or surroundings
  4. passing gas
  5. sensation of spinning
  6. stomach soreness or discomfort

Rare

  1. Appetite changes
  2. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  3. burning, dry, or itching eyes
  4. difficulty with moving
  5. discharge, excessive tearing
  6. general feeling of discomfort or illness
  7. lack or loss of strength
  8. menstrual changes
  9. muscle aching, cramping, stiffness, or weakness
  10. not able to concentrate
  11. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  12. seeing, hearing, or feeling things that are not there
  13. shakiness in the legs, arms, hands, or feet
  14. sleeplessness
  15. swollen joints
  16. trembling or shaking of the hands or feet
  17. trouble getting pregnant
  18. trouble performing routine tasks
  19. trouble sleeping
  20. unable to sleep
  21. 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.