What is naproxen

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) medicine. Naproxen sodium works by inhibiting the enzymes Cyclooxygenase 1 (COX-1) and Cyclooxygenase 2 (COX-2) by reducing hormones prostaglandin that cause inflammation, fever and pain in the body ¹⁾. Naproxen is used to treat inflammation and pain in joints and muscles such as arthritis, osteoarthritis, ankylosing spondylitis, rheumatoid arthritis, tendinitis, bursitis, gout, or menstrual cramps. Cyclooxygenase 1 (COX-1) is constitutively active and is expressed in most tissues, including kidney, lung, stomach, duodenum, jejunum, ileum, colon, and cecum. Cyclooxygenase 1 (COX-1) functions in gastric cytoprotection, vascular homeostasis, platelet aggregation, and maintenance of normal kidney function ²⁾. Cyclooxygenase 2 (COX-2) is an inducible enzyme expressed in the brain, kidney, and possibly in the female reproductive system ³⁾. Cyclooxygenase 2 (COX-2) expression is increased during states of inflammation ⁴⁾. Cyclooxygenase 2 (COX-2) is a key source of prostacyclin (PGI₂) and is cardioprotective in ischemia–reperfusion injury ⁵⁾. Naproxen analgesic activity is primarily (although not exclusively) associated with inhibition of COX-2, while different side effects result from the inhibition of COX-1 and COX-2 ⁶⁾. Naproxen is available on prescription as tablets or as a liquid that you drink. You can buy it without a prescription from a pharmacy for period pain.

Prescription naproxen is used to:

• relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine).

Prescription naproxen tablets, delayed-release or extended-release naproxen, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period).

Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches.

Naproxen is NOT approved for use by anyone younger than 2 years old. Do not give naproxen to a child without medical advice. Naproxen can only be taken by children when it’s prescribed for them.

Key facts:

• Take naproxen tablets with or just after a meal or snack.
• Take the lowest dose of naproxen for the shortest time to control your symptoms.
• Naproxen may impair fertility and is not recommended in women attempting to conceive.
• The most common side effects of naproxen are confusion, headache, ringing in the ears, changes in vision, tiredness, drowsiness, dizziness and rashes.
• 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.
• Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. However, if it is necessary for you to take naproxen, your doctor will discuss the risks and benefits of taking this medicine during pregnancy.
• Naproxen can pass into breast milk and may cause side effects in the nursing baby. You should not breast-feed while using this medicine.
• If you take naproxen while you have an infection, naproxen may hide some of the signs of an infection (e.g. pain, fever). This may make you think, mistakenly, that you are better or that it is not serious.
• You plan to have surgery or you are being prepared for coronary bypass surgery, naproxen can prolong bleeding.
• Naproxen use in People Over 65 years: Older people may be at more risk of developing stomach ulcers and hence your doctor may prescribe a lower dose.
• Naproxen is also called by the brand names Aleve, EC-Naprosyn, Flanax Pain Reliever, Midol Extended Relief, Naprelan 375, Naprosyn, Anaprox, Anaprox-DS, Naprelan 500, Naproxen Sodium DS, Aleve Caplet, Aleve Gelcap, Aflaxen, Aleve Easy Open Arthritis, Leader Naproxen Sodium, Comfort Pac with Naproxen, Naprelan 750, Naprelan Dose Card.

Who can and can’t take naproxen

Naproxen can be taken by 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.

Taking naproxen during the last 3 months of pregnancy may harm the unborn baby.

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.

Naproxen can also be taken under medical supervision by children to treat:

• muscle and bone disorders for babies from 1 month
• diseases of the joints for children from 2 years
• period pain – for girls of any age

Naproxen isn’t suitable for certain people. Tell your doctor or pharmacist if you:

• have had an allergic reaction to naproxen or any other medicines in the past
• are allergic to aspirin or other anti-inflammatory medicines (like ibuprofen), or if you’ve developed signs of asthma (wheezing), runny nose, swelling of the skin (angioedema), or a skin rash
• have or have had stomach ulcers, bleeding in the stomach or intestines, or a hole in your stomach
• have high blood pressure
• have severe liver, kidney, or heart failure
• have Crohn’s disease or ulcerative colitis
• have lupus
• have a blood clotting disorder
• are pregnant, planning to become pregnant, or breastfeeding

Special precautions before taking naproxen

• Tell your doctor and pharmacist if you are allergic to naproxen, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and ketoprofen, any medications for pain or fever, other medications, or any of the ingredients in naproxen products. Ask your doctor or pharmacist for a list of the ingredients.

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, InnoPran); cholestyramine (Prevalite); diuretics (‘water pills’); lithium (Lithobid), medications for diabetes; methotrexate (Otrexup, Rasuvo, Trexall); probenecid (Probalan; Col-Probenecid); and sulfa medications such as sulfamethoxazole (in Bactrim, in Septra). If you are taking the delayed-release tablets, also tell your doctor if you are taking antacids or sucralfate (Carafate). Your doctor may need to change the doses of your medication or monitor you more carefully for side effects.

• DO NOT take nonprescription naproxen with any other medication for pain unless your doctor tells you that you should.

• Tell your doctor if you have been told to follow a low sodium diet and if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the inside of the nose); heart failure; swelling of the hands, arms, feet, ankles, or lower legs; anemia (red blood cells do not bring enough oxygen to all parts of the body); or liver or kidney disease.

• Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breastfeeding. If you become pregnant while taking naproxen, call your doctor.

• Talk to your doctor about the risks and benefits of taking naproxen if you are 65 years of age or older. Older adults should usually take lower doses of naproxen for short periods of time because higher doses used regularly may not be more effective and are more likely to cause serious side effects.

• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking naproxen.

• You should know that this medication may make you dizzy, drowsy, or depressed. Do not drive a car or operate machinery until you know how this drug affects you.

• Remember that alcohol can add to the drowsiness caused by this medication.

Pregnancy and breastfeeding

Naproxen isn’t normally recommended in pregnancy – especially if you’re 30 or more weeks – unless it’s prescribed by a doctor. This is because there might be a link between taking naproxen in pregnancy and some birth defects, in particular damage to the baby’s heart and blood vessels.

Tell your doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

There may also be a link between taking naproxen in early pregnancy and miscarriage.

Talk to your doctor about the benefits and possible harms of taking naproxen. It will depend on how many weeks pregnant you are and the reason you need to take the medicine. There may be other treatments that are safer for you.

Paracetamol is usually recommended as the first choice of painkiller for pregnant women.

Will naproxen affect my fertility?

Taking anti-inflammatory medicines, like naproxen, in large doses or for a long time can affect ovulation in women. This may make it more difficult to get pregnant.

Don’t take naproxen if you’re trying to get pregnant or you’re having tests for infertility. Paracetamol is a better painkiller in these situations.

Will naproxen affect my contraception?

Naproxen will not affect contraceptive pills or the morning after pill in women.

Naproxen and breastfeeding

Naproxen isn’t usually recommended during breastfeeding. Other anti-inflammatory medicines, such as ibuprofen, are safer.

However, if your baby is premature, had a low birth weight, or has an underlying medical condition, talk to your doctor before taking any painkillers.

Is naproxen an anti inflammatory?

Yes. Naproxen is a nonsteroidal anti-inflammatory drug that is used to treat inflammation and pain in joints and muscles such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

Is naproxen an NSAID?

Yes. Naproxen is a NSAID (nonsteroidal anti-inflammatory drug).

What is naproxen good for?

Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches.

When will I feel better?

You should start to feel better 1 hour after taking naproxen. However, it might take up to 3 days for naproxen to work properly if you take it regularly twice a day.

How long will I take naproxen for?

Depending on why you’re taking naproxen, you may only need to take it for a short time. For example, if you have a sore back or period pain, you may only need to take naproxen for a day or two.

You may need to take it for longer if you have a long-term condition, such as rheumatoid arthritis.

If you need to take naproxen for a long time, your doctor may prescribe a medicine to protect your stomach from side effects.

It’s best to take the lowest dose of naproxen for the shortest time to control your symptoms.

Talk to your doctor if you’re unsure how long you need to take naproxen for.

Can I take naproxen for a long time?

Naproxen can cause an ulcer in your stomach or gut if you take it for a long time or in big doses.

There’s also a small risk that people taking very big doses (at least twice the usual daily dose) for a long time may get heart failure or kidney failure.

It’s best to take the lowest dose that works for the shortest possible time.

If you need to take naproxen very often or you’re taking a big dose, talk to your doctor about your pain.

Are there other painkillers I can try?

The type of painkiller that’s best depends on what type of pain you have and the cause of your pain.

If naproxen doesn’t get rid of your pain, you can try painkillers that you can buy from shops and pharmacies, such as paracetamol or co-codamol (paracetamol combined with low-dose codeine).

If the medicine you buy isn’t controlling your pain, your doctor may recommend another type of treatment to help your pain, such as exercise or physiotherapy. Your doctor may also be able to prescribe a stronger painkiller, such as higher-dose co-codamol or codeine.

Naproxen doesn’t work for some types of pain, such as nerve pain. Your doctor will have to prescribe a different medicine if your pain is related to your nerves.

Why do I need to be careful of stomach ulcers?

Naproxen can cause an ulcer in your stomach or gut if you take it for a long time or in big doses, or if you’re elderly or in poor general health.

Your doctor may tell you not to take naproxen if you have a stomach ulcer or if you’ve had one in the past. If you need to take naproxen but you’re at risk of getting a stomach ulcer, your doctor may prescribe another medicine for you to take alongside naproxen to protect your stomach.

The most common symptom of a stomach ulcer is a burning or gnawing pain in the centre of the tummy. However, stomach ulcers aren’t always painful and some people may have other symptoms, such as indigestion, heartburn and feeling sick. If you think you may have symptoms of a stomach ulcer, stop taking naproxen and contact your doctor.

If you’re prone to stomach ulcers or have had one before, take paracetamol instead of naproxen as it’s gentler on your stomach.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

Can I drink alcohol with naproxen?

Yes, you can drink alcohol while taking naproxen. However, drinking too much alcohol may irritate your stomach and alcohol can add to the drowsiness caused by this medication.

Are there other painkillers I can try?

The type of painkiller that’s best depends on what type of pain you have and the cause of your pain.

If naproxen doesn’t get rid of your pain, you can try painkillers that you can buy from shops and pharmacies, such as paracetamol or co-codamol (paracetamol combined with low-dose codeine).

If the medicine you buy isn’t controlling your pain, your doctor may recommend another type of treatment to help your pain, such as exercise or physiotherapy. Your doctor may also be able to prescribe a stronger painkiller, such as higher-dose co-codamol or codeine.

Naproxen doesn’t work for some types of pain, such as nerve pain. Your doctor will have to prescribe a different medicine if your pain is related to your nerves.

Can naproxen cause heart failure?

It’s been said that taking anti-inflammatory medicines increases the chances of getting heart failure. However, the risk is very small for most people. The possibility of heart failure is only a problem if you have been taking very big doses (twice the usual daily dose) of naproxen for a long time.

If you find you need to take naproxen very often or you’re taking doses higher than recommended, talk to your doctor about your pain.

Some anti-inflammatory medicines are less risky than others. Your doctor will be able to help you decide which is the best one for you.

Does naproxen cause kidney failure?

Naproxen is safe for occasional use when taken as advised by a doctor. If you have problems with your kidney function, talk to your doctor about the best anti-inflammatory to take.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of sudden kidney failure and even progressive kidney damage.

Does naproxen cause an irregular heartbeat?

It’s thought some anti-inflammatory medicines, including naproxen, can increase the chance of you getting an irregular heartbeat (such as atrial fibrillation or atrial flutter).

However, the chances of getting an irregular heartbeat is small and not enough to recommend people stop taking these medicines.

If you’re prescribed naproxen for a long-term condition, keep taking it and talk to your doctor if you’re worried. If you buy naproxen from a shop, occasional doses or short courses (2 or 3 days) are safe.

Does naproxen cause hearing loss?

It’s been reported that women taking some anti-inflammatory medicines, including naproxen, twice a week for more than a year have a higher chance of losing their hearing.

However, there’s no proof that naproxen and similar anti-inflammatory medicines cause hearing loss.

Hearing loss is common as people get older. There are ways to protect your hearing – for example, limiting your exposure to loud noise, wearing hearing protection in noisy places, and keeping the volume down on personal headphones.

If you find you have to take naproxen several days a week, talk to your doctor about what’s causing your pain and whether there are better ways to manage it.

Naproxen uses

Naproxen is a medicine that reduces inflammation and pain in joints and muscles. Naproxen is also used for period pain and muscle and bone disorders, such as back pain and sprains and strains.

The delayed-release or extended-release naproxen 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.

What is naproxen used for?

Prescription naproxen comes as a regular tablet, a delayed-release (a tablet that releases the medication in the intestine to prevent damage to the stomach) tablet, an extended-release (long-acting) tablet, and a suspension (liquid) to take by mouth. The extended-release naproxen tablets are usually taken once a day. The naproxen sodium tablets, delayed-release tablets, and suspension are usually taken twice a day for arthritis. The tablets and suspension are usually taken every 8 hours for gout, and every 6 to 8 hours as needed for pain. If you are taking naproxen on a regular basis, you should take it at the same time(s) every day.

Nonprescription naproxen comes as tablet and a gelatin coated tablet to take by mouth. It is usually taken with a full glass of water every 8 to 12 hours as needed. Nonprescription naproxen may be taken with food or milk to prevent nausea.

Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take naproxen exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or written on the package.

Shake the liquid well before each use to mix the medication evenly. Use the measuring cup provided to measure each dose of the liquid.

Swallow the delayed-release tablets and extended release tablets whole; do not split, chew, or crush them.

If you are taking naproxen to relieve the symptoms of arthritis, your symptoms may begin to improve within 1 week. It may take 2 weeks or longer for you to feel the full benefit of the medication.

Stop taking nonprescription naproxen and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, the part of your body that was painful becomes red or swollen, your pain lasts for more than 10 days, or your fever lasts for more than 3 days.
Other uses for this medicine

Naproxen is also sometimes used to treat Paget’s disease of bone (a condition in which the bones become abnormally thick, fragile, and misshapen) and Bartter syndrome (a condition in which the body does not absorb enough potassium, causing muscle cramping and weakness and other symptoms). Talk to your doctor about the risks of using this medication for your condition.

Naproxen sodium is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Naproxen dosage

Applies to the following strengths: 125 mg/5 mL; naproxen sodium 550 mg; naproxen sodium 275 mg; 500 mg; 375 mg; 250 mg; 375 mg (as naproxen sodium); 500 mg (as naproxen sodium); naproxen sodium 220 mg; naproxen sodium; 750 mg (as naproxen sodium); 500 mg with analgesic balm; naproxen sodium varying strength.

General:

• When treating acute painful conditions, the delayed release form is not recommended due to delay in absorption.
• Different dose strengths and dosage forms are not necessarily bioequivalent; differences should be taken into consideration when changing formulations.
• Prior to initiating treatment, the potential benefits and risks of this drug should be weighed against other treatment options.
• The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• There is an increased risk of heart attack, heart failure, and stroke when taking nonsteroidal anti-inflammatory drugs (NSAIDs); these events may occur at any time during treatment and risk increases with long term use, a history of cardiovascular disease or risk factors for cardiovascular disease, and higher doses.

Monitoring:

• Cardiovascular: Monitor blood pressure closely during initiation and throughout course of therapy.
• Gastrointestinal: Monitor for signs/symptoms of gastrointestinal bleeding.
• Renal function: Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.
• Monitor blood counts, renal, and hepatic function periodically for patients receiving long-term therapy.

Usual Adult Dose for Ankylosing Spondylitis

Immediate Release Tablets and Suspension:
250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day

Controlled Release:
750 mg to 1000 mg orally once a day

Delayed Release:
375 mg to 500 mg orally twice a day

Comments:

• May increase to 1500 mg orally once a day for a limited time up to 6 months in patients requiring higher levels of anti-inflammatory/analgesic activity.
• When treating patients, especially at higher doses, sufficient increased clinical benefit should be observed to offset the potential for increased risk of adverse events.
• Symptomatic improvement of arthritis is usually observed within 1 week; however, treatment for 2 weeks may be required to achieve therapeutic benefit.

Uses: For the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis

Usual Adult Dose for Osteoarthritis

Immediate Release Tablets and Suspension:
250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day

Controlled Release:
750 mg to 1000 mg orally once a day

Delayed Release:
375 mg to 500 mg orally twice a day

Comments:

• May increase to 1500 mg orally once a day for a limited time up to 6 months in patients requiring higher levels of anti-inflammatory/analgesic activity.
• When treating patients, especially at higher doses, sufficient increased clinical benefit should be observed to offset the potential for increased risk of adverse events.
• Symptomatic improvement of arthritis is usually observed within 1 week; however, treatment for 2 weeks may be required to achieve therapeutic benefit.

Uses: For the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis

Usual Adult Dose for Rheumatoid Arthritis

Immediate Release Tablets and Suspension:
250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day

Controlled Release:
750 mg to 1000 mg orally once a day

Delayed Release:
375 mg to 500 mg orally twice a day

Comments:

• May increase to 1500 mg orally once a day for a limited time up to 6 months in patients requiring higher levels of anti-inflammatory/analgesic activity.
  When treating patients, especially at higher doses, sufficient increased clinical benefit should be observed to offset the potential for increased risk of adverse events.
• Symptomatic improvement of arthritis is usually observed within 1 week; however, treatment for 2 weeks may be required to achieve therapeutic benefit.

Uses: For the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis

Usual Adult Dose for Acute Gout

Immediate Release Tablets and Suspension:

• Initial dose: 750 mg (naproxen) or 825 mg (naproxen sodium) orally once on first day of attack
• Following initial dose: 250 mg (naproxen) or 275 mg (naproxen sodium) orally every 8 hours until attack subsides

Controlled Release:
1000 mg to 1500 mg orally once on first day of attack, followed by 1000 mg orally once a day until attack subsides

Comments:

• The delayed release tablets (EC-Naprosyn) are not recommended due to delayed absorption.

Use: For the relief of an acute gout attack

Usual Adult Dose for Bursitis

Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed

Maximum dose: Initial total daily dose not to exceed 1375 mg; thereafter, not to exceed 1100 mg/day

Comments:

• Naproxen (Naprosyn) may also but used, however, the delayed release tablets (EC-Naprosyn) are not recommended for initial treatment of acute pain due to delayed absorption.

Controlled Release:
1000 mg orally once a day

For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day

Uses: For the relief of signs and symptoms of bursitis and tendinitis

Usual Adult Dose for Tendonitis

Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed

Maximum dose: Initial total daily dose not to exceed 1375 mg; thereafter, not to exceed 1100 mg/day

Comments:

• Naproxen (Naprosyn) may also but used, however, the delayed release tablets (EC-Naprosyn) are not recommended for initial treatment of acute pain due to delayed absorption.

Controlled Release:
1000 mg orally once a day

For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day

Uses: For the relief of signs and symptoms of bursitis and tendinitis

Usual Adult Dose for Dysmenorrhea

Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed

Maximum dose: 1375 mg/day initial total daily dose; thereafter, not to exceed 1100 mg/day

Comments:

• Naproxen (Naprosyn) may also but used, however, the delayed release tablets (EC-Naprosyn) are not recommended for initial treatment of acute pain due to delayed absorption.

Controlled Release:
1000 mg orally once a day

For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day

Over the Counter:
220 mg orally every 8 to 12 hours while symptoms persist

May take 440 mg orally once in the first hour if needed

Maximum dose: 440 mg (in any 8 to 12 hour period); 660 mg (in any 24 hour period)

Uses: For the management of primary dysmenorrhea

Usual Adult Dose for Pain

Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed

Maximum dose: 1375 mg/day initial total daily dose; thereafter, not to exceed 1100 mg/day

Comments:

• Naproxen (Naprosyn) may also but used, however, the delayed release tablets (EC-Naprosyn) are not recommended for initial treatment of acute pain due to delayed absorption.

Controlled Release:
1000 mg orally once a day

For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day

Over the Counter:
220 mg orally every 8 to 12 hours while symptoms persist

May take 440 mg orally once in the first hour if needed

Maximum dose: 440 mg (in any 8 to 12 hour period); 660 mg (in any 24 hour period)

Uses: For the relief of mild to moderate pain

Usual Adult Dose for Fever

Over the Counter:
220 mg orally every 8 to 12 hours while symptoms persist

May take 440 mg orally once in the first hour if needed

Maximum dose: 440 mg (in any 8 to 12 hour period); 660 mg (in any 24 hour period)

Use: For the temporary reduction of fever

Usual Pediatric Dose for Fever

Over the Counter:
12 years or older: 220 mg orally every 8 to 12 hours while symptoms persist

May take 440 mg orally once in the first hour if needed

Maximum dose: 440 mg (in any 8 to 12 hour period); 660 mg (in any 24 hour period)

Uses: For the relief of minor aches and pains and for the temporary reduction of fever

Usual Pediatric Dose for Pain

Over the Counter:
12 years or older: 220 mg orally every 8 to 12 hours while symptoms persist

May take 440 mg orally once in the first hour if needed

Maximum dose: 440 mg (in any 8 to 12 hour period); 660 mg (in any 24 hour period)

Uses: For the relief of minor aches and pains and for the temporary reduction of fever

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

Immediate Release Tablets and Suspension:
2 years or older: 5 mg/kg orally twice a day

Comments:

• The oral suspension is recommended due to flexible dose titration based on patient’s weight.
• The delayed release formulation has not been studied in patients less than 18 years.

Use: For the relief of signs and symptoms of juvenile rheumatoid arthritis

Renal Dose Adjustments

• Mild renal dysfunction: Caution is recommended; lower doses should be considered
• Moderate to severe renal dysfunction: Not recommended.

Liver Dose Adjustments

• Dose adjustments may be required in patients with liver dysfunction, however, no specific guidelines have been suggested. Caution recommended.
• Patients who have an abnormal liver test or who develop signs or symptoms of liver dysfunction should be evaluated for hepatic dysfunction.
• If liver disease develops or if systemic manifestations such as eosinophilia or rash occur, this drug should be discontinued.

Dose Adjustments

Elderly patients may require lower doses due to increased risk for adverse effects and risk for concurrent hepatic and/or renal impairment.

How and when to take naproxen

Always take your naproxen tablets with or just after a meal so you don’t get an upset stomach. Do not take more than 3 tablets in 24 hours.

As a general rule in adults, the naproxen dose to treat:

• diseases of joints is 500mg to 1000mg a day in 1 or 2 doses
• muscle, bone disorders and painful periods is 500mg at first, then 250mg every 6 to 8 hours as required
• attacks of gout is 750mg, then 250mg every 8 hours until the attack has passed

Naproxen doses are usually lower for elderly people and people with heart, liver or kidney problems.

The doctor will use your child’s weight to work out the right naproxen dose.

If you get naproxen on prescription, the dose depends on the reason why you’re taking it, your age, how well your liver and kidneys work, and how well it helps your symptoms.

If you buy naproxen from a pharmacy for painful menstrual periods:

• on the first day – take 2 tablets when the pain starts, then after 6 to 8 hours one more tablet that day if you need to
• on the second and following days – take one tablet every 6 to 8 hours if needed

How to take naproxen

Naproxen on prescription comes as 2 different tablets – effervescent and gastro-resistant tablets.

Effervescent tablets are dissolved in water before you take them.

Gastro-resistant naproxen tablets have a coating to protect them from being broken down by the acid in your stomach. Instead, the medicine is released further down the gut in your intestine.

If you take gastro-resistant naproxen tablets, swallow them whole with or after food. Don’t crush or chew them.

If you take effervescent naproxen tablets, dissolve 1 to 2 tablets in a glass (150ml) of water and drink.

Doses of 3 tablets should be dissolved in 300ml. To make sure there is no medicine left, rinse the empty glass with a small amount of water and drink it. Take with or after food.

What if I forget to take naproxen?

Take your forgotten dose as soon as you remember, unless it’s nearly time for your next dose. Don’t take a double dose to make up for a forgotten dose.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much naproxen?

If you take too many naproxen tablets by accident, you’re more likely to get some of the common side effects. Contact your doctor straight away.

Naproxen side effects

Like all medicines, naproxen can cause side effects although not everyone gets them.

Common naproxen side effects

Common side effects of naproxen happen in more than 1 in 100 people and include:

• confusion
• headache
• ringing in the ears
• changes in vision
• tiredness and feeling sleepy
• dizziness
• rashes

Less common side effects of naproxen happen in more than 1 in 1,000 people. They include:

• depression
• irregular heartbeat (palpitations)
• abnormal dreams
• forgetfulness
• difficulty concentrating
• sensitivity of the skin to light (may cause blistering)
• difficulty sleeping

Rarely, naproxen can cause some side effects that happen in less than 1 in 1000 people:

• hair loss
• problems with hearing
• inflammation of blood vessels – causing fever, swelling, and generally not feeling well
• asthma getting worse
• muscle weakness and pain
• ulcers on the inner cheeks, gums and tongue

Talk to your doctor or pharmacist if these side effects bother you or don’t go away.

Serious naproxen side effects

Tell your doctor straight away if you have:

• severe indigestion, heartburn, pains in your stomach, feeling sick or vomiting or diarrhoea – these can be signs of an ulcer or inflammation in the stomach or gut
• vomiting blood or dark particles that look like coffee grounds, blood in your poo, or black, tarry-looking poo these could be signs of bleeding and perforation of the stomach or gut
• frequent sore throat, nose bleeds, and infections these can be signs of abnormalities in your blood cells, known as agranulocytosis
• fainting, chest pain, or breathlessness – these can be signs of anaemia
• fever, feeling sick or vomiting, confusion, headache, neck stiffness and sensitivity to light – these can be signs of aseptic meningitis
• a severe skin rash with flushing, blisters or ulcers – these can be signs of Stevens-Johnson syndrome)
• blood in your pee, a decrease in how much pee is passed, feeling sick or vomiting – these can be signs of kidney damage or infection
• yellowing of the skin or whites of the eyes – these can be signs of jaundice or inflammation of the liver
• irregular, slow heartbeats caused by high levels of potassium in the blood
• fever, stomach pain and vomiting – these can be signs of inflammation of the pancreas

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to naproxen.

A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue, or throat

These are not all the side effects of naproxen. For a full list see the leaflet inside your medicines packet.

How to cope with naproxen side effects

What to do about:

• headache – make sure you rest and drink plenty of fluids. Don’t drink too much alcohol. Ask your pharmacist to recommend a painkiller. Headaches should usually go away after the first week of taking naproxen. Talk to your doctor if they last longer than a week or are severe.
• feeling sleepy, tired or dizzy – as your body gets used to naproxen, these side effects should wear off.
• changes in vision – don’t drive for a week.
• dizziness – if naproxen makes you feel dizzy, stop what you’re doing and sit or lie down until you feel better.

Human Toxicity Reports

Most cases of naproxen overdosage have been reported in adults ⁷⁾. Adverse gastrointestinal effects (e.g., heartburn, vomiting) and seizures usually occur in these patients; drowsiness and prolongation of clotting time also may occur. The incidence of adverse effects in adults may differ from those in children since rash and prolonged bleeding time appear to occur more frequently in children while other reactions occur more frequently in adults; the incidence of adverse gastrointestinal and CNS (central nervous system) effects are similar ⁸⁾. Toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, urticaria, alopecia, erythema nodosum, fixed drug eruption, lichen planus, and pustular reaction have been reported during postmarketing experience ⁹⁾.

Pseudoporphyria, a cutaneous disorder characterized by skin fragility, vesiculation, and scarring, has been reported as a side effect of naproxen therapy in children with juvenile rheumatoid arthritis ¹⁰⁾. The results of a 6-month prospective study to determine the prevalence of pseudoporphyria in the juvenile rheumatoid arthritis population are presented. All the patients with pseudoporphyria had received naproxen for > or = 4 weeks at the time of the study. Of the patients treated with naproxen, 12% (9/74) developed this complication ¹¹⁾. No patient had significant elevation of free erythrocyte protoporphyrin, excluding the diagnosis of true erythropoietic protoporphyria. The study authors conclude that pseudoporphyria is a common side effect of naproxen therapy in children with juvenile rheumatoid arthritis, even in geographic areas without high sun exposure ¹²⁾. Because of the risk of facial scarring with pseudoporphyria, physicians and parents of children with juvenile rheumatoid arthritis should be aware of this complication.

Severe, sometimes fatal, toxicity has occurred following administration of a nonsteroidal anti-inflammatory drug (NSAID) concomitantly with methotrexate (principally high-dose therapy) in patients with various malignant neoplasms or rheumatoid arthritis ¹³⁾. The toxicity was associated with elevated and prolonged blood concentration of methotrexate. The exact mechanism of the interaction remains to be established, but it has been suggested that nonsteroidal anti-inflammatory drugs (NSAIDs) may inhibit renal elimination of methotrexate, possibly by decreasing renal perfusion via inhibition of renal prostaglandin synthesis or by competing for renal elimination ¹⁴⁾. Naproxen and methotrexate should be administered concomitantly with caution. Pending further accumulation of data, some clinicians recommend that nonsteroidal anti-inflammatory drugs be avoided in patients receiving methotrexate ¹⁵⁾.

Jaundice (including cholestatic jaundice which cleared promptly when naproxen was discontinued) and fatal hepatitis have been reported rarely in patients receiving naproxen ¹⁶⁾. Abnormal liver function test results, including mild and generally transient increases in serum alkaline phosphatase, have occurred in some patients.

A case report of a pre-term infant who developed severe hyponatremia and water retention associated with the ingestion of an overdose of the non-steroid anti-inflammatory drug naproxen eight hours before delivery is reported ¹⁷⁾. Recovery was complete and subsequent development unimpaired.

The development of acute renal failure and interstitial nephritis due to therapeutic doses of non-steroidal anti-inflammatory drugs (NSAIDs) has been documented repeatedly in adult patients but is rare in children ¹⁸⁾. This study report the occurrence of this complication in a child. Acute renal failure and hyperkalemia developed in a 2-year-old boy with juvenile rheumatoid arthritis after one month of naproxen sodium therapy ¹⁹⁾. The evidence of renal toxic effects became manifest after an episode of dehydration. A percutaneous renal biopsy specimen revealed interstitial nephritis. The patient recovered promptly after withdrawal of the drug ²⁰⁾.

The occurrence of severe acute renal failure in a 10-year-old girl with juvenile rheumatoid arthritis after 1 month of naproxen therapy is reported ²¹⁾. Renal biopsy showed severe acute interstitial nephritis. The patient recovered completely after discontinuation of naproxen and administration of methylprednisolone ²²⁾.

Renal failure occurred in a 14-year-old girl with peripheral arthritis associated with inflammatory bowel disease while she was being treated with naproxen ²³⁾. She had previously received aspirin and tolmetin sodium and had no complications. A renal biopsy showed a severe tubulointerstitial nephritis. Although her renal function improved somewhat with corticosteroid treatment, it worsened when the steroids were discontinued ²⁴⁾.

A case of a 3,790-g term neonate who developed persistent pulmonary hypertension after birth with a closed ductus arteriosus is reported ²⁵⁾. The mother admitted to taking naproxen sodium immediately prior to the birth of the infant. The course of illness was progressively better on conservative management. Like indomethacin, other nonsteroid anti-inflammatory drugs (NSAIDs) can also cause premature closure of fetal ductus arteriosus, pulmonary hypertension, and life-threatening problems to the neonate ²⁶⁾.

Pulmonary infiltrates developed in three middle-aged women while receiving naproxen sodium ²⁷⁾. Weakness, fatigue, cough, low-grade fever, and eosinophilia in blood and/or sputum were common to all. All symptoms and findings resolved within a few days after discontinuing naproxen therapy in two cases and with use of corticosteroids (prednisone) in one case. A hypersensitivity reaction due to naproxen seemed to be the likely cause ²⁸⁾.

A 12 year old boy developed scars at light-exposed areas following long-term therapy with naproxen for rheumatoid arthritis ²⁹⁾. Erythrocyte and urine porphyrin levels were not increased, and there was no evidence of increased photosensitivity. Pseudoporphyria is reported in 10-20% of those treated with naproxen for > 4 weeks ³⁰⁾. As compared to other nonsteroidal anti-inflammatory agents, the specific risk for naproxen is increased about 6 fold ³¹⁾. While the underlying abnormality has not been elucidated, formation of phototoxic metabolites in a subgroup of genetically predisposed individuals has been suggested as the most likely mechanism. Both dermatologists and rheumatologists should be aware of the risk of naproxen-induced pseudoporphyria and discontinue therapy early in order to avoid scar formation in light-exposed areas.

Transient prolongation of the prothrombin time (bleeding time) was observed in the setting of a 10 g overdose of naproxen ³²⁾. The patient reported was previously healthy, without chronic liver disease, bleeding disorders, or malnutrition. The most likely mechanism for this effect is direct inhibition of the synthesis of vitamin-K-dependent clotting factors, possibly via production of “abnormal” prothrombin.

A case report of a 39 yr old man who developed dyspnea and periorbital edema following a dosage increase in naproxen after he was previously stabilized on the drug for approximately 1 yr is reported ³³⁾. The patient had been taking oral naproxen 375 mg 3 times daily for back pain. He reported mild shortness of breath and hoarseness after taking the first dose of naproxen, but the reaction subsided and he continued treatment without further adverse effects. After approximately 1 yr, the patient began experiencing increased back pain and his physician increased the naproxen dosage to 500 mg 3 times daily. Within an hr of ingesting the 500 mg dose, the patient developed dyspnea, shortness of breath, hoarseness, and difficulty swallowing. Upon arrival at the emergency room, he was noted to have bilateral periorbital edema. He was treated with subcutaneous epinephrine, parenteral methylprednisolone, and oral diphenhydramine with adequate response. Naproxen therapy was discontinued and the patient was discharged the following day ³⁴⁾.

Naproxen emergency/overdose

In case of overdose, call the Poison Help hotline at 1-800-222-1222 from anywhere in the United States. This hotline number will let you talk to experts in poisoning. They will give you further instructions. This is a free and confidential service. You should call if you have any questions about poisoning or poison prevention. You can call 24 hours a day, 7 days a week.

Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call your local emergency services number.

Symptoms of overdose may include the following:

• Dizziness, unsteadiness, movement problems
• Extreme tiredness
• Drowsiness
• Stomach pain (possible bleeding in the stomach and intestines)
• Heartburn
• Nausea
• Vomiting
• Slow labored breathing, wheezing or difficult breathing
• Agitation, confusion, incoherence (the person is not understandable)
• Blurred vision
• Coma
• Convulsions (seizures)
• Diarrhea
• Headache — severe
• Rash
• Ringing in the ears

What to Expect at the Emergency Room

The health care provider will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure. Symptoms will be treated as appropriate. The person may receive:

• Activated charcoal
• Blood and urine tests
• Fluids through a vein (IV)
• Laxatives
• Medicines to treat symptoms

In rare, serious cases, more treatments may be needed. Most people will be discharged from the emergency department after being observed for a period of time.

Outlook (Prognosis)

Recovery is likely.