What is Aleve

Aleve is a non-steroidal anti-inflammatory drug (NSAID) containing the active ingredient Naproxen. Aleve (naproxen) is a medicine that reduces inflammation and pain in joints and muscles. Aleve (naproxen) is used to treat diseases of joints, such as rheumatoid arthritis, osteoarthritis, and gout. Aleve (naproxen) 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⁾. 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⁾. Aleve (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⁾.

Aleve (naproxen) is also used for period pain (dysmenorrhea) and muscle and bone disorders, such as back pain and sprains and strains.

Aleve (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.

Aleve (naproxen) can only be taken by children when it’s prescribed for them.

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

Key facts:

• Take Aleve (naproxen) tablets with or just after a meal or snack.
• Take the lowest dose of Aleve (naproxen) for the shortest time to control your symptoms.
• Aleve (naproxen) may impair fertility and is not recommended in women attempting to conceive.
• Aleve (naproxen) may affect your developing baby if you take it during pregnancy. However, if it is necessary for you to take Aleve (naproxen), your doctor will discuss the risks and benefits of taking this medicine during pregnancy.
• If you take Aleve (naproxen) while you have an infection, the Aleve 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, Aleve (naproxen) can prolong bleeding.
• Aleve (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.
• Be careful driving or operating machinery until you know how Aleve (naproxen) affects you. Aleve (naproxen) may cause dizziness or light-headedness in some people. Make sure you know how you react to Aleve (naproxen) before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive. If you drink alcohol, dizziness or light-headedness may be worse.
• The most common side effects of Aleve (naproxen) are confusion, headache, ringing in the ears, changes in vision, tiredness, drowsiness, dizziness and rashes.

When will I feel better?

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

How long will I take Aleve for?

Depending on why you’re taking Aleve (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 Aleve (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 Aleve (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 Aleve (naproxen) for the shortest time to control your symptoms.

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

Can I take Aleve for a long time?

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

Aleve (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?

Aleve (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.

• If you think you may have symptoms of a stomach ulcer, stop taking Aleve (naproxen) and contact your doctor.

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

The most common symptom of a stomach ulcer is a burning or gnawing pain in the center of the abdomen. However, stomach ulcers aren’t always painful and some people may have other symptoms, such as indigestion, heartburn and feeling sick.

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

Can Aleve 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 Aleve (naproxen) for a long time.

If you find you need to take Aleve (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 Aleve cause an irregular heartbeat?

It’s thought some anti-inflammatory medicines, including Aleve (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 Aleve (naproxen) for a long-term condition, keep taking it and talk to your doctor if you’re worried. If you buy Aleve (naproxen) from a shop, occasional doses or short courses (2 or 3 days) are safe.

Does Aleve cause kidney failure?

Aleve (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.

Non-Steroidal Anti-Inflammatory Drugs (or NSAIDs) may cause an increased risk of sudden kidney failure and even progressive kidney damage.

Does Aleve cause hearing loss?

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

However, there’s no proof that Aleve (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 Aleve (naproxen) several days a week, talk to your doctor about what’s causing your pain and whether there are better ways to manage it.

Will Aleve affect my fertility?

Taking anti-inflammatory medicines, like Aleve (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 Aleve (naproxen) if you’re trying to get pregnant or you’re having tests for infertility. Acetaminophen (paracetamol) is a better painkiller in these situations.

Will Aleve affect my contraception?

Aleve (naproxen) will not affect contraceptive pills or the morning after pill in women.

Can I drink alcohol with Aleve?

Yes, you can drink alcohol while taking Aleve (naproxen). However, drinking too much alcohol may irritate your stomach and Aleve (naproxen) contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you have 3 or more alcoholic drinks every day while using Aleve (naproxen).

Who can and can’t take Aleve

Aleve (naproxen) can be taken by adults.

Aleve (naproxen) relieves pain and reduces inflammation (swelling, redness and soreness) that may occur in the following:

• different types of arthritis including rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
• muscle and bone injuries such as sprains, strains, low back pain (lumbago), rheumatism and tendonitis, such as tennis elbow
• swelling and pain after setting broken or dislocated bones
• menstrual cramps (period pain)
• headache, including migraines
• following surgery
• dental pain.

Although Aleve (naproxen) can relieve the symptoms of pain and inflammation, it will not cure your condition.

Aleve (naproxen) belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (or NSAIDs).

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

It 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

Aleve (naproxen) isn’t suitable for certain people. Tell your doctor or pharmacist if you:

• have had an allergic reaction to Aleve (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
• Do NOT give Aleve (naproxen) to a child under 2 years of age. The safety and effectiveness in children under 2 years of age has not been established.

When you must not be given Aleve

Do NOT take Aleve (naproxen) if you have an allergy to:

• Aleve (naproxen) or any of the ingredients listed on the medicine leaflet
• aspirin or any other non-steroidal anti-inflammatory drug (NSAID) medicine.

Many medicines used to treat headache, period pain and other aches and pains contain aspirin or non-steroidal anti-inflammatory drug (NSAID) medicines. If you are not sure if you are taking any of these medicines, ask your pharmacist.

Some of the symptoms of an allergic reaction may include:

• asthma, wheezing or shortness of breath
• swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
• hives, itching or skin rash
• fainting.

If you are allergic to aspirin or non-steroidal anti-inflammatory drug (NSAID) medicines and take Aleve (naproxen) Suspension, these symptoms may be severe.

Do NOT take Aleve (naproxen) if:

• you are vomiting blood or material that looks like coffee grounds
• you are bleeding from the rectum (back passage), have black sticky bowel motions (stools) or bloody diarrhoea
• you have a peptic ulcer (i.e. stomach or duodenal ulcer), or have had peptic ulcers before
• you are taking other medicines which contain Naproxen or Naproxen Sodium (e.g. Naprogesic, Inza, Anaprox, 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)
• you have severe heart failure.

Pregnancy and breastfeeding

Aleve (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 Aleve (naproxen) in pregnancy and some birth defects, in particular damage to the baby’s heart and blood vessels.

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

Talk to your doctor about the benefits and possible harms of taking Aleve (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.

Acetaminophen (Tylenol) is usually recommended as the first choice of painkiller for pregnant women.

Aleve (naproxen) and breastfeeding

Aleve (naproxen) isn’t usually recommended during breastfeeding. Aleve (naproxen) passes into breast milk. The effect on the baby is not known.

Other anti-inflammatory medicines, such as ibuprofen (e.g., Advil or Motrin), 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.

Cautions with other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist.

There are some medicines that interfere with the way Aleve (naproxen) works. Tell your doctor if you’re taking:

• other anti-inflammatory medicines, such as aspirin or ibuprofen (e.g., Advil or Motrin)
• medicines that thin the blood to prevent blood clots, such as warfarin or rivaroxaban
• heparin, a medicine used to prevent blood clots
• steroids, such as prednisolone
• water tablets, such as furosemide
• medicines used to treat high blood pressure including ACE inhibitors, angiotensin receptor antagonists and beta-blockers
• antidepressants, such as citalopram
• medicine used to treat rheumatoid arthritis and some cancers, such as methotrexate
• antacids, medicines used to treat indigestion and heartburn
• aspirin, salicylates or other NSAID medicines
• cholestyramine, a medicine used to treat high cholesterol levels
• diuretics, also called fluid or water tablets
• lithium, a medicine used to treat some types of depression
• probenecid, a medicine used to treat gout
• phenytoin, a medicine used to treat epilepsy
• sucralfate, a medicine used to treat and prevent stomach ulcers
• certain antibiotics called sulfonamides/quinolones
• some medicines used to treat diabetes
• sodium bicarbonate, a medicine used to treat stomach upset or ulcers
• steroids, medicines used to treat inflammation
• serotonin reuptake inhibitors, also known as SSRIs, medicines used to treat some types of depression
• zidovudine, a medicine used to treat HIV infection.

Tell your doctor and pharmacist if you’re taking any other medicines, including herbal remedies, vitamins or supplements.

These medicines may be affected by Aleve (naproxen) or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor has more information on medicines to be careful with or avoid while being given this medicine.

Ask your doctor or pharmacist if you are not sure about this list of medicines.

Can you take ibuprofen with aleve

No. Both ibuprofen and Aleve (naproxen) come from a class of drug known as non-steroidal anti-inflammatory drugs (NSAIDs). By taking both ibuprofen and Aleve (naproxen) together you’re increasing your chances of getting side effects.

Can you take tylenol with aleve

Yes, but on the condition that you’ve been directed to do so by your doctor. Do not take Aleve (naproxen) and Tylenol (acetaminophen) together, though. Instead, if you’ve been given Tylenol (acetaminophen) to take and you’re still feverish or in pain when the next dose is due, you could try Aleve (naproxen) instead.

Tylenol contains the active ingredient acetaminophen (paracetamol) that works differently to Aleve (naproxen).

Aleve (naproxen) is better for reducing inflammation (redness and swelling), including teething and toothache.

Whereas Tylenol (acetaminophen) is usually best for most types of pain, including headache and stomach ache.

Tylenol (acetaminophen) and Aleve (naproxen) are similar strengths, but they work in different ways. So Tylenol (acetaminophen) is better for some types of pain than Aleve (naproxen).

Don’t take more than the maximum daily dose of either medicine. See your doctor if you’ve tried both Aleve (naproxen) and Tylenol (acetaminophen) and they haven’t helped.

Aleve cold and sinus

Aleve-D Sinus & Cold Caplets

Available behind the pharmacy counter without a prescription.

Active ingredients (in each caplet) ⁷⁾:

1. Naproxen sodium 220 mg (naproxen 200 mg) for pain reliever/fever reducer
2. Pseudoephedrine HCl 120 mg, extended-release as nasal decongestant

Inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Other information

• each caplet contains: sodium 22 mg
• store at 20-25 °C (68-77 °F)
• store in a dry place

Aleve cold and sinus caplets Uses

Temporarily relieves these cold, sinus, and flu symptoms:

• sinus pressure
• minor body aches and pains
• headache
• nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
• fever

Directions of use:

• do NOT take more than directed
• the smallest effective dose should be used
• swallow whole; do not crush or chew
• drink a full glass of water with each dose
  • Adults and children 12 years and older: 1 caplet every 12 hours
  • Do not take more than 2 caplets in 24 hours
  • Children under 12 years: do NOT use, except under the advice and supervision of a doctor.

Aleve-D Sinus & Cold Caplets Warnings

Allergy alert

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives
• facial swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do NOT use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• in children under 12 years of age

Ask a doctor before use if:

• the stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have:
  • asthma
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are:

• under a doctor’s care for any serious condition
• taking any other drug

When using this product:

• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if:

● you experience any of the following signs of stomach bleeding:
● feel faint ● vomit blood ● have bloody or black stools
● have stomach pain that does not get better
● redness or swelling is present in the painful area
● any new symptoms appear
● fever gets worse or lasts more than 3 days
● you have difficulty swallowing or the caplet feels stuck in your throat
● you get nervous, dizzy, or sleepless
● nasal congestion lasts more than 7 days

If pregnant or breast-feeding

Ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Aleve vs Advil

Advil is a brand of tablets or capsules containing the active ingredient Ibuprofen, like Aleve (naproxen), Advil (ibuprofen) is also a non-steroidal anti-inflammatory drug (NSAID). You can buy it without a prescription from a grocery store or a pharmacy.

Some other common non-steroidal anti-inflammatory drugs (NSAIDs) are:

• aspirin
• celecoxib
• diclofenac
• indomethacin
• meloxicam

There are many others. You can check whether a medicine you’re taking is an NSAID, or contains an NSAID by asking your pharmacist.

Advil (ibuprofen) is used to temporarily relief of acute pain where inflammation is present such as back, neck and muscle pain. Temporary relief of headache, migraine headache, tension headache, period pain, dental pain, arthritis pain, rheumatic pain, tennis elbow pain, sore throat, sinus pain, and pain associated with the common cold and flu. Advil (ibuprofen) is also used to relieve fever.

Advil (ibuprofen) is used to reduce pain and inflammation (redness and swelling) in conditions such as osteoarthritis and rheumatoid arthritis. It is also used in muscle and bone injuries such as sprains, strains, low back pain, rheumatism and tendonitis. Moreover, like Aleve, Advil does not cure these conditions.

Advil can also be used to relieve period pain, dental pain and post-surgery pain.

Swallow Advil (ibuprofen) whole with a full glass of water or milk, preferably with or straight after food.

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional. HealthJade medicines information is not intended for use in an emergency. This information is not intended to substitute medical advice, diagnosis or treatment and should not be exclusively relied on to manage or diagnose a medical condition. Please refer to our terms and conditions. If you are suffering an acute illness, overdose, or emergency condition, call your local emergency number and ask for an ambulance.

How and when to take Aleve

Always take your Aleve (naproxen) tablets with or just after a meal so you don’t get an upset stomach.

As a general rule in adults, the 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

Do NOT take more than 3 tablets in 24 hours.

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 dose.

If you get Aleve (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 Aleve (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 Aleve

Use Aleve (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.

Aleve (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 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 tablets, swallow them whole with or after food. Don’t crush or chew them.

If you take effervescent 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 it?

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?

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

Aleve dosage

Take Aleve (naproxen) during or immediately after food with a full glass of water or milk. This may help reduce the possibility of an upset stomach.

Sprains, strains and period pain

• The recommended dose is 500 mg, followed by 250 mg every 6 to 8 hours, as needed. Total daily dose is 1250 mg.

Migraine Headache

• The recommended dose is 750 mg taken at the first sign of a migraine. An additional dose of 250 mg to 500 mg can be taken at least an hour after the initial dose, if required. The total daily dose should not exceed 1250 mg.

Arthritis

• The recommended dose is 375 mg to 1000 mg a day in two divided doses.

Juvenile Rheumatoid Arthritis

• The recommended dose for children 5 years and above is 10 mg/kg body weight given in 2 equal divided doses (i.e. 5 mg/kg body weight twice a day).

Aleve (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.

How many Aleve can I take?

Take one tablet, caplet, gelcap or liquid gel every 8 to 12 hours while symptoms last. For the first dose, you may take 2 pills within the first hour.

Do not exceed more than 2 tablets, caplets, gelcaps or liquid gels in 12 hours, and do not exceed 3 tablets, caplets, gelcaps or liquid gels in 24 hours. The smallest effective dose should be used. Drink a full glass of water with each dose.

Do not take for more than 10 consecutive days for pain or 3 days for fever, unless directed by a doctor.

What’s the dose for children under 12?

Do NOT give this product to children under age 12, except under the advice and supervision of a doctor.

For how many days can I take Aleve?

Do not take for more than 10 consecutive days for pain or 3 days for fever unless directed by a doctor.

Aleve side effects

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

Common side effects

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

• confusion
• headache
• buzzing or ringing in the ears
• changes in vision
• tiredness and feeling sleepy
• dizziness
• rashes
• stomach upset including nausea (feeling sick), heartburn, indigestion, cramps
• constipation, diarrhea, pain in the stomach
• loss of appetite
• dizziness, light-headedness
• drowsiness, sleepiness
• feeling thirsty
• aching muscles, muscle tenderness or weakness, not caused by exercise.

Less common side effects of Aleve

Less common side effects of Aleve (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, Aleve (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 side effects

Tell your doctor straight away or go to the Emergency Department at your nearest hospital if you experience any of the following:

• severe indigestion, heartburn, pains in your stomach, feeling sick or vomiting or diarrhea – 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 anemia
• 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
• bleeding or bruising more easily than normal, reddish or purplish blotches under the skin
• 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
• fast or irregular heartbeats, also called palpitations
• fever, stomach pain and vomiting – these can be signs of inflammation of the pancreas
• eye problems such as blurred vision
• severe or persistent headache
• difficulty hearing, deafness
• signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers
• unusual weight gain, swelling of ankles or legs

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

This is not a complete list of all possible side effects. Others may occur in some people, and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list. Ask your doctor or pharmacist if you don’t understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Aleve (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 Aleve (naproxen). For a full list see the leaflet inside your medicines packet.

How to cope with 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 Aleve (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 Aleve (naproxen), these side effects should wear off.
• changes in vision – don’t drive for a week.
• dizziness – if Aleve (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 ⁸⁾. 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 ⁹⁾. 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 ¹⁰⁾.

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 ¹¹⁾. 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 ¹²⁾. 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 ¹³⁾. 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 ¹⁴⁾. 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 ¹⁵⁾. 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 ¹⁶⁾.

Jaundice (including cholestatic jaundice which cleared promptly when naproxen was discontinued) and fatal hepatitis have been reported rarely in patients receiving naproxen ¹⁷⁾. 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 ¹⁸⁾. 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 ¹⁹⁾. 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 ²⁰⁾. 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 ²¹⁾.

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 ²²⁾. Renal biopsy showed severe acute interstitial nephritis. The patient recovered completely after discontinuation of naproxen and administration of methylprednisolone ²³⁾.

Renal failure occurred in a 14-year-old girl with peripheral arthritis associated with inflammatory bowel disease while she was being treated with naproxen ²⁴⁾. 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 ²⁵⁾.

A case of a 3,790-g term neonate who developed persistent pulmonary hypertension after birth with a closed ductus arteriosus is reported ²⁶⁾. 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 ²⁷⁾.

Pulmonary infiltrates developed in three middle-aged women while receiving naproxen sodium ²⁸⁾. 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 ²⁹⁾.

A 12 year old boy developed scars at light-exposed areas following long-term therapy with naproxen for rheumatoid arthritis ³⁰⁾. 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 ³¹⁾. As compared to other nonsteroidal anti-inflammatory agents, the specific risk for naproxen is increased about 6 fold ³²⁾. 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 ³³⁾. 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 ³⁴⁾. 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 ³⁵⁾.

Aleve (naproxen) overdose

Symptoms of Aleve (naproxen) overdose include:

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

Your local poison center can be reached directly by calling the national toll-free Poison Help hotline (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.

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.