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Naproxen dangers. Naproxen: Uses, Risks, and Safe Usage Guidelines for Pain Relief

What are the key uses of naproxen. How does naproxen impact cardiovascular health. What are the recommended dosages and precautions for using naproxen safely. How does naproxen compare to other NSAIDs for pain relief.

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Understanding Naproxen: A Powerful NSAID for Pain Management

Naproxen belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is widely used to treat pain, inflammation, and fever associated with various conditions. Available in both over-the-counter and prescription forms, naproxen has become a popular choice for managing acute and chronic pain.

Key Uses of Naproxen

  • Arthritis pain relief
  • Menstrual cramps
  • Headaches and migraines
  • Backaches
  • Toothaches
  • Muscle aches and sprains

Naproxen works by reducing the production of prostaglandins, substances in the body that cause pain and inflammation. This mechanism of action makes it effective for a wide range of pain-related conditions.

The Cardiovascular Impact of Naproxen and Other NSAIDs

Recent studies have raised concerns about the potential cardiovascular risks associated with NSAID use, including naproxen. While the overall risk is considered low for most users, it’s important to understand the potential implications, especially for those with pre-existing heart conditions.

Cardiovascular Risks Associated with NSAIDs

  • Increased risk of heart attack
  • Higher likelihood of stroke
  • Potential for heart failure
  • Possible development of atrial fibrillation

Research suggests that the cardiovascular risks associated with NSAIDs may vary depending on the specific medication, dosage, and duration of use. For instance, naproxen is often considered to have a relatively favorable cardiovascular risk profile compared to some other NSAIDs.

Naproxen Dosage Guidelines and Formulations

Naproxen is available in various forms and strengths to cater to different needs and conditions. Understanding the appropriate dosage is crucial for safe and effective use.

Common Naproxen Formulations

  1. Immediate-release tablets
  2. Delayed-release tablets
  3. Oral suspension
  4. Extended-release tablets

The dosage of naproxen varies depending on the specific condition being treated, the patient’s age, and other individual factors. It’s essential to follow the prescribed dosage or the instructions on the over-the-counter package carefully.

Is there a maximum daily dose for naproxen?

Yes, there is a maximum recommended daily dose for naproxen. For adults, the typical maximum daily dose is 1500 mg of naproxen or 1650 mg of naproxen sodium. However, this can vary based on the specific condition being treated and individual patient factors. It’s crucial to never exceed the recommended dose without consulting a healthcare provider.

Safe Usage Guidelines and Precautions for Naproxen

While naproxen can be highly effective for pain relief, it’s important to use it safely to minimize the risk of side effects and complications.

Key Precautions When Using Naproxen

  • Take with food to reduce stomach upset
  • Avoid alcohol consumption while using naproxen
  • Don’t combine with other NSAIDs unless directed by a doctor
  • Use caution if you have a history of ulcers or bleeding disorders
  • Inform your doctor of all medications you’re taking to avoid interactions

Pregnant women, especially in the third trimester, should avoid naproxen unless specifically advised by their healthcare provider. The medication can potentially cause complications during pregnancy and delivery.

Can naproxen be used long-term for chronic pain conditions?

While naproxen can be effective for managing chronic pain, long-term use should be carefully monitored by a healthcare provider. Prolonged use of NSAIDs like naproxen may increase the risk of gastrointestinal, cardiovascular, and renal side effects. For chronic pain conditions, doctors often recommend using the lowest effective dose for the shortest duration possible, or exploring alternative pain management strategies.

Comparing Naproxen to Other NSAIDs: Effectiveness and Safety

When choosing an NSAID for pain relief, it’s helpful to understand how naproxen compares to other options in terms of effectiveness and safety profile.

Naproxen vs. Ibuprofen

  • Both are effective for pain relief and reducing inflammation
  • Naproxen typically has a longer duration of action
  • Ibuprofen may have a slightly lower risk of gastrointestinal side effects
  • Naproxen is often preferred for conditions requiring around-the-clock pain relief

Naproxen vs. Celecoxib

  • Celecoxib is a COX-2 selective NSAID, potentially offering a lower risk of gastrointestinal side effects
  • Naproxen may have a more favorable cardiovascular risk profile
  • Both are effective for managing arthritis pain and inflammation

The choice between different NSAIDs often depends on individual patient factors, including the specific condition being treated, potential side effects, and existing health conditions.

Managing Side Effects and Potential Complications of Naproxen Use

Like all medications, naproxen can cause side effects. Being aware of these potential effects and knowing how to manage them is crucial for safe use.

Common Side Effects of Naproxen

  • Stomach upset or pain
  • Heartburn
  • Nausea
  • Headache
  • Dizziness
  • Drowsiness

Most side effects are mild and often resolve on their own. However, some side effects may be more serious and require medical attention.

When should you seek medical attention while taking naproxen?

You should contact your healthcare provider immediately if you experience any of the following while taking naproxen:

  • Signs of an allergic reaction (rash, itching, swelling, severe dizziness, difficulty breathing)
  • Signs of stomach bleeding (bloody or black stools, vomiting blood)
  • Chest pain or pressure
  • Sudden weakness or numbness, especially on one side of the body
  • Severe headache or vision problems
  • Unexplained weight gain or swelling

These symptoms could indicate serious complications and require prompt medical evaluation.

Naproxen Interactions: Medications and Substances to Avoid

Naproxen can interact with various medications and substances, potentially altering its effectiveness or increasing the risk of side effects.

Key Interactions to Be Aware Of

  • Other NSAIDs (including aspirin)
  • Blood thinners (e.g., warfarin)
  • Certain antidepressants (SSRIs)
  • ACE inhibitors and ARBs (used for high blood pressure)
  • Diuretics
  • Lithium
  • Methotrexate

Always inform your healthcare provider about all medications, supplements, and herbal products you’re taking before starting naproxen.

Does alcohol consumption affect naproxen’s safety or effectiveness?

Yes, alcohol consumption can impact the safety and effectiveness of naproxen. Combining alcohol with naproxen can increase the risk of gastrointestinal side effects, including stomach bleeding and ulcers. Additionally, both alcohol and naproxen can affect liver function, and their combined use may increase the risk of liver damage. It’s generally recommended to avoid or limit alcohol consumption while taking naproxen or any other NSAID.

Alternative Pain Management Strategies: When to Consider Options Beyond Naproxen

While naproxen can be highly effective for pain relief, there may be situations where alternative approaches are more appropriate or necessary.

Non-Pharmacological Pain Management Options

  • Physical therapy
  • Acupuncture
  • Massage therapy
  • Heat or cold therapy
  • Mindfulness and relaxation techniques
  • Exercise and stretching programs

These non-pharmacological approaches can be particularly beneficial for managing chronic pain conditions, either as alternatives to or in conjunction with medication-based treatments.

When might a healthcare provider recommend alternatives to naproxen?

A healthcare provider might suggest alternatives to naproxen in several scenarios:

  • For patients with a high risk of cardiovascular complications
  • In cases of known gastrointestinal sensitivity or history of ulcers
  • For long-term pain management to minimize the risk of side effects
  • When naproxen proves ineffective for a particular condition
  • In situations where drug interactions make naproxen use risky

The decision to explore alternative pain management strategies should always be made in consultation with a healthcare professional, taking into account individual health factors and the specific nature of the pain condition.

NSAIDs: How dangerous are they for your heart?

Harvard Health Blog

By
Christian Ruff, MD, MPH,

Contributor

Nonsteroidal anti-inflammatory drugs, commonly referred to as NSAIDs, are one of the most common medications used to treat pain and inflammation. Ibuprofen, naproxen, indomethacin, and other NSAIDs are effective across a variety of common conditions, from acute musculoskeletal pain to chronic arthritis. They work by blocking specific proteins, called COX enzymes. This results in the reduction of prostaglandins, which play a key role in pain and inflammation. There are two types of NSAIDs: nonselective NSAIDs and COX-2 selective NSAIDs (these are sometimes referred to as “coxibs”).

There is a growing body of evidence that NSAIDs may increase the risk of harmful cardiovascular events including heart attack, stroke, heart failure, and atrial fibrillation. Given the widespread use of NSAIDs, these findings have generated significant concern among patients and healthcare providers. I am frequently asked by patients: is it safe to continue to take NSAIDs?

NSAIDs and cardiovascular disease: Minimizing the risks

There are several factors to consider when evaluating the potential risk of NSAID therapy. The first is the duration of treatment. The risk of having a heart attack or stroke is extremely small over a short course of therapy (less than one month), such as would be the case in treating acute pain from a musculoskeletal injury like tendonitis. Another important consideration is dose and frequency. The risk tends to increase with higher doses and increased frequency. The third factor is whether the person has existing cardiovascular disease. In people without known cardiovascular disease, the absolute increase in risk is incredibly small (one to two excess cardiovascular events for every 1,000 people who take NSAIDs).

My general principles for NSAID use are:

  1. In all patients, I recommend the lowest effective NSAID dose for the shortest duration of time to limit potential side effects.
  2. In people without known cardiovascular disease, the increase in risk is so minimal that it rarely influences my decision about whether to use NSAIDs.
  3. In patients with known cardiovascular disease, I might advise an alternative treatment. Many patients with pre-existing heart disease can be safely treated with short courses of NSAIDs. However, the choice of specific NSAID and dose is more important in these patients. I generally recommend the nonselective NSAID naproxen or the COX-2 selective NSAID celecoxib, as studies have demonstrated that these two drugs may have the best safety profile in higher-risk patients.

In summary, although all NSAIDs are associated with an increased cardiovascular risk, the magnitude of the increased risk is minimal for most people without cardiovascular disease taking them for short periods of time. For patients who have heart disease or who require long-term treatment with high doses of NSAIDs, the increased risk is more of a concern. If you fall into this category, discuss your options with your healthcare provider to determine whether an alternative therapy is possible, or to help select the safest NSAID option for you.

About the Author

Christian Ruff, MD, MPH,
Contributor

Christian Thomas Ruff, MD, MPH, Director, Genetics Core Laboratory; Assistant Professor of Medicine, Harvard Medical School, Brigham and Women’s Faulkner Hospital, Boston, Massachusetts
Christian T. Ruff, MD, MPH is the Director of General Cardiology at Brigham …
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Side Effects, Dosage, Uses, and More

  1. Prescription naproxen oral tablet is available as both a generic and brand-name drug. Brand name: Anaprox DS, Naprelan, and Naprosyn.
  2. There are two kinds of prescription naproxen: regular naproxen and naproxen sodium. Regular naproxen comes as an oral immediate-release tablet, an oral delayed-release tablet, and an oral suspension. Naproxen sodium comes as an oral immediate-release tablet and an oral extended-release tablet. Naproxen is also available in over-the-counter forms.
  3. All forms of prescription naproxen oral tablets help reduce swelling and pain. They’re taken to treat many conditions, including arthritis, menstrual pain, muscle and joint inflammation, and gout.

There are two kinds of prescription naproxen: regular naproxen and naproxen sodium.

Regular naproxen comes as an oral immediate-release tablet, an oral delayed-release tablet, and an oral suspension (a kind of liquid mixture).

Naproxen sodium comes as an oral immediate-release tablet and an oral extended-release tablet.

Naproxen is also available in over-the-counter forms. This article only addresses prescription forms of naproxen.

Prescription naproxen oral tablets are available as the brand-name drugs Anaprox DS, Naprelan, and Naprosyn. They’re also available as generic drugs. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.

Why it’s used

Prescription naproxen oral tablets are used to treat pain and inflammation (swelling and damage) in a variety of conditions. This drug is approved to treat:

  • rheumatoid arthritis (an autoimmune disease that affects the joints)
  • osteoarthritis (a condition caused by breakdown of joint tissue)
  • ankylosing spondylitis (a kind of arthritis affecting the spine)
  • polyarticular juvenile idiopathic arthritis (a kind of arthritis in children that affects one or more joints)
  • menstrual period pain
  • tendonitis (inflammation of the tendons)
  • bursitis (inflammation of fluid-filled sacs surrounding the joints)
  • symptoms of gout (a condition caused by uric acid buildup)

How it works

Prescription naproxen oral tablets belong to a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs help reduce pain, inflammation (swelling and damage), and fever. It isn’t fully understood how this medication works to decrease pain. It may help reduce swelling by lowering levels of prostaglandin. This is a hormone-like substance that usually causes inflammation.

How long it lasts

After you take a dose of naproxen, the drug may last as long as 4 days in your body.

Depending on the condition you’re treating with naproxen, you may take a dose every 6 to 12 hours. Or you may take naproxen up to twice per day. Regardless of how often you take naproxen, you’ll likely only take it until your symptoms go away.

Studies have determined the dosages that help keep an effective level of the drug in the body for the different conditions naproxen treats. Your doctor will recommend the right dosage of naproxen for your condition.

After you stop taking naproxen, the drug should be fully gone from your body in about 4 days.

If you have questions about how long naproxen lasts in your body, ask your doctor or pharmacist.

Prescription naproxen oral tablets may cause drowsiness. You shouldn’t drive, use machinery, or do other activities that require alertness until you know you can function as you usually would. This drug can also cause other side effects.

More common side effects

The more common side effects that occur with naproxen oral tablet include:

  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea and vomiting
  • dizziness

Mild side effects may go away within a few days or a couple of weeks. Talk with your doctor or pharmacist if they’re more severe or don’t go away.

Serious side effects

Contact your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • chest pain
  • shortness of breath or trouble breathing
  • weakness in one part or side of your body
  • trouble speaking
  • swelling of the face or throat
  • high blood pressure
  • bleeding and ulcers in your stomach and intestines, with symptoms such as:
    • stomach pain
    • bloody vomit
    • blood in your stool
    • black and sticky stool
    • asthma attacks in people who have asthma
    • fatigue (low energy), lethargy, or weakness, which may be caused by low red blood cell count
    • yellowing of your skin or the whites of your eyes
    • unusual weight gain or swelling of your arms, legs, hands, and feet
    • skin rash or blisters with fever

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare professional who knows your medical history.

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

Dosage forms and strengths

The table below lists the forms and strengths available for generic naproxen and naproxen sodium, as well as some of the brand-name versions of the drug.

All forms listed are taken orally (swallowed). Strengths are given in milligrams (mg).

Generic nameBrand nameForm*Strengths
naproxenNaprosynimmediate-release tablet• naproxen: 250 mg, 375 mg, 500 mg
• Naprosyn: 500 mg
naproxenEC-Naprosyndelayed-release tablet375 mg, 500 mg
naproxen sodiumAnaprox DSimmediate-release tablet• naproxen: 220mg, 275 mg, 550 mg
• Anaprox DS: 550 mg
naproxen sodiumNaprelanextended-release tablet375 mg, 500 mg, 750 mg

* An immediate-release tablet releases the drug right away in the body. A delayed-release tablet releases the drug after a period of time. An extended-release tablet releases the drug slowly over a certain period of time.

Dosage for osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis

Adult dosage (ages 18 years and older)

Naproxen:

Immediate-release oral tablet

  • The usual dosage is 250 mg to 500 mg twice daily.
  • The maximum dose is 1,500 mg per day. This should be given for a limited time (up to 6 months).

Delayed-release oral tablet

  • The usual dosage is 375 mg to 500 mg twice daily.
  • The maximum dose is 1,500 mg per day. This should be given for a limited time (up to 6 months).

Naproxen sodium:

Immediate-release oral tablet

  • The usual dosage is 275 mg to 550 mg twice daily.
  • The maximum dose is 1,650 mg per day. This should be given for a limited time (up to 6 months).

Extended-release oral tablet

  • The usual dosage is 750 mg or 1,000 mg once daily.
  • The maximum dose is 1,500 mg per day. This should be given for a limited time.

Child dosage (ages 0 to 17 years)

A dosage for people younger than 18 years hasn’t been established.

Special dosage considerations

If you’re older than 65 years, your body may process this drug more slowly. At the start of treatment, your doctor may prescribe a reduced dose so that too much of this drug doesn’t build up in your body. Too much of the drug in your body can be dangerous.

Dosage for polyarticular juvenile idiopathic arthritis

Child dosage (ages 2 to 17 years)

Children in this age group generally receive the oral suspension form of this drug (a kind of liquid mixture). The dosage will be based on your child’s weight. It should be given twice daily in doses that are evenly spaced throughout the day.

Child dosage (ages 0 to 23 months)

Dosage for children younger than 2 years hasn’t been established.

Dosage for tendonitis, bursitis, and menstrual pain

Adult dosage (ages 18 years and older)

Naproxen:

Immediate-release oral tablet

  • The initial dose is 500 mg, followed by 250 mg every 6 to 8 hours as needed.
  • The maximum daily dose on day 1 of therapy is 1,250 mg. Additional daily doses should not exceed 1,000 mg.

Delayed-release oral tablet

  • The initial dose is 1,000 mg once daily.
  • The dose may be temporarily increased to 1,500 mg once daily if greater pain relief is needed.

Naproxen sodium:

Immediate-release oral tablet

  • The initial dose is 550 mg, followed by 275 mg every 6 to 8 hours or 550 mg every 12 hours as needed.
  • The maximum daily dose on day 1 of therapy is 1,375 mg. Additional daily doses should not exceed 1,100 mg.

Child dosage (ages 0 to 17 years)

Dosage for people younger than 18 years hasn’t been established.

Special dosage considerations

If you’re older than 65 years, your body may process this drug more slowly. At the start of treatment, your doctor may prescribe a reduced dose so that too much of this drug doesn’t build up in your body. Too much of the drug in your body can be dangerous.

Dosage for gout pain and inflammation

Adult dosage (ages 18 years and older)

Naproxen:

Immediate-release oral tablet

  • The initial dose is 750 mg, followed by 250 mg every 8 hours until the attack subsides.

Delayed-release oral tablet

  • The initial dose is 1,000 mg to 1,500 mg once daily followed by 1,000 mg once daily until the attack subsides.

Naproxen sodium:

Immediate-release oral tablet

  • The initial dose is 825 mg, followed by 275 mg every 8 hours until the attack subsides.

Child dosage (ages 0 to 17 years)

Dosage for people younger than 18 years hasn’t been established.

Special dosage considerations

If you’re older than 65 years, your body may process this drug more slowly. At the start of treatment, your doctor may prescribe a reduced dose so that too much of this drug doesn’t build up in your body. Too much of the drug in your body can be dangerous.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Prescription naproxen oral tablets can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk with your doctor or pharmacist.

Examples of drugs that can cause interactions with naproxen are listed below.

Antidepressant drugs

Combining selective serotonin reuptake inhibitors (SSRIs) with naproxen increases your risk of stomach and intestinal bleeding. Examples of these drugs include:

  • citalopram (Celexa)
  • fluoxetine (Prozac)
  • fluvoxamine (Luvox)
  • paroxetine (Brisdelle, Paxil)

Blood pressure drugs

Naproxen might make your blood pressure medications less effective. If you’re older than 65 years, combining naproxen with certain blood pressure medications may damage your kidneys. Examples of these medications include:

  • angiotensin-converting enzyme (ACE) inhibitors, such as lisinopril (Zestril)
  • angiotensin II receptor blockers, such as valsartan (Diovan) and losartan (Cozaar)
  • beta-blockers, such as propranolol (Inderal LA) and metoprolol tartrate (Lopressor)
  • diuretics, such as hydrochlorothiazide and furosemide (Lasix)

Heartburn drugs and drugs that protect the stomach

Taking any of these medications with naproxen may make naproxen treat your pain more slowly:

  • aluminum hydroxide
  • magnesium oxide
  • sucralfate (Carafate)

Nonsteroidal anti-inflammatory drugs (NSAIDs)

Combining naproxen with other NSAIDs increases your risk of stomach and intestinal bleeding. Examples of these medications include:

  • aspirin (Bayer, Bufferin)
  • ibuprofen (Advil, Motrin)
  • etodolac
  • diclofenac (Cambia)
  • flurbiprofen
  • ketoprofen
  • ketorolac

Cholestyramine

If you take cholestyramine (Prevalite) with naproxen, your body may absorb naproxen more slowly than usual. That means it may take longer to work.

Lithium

If you take naproxen with lithium (Lithobid), it may increase the lithium in your body to harmful levels.

Methotrexate

Taking methotrexate (Trexall) with naproxen can lead to harmful levels of methotrexate in your body.

Warfarin

Taking warfarin (Jantoven) with naproxen increases your risk of stomach and intestinal bleeding.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare professional about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

FDA warnings

  • This drug has boxed warnings. These are the most serious warnings from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.
  • Naproxen may increase the risk of heart disease. Taking naproxen in the long term or at high doses increases your risk. People with heart disease or risk factors for heart disease, such as high blood pressure, also have higher risk. Naproxen shouldn’t be taken for pain before or after heart bypass surgery. Doing so may increase your risk of a heart attack and stroke.
  • Naproxen may cause ulcers and bleeding in your stomach and intestines. This can happen at any time during treatment and may occur without symptoms. This effect can be fatal. You’re at higher risk if you’re older than 65 years.

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High blood pressure warning

Naproxen can cause high blood pressure or make your high blood pressure worse. It can also make your high blood pressure medications less effective. You may need to watch your blood pressure carefully while taking naproxen.

Water retention and swelling warning

Some formulations of this medication have extra salt in them. Talk with your doctor about which formulation to take if you’re watching your salt intake.

Asthma warning

Naproxen can cause an asthma attack. If you have asthma that can be triggered by aspirin or other NSAIDs, don’t use naproxen.

Allergic reaction warning

Naproxen can cause a severe allergic reaction. Symptoms may include:

  • trouble breathing
  • swelling of your throat or tongue
  • hives

If you have an allergic reaction, contact your doctor right away. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. If your symptoms are severe, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal.

Alcohol interaction warning

Combining naproxen and alcohol increases your risk of an ulcer and stomach bleeding.

Drug reaction with eosinophilia and systemic reactions (DRESS) warning

Naproxen may cause a serious condition called DRESS. It can occur 2 to 6 weeks after starting this drug and may be fatal. Symptoms can include:

  • skin rash
  • fever
  • swollen lymph glands
  • organ damage, including liver failure

Serious skin reactions warning

Naproxen may cause life threatening allergic reactions called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Either can cause severe damage to your skin or internal organs and can lead to death.

Call your doctor right away if you have any of these symptoms while taking this drug:

  • skin rash
  • hives
  • sores in your mouth
  • blistering or peeling of your skin

Harm to a fetus

Naproxen can cause harm to a fetus if taken at 20 weeks or later in pregnancy. Tell your doctor if you’re pregnant or plan to become pregnant before taking this drug.

Warnings for certain groups

For people with stomach problems: If you have a history of ulcers or stomach or intestinal bleeding, naproxen increases your risk of stomach or intestinal bleeding.

For people with kidney disease: Naproxen can cause kidney damage when it’s taken for a long time. If you have serious kidney disease, you should not take this drug.

For pregnant people: Not enough studies have been done to know for sure how naproxen might affect a fetus during pregnancy. But it’s thought that the drug could cause fetal harm.

The FDA recommends avoiding naproxen during pregnancy from 20 weeks as it could result in low amniotic fluid.

Talk with your doctor if you’re pregnant or plan to become pregnant before taking this drug.

For people who are breastfeeding: Naproxen passes into breast milk and could cause side effects in a child who is breastfed. Breastfeeding is not recommended while taking this medication.

For older adults: Use caution when taking naproxen if you’re older than 65 years. Your body may process this drug more slowly. At the start of treatment, your doctor may prescribe a reduced dose so that this drug doesn’t build up too much in your body. Too much of the drug in your body can be harmful.

For children: The safety and effectiveness of naproxen haven’t been established in children who are younger than 2 years.

Prescription naproxen oral tablet is a short-term drug treatment. It comes with risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: You may experience more pain and inflammation (swelling and damage) caused by your condition.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

  • fatigue
  • drowsiness
  • upset stomach
  • heartburn
  • nausea and vomiting
  • loss of consciousness
  • stomach bleeding

In rare cases, an overdose can cause:

  • dangerous allergic reactions
  • high blood pressure
  • kidney failure
  • trouble breathing
  • coma

If you think you’ve taken too much of this drug, contact your doctor right away. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: If you miss your dose of naproxen, take it as soon as you can. However, if it’s just a few hours until your next dose, wait until the scheduled time and take a single dose.

Never try to catch up by taking two doses at once. This could result in toxic side effects.

How to tell if the drug is working: Signs that the drug is working will depend on the condition being treated.

  • Adult arthritis: Your pain and swelling may get better, you may be able to walk faster, and your morning stiffness may get better.
  • Polyarticular juvenile idiopathic arthritis: Your pain and swelling may get better and you may be able to walk faster.
  • Menstrual pain: Your pain may get better.
  • Tendonitis or bursitis: Your pain, skin discoloration, and inflammation (swelling and damage) may get better.
  • Gout: Your pain and inflammation may get better and the temperature of your skin may start to return to usual.

General

  • You can take naproxen with or without food. Taking it with food may reduce your risk of upset stomach.
  • You can cut or crush the immediate-release tablet to make it easier to take. However, don’t cut or break the delayed-release or extended-release forms. Breaking them apart can increase your risk of stomach damage.
  • You may need to space your doses evenly throughout the day. If your doctor recommends taking a regularly scheduled dose, you may take the doses every 12 hours or every 6 to 8 hours.

Storage

  • Store naproxen at room temperature between 68°F and 77°F (20°C and 25°C).
  • Keep the container tightly closed and protect the drug from light.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

  • Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
  • Don’t worry about airport X-ray machines. They won’t damage your medication.
  • You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
  • Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

Your doctor will request tests to check your health and make sure this drug is working for you. These tests may include:

  • blood test
  • kidney function test
  • liver function test
  • stool sample test

Other drugs are available to treat your condition. Some may be more suitable for you than others. Examples include:

  • acetaminophen (Tylenol)
  • aspirin (Bayer, Bufferin)
  • ibuprofen (Advil, Motrin)
  • diclofenac (Cambia)
  • meloxicam (Mobic)

Not all of the alternatives for naproxen are listed above. Additionally, not all of the drugs listed above treat the same conditions as naproxen is prescribed for. Talk with your doctor about possible alternatives.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Cardiovascular safety of celecoxib, naproxen and ibuprofen in patients with arthritis

PUBLICATIONS

Nonsteroidal anti-inflammatory drugs (NSAIDs) were first used in clinical practice in the 1960s and are currently one of the most commonly prescribed drugs (more than 100,000 prescriptions annually in the US alone). The mechanism of action of NSAIDs is the inhibition of cyclooxygenase (COX), which is accompanied by a decrease in inflammation and pain by reducing the synthesis of prostaglandins. However, it must be remembered that the downside of reducing the synthesis of prostaglandins in the stomach is an increased risk of erosive and ulcerative lesions. This problem can be solved by using selective COX-2 inhibitors.

But not everything is so simple with these drugs. Rofecoxib was banned in 2004 due to high cardiovascular risk. Another study showed increased CV risk with higher-than-allowed doses of celecoxib. In this regard, the results of the Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen (PRECISION) study, which compared the outcomes of celecoxib therapy (including cardiovascular), naproxen and ibuprofen, are of interest.

Methods

The analysis included patients with rheumatic diseases (osteoarthritis, rheumatoid arthritis) who were randomized to ibuprofen, naproxen, or celecoxib.

Study aimed to prove that celecoxib met the threshold of noninferiority in terms of composite cardiovascular death (including death due to bleeding), myocardial infarction and non-fatal stroke

Noninferiority was defined as a hazard ratio (HR) of 1.12 or below with an upper bound of 97.5% confidence interval (CI) of 1.33 or below in the intention-to-treat analysis or 1.40 or below in the on-treatment analysis .

Results

A total of 24,081 patients were randomized to the study, with a median daily dose of 209 mg celecoxib, 852 mg naproxen, and 2045 mg ibuprofen. The mean duration of treatment was 20.3±16.0 months, and the mean follow-up period was 34.1±13.4 months.

It was noted that 68.8% of patients discontinued study drug therapy and 27. 4% of patients were excluded from the analysis.

In the intention-to-treat analysis, 188 patients in the celecoxib group (2.3%), 201 patients in the naproxen group (2.5%), and 218 patients in the ibuprofen group (2.7%) reached the composite endpoint. HR for celecoxib vs. naproxen was 0.93; 95% CI, 0.76-1.13; HR for celecoxib vs. ibuprofen was 0.85; 95% CI, 0.70-1.04; P<0.001 for noninferiority for both comparisons).

In the on-treatment analysis, 134 patients in the celecoxib group (1.7%), 144 in the naproxen group (1.8%), and 155 patients in the ibuprofen group (1.9%) reached the composite endpoint. HR for celecoxib vs. naproxen is 0.90; 95% CI, 0.71-1.15; HR for celecoxib vs. ibuprofen was 0.81; 95% CI, 0.65-1.02; P<0.001 for noninferiority for both comparisons).

Conclusion

The use of celecoxib in medium doses is not inferior in terms of cardiovascular safety to naproxen and ibuprofen.

Source: Steven E. Nissen, et al. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. November 2016

Memorial Sloan Kettering Cancer Center

Adult Medication

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This document, provided by Lexicomp ® , contains all the information you need to know about this medicine, including indications, directions for use, side effects, and when your healthcare provider should be contacted.

Trade names: USA

Aleve [OTC]; All Day Pain Relief [OTC] [DSC]; All Day Relief [OTC]; Anaprox DS; EC-Naprosyn; EC-Naproxen; Flanax Pain Relief [OTC] [DSC]; GoodSense Naproxen Sodium [OTC]; Mediproxen [OTC]; Naprelan; Naprosyn; Naproxen Comfort Pac [DSC]

Brand names: Canada

Anaprox; Anaprox DS; APO-Napro-Na; APO-Naproxen; APO-Naproxen EC; Naprosyn; Naproxen-250; Naproxen-500; Naproxen-Na; Naxen EC; Pediapharm Naproxen; PMS-Naproxen EC [DSC]; PMS-Naproxen [DSC]; PRO-Naproxen EC; TEVA-Naproxen; TEVA-Naproxen EC; TEVA-Naproxen Sodium; TEVA-Naproxen Sodium DS

Warning

  • This drug may increase the risk of heart and blood vessel problems such as myocardial infarction and stroke. These effects can be deadly. This risk may be increased if you have heart disease or risk factors for heart disease. However, the risk may be increased even for people who do not have or are at risk of developing heart disease. The risk may occur during the first weeks of using this drug and may increase with higher doses or long-term use. This drug should not be used immediately before or after coronary bypass surgery.
  • This drug may increase the chance of developing severe and sometimes deadly stomach or intestinal problems, such as ulcers or bleeding. The risk is increased in the elderly and in people who have previously had ulcers or bleeding in the stomach or intestines. Such disturbances can occur suddenly.

What is this drug used for?

  • It is used to relieve pain, reduce inflammation and fever.
  • It is used to relieve pain during the menstrual cycle.
  • Used to treat certain types of arthritis.
  • This drug is used to treat ankylosing spondylitis.
  • Used to treat gout.
  • This drug may also be used for other indications. Consult your doctor.

What should I tell my doctor BEFORE taking this drug?

  • If you have an allergy to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergies and how they have manifested.
  • If you are allergic to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen.
  • If you have ever had asthma caused by salicylates, such as aspirin, or drugs such as this drug, such as non-steroidal anti-inflammatory drugs (NSAIDs).
  • If you have any of the following health problems: gastrointestinal bleeding or kidney problems.
  • If you have any of the following health conditions: Heart failure (weak heart) or a recent heart attack.
  • If you are taking an NSAID, a salicylate such as aspirin, or pemetrexed.
  • If you are unable to conceive or are testing to see if you are able to conceive.
  • If you are pregnant, plan to become pregnant, or become pregnant while taking this drug. If you take this drug after 20 weeks of pregnancy, it may harm the fetus. If you are 20 to 30 weeks pregnant, take this drug only as directed by your doctor. Do not use this drug after 30 weeks of pregnancy.

This list of drugs and conditions that may interact with this drug is not exhaustive.

Tell your doctor and pharmacist about all medicines you take (prescription and over-the-counter, natural products and vitamins) and any health problems you have. You need to make sure that this drug is safe for your conditions and in combination with other drugs you are already taking. Do not start or stop taking any drug or change the dosage without your doctor’s advice.

What do I need to know or do while taking this drug?

  • Tell all your health care workers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
  • With prolonged use of the drug, it is necessary to conduct a blood test. Talk to a medical specialist.
  • This drug may affect the results of some lab tests. Tell all your health care workers and laboratory staff that you are taking this drug.
  • The use of drugs of this kind was accompanied by high blood pressure. Monitor your blood pressure as directed by your doctor.
  • Consult your doctor before drinking alcohol.
  • If you smoke, please consult your doctor.
  • Do not take the drug in higher doses than prescribed by your doctor. Taking more than the prescribed amount of the drug increases the risk of serious side effects.
  • Do not take this drug for longer than the length of time your doctor has prescribed.
  • If you have asthma, check with your doctor. You may be more sensitive to the drug.
  • There is an increased chance of bleeding. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • The risk of developing heart failure increases with the use of drugs of this kind. People with heart failure have an increased risk of myocardial infarction, hospitalization for heart failure, and death. Consult your doctor.
  • People who have had a heart attack and are taking this type of drug are at increased risk of having another heart attack and dying from a heart problem. People who took drugs of this kind after their first myocardial infarction were also more likely to die one year after myocardial infarction than those who did not take such drugs. Consult your doctor.
  • If you are taking aspirin to prevent myocardial infarction, talk to your doctor.
  • Tell your doctor if you are on a low-sodium or salt-free diet. Some of these drugs contain sodium.
  • The use of drugs like this has been associated with liver problems. In some cases, this has led to death. Call your doctor right away if you develop signs of liver problems such as dark urine, fatigue, lack of appetite, nausea or abdominal pain, light-colored stools, vomiting, yellowing of the skin or eyes.
  • Other drugs of this kind have been associated with severe and sometimes fatal reactions. In most cases, this reaction was accompanied by symptoms such as fever, rash, inflammation of the lymph nodes, and dysfunction of various organs such as the liver, kidneys, blood, heart, muscles, joints and lungs. If you have any questions, please consult your doctor.
  • If you are 60 years of age or older, take this drug with caution. You may experience more side effects.
  • Non-steroidal anti-inflammatory drugs (NSAIDs), such as this drug, may interfere with the release of an egg (ovulation). This can negatively affect the ability to get pregnant. As a rule, the process of ovulation is restored after stopping this drug. Consult your doctor.
  • Tell your doctor if you are breastfeeding. It is necessary to consult whether the drug poses any risk to the child.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, this drug can cause serious and sometimes deadly side effects in some patients. Call your doctor right away or get medical help if you have any of the following signs or symptoms that could be associated with serious side effects:

  • Signs of an allergic reaction such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly in combination with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat.
  • signs of bleeding, such as vomiting or coughing up blood; vomiting of the type of coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; non-cyclic vaginal bleeding; bruises that appear or increase for no reason; bleeding that you cannot stop.
  • Signs of kidney problems, including not passing urine, changes in the volume of urine, blood in the urine, or rapid weight gain.
  • Signs of elevated potassium levels such as feeling of an abnormal heartbeat, confusion, feeling weak or dizzy, feeling faint, feeling numb or tingly, or short of breath.
  • Signs of high blood pressure, such as a very severe headache, or dizziness, or loss of consciousness, or blurred vision.
  • Shortness of breath, sudden weight gain, or swelling of the arms or legs.
  • Pain or pressure in the chest or a fast heartbeat.
  • Weakness on 1 side of the body, difficulty speaking or thinking, problems with balance, sagging on one side of the face, or blurred vision.
  • Feeling extremely tired or weak.
  • Tinnitus.
  • Severe back pain.
  • Flu-like symptoms.
  • Swelling of the gland.
  • Possible severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis). This can lead to severe health problems, which can be permanent, and sometimes death. Seek immediate medical attention if you experience symptoms such as redness, swelling of the skin with blistering or peeling (with or without fever), redness or irritation of the eyes, and sores in the mouth, throat, nose, or eyes.

What are some other side effects of this drug?

Any medicine can have side effects. However, for many people, side effects are either minor or non-existent. Contact your doctor or seek medical attention if these or any other side effects bother you or do not go away:

  • Abdominal pain or heartburn.
  • Nausea.
  • Constipation.
  • Dizziness or headache.
  • Drowsiness.

This list of possible side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Board.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

All forms:
  • Take with or without food. Take with food if medicine causes nausea.
  • Take this drug with a full glass of water.
  • Do not take sucralfate or antacids containing magnesium or aluminum at the same time as this drug.
Modified release tablets:
  • Swallow whole. Do not chew, break or crush.
Suspension:
  • Shake well before use.
  • Liquid doses should be measured with caution. Use the dispenser that comes with the medication. If the dispenser is not provided in the package, ask the pharmacist for a dosing agent for this drug.
  • This drug can not be measured with an ordinary teaspoon or tablespoon. This may lead to an overdose of the drug.

What if I miss a dose of a drug?

  • If you take the drug regularly, take the missed dose as soon as you can.
  • If it’s time for your next dose, don’t take the missed dose and then go back to your regular dosing schedule.
  • Do not take 2 doses or an additional dose at the same time.
  • In most cases, this drug is used as needed. Do not take the drug more often than prescribed by your doctor.

How do I store and/or discard this drug?

  • Store at room temperature, protected from light. Store in a dry place. Do not store in the bathroom.
  • Keep all medicines in a safe place. Keep all medicines out of the reach of children and pets.
  • Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General information about medicines

  • If your health does not improve or even worsens, see your doctor.
  • Do not give your medicine to anyone and do not take other people’s medicines.
  • Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
  • A separate instruction for patients is attached to the drug. Please read this information carefully. Reread it each time you refill your supply. If you have any questions about this drug, ask your doctor, pharmacist, or other health care professional.
  • If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened.

Consumer Use of Information and Limitation of Liability

This summary information includes a summary of the diagnosis, treatment, and/or drug product. It is not intended to be a comprehensive source of data and should be used as a tool to help the user understand and/or evaluate potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a particular patient.