naproxen sodium ER
Prescription-strength naproxen sodium ER (Naprelan) is a non-steroidal anti-inflammatory drug (NSAID). It relieves pain and inflammation in adults by blocking specific proteins called cyclooxygenases. Naproxen sodium ER (Naprelan) can help with certain conditions, such as rheumatoid arthritis, osteoarthritis, or gout. This medication is available as an extended-release (ER) tablet that's taken by mouth mostly once per day. Some side effects include headache, indigestion, and flu-like symptoms.
What is Naproxen sodium ER (Naprelan)?
What is Naproxen sodium ER (Naprelan) used for?
Ankylosing spondylitis (AS) (arthritis of the spine)
Tendonitis and bursitis
Pain
How Naproxen sodium ER (Naprelan) works
Naproxen sodium ER (Naprelan) is a non-steroidal anti-inflammatory drug (NSAID). It works by blocking proteins (called cyclooxygenase, or COX) in your body that cause inflammation, pain, and swelling.
Drug Facts
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What are the side effects of Naproxen sodium ER (Naprelan)?
Common Side Effects
- Headache (15%)
- Indigestion (14%)
- Cold or flu-like symptoms (up to 10%)
- Heartburn (up to 9%)
- General pain and stomach pain (up to 9%)
- Constipation or diarrhea (up to 9%)
- Nausea (up to 9%)
- Drowsiness (up to 9%)
- Itchy skin (up to 9%)
- Bruising (up to 9%)
- Ringing in the ears (up to 9%)
- Swelling (up to 9%)
- Shortness of breath (up to 9%)
Other Side Effects
- Passing gas
- Vomiting
- Trouble swallowing
- Mouth sores
- Dizziness
- Leg cramps
- Muscle or joint pain
- Changes in hearing or vision
- Feeling more thirsty
Serious Side Effects
- Stomach bleeding: feeling faint, vomiting blood, bloody or dark stools, severe stomach pain or discomfort
- Heart attack: chest pain or tightness, pain that radiates up to your shoulder, arm, neck, or jaw
- Stroke: chest pain, trouble breathing, weakness in one part of your body or face, slurred speech
- Heart failure: difficulty breathing, swelling, fast heartbeat
- Dangerously high blood pressure: headache, shortness of breath, changes in vision, light-headedness, fatigue
- Worsening liver problems or liver failure: swelling of your stomach, yellowing of your skin or the whites of your eyes, confusion, dark or brown urine
- Kidney problems: tiredness, dry and itchy skin, low appetite, urinating less than usual, foamy or bloody urine, muscle cramps
- Allergic reactions: hives, rash, blisters, swelling of the lips or tongue, difficulty breathing
- Serious skin reaction: skin reddening, blisters, rash
Source: DailyMed
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The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
- Increase in blood pressure
- Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Rash, fever, and swollen lymph nodes
- Redness, blistering, peeling, or loosening of the skin, including inside the mouth
- Round red or dark patches on the skin that may itch, burn, and blister
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Headache
- Loss of appetite
- Nausea
- Upset stomach
Pros and cons of Naproxen sodium ER (Naprelan)
Pros
Taken by mouth
Effect lasts longer than some other NSAIDs, such as ibuprofen (Advil)
Long-acting version of naproxen; typically taken once daily
Cons
Cannot crush or split naproxen sodium ER (Naprelan) tablets
Can't be taken by children
Can't take during pregnancy
Pharmacist tips for Naproxen sodium ER (Naprelan)
Take naproxen sodium ER (Naprelan) with food or milk to help ease stomach-related side effects, such as stomach pain and irritation.
The naproxen sodium ER (Naprelan) tablets have a special coating on them, so you'll need to swallow them whole. Don't break, crush, or chew the tablets. Doing so will damage the special coating and affect how naproxen sodium ER (Naprelan) is absorbed by your body. If you're having trouble swallowing the tablets, let your prescriber know. They might consider switching you naproxen (Naprosyn) suspension.
Naproxen sodium ER (Naprelan) raises the risk of stomach bleeding. Tell your prescriber right away if you experience unexplained vomiting or stomach pain, or blood in your vomit or stool. They can let you know if you need more medical attention.
It's best to avoid drinking alcohol while taking naproxen sodium ER (Naprelan). Doing so can raise your risk for stomach bleeding and other stomach-related side effects. If you drink alcohol regularly and it's difficult for you to stop, talk with your healthcare team. They can recommend resources to help you stop drinking, or they can discuss other alternative options to help with your condition.
Naproxen sodium ER (Naprelan) might raise your blood pressure. If you already have high blood pressure, your healthcare provider might ask you to check your blood pressure at home more often. If needed, they might make changes to your blood pressure medications.
Never take naproxen sodium ER (Naprelan) with other NSAIDs, such as ibuprofen (Motrin, Advil). Doing so puts you at higher risk for stomach bleeds, stroke, and heart attack. Make sure to carefully check the manufacturer's label for over-the-counter pain and cold medications because they might contain NSAIDs. Ask a healthcare professional if you're not sure whether you're already taking a medication with an NSAID.
If you're pregnant, talk to your healthcare team about safer alternatives than naproxen sodium ER (Naprelan) for pain. You should avoid taking naproxen sodium ER (Naprelan) during the second half of pregnancy because it might cause problems to your unborn baby or cause complications during delivery. And the safety of naproxen sodium ER (Naprelan) in the first half of pregnancy isn't clear.
If you're breastfeeding, discuss with your healthcare team about the risks and benefits of taking naproxen sodium ER (Naprelan). Limited research shows that naproxen sodium ER (Naprelan) can get into breastmilk. This means there might be a small risk of harm to the breastfed baby.
Frequently asked questions about Naproxen sodium ER (Naprelan)
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What are the risks and warnings for Naproxen sodium ER (Naprelan)?
Naproxen sodium ER (Naprelan) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Stomach bleeding
Risk factors: Older adult | History of stomach bleeding or bleeding problems | Liver problems | Taking other medications that raise your risk of bleeds | Drinking alcohol | Smoking | Taking naproxen sodium ER (Naprelan) for a long time
Naproxen sodium ER (Naprelan), like all NSAIDS, raises your risk for stomach ulcers (sores) and bleeds. Stomach bleeding can happen at anytime during treatment; it's a dangerous side effect that requires treatment right away. Often times, people who have stomach bleeds don't experience any symptoms. Make sure to tell your healthcare professional (HCP) or pharmacist about all of your conditions and medications before starting naproxen sodium ER (Naprelan) so they can talk with you about your risk for stomach bleeding. If you're feeling faint, vomiting blood, have bloody or dark stools, or have severe stomach pain or discomfort that doesn't go away while taking naproxen sodium ER (Naprelan), seek medical attention right away.
Heart attack and stroke
Risk factors: Heart problems | Taking higher doses of naproxen sodium ER (Naprelan) | Taking naproxen sodium ER (Naprelan) for a long time | Past or planned heart surgery
Naproxen sodium ER (Naprelan) might raise your risk of having blood clots, which can cause a heart attack or stroke. To lower your risk of blood clots and heart problems, your HCP will prescribe naproxen sodium ER (Naprelan) for the shortest time needed to treat your condition. If you have heart problems, talk to your HCP before starting this medication. Don't take naproxen sodium ER (Naprelan) if you had, or will have, heart surgery. Call 911 or get immediate help if you experience chest pain, shortness of breath, weakness on one side of your body, or trouble speaking or walking.
High blood pressure and heart failure
Risk factors: Heart problems
Naproxen sodium ER (Naprelan) can cause your body to hold onto extra fluid, which can raise your blood pressure or put you at risk for heart failure. Tell your HCP if you have a history of heart problems, or are taking blood pressure medications, before starting naproxen sodium ER (Naprelan) to make sure it's safe for you. Your HCP will screen you for heart problems before starting you on this medication. Some forms of naproxen sodium ER (Naprelan) contains sodium, so it's important to keep track of how much you're getting from your doses if you're on a low-salt diet. If you experience unexplained fainting, chest pain with physical activity, or irregular heartbeat while taking naproxen sodium ER (Naprelan), contact your HCP.
Kidney damage
Risk factors: Older adult | Kidney problems | Heart failure | Liver problems | High blood sugar levels | Not enough fluids in the body (dehydration) | Taking other medications that can cause kidney problems
Naproxen sodium ER (Naprelan) can cause kidney problems. Your risk is higher if you have certain factors like older age, certain medical problems like diabetes, or you're taking medications that can cause kidney problems. Your healthcare professional might order lab tests to monitor your kidney health before and during treatment with naproxen sodium ER (Naprelan). If your kidney health worsens, your HCP might stop your naproxen sodium ER (Naprelan) treatment. Contact your HCP if you develop any signs or symptoms of kidney failure, including changes in your need to urinate, tiredness, dry and itchy skin, low appetite, and muscle cramps.
Liver problems
Risk factors: History of liver problems
Though rare, naproxen sodium ER (Naprelan) can cause serious liver problems that can lead to liver failure. Get medical attention right away if you notice swelling of your stomach, stomach pain, yellowing of your skin or the whites of your eyes, stool changes (black, tarry, or bloody stools), nausea, vomiting, confusion, or dark or brown urine. You might need to stop using the medication to prevent further liver damage.
Severe allergic reactions
Risk factors: Aspirin allergy | Aspirin-sensitive asthma | Nasal polyps | NSAID allergy
Severe allergic reactions to naproxen sodium ER (Naprelan) are possible, including life-threatening reactions like facial swelling, shock, and anaphylaxis. Let your HCP know if you have an allergy to aspirin or other NSAIDs before starting naproxen sodium ER (Naprelan). If you notice hives, rash, red skin, swelling of the lips or tongue, or difficulty breathing after using naproxen sodium ER (Naprelan), get medical attention right away.
Although rare, naproxen sodium ER (Naprelan) can cause serious skin reactions called Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS). If you notice changes in your skin, such as rash, blisters, skin reddening, or skin peeling, stop using naproxen sodium ER (Naprelan) and get medical attention right away.
Not for use in pregnant or breastfeeding females
Naproxen sodium ER (Naprelan) can cause harm to your unborn baby, especially if it's taken in the second half of pregnancy (after week 20). It can cause serious complications, such as heart or kidney problems in your unborn baby or problems during delivery. Speak to your HCP about the risks and benefits of taking naproxen sodium ER (Naprelan) if you're pregnant before taking this medication. Ask whether there are safer alternatives.
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Naproxen sodium ER (Naprelan) dosage forms
Typical dosing for Naproxen sodium ER (Naprelan)
The different strengths and formulations of naproxen aren't interchangeable. Your healthcare team will likely need to adjust your dose if they're switching you from one form of naproxen to another.
RA, OA, and AS: The typical dose is 750 mg by mouth once per day, or 500 mg by mouth twice per day. The maximum daily dose is 1,500 mg but only for a short period of time.
Pain, menstrual cramps, tendonitis, and bursitis: The typical dose 1,000 mg by mouth once daily. If more pain relief is needed, the dose can be raised to 1,500 mg by mouth once daily for a short amount of time.
Gout: The typical dose is 1,000 mg to 1,500 mg by mouth on the first day of a gout attack, then 1,000 mg by mouth once daily until your symptoms go away.
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How much does Naproxen sodium ER (Naprelan) cost?
Naproxen sodium ER (Naprelan) contraindications
History of asthma, hives, or other allergic reactions after taking aspirin or another NSAID
Right before or after coronary artery bypass graft surgery (CABG), a type of open heart surgery
What are alternatives to Naproxen sodium ER (Naprelan)?
Ankylosing spondylitis (AS) (arthritis of the spine)
Tendonitis and bursitis
Pain
Osteoarthritis
Rheumatoid arthritis
Juvenile rheumatoid arthritis
Short-term relief of minor aches and pains due to headache, muscle aches, minor arthritis pain, toothache, backache, the common cold, or menstrual cramps
Fever
Mild-to-moderate pain
Pain from rheumatoid arthritis (RA) or osteoarthritis (OA)
Pain from menstrual cramps
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Naproxen sodium ER (Naprelan) images
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References
Best studies we foundAlmatica Pharma Inc. (2024). Naprelan- naproxen sodium tablet, film coated, extended release [package insert]. DailyMed.
Drugs and Lactation Database (LactMed®). (2024). Naproxen. National Institute of Child Health and Human Development.
National Heart, Lung, and Blood Institute. (2022). What is coronary artery bypass grafting?
National Kidney Foundation. (2020). 10 signs you may have kidney disease.
U.S. Food and Drug Administration. (2016). FDA Drug Safety Communication: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen.
U.S. Food and Drug Administration. (2022). FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid.
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