- NSAIDs1 may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).
- Naproxen delayed-release tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).
NAPROXEN DELAYED-RELEASE TABLETS
Naproxen is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (+)-6-Methoxy-a-methyl-2-naphthaleneacetic acid. Naproxen has the following structural formula.
Carefully consider the potential benefits and risks of naproxen delayed-release tablets and other treatment options before deciding to use naproxen delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Naproxen delayed-release tablets are indicated:
- For the relief of the signs and symptoms of rheumatoid arthritis
- For the relief of the signs and symptoms of osteoarthritis
- For the relief of the signs and symptoms of ankylosing spondylitis
- For the relief of the signs and symptoms of juvenile arthritis
Naproxen delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
Published Studies Related to Naproxen
Comparison of the analgesic effects of oral tramadol and naproxen sodium on pain
relief during IUD insertion. 
on pain during insertion of an intrauterine device (IUD)... CONCLUSION: Prophylactic analgesia using 50 mg tramadol and 550 mg naproxen,
Impact of a Fixed-Dose Combination of Naproxen and Esomeprazole Magnesium on Serum Thromboxane B(2) Inhibition by Low-Dose Aspirin Over 5 Days in Healthy Adults: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Noninferiority Trial. [2011.11.09]
Background: Low-dose aspirin (LDA) and nonsteroidal anti-inflammatory drugs (NSAIDs) are often used concomitantly; however, some NSAIDs may interfere with LDA antiplatelet activity. OBJECTIVE: We evaluated the impact of coadministered enteric-coated naproxen 500 mg and immediate-release esomeprazole magnesium 20 mg (fixed-dose combination) on LDA-mediated platelet cyclooxygenase (COX)-1 inhibition... CONCLUSIONS: This pilot investigation suggests that LDA coadministered with naproxen/esomeprazole magnesium is noninferior to LDA alone for platelet COX-1 inhibition, as measured by serum TXB(2) concentration, in healthy volunteers. ClinicalTrials.gov identifier: NCT01094483. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.
Naproxen as prophylaxis against atrial fibrillation after cardiac surgery: the NAFARM randomized trial. [2011.11]
PURPOSE: We sought to assess the effect of naproxen versus placebo on prevention of atrial fibrillation after coronary artery bypass graft (CABG) surgery... CONCLUSIONS: Postoperative use of naproxen did not reduce the incidence of atrial fibrillation but decreased its duration, in a limited sample of patients after CABG surgery. There was a significant increase in acute renal failure in patients receiving naproxen 275 mg twice daily. Our study does not support the routine use of naproxen after CABG surgery for the prevention of atrial fibrillation. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Naproxen or estradiol for bleeding and spotting with the levonorgestrel intrauterine system: a randomized controlled trial. [2011.09.24]
OBJECTIVE: The purpose of this study was to evaluate whether oral naproxen or transdermal estradiol decreases bleeding and spotting in women who are initiating the levonorgestrel-releasing intrauterine system... CONCLUSION: The administration of naproxen resulted in a reduction in bleeding and spotting days compared with placebo. Copyright A(c) 2011 Mosby, Inc. All rights reserved.
Celecoxib or Naproxen Treatment Does Not Benefit Depressive Symptoms in Persons Age 70 and Older: Findings From a Randomized Controlled Trial. [2011.07.19]
BACKGROUND:: Several lines of evidence suggest that inflammatory mechanisms may be involved in the severity and progression of depression. One pathway implicated is the production of prostaglandins via the enzyme cyclooxygenase (COX). Although late-life depression in particular has been associated with inflammation, we know of no published studies using COX inhibitors, such as nonsteroidal anti-inflammatory drugs (NSAIDs), in the treatment of depressive syndromes in this population. OBJECTIVE:: To evaluate the effect of the NSAIDs celecoxib and naproxen on depressive symptoms in older adults... CONCLUSION:: Treatment with celecoxib or naproxen did not improve depressive symptoms over time compared with placebo. While inflammation has been implicated in late-life depression, these results do not support the hypothesis that inhibition of the COX pathway with these NSAIDs at these doses alleviates depressive symptoms in older adults.
Clinical Trials Related to Naproxen
Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations [Completed]
We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent
Naproxen for the Prevention of HO After Complex Elbow Trauma [Recruiting]
Complex elbow fractures can lead to formation of new bone (called Heterotopic ossification).
This new bone is unwanted and it can restrict motion. This research study is being done to
learn more about the effect of the drug naproxen, on unwanted formation of new bone around
the elbow as it heals after a fracture. Naproxen belongs to a class of drugs called NSAIDs
which stands for non-steroidal anti-inflammatory drugs.
Several research studies suggest that NSAIDs such as Naproxen can prevent the unwanted
formation of new bone around the hip. The effect of NSAIDS on the formation of bone around
the elbow has not been studied as well as it has been studied for their effect on the hip.
The drug, Naproxen is approved by the US food and drug administration (FDA) for sale but ot
specifically for the treatment of heterotopic ossification.
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E [Recruiting]
The purpose of the study is to investigate the uptake in the body of naproxen; one of the
two active substances in PN400. We also want to show that the body's uptake of naproxen
given as PN400 is comparable to that of currently marketed naproxen tablets.
A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee [Recruiting]
PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which
is involved in the pathway that causes inflammation and pain. The purpose of this study is
to test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of
the knee by itself or with naproxen, particularly to test if patients have less pain.
Trial of Naproxen to Evaluate Various Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee [Recruiting]
This study aims to evaluate various methods of measuring pain relief in subjects who have
chronic OA of the knee. After a 1 week of wash-out from existing therapy, subjects will be
treated in a blinded fashion for 1 week with either naproxen (3 days at 250 mg twice a day
followed by 4 days at 500 mg twice a day) or placebo. After the first week of treatment,
subjects will have another week of wash-out followed by a second period of 1 week of the
alternate treatment. Subjects will not be allowed to use oral non-steroidal
anti-inflammatory drugs (NSAIDs) or other oral analgesics, or topical medications on their
target knees during the study. Acetaminophen will be allowed as a rescue medication.
Reports of Suspected Naproxen Side Effects
Completed Suicide (120),
Gastrointestinal Haemorrhage (71),
Haemoglobin Decreased (51),
Toxicity TO Various Agents (46),
Gastric Ulcer (38),
Cardiac Arrest (33),
Dyspnoea (31), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 18 ratings/reviews, Naproxen has an overall score of 4.89. The effectiveness score is 5.89 and the side effect score is 6.33. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Naproxen review by 25 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || period cramps|
|Dosage & duration:|| || 500 mg taken 3 days per month for the period of almost 6 years|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || I was able to do normal daily activities again|
|Side effects:|| || I had no side effects.|
|Comments:|| || I always have had really bad cramps. I have tried many different prescription pain killers over the years and none have really made the pain any better. I first started taking Naproxen in 200mg as you can get this over the counter as Aleve in the States. Canada has no such product available. I found that even in 200 mg strength sometimes was enough to make my day bearable. I now get it from my Dr. in 500 mg strength and am able to carry out my normal daily activities as I was unable to even go to work some days before.|
Naproxen review by 16 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Ineffective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || Juvenile Idiopathic Arthritis|
|Dosage & duration:|| || 500mg taken twice a day/at 12 hour intervals for the period of Four weeks|
|Other conditions:|| || None|
|Other drugs taken:|| || None|
|Benefits:|| || The treatment did not affect the level of joint pain that I experienced, nor did it improve joint stiffness. I cannot comment on it's effect on inflammation as my inflammation tends not to be visible anyway. This may be the reason that Naproxen did not benefit me|
|Side effects:|| || Caused nausea and stomach pain. The nausea would alleviate a couple of hours before the next dose was due, and start within an hour of the dose. It did not cause actual vomitting, but there were a few occasions on which I felt so nauseous I was convinced I would be sick at any moment. |
|Comments:|| || I would never take Naproxen again without having a LONG discussion with both a doctor and pharmacist.|
Naproxen review by 37 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Marginally Effective|
|Side effects:|| || Extremely Severe Side Effects|
|Condition / reason:|| || joint pain|
|Dosage & duration:|| || 500 mg taken 2 in 1 day for the period of 1day|
|Other conditions:|| || only had joint pain before I took this drug|
|Other drugs taken:|| || none|
|Benefits:|| || I didn't feel my joint pain after taking this, I think because I was too bothered by the side effects.|
|Side effects:|| || I had the most intense stomach pain I've ever had in my life. The pain was nearly unbearable. It felt like I had an acid stomach with extreme pain. I drank milk and had taken this will food and still had stomach pain. |
|Comments:|| || I would much ranther have the joint pain, then go through this stomach pain ever again. I've stopped using this and would not recommend it to anyone.|
Page last updated: 2013-02-10