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Naproxen (Naproxen) - Summary


Boxed Warning Section

Cardiovascular Risk                                                                                                                                             

  • NSAIDs 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 is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Gastrointestinal Risk                                                                                                                   

  • 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 is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.

Carefully consider the potential benefits and risks of naproxen and other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Naproxen 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 juvenilearthritis

Naproxen tablets are also indicated:

  • For relief of the signs and symptoms of tendonitis
  • For relief of the signs and symptoms of bursitis
  • For relief of the signs and symptoms of acute gout
  • For the management of pain
  • For the management of primary dysmenorrhea

See all Naproxen indications & dosage >>


Published Studies Related to Naproxen

Sumatriptan plus naproxen for acute migraine attacks in adults. [2013]
CONCLUSIONS: Combination treatment was effective in the acute treatment

Effect of naproxen and acetaminophen on blood pressure lowering by ramipril, valsartan and aliskiren in hypertensive patients. [2013]
CONCLUSIONS: Both naproxen and acetaminophen can affect anti-hypertensive therapy

The effects of the antiplatelet agents, aspirin and naproxen, on pharmacokinetics and pharmacodynamics of the anticoagulant edoxaban, a direct factor Xa inhibitor. [2013]
Edoxaban is an oral factor Xa (FXa) inhibitor in clinical development for stroke prevention in patients with atrial fibrillation, an elderly population that frequently receives aspirin (ASA) and/or nonsteroidal anti-inflammatory drugs for concurrent illnesses.Concomitant administration of edoxaban and ASA or naproxen was well tolerated.

Comparison of the analgesic effects of oral tramadol and naproxen sodium on pain relief during IUD insertion. [2012]
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.

more studies >>

Clinical Trials Related to Naproxen

Naproxen in Preventing DNA Mismatch Repair Deficient Colorectal Cancer in Patients With Lynch Syndrome [Recruiting]
This randomized phase Ib trial studies the side effects and best dose of naproxen in preventing deoxyribonucleic acid (DNA) mismatch repair deficient colorectal cancer in patients with Lynch syndrome. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of naproxen may keep cancer from forming in patients with Lynch syndrome.

A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period [Completed]
The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen sodium combination tablets, tablets containing only sumatriptan, and tablets containing only naproxen sodium when these drugs are taken to treat migraine headaches that occur during a 6-month period.

Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal [Recruiting]
The present clinical trial randomized compared the clinical efficacy of the naproxen associated or not with esomeprazol, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower third molars, in two separate appointments (one to two months apart), under local anesthesia with either articaine 4% (1: 200,000 adrenaline) in a doubleblind, randomized and crossed manner.

Influence of Naproxen on Heterotropic Bone Formation Following Hip Arthroscopy [Active, not recruiting]
In a brief summary the study would like to evaluate the effectiveness of Naproxen in preventing radiographically detected heterotopic ossification following hip arthroscopy for the treatment of femoroacetabular impingement.

Naproxen for the Prevention of HO After Complex Elbow Trauma [Withdrawn]
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.

more trials >>

Reports of Suspected Naproxen Side Effects

Completed Suicide (120)Gastrointestinal Haemorrhage (71)Haemoglobin Decreased (51)Toxicity TO Various Agents (46)Dizziness (40)Nausea (39)Gastric Ulcer (38)Diarrhoea (36)Cardiac Arrest (33)Dyspnoea (31)more >>


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
Treatment Info
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
Reported Results
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
Treatment Info
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
Reported Results
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
Treatment Info
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
Reported Results
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.

See all Naproxen reviews / ratings >>

Page last updated: 2014-11-30

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