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Naprosyn (Naproxen Sodium) - Summary


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 as NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN Suspension 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).


Cardiovascular Risk

Naproxen is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs.

Naproxen as NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN Suspension are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile arthritis.

Naproxen as NAPROSYN Suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight.

Naproxen as NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension are also indicated for the treatment of tendonitis, bursitis, acute gout, and for the management of pain and primary dysmenorrhea. EC-NAPROSYN is 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).

See all Naprosyn indications & dosage >>


Published Studies Related to Naprosyn (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 Naprosyn (Naproxen)

Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone [Completed]
The purpose of this study is to determine whether the absorption of naproxen from the PN 400 combination (Naprosyn and Esomeprazole) tablets is similar to that from the naproxen tablets (Naprosyn«), which are currently sold in Australia.

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 Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels [Completed]

Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn´┐Ż [Completed]
LT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients receiving either LT-NS001 at a dose which provides comparable dose levels of Naproxen, or Naprosyn« 500mg (an approved treatment for OA).

Phase I Study PK Study With OXP005 and Naprosyn [Completed]
The Sponsor is developing a new form of naproxen (the study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The study will compare the study drug to an already marketed formulation of prescription strength naproxen (Naprosyn« the reference product) by looking at how a single dose of the drug is taken up by the body. The safety and tolerability of the drug will also be assessed.

more trials >>

Reports of Suspected Naprosyn (Naproxen) Side Effects

Abdominal Discomfort (10)Abdominal Pain (8)Drug Ineffective (8)Pain (8)Nausea (8)Drug Hypersensitivity (8)Pain in Extremity (7)Abdominal Pain Upper (6)Malaise (5)Oedema Peripheral (5)more >>


Based on a total of 5 ratings/reviews, Naprosyn has an overall score of 5.80. The effectiveness score is 6 and the side effect score is 8.40. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Naprosyn review by 46 year old male patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   ankylosing spondylitis
Dosage & duration:   500mg taken 2 per day for the period of 24 years
Other conditions:   none
Other drugs taken:   painkillers
Reported Results
Benefits:   enables me to get on with my life and be mobile. without it my back and neck become "stiff" so I also combine taking the drug with daily exercise to keep myself as fit as is possible. my condition was inherited from my father.
Side effects:   none that I know of.
Comments:   twice per day, with meals (morning and night).


Naprosyn review by 31 year old female patient

Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Moderate Side Effects
Treatment Info
Condition / reason:   Rheumatoid Arthritis
Dosage & duration:   Twice Daily (dosage frequency: once a month) for the period of 4 month
Other conditions:   none
Other drugs taken:   celebrex
Reported Results
Benefits:   join pain and swelling
Side effects:   nausea, vomit, gastrointestial disorders
Comments:   The medicine woks but I still can feel the pain, so for me is not working because of the side effects, I have to take the medicine with food and milk and still have this severe stomach pain, nausea and some times vomits. My doctors are working on put me on something else that could work better for me


Naprosyn review by 50 year old female patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   muscle inflammation
Dosage & duration:   500 mg taken 2 times a day for the period of 6 weeks
Other conditions:   whiplash
Other drugs taken:   none
Reported Results
Benefits:   None. I was told it would take 6 weeks for the medicine to accumulate and become completely effective. It did not produce any results that were apparent. Not in inflammation reduction or in pain reduction due to the inflammation were any results ascertainable. I suffered while waiting for this medication to do anything. Further, you are told to consume food to protect the lining of your stomach from this medication. Not always something you want to do when you are experiencing a lot of pain because pain can make you feel like vomiting.
Side effects:   Stomach issues, burning The more adverse affect was the constant pain due to the continuing inflammation with the added and increasing reduction in movement, and muscle usage. Worst, was the waste of time. Another med could have been prescribed in the time I used this medicine that would have been more effective and time healing would not have been wasted. In fact, another anti-inflammatory was prescribed that provided immediate benefits (30 minutes) without the build-up in your system that the M.D. and pharmacist said Naprosyn requires before it becomes effective.
Comments:   Tried various dosages from the lowest, to more frequency. It simply had little affect on inflammation or pain. No other pain medication was added to this treatment and no other medication was given. I had a car accident and suffered whiplash, thoracic muscle strain, herniation of entire lumbar region, etc. Inflammation was rampant from hip level up. Any relief would have been noted and appreciated. Another drug was later prescribed, another anti-inflammatory, which proved just how much the naprosyn did not work. I had immediate pain relief in 30 minutes and notable inflammation reduction very quickly. In fact, after a 3 week loading of this drug, I was able to get out of bed, move around, and be functional! The Doctor insisted on trying this level, Naprosyn, first and then changed after 6 weeks, to supposedly stronger medication in some kind of protocol progression. I now tell my doctors which medication works and refuse anything else. They waste time on ineffective medications allowing suffering. I saw the doctors within the 6 week period declaring and their noting how ineffective this medication was.

See all Naprosyn reviews / ratings >>

Page last updated: 2014-11-30

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