Naproxen Side Effects


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A fatal case of cutaneous adverse
 drug-induced toxic epidermal necrolysis
associated with severe rhabdomyolysis

From theDepartment of Critical Care Medicine, Centre Hospitalier Universitaire, Brugmann....

Noordally SO, ... Med 2012;32(3):309-311.  DOI: 10.5144/0256-4947.2012.309


Toxic epidermal necrolysis represents an immunologic reaction to a foreign antigen and is most often caused by drugs. Atorvastatin, a blood cholesterol–lowering agent, is a recognized cause of rhabdomyolysis; while naproxen, a widely used nonsteroidal anti-inflammatory drug, is a known cause of photo-induced skin lesions.

We report the first fatal case of drug-induced toxic epidermal necrolysis associated with severe muscle necrosis due to the use of a nonsteroidal anti-inflammatory drug and a statin with very high levels of creatine phosphokinase leading to acute kidney injury, disseminated intravascular coagulation, and complete skin necrosis leading to death.

Toxic epidermal necrolysis (TEN) is a cutaneous drug-induced reaction characterized by a widespread exfoliation and necrosis of the epidermis, involving more than 30% of body surface area. Rhabdomyolysis and necrosis of smooth muscle fibers have never been reported with TEN. We report the first case of a non–photo-induced, fatal skin necrolysis accompanied by severe rhabdomyolysis due to naproxen and atorvastatin use in a 61-year-old woman.


A 61-year-old female patient presented with complaints of breathing difficulties, vomiting, and diarrhea that started 2 days prior to admission; she also complained of right hemithoracic pain.

Her medical history revealed arterial hypertension, hypercholesterolemia, arthritis, and type 2 diabetes. She did not consume alcohol and was a nonsmoker. She had allergy to molds.


Her medications consisted of metformin 500 mg once daily, co-lisinopril (lisinopil and hydrochlorothiaride) 20/12.5 mg once daily, tramadol 100 mg twice daily as needed, atorvastatin 10 mg once daily, allopurinol 300 mg once daily, ranitidine 500 mg once daily, and quinine sulfate 100 mg once daily.

She was taking naproxen 500 mg three times a day and as needed for arthritis, 10 days prior to admission. On the day of admission, she had consumed 1.5 g of naproxen for her arthritis and chest pain. 


Naprosyn / Naproxen Naprosyn

Manufacturer: Roche Naproxen is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), and is primarily used to reduce pain, inflammation, and stiffness caused by many conditions, such as osteoarthritis, rheumatoid arthritis, gout, ankylosing spondylitis (arthritis and stiffness of the spine), injury, abdominal cramps associated with menstruation, tendinitis, and bursitis.

Naproxen (NSAIDs) and Children All ADRs to aspirin, celecoxib, ibuprofen, indomethacin, naproxen and rofecoxib from January 1999 to December 2003 inclusive, were retrieved from the ADR database. 

These drugs incorporate all the NSAIDs and COX-2 inhibitors in use at the hospital over this period. Free legal Naprosyn / Naproxen consultation FDA NSAIDs Decision Memo

SUBJECT: Analysis and recommendations for Agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk Executive Summary Following a thorough review of the available data we have reached the following conclusions regarding currently approved COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and the risk of adverse cardiovascular (CV) events:2

• The three approved COX-2 selective NSAIDs (i.e., celecoxib, rofecoxib, and valdecoxib) are associated with an increased risk of serious adverse CV events compared to placebo. The available data do not permit a rank ordering of these drugs with regard to CV risk.

• Data from large long-term controlled clinical trials that have included a comparison of COX-2 selective and non-selective NSAIDs do not clearly demonstrate that the COX-2 selective agents confer a greater risk of serious adverse CV events than non-selective NSAIDs.

Able Laboratories produces such popular medications, as Percocet, Aleve, Naprosyn and other medicines. Naprosyn / Naproxen A former Vice President in charge of the Quality Control Department and three supervisory chemists at now-defunct New Jersey generic drug manufacturer

Able Laboratories pleaded guilty today to a conspiracy involving the rampant falsification and manipulation of testing data of its drugs, U.S. Attorney Christopher J. Christie announced......Full Text



2004 Dec 21
Federal officials announced that naproxen, a painkiller sold by prescription and also over the counter as Aleve, might increase people's risk of having a heart attack or stroke.