Aleve Gelcap Side Effects

Generic Name: naproxen, naprosyn

Please note - some side effects for Aleve Gelcap may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: compounding powder; oral capsule; oral delayed release tablet; oral suspension; oral tablet; oral tablet, extended release; oral and topical kit

Gastrointestinal

Gastrointestinal side effects have been reported the most frequently. These have included constipation (3% to 9%), general abdominal discomfort (3% to 9%), nausea (3% to 9%), dyspepsia (3% to 9%), diarrhea, and stomatitis. Serious gastrointestinal side effects include peptic ulcerations, and, in rare cases, gastrointestinal hemorrhage or perforation. Ulcerative esophagitis, eosinophilic colitis, allergic sialadenitis, and pancreatitis have been reported. Heartburn and stomatitis have been reported in patients receiving the controlled release formulation of naproxen.

Because peptic irritation may be asymptomatic, occasional monitoring of the hematocrit and of the stool for occult blood loss is recommended.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Naproxen should be used with caution in these patients.

A new study reports that the combination of naproxen and alendronate have a synergistic effect in the development of gastric ulcers.

Hepatic

Elevations in liver function tests three times normal values occur in less than 1% of patients. Naproxen-induced hepatitis has been associated with fatal outcome in some cases.

In patients with liver disease, frequent monitoring of the liver function tests during naproxen therapy is recommended.

Hepatic side effects have included elevations in liver function tests (15%), jaundice, and hepatitis.

Nervous system

Nervous system side effects have included inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, and cognitive dysfunction.

Renal

Renal side effects have included the development of mild renal insufficiency, nephrotic syndrome (with or without renal failure), acute renal failure due to tubulointerstitial nephritis, papillary necrosis, and acute tubular necrosis. Hypersensitivity may play a role in some cases of renal failure.

A 52-year-old male developed cutaneous necrotizing vasculitis, renal failure, and nephrotic syndrome following administration of naproxen 250 mg every 12 hours and dicloxacillin 250 mg every six hours for three days for the treatment of a blunt injury to the leg. Renal pathology was suggestive of a hypersensitivity angiitis. Symptoms resolved following discontinuation of naproxen.

Naproxen may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for naproxen-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.

Patients with reduced renal function may be at increased risk for renal side effects.

Cardiovascular

Cardiovascular side effects have included peripheral edema (3% to 9%) and palpitations (3%). Blood pressure may be elevated by naproxen, which may have clinical relevance in patients with comorbid illnesses. Dyspnea has been reported in patients receiving controlled release naproxen. An increased risk of cardiovascular events has been observed in preliminary study results from a clinical trial conducted by the National Institute of Aging evaluating the use of NSAIDs in patients at risk of developing Alzheimer's disease.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk of the initiation of antihypertensive therapy. NSAIDs may antagonize the blood-pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

The cumulative rate of serious cardiovascular thromboembolic adverse events (heart attacks, angina pectoris, and peripheral vascular events) observed in the Vioxx Gastrointestinal Outcomes research (Vigor) study was reported by a smaller percentage of patients taking naproxen compared to rofecoxib (0.6% vs 1.8% respectively).

Preliminary results of a clinical trial evaluating the use of nonsteroidal anti-inflammatory drugs in patients at risk of developing Alzheimer's disease has shown some evidence of increased risk of cardiovascular events in the group of patients on naproxen, when compared to placebo. The National Institute of Health stopped the study.

Hematologic

Hematologic side effects have included platelet dysfunction resulting in increased bleeding times, decreased hematocrit (1% to 2%), eosinophilia, granulocytopenia, neutropenia, leukopenia, thrombocytopenia, and agranulocytosis. Aplastic anemia and hemolytic anemia have also been reported, causality is unknown.

Hypersensitivity

Hypersensitivity side effects have been reported rarely. These may result in an erythematous or urticarial rash, angioedema, and bronchospasm, especially in patients with aspirin-sensitive asthma. Anaphylactoid reactions have been reported as well. Hypersensitivity has been implicated in cases of renal failure, pneumonitis, and colitis.

Dermatologic

Excessive sun exposure may play a role in cases of skin eruptions resembling porphyria cutanea tarda. Biochemical evidence of porphyria, such as elevated serum porphyrins, is lacking in these cases. Photosensitivity reactions have also been associated with lesions resembling those of epidermolysis bullosa.

Although rarely reported with the use of naproxen, a 14-year-old girl is diagnosed with periareolar fixed drug eruption after taking naproxen during menses for dysmenorrhea.

Dermatologic side effects have included pruritus (3% to 9%), ecchymoses (3% to 9%), purpura, rash, and photosensitivity. Rare cases of pseudoporphyria cutanea tarda, toxic epidermal necrolysis, generalized bullous fixed drug eruption, erythema multiforme, and Stevens-Johnson syndrome have also been reported. Skin eruptions have been reported in patients receiving the controlled release formulation of naproxen.

Respiratory

Respiratory side effects have included bronchospasm. Rarely, cases of eosinophilic pneumonitis have been reported.

Several cases of pulmonary infiltration accompanied by eosinophilia have been reported in the literature. Fever, malaise, and respiratory symptoms are typically present. Discontinuation of naproxen results in resolution of symptoms.

Other

Other side effects have included tinnitus, altered hearing, vertigo, visual disturbances, and keratopathy. Increased thirst has been reported in patients receiving the controlled release naproxen.

Metabolic

Metabolic side effects have rarely included hypoglycemia and hyperglycemia.

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