Naproxen / pseudoephedrine Side Effects

It is possible that some side effects of naproxen / pseudoephedrine may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to naproxen / pseudoephedrine: tablets

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; gas; heartburn; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur while taking naproxen / pseudoephedrine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of appetite; mood or mental changes; numbness of an arm or leg; 1-sided weakness; pale stools; persistent trouble sleeping; red, swollen, blistered, or peeling skin; restlessness; ringing in the ears or hearing changes; seizures; severe dizziness, light-headedness, or headache; severe drowsiness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; tremor; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of skin or eyes.

For Healthcare Professionals

Applies to naproxen / pseudoephedrine: oral tablet extended release

Cardiovascular

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.

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.[Ref]

Cardiovascular side effects have included tachycardia and elevation of blood pressure, 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.[Ref]

Gastrointestinal

Gastrointestinal (GI) side effects have been reported the most frequently with the use of naproxen. 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. The GI side effects associated with the use of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat have occurred in up to 15% of patients.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Nervous system

Nervous system side effects have included insomnia in up to 30% of patients taking pseudoephedrine. Tremor, anxiety, nervousness, and headache have also been reported. Depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, inability to concentrate, and cognitive dysfunction have been reported with the use of naproxen.[Ref]

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.[Ref]

Dermatologic side effects have included pruritus, ecchymoses, 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.[Ref]

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. Fixed drug eruptions have been reported with the use of pseudoephedrine.[Ref]

Respiratory

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.[Ref]

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

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.[Ref]

References

1. "Product Information. Aleve Cold and Sinus (naproxen-pseudoephedrine)." Bayer Pharmaceutical Inc, West Haven, CT.

2. "Product Information. Anaprox (naproxen)." Roche Laboratories, Nutley, NJ.

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