Aflaxen Side Effects

Generic Name: naproxen

Note: This page contains information about the side effects of naproxen. Some of the dosage forms included on this document may not apply to the brand name Aflaxen.

Not all side effects for Aflaxen may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to naproxen: oral capsule liquid filled, oral suspension, oral tablet, oral tablet enteric coated, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by naproxen (the active ingredient contained in Aflaxen). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking naproxen:

More common
  • Belching
  • bruising
  • difficult or labored breathing
  • feeling of indigestion
  • headache
  • itching skin
  • large, flat, blue, or purplish patches in the skin
  • pain in the chest below the breastbone
  • shortness of breath
  • skin eruptions
  • stomach pain
  • swelling
  • tightness in the chest
  • wheezing
Less common
  • Bloating
  • bloody or black, tarry stools
  • blurred or loss of vision
  • burning upper abdominal or stomach pain
  • cloudy urine
  • constipation
  • decrease in urine output or decrease in urine-concentrating ability
  • disturbed color perception
  • double vision
  • fast, irregular, pounding, or racing heartbeat or pulse
  • halos around lights
  • indigestion
  • loss of appetite
  • nausea or vomiting
  • night blindness
  • overbright appearance of lights
  • pale skin
  • pinpoint red or purple spots on the skin
  • severe and continuing nausea
  • severe stomach burning, cramping, or pain
  • skin rash
  • swelling or inflammation of the mouth
  • troubled breathing with exertion
  • tunnel vision
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of material that looks like coffee grounds
  • weight loss
  • Anxiety
  • back or leg pains
  • bleeding gums
  • blindness
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • blue lips and fingernails
  • canker sores
  • change in the ability to see colors, especially blue or yellow
  • chest pain or discomfort
  • clay-colored stools
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • cough or hoarseness
  • coughing that sometimes produces a pink frothy sputum
  • cracks in the skin
  • darkened urine
  • decreased vision
  • depression
  • diarrhea
  • difficult, burning, or painful urination
  • difficult, fast, or noisy breathing
  • difficulty with swallowing
  • dilated neck veins
  • dizziness
  • dry cough
  • dry mouth
  • early appearance of redness, or swelling of the skin
  • excess air or gas in the stomach
  • extreme fatigue
  • eye pain
  • fainting
  • fever with or without chills
  • fluid-filled skin blisters
  • flushed, dry skin
  • frequent urination
  • fruit-like breath odor
  • greatly decreased frequency of urination or amount of urine
  • hair loss
  • high fever
  • hives
  • increased hunger
  • increased sensitivity of the skin to sunlight
  • increased sweating
  • increased thirst
  • increased urination
  • increased volume of pale, dilute urine
  • irregular breathing
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • late appearance of rash with or without weeping blisters that become crusted, especially in sun-exposed areas of skin, may extend to unexposed areas
  • light-colored stools
  • lightheadedness
  • loss of heat from the body
  • lower back or side pain
  • nervousness
  • nightmares
  • no blood pressure
  • no breathing
  • no pulse
  • nosebleeds
  • numbness or tingling in the hands, feet, or lips
  • pain in the ankles or knees
  • pain or burning in the throat
  • pain or discomfort in the arms, jaw, back, or neck
  • painful, red lumps under the skin, mostly on the legs
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale or blue lips, fingernails, or skin
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid, shallow breathing
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • red-green color blindness
  • redness or other discoloration of the skin
  • redness, swelling, or soreness of the tongue
  • scaly skin
  • seizures
  • severe sunburn
  • shakiness
  • skin thinness
  • slurred speech
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • sores, welting, or blisters
  • spots on your skin resembling a blister or pimple
  • stiff neck or back
  • stomach cramps or tenderness
  • stomach upset
  • swelling in the legs and ankles
  • swelling of the face, fingers, feet, or lower legs
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tiny bumps on the inner lining of the eyelid
  • unexplained weight loss
  • unpleasant breath odor
  • watery or bloody diarrhea
  • weakness or heaviness of the legs
  • weight gain
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking naproxen, get emergency help immediately:

Symptoms of overdose
  • Bleeding under the skin
  • confusion about identity, place, and time
  • muscle tremors
  • restlessness
  • sleepiness

Some of the side effects that can occur with naproxen may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Continuing ringing or buzzing or other unexplained noise in the ears
  • hearing loss
Less common
  • Acid or sour stomach
  • change in hearing
  • feeling of constant movement of self or surroundings
  • passing gas
  • sensation of spinning
  • stomach soreness or discomfort
  • Appetite changes
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • burning, dry, or itching eyes
  • difficulty with moving
  • discharge, excessive tearing
  • general feeling of discomfort or illness
  • lack or loss of strength
  • menstrual changes
  • muscle aching, cramping, stiffness, or weakness
  • not able to concentrate
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • seeing, hearing, or feeling things that are not there
  • shakiness in the legs, arms, hands, or feet
  • sleeplessness
  • swollen joints
  • trembling or shaking of the hands or feet
  • trouble getting pregnant
  • trouble performing routine tasks
  • trouble sleeping
  • unable to sleep
  • unusual drowsiness, dullness, or feeling of sluggishness

For Healthcare Professionals

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


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 (the active ingredient contained in Aflaxen)

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.


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 (the active ingredient contained in Aflaxen) 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 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 side effects have included peripheral edema (3% to 9%) and palpitations (3%). Blood pressure may be elevated by naproxen (the active ingredient contained in Aflaxen) 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 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 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 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 (the active ingredient contained in Aflaxen)

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.


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 side effects have included tinnitus, altered hearing, vertigo, visual disturbances, and keratopathy. Increased thirst has been reported in patients receiving the controlled release naproxen (the active ingredient contained in Aflaxen)


Metabolic side effects have rarely included hypoglycemia and hyperglycemia.

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