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Naproxen Side Effects

For the Consumer

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

As well as its needed effects, naproxen may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking naproxen, check with your doctor immediately:

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

Rare

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

Minor Side Effects

Some naproxen side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

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

Rare

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

Very common (10% or more): Dyspepsia (14%), heartburn, nausea, constipation Common (1% to 10%): Diarrhea, abdominal pain Very rare (less than 0.01%): Pancreatitis Frequency not reported: Flatulence, gastritis, vomiting, dysphagia, stomatitis, abdomen enlarged, eructation, GI hemorrhage, rectal hemorrhage, aphthous, mouth ulcer, stomach ulcer, cardiospasm, colitis, esophagitis, gastroenteritis, GI disorder, rectal disorder, tooth disorder, melena esophageal ulcer, hematemesis, non-peptic GI ulceration, ulcerative stomatitis, sialadenitis, colitis Postmarketing reports: Inflammation, bleeding, ulceration, perforation, obstruction, exacerbation of inflammatory bowel disease [Ref ]

Hepatic

Rare (less than 0.1%): Hepatitis, jaundice Frequency not reported: Cholecystitis, cholelithiasis, hepatosplenomegaly, liver function abnormality, SGOT increased, SGPT increased, elevated liver enzymes [Ref ]

Nervous system

Very common (10% or more): Headache (15%) Common (1% to 10%): Drowsiness, dizziness Uncommon (0.1% to 1%): Cognitive dysfunction, poor concentration Very rare (less than 0.01%): Convulsions, stroke Frequency not reported: Paresthesia, lightheadedness, migraine, syncope, hypertonia, neuralgia, neuritis, amnesia, paralysis [Ref ]

Renal

Very rare (less than 0.01%): Glomerular nephritis, interstitial nephritis, nephrotic syndrome, renal papillary necrosis Frequency not reported: Kidney function abnormality, pyelonephritis, creatinine increased, glucosuria, albuminuria, BUN increased, renal failure, renal disease, kidney pain, nephrosclerosis, kidney failure, kidney calculus, nephropathy [Ref ]

Cardiovascular

Uncommon (0.1% to 1%): Palpitations Rare (0.01% to 0.1%): Vasculitis Very rare (less than 0.01%): Arterial thrombotic events, myocardial infarction Frequency not reported: Hypertension, angina pectoris, coronary artery disease, deep thrombophlebitis, vasodilation, vascular anomaly, arrhythmia, bundle branch block, abnormal ECG, right heart failure, hemorrhage, aortic stenosis, tachycardia, congestive heart failure Postmarketing reports: Cardiac failure [Ref ]

Hematologic

Rare (0.01% to 0.1%): Hemolytic anemia Very rare (less than 0.01%): Granulocytopenia, thrombocytopenia, agranulocytosis Frequency not reported: Anemia, aplastic anemia, leukopenia, bleeding time increased, eosinophilia, abnormal RBC, abnormal WBC, neutropenia, pancytopenia [Ref ]

Hypersensitivity

Rare (less than 0.1%): Allergic reaction, anaphylactoid/anaphylaxis reaction, hypersensitivity reaction [Ref ]

Dermatologic

Common (1% to 10%): Ecchymosis, rash, skin eruptions, pruritus, purpura Uncommon (0.1% to 1%): Urticaria, photosensitivity Rare (0.01% to 0.1%): Alopecia, pseudo-porphyria Very rare (less than 0.01%): Toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, epidermolysis bullosa Frequency not reported: Angioneurotic edema/angioedema, angiodermatitis, dry skin, sweating, skin ulcer, acne, contact dermatitis, eczema, skin necrosis, subcutaneous nodule, photosensitive dermatitis, porphyria cutaneous tarda, nail disorder, epidermal necrosis, exfoliative dermatoses, bullous dermatoses, lichen planus Postmarketing reports: Erythema nodosum, fixed drug eruption, pustular reaction, bullous reactions [Ref ]

Respiratory

Common (1% to 10%): Pharyngitis, rhinitis, dyspnea Rare (less than 0.1%): Aggravated asthma, eosinophilic pneumonitis Frequency not reported: Bronchitis, cough increased, asthma, pulmonary edema, laryngitis, lung disorder, epistaxis, pneumonia, respiratory distress, respiratory disorder, bronchospasm, sore throat [Ref ]

Other

Very common (10% or more): Influenza-like syndrome (10%) Common (1% to 10%): Infection, edema, tinnitus, fatigue Rare (0.01% to 0.1%): Hearing impairment Very rare (less than 0.01%): Aseptic meningitis Frequency not reported: Fever, accidental injury, asthenia, chest pain, peripheral edema, hearing disturbances, thirst, abscess, cellulitis, malaise, mucous membrane disorder, periodontal abscess, necrosis, aseptic meningitis, chills, weight increased, otitis media, deafness, ear disorder, herpes simplex, herpes zoster, vertigo, subdural hematoma, exacerbation of Parkinson's disease [Ref ]

Metabolic

Rare (less than 0.1%): Hyperkalemia Frequency not reported: Hyperglycemia, anorexia, hypoglycemia, hypercholesteremia, alkalosis, dehydration, glucose tolerance increase, hyperuricemia, hypokalemia [Ref ]

Endocrine

Postmarketing reports: Infertility [Ref ]

General

The most frequently reported adverse events were headache, dyspepsia, nausea, constipation, heartburn, abdominal pain, and influenza-like syndrome. [Ref ]

Genitourinary

Common (1% to 10%): Urinary tract infection Very rare (less than 0.01%): Hematuria Frequency not reported: Cystitis, monilia, pelvic pain, dysmenorrhea, dysuria, nocturia, prostate disorder, urinary incontinence, menorrhagia, menstrual disorders, vaginitis, uterine spasm, urinary retention, urinary frequency, abnormal urine, pyuria, metrorrhagia [Ref ]

Musculoskeletal

Common (1% to 10%): Back pain Rare (less than 0.1%): Myalgia, muscle weakness Frequency not reported: Leg cramps, arthralgia, joint disorder, tendon disorder, neck rigid/pain, LE syndrome, myasthenia, bone disorder, spontaneous bone fracture, fibrotendinitis, bone pain, spasm, bursitis Postmarketing reports: Systemic lupus erythematosus [Ref ]

Ocular

Common (1% to 10%): Visual disturbances Frequency not reported: Ptosis, amblyopia, scleritis, cataract, conjunctivitis, keratoconjunctivitis, lacrimation disorder, eye pain, diplopia, retrobulbar optic neuritis Postmarketing reports: Corneal opacity, papillitis, papilledema [Ref ]

Oncologic

Frequency not reported: Carcinoma, breast carcinoma, breast neoplasm, skin neoplasm [Ref ]

Psychiatric

Common (1% to 10%): Confusion Uncommon (0.1% to 1%): Depression, dream abnormalities, mood alterations Frequency not reported: Insomnia, anxiety, nervousness, emotional lability, hallucinations [Ref ]

References

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

2. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www. mhra. gov. uk/Safetyinformation/DrugSafetyUpdate."

3. "Product Information. Naprelan 375 (naproxen)." Shionogi USA Inc, Florham Park, NJ.

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

6. "Product Information. Naprosyn (naproxen)." Syntex Laboratories Inc, Palo Alto, CA.

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

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