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Applies to naproxen: oral capsule liquid filled, oral suspension, oral tablet, oral tablet enteric coated, oral tablet extended release
Oral route (Tablet; Tablet, Enteric Coated; Suspension)
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen is contraindicated in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Elderly patients and patients with a history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Oral route (Tablet, Extended Release; Tablet)
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen sodium is contraindicated in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Elderly patients and patients with a history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Along with its needed effects, naproxen may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking naproxen:
More common
Less common
Rare
Get emergency help immediately if any of the following symptoms of overdose occur while taking naproxen:
Symptoms of overdose
Some side effects of naproxen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Rare
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
GastrointestinalVery 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
HepaticRare (less than 0.1%): Hepatitis, jaundice
Frequency not reported: Cholecystitis, cholelithiasis, hepatosplenomegaly, liver function abnormality, SGOT increased, SGPT increased, elevated liver enzymes
Nervous systemVery 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
RenalVery 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
CardiovascularUncommon (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
HematologicRare (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
HypersensitivityRare (less than 0.1%): Allergic reaction, anaphylactoid/anaphylaxis reaction, hypersensitivity reaction
DermatologicCommon (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
RespiratoryCommon (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
OtherVery 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
MetabolicRare (less than 0.1%): Hyperkalemia
Frequency not reported: Hyperglycemia, anorexia, hypoglycemia, hypercholesteremia, alkalosis, dehydration, glucose tolerance increase, hyperuricemia, hypokalemia
EndocrinePostmarketing reports: Infertility
GeneralThe most frequently reported adverse events were headache, dyspepsia, nausea, constipation, heartburn, abdominal pain, and influenza-like syndrome.
GenitourinaryCommon (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
MusculoskeletalCommon (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
OcularCommon (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
OncologicFrequency not reported: Carcinoma, breast carcinoma, breast neoplasm, skin neoplasm
PsychiatricCommon (1% to 10%): Confusion
Uncommon (0.1% to 1%): Depression, dream abnormalities, mood alterations
Frequency not reported: Insomnia, anxiety, nervousness, emotional lability, hallucinations
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/3/2022.
Source: Drugs.com Naproxen (www.drugs.com/naproxen.html).
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