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Aleve Side Effects

Generic name: naproxen

Medically reviewed by Drugs.com. Last updated on Oct 9, 2023.

Note: This document contains side effect information about naproxen. Some dosage forms listed on this page may not apply to the brand name Aleve.

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

Warning

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.

Serious side effects of Aleve

Along with its needed effects, naproxen (the active ingredient contained in Aleve) 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

Other side effects of Aleve

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.

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]

Frequently asked questions

References

1. Product Information. Naprosyn (naproxen). Syntex Laboratories Inc. 2002;PROD.

2. Product Information. Anaprox (naproxen). Roche Laboratories. 2006;PROD.

3. Cerner Multum, Inc. UK Summary of Product Characteristics.

4. Cerner Multum, Inc. Australian Product Information.

5. Product Information. Naprelan 375 (naproxen). Shionogi USA Inc. 2010.

6. MHRA. Medicines and Health Regulatory Agency. MHRA Drug Safety Update. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate 2013.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.