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Aleve Back and Muscle Pain Side Effects

Generic name: naproxen

Medically reviewed by Last updated on Oct 18, 2021.

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

Applies to naproxen: oral conventional and delayed-release tablets, oral extended-release tablets, oral suspension, oral tablets containing delayed-release naproxen and immediate-release esomeprazole, oral tablets containing naproxen sodium and sumatriptan.


    Cardiovascular Risk
  • Increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).225 500 502 Risk may occur early in treatment and may increase with duration of use.225 500 502 505 506 (See Cardiovascular Thrombotic Effects under Cautions.)

  • Contraindicated in the setting of CABG surgery.225

    GI Risk
  • Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).225 Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.225 Geriatric individuals and patients with a history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.225 (See GI Effects under Cautions.)

Side effects include:

Abdominal pain, dyspepsia, edema, ecchymoses, flu-like syndrome, headache, nausea, rash.

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.


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]


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]


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]


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]


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]


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


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]


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]


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]


Rare (less than 0.1%): Hyperkalemia

Frequency not reported: Hyperglycemia, anorexia, hypoglycemia, hypercholesteremia, alkalosis, dehydration, glucose tolerance increase, hyperuricemia, hypokalemia[Ref]


Postmarketing reports: Infertility[Ref]


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


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]


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]


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]


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


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


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

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

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. 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.