EC-Naprosyn Side Effects

Generic name: naproxen

Medically reviewed by Drugs.com. Last updated on Oct 8, 2024.

Note: This document provides detailed information about EC-Naprosyn Side Effects associated with naproxen. Some dosage forms listed on this page may not apply specifically to the brand name EC-Naprosyn.

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

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease or in people who use this medicine for a longer time.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (eg, steroid medicine, blood thinner).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)can occur during treatment with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Some possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs, severe stomach pain, black, tarry stools, or vomiting of blood or material that looks like coffee grounds, unusual weight gain, yellow skin or eyes, decreased urination, unusual bleeding or bruising, or skin rash. Also, signs of serious heart problems could occur including chest pain or tightness fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Check with your doctor immediately if you notice any of these warning signs.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

This medicine may also cause serious allergic reaction called anaphylaxis, which can be life-threatening and requires medical attention. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Using this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert. .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of EC-Naprosyn

Along with its needed effects, naproxen (the active ingredient contained in EC-Naprosyn) 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:

Get emergency help immediately if any of the following symptoms of overdose occur while taking naproxen:

Symptoms of overdose

• bleeding under the skin
• confusion about identity, place, and time
• muscle tremors
• restlessness
• sleepiness

Other side effects of EC-Naprosyn

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:

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.

General adverse events

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

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]

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]

See also:

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Further information

EC-Naprosyn side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer