Aleve

naproxen sodium

By Bayer

What side effects are possible with this medication?

A side effect is an unwanted response to a medication when it is taken in normal doses and cannot be anticipated. It can be mild or severe, temporary or permanent, but does not occur in everyone. The following side effects have been reported by at least 1% of people taking this medication. If you develop any of these side effects (or any other side effects not listed here) or they change in intensity, speak to your doctor or pharmacist for advice on managing them and on the risks and benefits of the medication.

  • abdominal pain
  • back pain
  • confusion
  • constipation
  • coughing
  • diarrhea
  • difficulty breathing
  • difficulty swallowing
  • difficulty urinating
  • dizziness
  • dry mouth
  • drowsiness
  • gas
  • hair loss
  • headache
  • hearing or vision changes
  • heart palpitations or flutters
  • heartburn
  • higher than normal blood pressure readings
  • higher than normal blood sugar readings
  • increased sweating
  • increased thirst
  • insomnia
  • itching
  • lightheadedness
  • menstrual problems
  • migraine
  • nausea
  • racing heart rate
  • rectal bleeding
  • respiratory infection
  • ringing in the ears
  • runny nose
  • skin infections (e.g., herpes simplex)
  • skin rash (mild)
  • sore throat
  • stuffy nose
  • swelling of the legs, ankles, or feet
  • vertigo
  • vomiting
  • weight gain
Click here to learn about serious side effects that can potentially occur with any medication. These examples are provided for information purposes only and are not meant to be exhaustive. Always consult your doctor for sound medical advice specific to your particular medication and treatment.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone at 1-800-332-1088.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: In rare cases, some people may develop an allergic reaction to this medication. This is more common in people who have asthma, nasal polyps, or are allergic to aspirin. Signs of an allergic reaction include a severe rash (that may include blisters and fever), a swollen face or throat, or difficulty breathing. If these occur, stop using naproxen and get emergency medical care.

Anemia: Naproxen may cause or worsen anemia (loss of red blood cells). Your doctor will check your blood for anemia regularly while you are taking this medication. If you experience symptoms of anemia (e.g., weakness, tiredness, looking pale, fast heart rate), contact your doctor immediately. If you have anemia, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Asthma: If you have asthma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Blood pressure: This medication may cause increased blood pressure. You should be closely monitored by your doctor while taking this medication if you have high blood pressure.

Heart attack and stroke: People who take NSAIDs or COX-2 inhibitors have a higher risk of experiencing a heart attack and stroke, which may result in hospitalization and even death. The risk for these side effects is higher with larger total daily doses and longer treatment periods. If you have heart disease or are at high risk of developing heart disease, use the lowest possible dose of naproxen. If you have heart conditions, high blood pressure, or are planning to have open heart (bypass) surgery, you should be closely monitored by your doctors while taking this medication.

If you notice any of these symptoms, seek medical attention immediately: shortness of breath, chest pain, slurred speech, weakness on one side of your body, and swelling of the face or throat.

Heart failure and fluid retention: People with heart failure, high blood pressure, or fluid retention may experience edema (swelling of the lower legs, ankles, and feet) or shortness of breath while taking NSAIDs (such as this medication) or COX-2 inhibitors. If you develop any of these symptoms while taking this medication, contact your doctor immediately.

If you have heart failure, discuss with your doctor how this medication may affect your condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

High blood pressure: The use of NSAIDs such as naproxen can cause or worsen high blood pressure. If you have high blood pressure (hypertension), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney disease: Long-term use of naproxen or other NSAIDs can cause kidney damage and is not recommended. This is most common for people who already have kidney disease, liver disease, or heart failure; for people who take diuretics (water pills); and for seniors. In general, NSAIDs and COX-2 inhibitors are not recommended if you have severe kidney disease or limited kidney function.

If you have kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver disease: Naproxen may increase your liver test results and worsen liver disease. If you have liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Risk of bleeding: This medication can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding.

Skin reactions: This medication has been associated with serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). If you notice symptoms including a rash, itching, blistering, or peeling skin, stop using this medication and contact your doctor right away.

Stomach problems: Stomach ulcers, perforation, and bleeding from the stomach have been known to occur while taking naproxen. These complications can occur at any time, and are sometimes severe enough to require immediate medical attention. The risk of stomach ulcers is increased for those with a history of peptic ulcer disease or gastrointestinal bleeding, with higher total daily doses and longer treatment periods, for those who smoke, use alcohol, are older, or are generally in poorer health. To reduce this risk, use the lowest effective dose for the shortest possible duration.

Naproxen should be taken under close medical supervision by people who are taking oral corticosteroids or anticoagulants, require long term therapy with NSAIDs, smoke, use alcohol, are older, are generally in poorer health, or are prone to irritation of the stomach and intestines.

Naproxen should be taken under particularly close medical supervision by those who have had a stomach ulcer, bloody stools, or diverticulosis or other inflammatory diseases of the stomach or intestines (such as ulcerative colitis or Crohn's disease). In these cases, your doctor must weigh the benefits of treatment against the possible risks.

Stop taking the medication and contact your doctor immediately if you experience symptoms or signs of stomach ulcers or bleeding in the stomach (black, tarry stools). These reactions can occur at any time during treatment without warning.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, stop taking it immediately and call your doctor.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking this medication, talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children less than 2 years of age.

Seniors: Seniors who take this medication should be closely monitored by their doctors. Seniors may be more likely to develop side effects and may require a lower dose.

What other drugs could interact with this medication?

There may be an interaction between naproxen sodium and any of the following:

  • ACE inhibitors (e.g., enalapril, ramipril)
  • alcohol
  • angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan)
  • antacids
  • aspirin and other salicylate medications
  • beta-blockers (e.g., propranolol)
  • cholestyramine
  • corticosteroids (e.g., prednisone)
  • furosemide
  • hydantoins
  • lithium
  • methotrexate
  • other NSAIDs (e.g., ibuprofen, etodolac)
  • probenecid
  • selective serotonin reuptake inhibitor (SSRI) antidepressants (e.g., citalopram, sertraline)
  • sucralfate
  • sulphonylureas
  • thiazide diuretics (e.g., hydrochlorothiazide)
  • warfarin

Extended-release formulations of naproxen sodium should not be taken with H2-blockers, sucralfate, and intensive antacid therapy.

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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The contents of this health site are for informational purposes only. Always seek the advice of your physician or other qualified healthcare provider regarding any questions you may have about a medical condition.

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