Aleve

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Aleve (Naproxen-sodium). If you are concerned about side effects, discuss the risks and benefits of Aleve (Naproxen-sodium) with your doctor.

The following side effects have been reported by at least 1% of people taking Aleve (Naproxen-sodium). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bloating
• Constipation
• Diarrhea
• drowsiness
• heartburn
• lightheadedness
• nausea
• ringing or buzzing in the ears
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• asthma (e.g., wheezing, shortness of breath, chest tightness)
• swelling of the feet or lower legs
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• vomiting blood
• bloody or black tarry stools
• severe stomach pain
• symptoms of an allergic reaction (Hives; itching; difficulty breathing; swelling of the face, mouth, tongue, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Aleve (Naproxen-sodium).

Each caplet contains naproxen sodium 220 mg, of which 20 mg is sodium. Nonmedicinal ingredients: FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide, and talc.

Do not take Aleve (Naproxen-sodium) if you:

• are allergic to naproxen, naproxen sodium, or any ingredients of the medication
• are in the third trimester (last 3 months) of pregnancy
• have an active stomach ulcer, a history of recurrent ulceration, or a bleeding ulcer in the stomach or intestines
• have had Asthma, an allergic reaction, or allergic-type reaction (e.g., nasal polyps; runny nose; sinus congestion; difficulty breathing; wheezing; itchy skin rash; swelling of the face, throat, or tongue) to Asa or any other nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., Ibuprofen, Ketorolac, Indomethacin)
• have inflammatory bowel disease (e.g., Ulcerative Colitis, Crohn's Disease)
• have severely reduced kidney function
• have severely reduced liver function or active liver disease

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

• acetylsalicylic acid (ASA)
• alcohol
• Aliskiren
• alteplase
• aminoglycoside antibiotics (e.g., Amikacin, gentamicin, tobramycin)
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, Enalapril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., Candesartan, Irbesartan, Losartan)
• Apixaban
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• Bimatoprost
• bisphosphonates (e.g., Alendronate, etidronate)
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Celecoxib
• Cholestyramine
• Colestipol
• Colesevelam
• Clopidogrel
• oral corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• dabigatran
• Dasatinib
• Deferasirox
• Desmopressin
• Digoxin
• Dipyridamole
• diuretics (e.g., Spironolactone, triamterene, Furosemide, Hydrochlorothiazide)
• Edoxaban
• Eplerenone
• glucosamine
• Haloperidol
• Heparin
• Hydralazine
• Latanoprost
• lithium
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• Mesalamine
• Methotrexate
• multivitamins with Vitamin A, D, E
• other NSAIDs (e.g., ketorolac, ibuprofen, Diclofenac)
• Obinutuzumab
• omega-3 fatty acids
• Pemetrexed
• Pentoxifylline
• Porfimer
• Prasugrel
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• Rivaroxaban
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• sodium phosphates
• Sulfasalazine
• Tacrolimus
• tenofovir
• Ticagrelor
• Ticlopidine
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• urokinase
• vancomycin
• warfarin

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 Aleve (Naproxen-sodium). 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.

Before you begin taking 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 Aleve (Naproxen-sodium).

Allergic reactions: Aleve (Naproxen-sodium) should not be given to people who have had a reaction to acetylsalicylic acid (ASA) that included a runny nose, itchy skin rash, nasal polyps, or shortness of breath and wheezing. If you experience symptoms of a Anaphylaxis (severe allergic reaction) (e.g., hives; difficulty breathing; wheezing; swelling of the face, tongue, or throat), get immediate medical attention. If you have a history of asthma, runny nose not caused by the common cold, or nasal polyps, discuss with your doctor how Aleve (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aleve (Naproxen-sodium), and whether any special monitoring is needed.

Blood clotting: Aleve (Naproxen-sodium) may reduce the ability of the blood to clot for some people. If you are taking acetylsalicylic acid (ASA) or blood thinners (e.g., Warfarin), discuss with your doctor or pharmacist how Aleve (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aleve (Naproxen-sodium), and whether any special monitoring is needed.

If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Drowsiness/reduced alertness: As with other NSAIDs, naproxen sodium can cause drowsiness, dizziness, blurred vision, and ringing in the ears. Avoid driving and other activities that require alertness and concentration until you determine how Aleve (Naproxen-sodium) affects you.

Heart failure and high blood pressure: NSAIDs such as naproxen sodium can cause fluid retention and edema (swelling). This can lead to high blood pressure or worsening of heart failure. If you have heart failure or high blood pressure, discuss with your doctor or pharmacist how Aleve (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aleve (Naproxen-sodium), and whether any special monitoring is needed.

Ulcers or bleeding in the stomach or intestines: NSAIDs such as naproxen sodium can cause stomach ulcers and bleeding from the stomach. If you have a history of these conditions, discuss with your doctor or pharmacist how Aleve (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aleve (Naproxen-sodium), and whether any special monitoring is needed. People with inflammatory bowel disease, such Crohn's disease or ulcerative colitis or those who have ulcers in the stomach or intestines that are bleeding, should not take Aleve (Naproxen-sodium).

If you experience symptoms of bleeding in the digestive system, such as black, tarry stools or stomach pain, contact your doctor immediately.

Pregnancy: Aleve (Naproxen-sodium) should not be used during the third trimester (last 3 months) of pregnancy. Aleve (Naproxen-sodium) should not be used during the first and second trimester (first 6 months) of pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Aleve (Naproxen-sodium), contact your doctor immediately.

Aleve (Naproxen-sodium) may reduce your ability to become pregnant. Taking Aleve (Naproxen-sodium) while trying to become pregnant is not recommended.

Breast-feeding: Aleve (Naproxen-sodium) passes into breast milk. If you are a breast-feeding mother and are taking naproxen sodium, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Aleve (Naproxen-sodium) have not been established for children under 12 years of age.

Seniors: Seniors appear to have a higher risk of side effects. If you are over the age of 65, use the lowest effective dosage under close medical supervision. Ask your doctor or pharmacist about all available treatment options that may be right for you.