NAPROXEN-ORAL (cont.)
SIDE EFFECTS: Upset stomach, nausea, vomiting, heartburn, headache, diarrhea, constipation, drowsiness, and dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: stomach pain, swelling of the hands or feet, sudden or unexplained weight gain, ringing in the ears (tinnitus). Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes, rapid or pounding heartbeat, easy bruising or bleeding. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: change in amount of urine, severe headache, very stiff neck, mental/mood changes, persistent sore throat or fever. This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. If you notice any of the following unlikely but very serious side effects, stop taking naproxen and consult your doctor or pharmacist immediately: black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds. This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking naproxen and consult your doctor or pharmacist immediately: yellowing eyes and skin, dark urine, unusual/extreme tiredness. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease, allergies to aspirin or other NSAIDs (e.g., ibuprofen, celecoxib). Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, poorly controlled diabetes, stomach problems (e.g., bleeding, ulcers), heart disease (e.g., congestive heart failure), high blood pressure, swelling (edema, fluid retention), dehydration, blood disorders (e.g., anemia), bleeding or clotting problems, asthma, growths in the nose (nasal polyps), history of an allergic reaction with symptoms of lip/tongue/throat swelling (angioedema), any allergies in addition to those listed above. This medication contains salt (sodium). Tell your doctor if you are on a salt-restricted diet. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Consult your doctor or pharmacist for more information. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially stomach bleeding and kidney effects. This medication should be used only when clearly needed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to the potential for fetal harm and interference with normal labor/delivery. Discuss the risks and benefits with your doctor. This drug passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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