Nonsteroidal anti-inflammatory drugs (including naproxen) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while taking this drug but is more likely if you take it for a long time. The risk may be greater in older adults or if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). Do not take this drug right before or after heart bypass surgery (CABG).
This drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning at any time while taking this drug. Older adults may be at higher risk for this effect.
Stop taking this medication and get medical help right away if you notice any of these rare but serious side effects: stomach/abdominal pain that doesn't go away, black/tarry stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, trouble speaking, sudden vision changes.
Talk to your doctor or pharmacist about the benefits and risks of taking this drug.
See also Warning section.
Before taking this product, tell your doctor or pharmacist if you are allergic to naproxen or to sumatriptan; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), blood circulation problems (for example, in your legs, arms/hands, or stomach), blood disorders (such as anemia, bleeding/clotting problems), growths in the nose (nasal polyps), certain types of headaches (hemiplegic or basilar migraine), heart problems (such as chest pain, irregular heartbeat, previous heart attack), liver disease, seizure, stroke or "mini-stroke" (transient ischemic attack), throat/stomach/intestinal problems (such as bleeding, heartburn, ulcers), swelling (edema, fluid retention).
Certain conditions can increase your risk for heart problems. Tell your doctor if you have any of these conditions, including: high blood pressure, high cholesterol, diabetes, family history of heart disease, overweight, smoker, postmenopausal (women), age more than 40 years (men).
Kidney problems can sometimes occur with the use of NSAID medications, including naproxen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.
This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis).
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. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.
This product contains salt (sodium). Before using this drug, tell your doctor if you are limiting the amount of salt in your diet.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.
Older adults may be at greater risk for stomach/intestinal bleeding, increased blood pressure, kidney problems, heart attack, and stroke while using this drug.
Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.
These drugs pass into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
See also Warning section.
Flushing, feelings of tingling/numbness/prickling/heat, nausea, upset stomach, tiredness, weakness, drowsiness, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor right away if you have any serious side effects, including: blue fingers/toes/nails, cold hands/feet, difficult/painful swallowing, easy bleeding/bruising, hearing changes (such as ringing in the ears), mental/mood changes, signs of kidney problems (such as change in the amount of urine), symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).
Sumatriptan can commonly cause chest/jaw/neck tightness, pain, or pressure that is usually not serious. However, these side effects are like symptoms of a heart attack, which may include chest/jaw/left arm pain, shortness of breath, or unusual sweating. Get medical help right away if these or other serious side effects occur, including: fast/irregular heartbeat, fainting, severe stomach/abdominal pain, bloody diarrhea, seizure, signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion).
This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, dark urine, yellowing eyes/skin.
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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