Applies to naproxen / pseudoephedrine: oral tablet extended release.
Naproxen can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Naproxen may also cause stomach or intestinal bleeding, which can be fatal.
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, feeling light-headed, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.
Stop using this medicine and call your doctor at once if you have:
severe dizziness or nervousness, trouble sleeping;
swelling, rapid weight gain;
shortness of breath;
new or worsening stomach pain; or
signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Common side effects may include:
heartburn, stomach pain, nausea, vomiting;
sleep problems (insomnia); or
feeling nervous or excited.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to naproxen/pseudoephedrine: oral tablet extended release.
The manufacturer has not provided adverse event information.[Ref]