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Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.
Do not use this medication if you are allergic to sulindac, or to aspirin or other NSAIDs.
Before taking sulindac, tell your doctor if you are allergic to any drugs, or if you have:
If you have any of these conditions, you may need a dose adjustment or special tests to safely take sulindac.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking sulindac during the last 3 months of pregnancy may result in birth defects. Do not take sulindac during pregnancy unless your doctor has told you to.
It is not known whether sulindac passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Do not give this medicine to a child without the advice of a doctor.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. The maximum amount of sulindac for adults is 400 milligrams (mg) per day. Know the amount of sulindac in the specific product you are taking.
If you take sulindac for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.
Store sulindac at room temperature, away from moisture, heat, and light.
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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