Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat pain or inflammation caused by arthritis.

The ketoprofen regular capsule is also used to treat mild to moderate pain, or menstrual pain.

Only ketoprofen extended-release capsules are used for treating arthritis. This form of ketoprofen will not work fast enough to treat acute (immediate) pain.

Ketoprofen may also be used for purposes not listed in this medication guide.

Ketoprofen can increase your risk of fatal heart attack or stroke. Do not use ketoprofen just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Ketoprofen may also cause stomach or intestinal bleeding, which can be fatal.

Prescription ketoprofen comes as a capsule and extended-release (long-acting) capsule to take by mouth. The capsules are usually taken three or four times a day for arthritis or every 6 to 8 hours as needed for pain. The extended-release capsules are usually taken once daily. If you take ketoprofen regularly, take it at around the same times every day.

Nonprescription ketoprofen comes as a tablet to take by mouth. It is usually taken with a full glass of water or other liquid every 4 to 6 hours as needed.

Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ketoprofen exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or written on the label.

Ketoprofen may be taken with food or milk to prevent upset stomach. Your doctor may also recommend that you take ketoprofen with an antacid to reduce stomach upset.

Your doctor may start you on an average dose of prescription ketoprofen and may increase or decrease on your dose depending on how well you respond to the medication and the side effects you experience. Follow these directions carefully.

Stop taking nonprescription ketoprofen and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, the part of your body that was painful becomes red or swollen, your pain lasts for more than 10 days or your fever lasts for more than 3 days.

Use exactly as directed on the label, or as prescribed by your doctor. Use the lowest dose that is effective in treating your condition.

Ketoprofen may be taken with food or milk if it upsets your stomach.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you use ketoprofen long-term, you may need frequent medical tests.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Ketoprofen can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ketoprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ketoprofen, especially in older adults.

You should not use ketoprofen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor or pharmacist if this medicine is safe to use if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

• a heart attack, stroke, or blood clot;

• stomach ulcers or bleeding;

• asthma;

• liver or kidney disease; or

• fluid retention.

If you are pregnant, you should not take ketoprofen unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Ask a doctor before using this medicine if you are breastfeeding.

Ketoprofen is not approved for use by anyone younger than 18 years old.

Since ketoprofen is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Do not take ketoprofen regular capsules and extended-release capsules at the same time.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to ketoprofen (such as aspirin, ibuprofen, or naproxen).

Get emergency medical help if you have signs of an allergic reaction (sneezing, runny or stuffy nose, hives, wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with 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, feeling short of breath.

Ketoprofen may cause serious side effects. Stop using ketoprofen and call your doctor at once if you have:

• shortness of breath (even with mild exertion);

• swelling or rapid weight gain;

• nausea, diarrhea, flu-like symptoms (fever, swollen glands, muscle aches, severe weakness);

• a skin rash, no matter how mild;

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of ketoprofen may include:

• heartburn, stomach pain, gas, nausea, vomiting;

• diarrhea, constipation; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using ketoprofen if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist before using ketoprofen with any other medications, especially:

• lithium;

• methotrexate;

• probenecid;

• a blood thinner (warfarin, Coumadin, Jantoven);

• heart or blood pressure medication, including a diuretic or "water pill"; or

• steroid medicine (such as prednisone).

This list is not complete. Other drugs may affect ketoprofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking ketoprofen.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.