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, 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.

Use Orudis (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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.

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 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.

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).