Brand Names: Actron, Orudis KT

Generic Name: ketoprofen (Pronunciation: kee toe PROE fen)

• What is ketoprofen (Orudis)?
• What are the possible side effects of ketoprofen (Orudis)?
• What is the most important information I should know about ketoprofen (Orudis)?
• What should I discuss with my healthcare provider before taking ketoprofen (Orudis)?
• How should I take ketoprofen (Orudis)?
• What happens if I miss a dose (Orudis)?
• What happens if I overdose (Orudis)?
• What should I avoid while taking ketoprofen (Orudis)?
• What other drugs will affect ketoprofen (Orudis)?
• Where can I get more information?

What is ketoprofen (Orudis)?

Ketoprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketoprofen works by reducing hormones that cause inflammation and pain in the body.

Ketoprofen is used to treat pain or inflammation caused by arthritis. It is also used to treat menstrual pain.

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

Ketoprofen 50 mg-ESI

green, imprinted with Lederle K2

Ketoprofen 50 mg-MYL

green, imprinted with MYLAN 4070

Ketoprofen 50 mg-TEV

blue/turquoise, imprinted with 93 3193

Ketoprofen 75 mg-ESI

white, imprinted with Lederle K3

Ketoprofen 75 mg-MYL

blue, imprinted with MYLAN 5750

Ketoprofen 75 mg-TEV

blue/white, imprinted with 93 3195

What are the possible side effects of ketoprofen (Orudis)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ketoprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
• black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• confusion, tremors or shaking;
• urinating less than usual or not at all;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;
• dizziness, headache, nervousness;
• skin itching or rash;
• dry mouth;
• increased sweating, runny nose;
• blurred vision; or
• ringing in your ears.

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.

What is the most important information I should know about ketoprofen (Orudis)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine 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 ketoprofen. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.