Generic Name: ketoprofen (kee-toe-PROE-fen)
Brand Names: Actron®, Orudis®, Orudis KT®, Oruvail®
Classification: Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Issue Date: 1989

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 is used in the treatment of fibromyalgia.

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
• 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
• coughing up blood
• vomit that looks like coffee grounds

Take this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Ketoprofen should not be used to treat minor aches and pains.

The maximum amount of Ketoprofen for adults is 300 milligrams (mg), or 200 mg of prescription Ketoprofen. Know the amount of Ketoprofen in the specific product you are taking.

If you take Ketoprofen 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 Ketoprofen at room temperature, away from moisture, heat, and light.

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 Ketoprofen, or to aspirin or other NSAIDs.

Before taking Ketoprofen, tell your doctor if you are allergic to any drugs, or if you have:

• a history of heart attack, stroke, or blood clot
• heart disease, congestive heart failure, high blood pressure
• a history of stomach ulcers or bleeding, bowel problems, diverticulosis
• liver or kidney disease
• asthma
• polyps in your nose
• if you smoke

If you have any of these conditions, you may not be able to use Ketoprofen, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Ketoprofen 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.

Since Ketoprofen is sometimes taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

If You Overdose

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a Ketoprofen overdose may include:

• nausea
• vomiting
• dizziness
• drowsiness
• black or bloody stools
• coughing up blood
• shallow breathing
• urinating less than usual or not at all
• fainting
• seizure (convulsion)
• coma

Side Effects

Get EMERGENCY medical help if you have any of these signs of an allergic reaction:

• skin rash or hives
• difficulty breathing
• swelling of your face, lips, tongue, or throat

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 are more likely to occur, such as:

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

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

Before taking Ketoprofen, tell your doctor if you are taking any of the following drugs:

• cyclosporine (Gengraf®, Neoral®, Sandimmune®)
• lithium (Eskalith®, Lithobid®)
• methotrexate (Rheumatrex®, Trexall®)
• probenecid (Benemid®)
• steroids (prednisone and others)
• a blood thinner such as warfarin (Coumadin®)

• an anti-platelet medication such as:
• clopidogrel (Plavix®)
• dipyridamole (Persantine®)
• ticlopidine (Ticlid®), and others

• aspirin or NSAIDs (non-steroidal anti-inflammatory drugs) such as:
• diclofenac (Voltaren®)
• etodolac (Lodine®)
• fenoprofen (Nalfon®)
• flurbiprofen (Ansaid®)
• ibuprofen (Advil®, Motrin®)
• indomethacin (Indocin®)
• ketorolac (Toradol®)
• mefenamic acid (Ponstel®)
• meloxicam (Mobic®)
• nabumetone (Relafen®)
• naproxen (Aleve®, Naprosyn®)
• piroxicam (Feldene®), and others

If you are using any of these drugs, you may not be able to use Ketoprofen or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Ketoprofen. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.