Rofecoxib (roe-fe-KOX-ib)

This medicine was withdrawn from the US market in September 2004 because it may cause rare but serious side effects. Treats pain caused by arthritis, menstruation, or recent medical surgery or dental surgery. Treats pain caused by migraine headaches. Also treats pain caused by certain kinds of arthritis in children. This medicine is a non-steroidal anti-inflammatory drug (NSAID).

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet, Liquid

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. Shake the medicine well just before measuring each dose.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Keep all medicine away from children and never share your medicine with anyone.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using aspirin, lithium, methotrexate, theophylline, or rifampin (Rifadin®). Make sure your doctor knows if you are also using a steroid taken by mouth, such as cortisone, prednisone, Celestone®, Cortone®, Decadron®, Deltasone®, Pediapred®, or if you are also using a blood thinner, such as warfarin (Coumadin®).
• Make sure your doctor knows if you are also using any diuretics or "water pills," such as furosemide, hydrochlorothiazide, spironolactone, torsemide, triamterene, Aldactone®, Demadex®, Lasix®, or Maxzide®. Make sure your doctor knows if you are also using a blood pressure medicine, such as enalapril, lisinopril, Accupril®, Lotrel®, or Zestril®.
• Tell your doctor if you are currently taking low-dose aspirin for the prevention of heart attacks. Rofecoxib is not a blood thinner, and you will probably need to continue with your aspirin regimen.
• Drinking alcohol or smoking while using this medicine may increase your risk of side effects.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breast feeding. You should not use this medicine during the last 3 months of pregnancy. Make sure your doctor knows if you have asthma, kidney problems, liver problems, heart problems, or high blood pressure, or if you have other general health problems.
• This medicine may cause stomach ulcers or bleeding, sometimes without warning signs. This risk increases if you have had ulcers or other stomach problems in the past, or if you use this medicine for a long time. Make sure your doctor knows if you have ever had ulcers or stomach problems. Be sure you understand what side effects to watch for while using this medicine.
• This medicine may make you dizzy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
• Blistering, peeling, red skin rash.
• Bloody or black, tarry stools.
• Chest pain.
• Dark-colored urine or pale stools.
• Decrease in how often or how much you urinate, painful urination, or extreme thirst.
• Fever.
• Severe coughing or difficulty breathing.
• Severe stomach pain.
• Swelling in your hands, ankles, or feet.
• Unexplained tiredness, weakness, or body aches.
• Uneven, pounding, or fast heartbeat.
• Unexplained weight gain.
• Vomiting blood or material that looks like coffee grounds.
• Yellow skin or eyes, pain in the upper stomach, loss of appetite.

If you notice these less serious side effects, talk with your doctor:

• Dry mouth.
• Headache.
• Light-headedness, or dizziness.
• Mild heartburn, nausea, upset stomach, stomach pain, or diarrhea.
• Sleeping too much.
• Stuffy or runny nose, or sore throat.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088