Valdecoxib (By mouth)

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

Introduction

Valdecoxib (val-de-KOX-ib)

Treats symptoms of osteoarthritis and rheumatoid arthritis, and also treats painful menstrual periods. This medicine is a nonsteroidal anti-inflammatory drug (NSAID). This medicine was withdrawn from the U.S. market on April 7, 2005, because it may cause rare but serious side effects.

Brand Name(s)

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• 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.
• It is best to take this medicine with food or milk, so it does not upset your stomach.
• Use this medicine for the shortest time possible and in the smallest dose possible. This will help lower the risk of side effects.

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.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

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 using diazepam (Valium®), glyburide (Diabeta®, Glynase®), or a medicine to treat fungal infections such as fluconazole, ketoconazole, Diflucan®, or Nizoral®. Tell your doctor if you are using birth control pills, omeprazole (Nexium®, Prilosec®), a blood thinner such as warfarin (Coumadin®), or a cough and cold medicine that contains dextromethorphan.
• Tell your doctor if you are using lithium, phenytoin (Dilantin®), or a steroid such as cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, Orapred®. Make sure your doctor knows if you are using a diuretic ("water pill") such as furosemide, hydrochlorothiazide (HCTZ), torsemide, Demadex®, or Lasix®. Tell your doctor if you are using a medicine to lower blood pressure such as enalapril, lisinopril, Accupril®, Lotrel®, Zestril®.
• Do not use any other NSAID medicine unless your doctor says it is okay. Some other names are aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Ecotrin®, Motrin®, or Voltaren®.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding. You should not use this medicine during the later part of pregnancy unless your doctor tells you to.
• Make sure your doctor knows if you have high blood pressure, congestive heart failure (CHF), or other heart or circulation problems. Also tell your doctor if you have liver disease, kidney disease, asthma, or a bleeding problem.
• This medicine might cause bleeding in your stomach or intestines. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner).
• This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.
  • 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.
• Change in how much or how often you urinate.
• Chest pain, shortness of breath, or coughing up blood.
• Dark-colored urine or pale stools.
• Diarrhea that may contain blood.
• Flu-like symptoms.
• Lightheadedness or fainting.
• Nausea, vomiting, loss of appetite, pain in your upper stomach.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Problems with vision, speech, or walking.
• Rapid weight gain.
• Severe stomach pain.
• Shortness of breath, cold sweat, and bluish-colored skin.
• Sores in your mouth or nose.
• Sudden or severe headache.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.
• Vomiting blood or something that looks like coffee grounds.
• Yellowing of your skin or the whites of your eyes.