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VALDECOXIB (Systemic)*

Some commonly used brand names are:

In the U.S.—

  • Not commercially available
  • Note:

    Valdecoxib was voluntarily withdrawn from the market in April 2005.

* Not commercially available in the U.S.


  • Antirheumatic (nonsteroidal anti-inflammatory), antidysmenorrheal


Valdecoxib (val-de-KOX-ib) is a non-steroidal anti-inflammatory drug. Nonsteroidal anti-inflammatory drugs (also called NSAIDs) are used to relieve some symptoms caused by arthritis (rheumatism), such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to take it. It may also be used to treat pain associated with menstrual periods.

This medicine is available only with your doctor"s prescription, in the following dosage form:

  • Oral
  • Tablets

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For valdecoxib, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to valdecoxib, other nonsteroidal anti-inflammatory drugs, aspirin or other salicylates or sulfonamides. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Valdecoxib has not been studied in pregnant women. However, studies in animals have shown that valdecoxib causes birth defects and other problems. Valdecoxib may cause problems in the baby"s heart and lungs and is not recommended late in pregnancy. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding— It is not known whether valdecoxib passes into human breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of valdecoxib in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking valdecoxib, it is especially important that your doctor and pharmacist know if you are taking any of the following:

  • Aspirin—Use of valdecoxib with this medicine may cause stomach upset or problems
  • Fluconazole (e.g., Diflucan) or
  • Ketoconazole (e.g., Nizoral) or
  • Lithium (e.g., Lithane)—Taking these medicines may cause the amount of valdecoxib in your blood to be too high
  • Oral contraceptives (birth control pills), norethindrone/ethinyl estradiol (e.g., Ortho-Novum 1/35)—May increase your chance of getting oral contraceptive side effects.

Other medical problems—The presence of other medical problems may affect the use of valdecoxib. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse (or history of ) or
  • Bleeding problems or
  • Stomach ulcer or other stomach or intestinal problems or
  • Poor general health or
  • Tobacco use (or recent history of)—The chance of side effects may be increased
  • Allergy to aspirin or other nonsteroidal anti-inflammatory medicines or
  • Asthma with inflammation in the nose (with or without polyps) or with spasm in the breathing tubes caused by aspirin or other non-steroidal anti-inflammatory medicines or
  • Skin rash after taking aspirin or NSAIDs—Using valdecoxib with these medicines may cause these problems to become much worse.
  • Allergy to sulfonamides (sulfamethoxazole and trimethoprim [e.g., Bactrim, Cotrim], sulfisoxazole [e.g., Gantrisin])—May be at greater risk of serious skin reactions
  • Anemia or
  • Dehydration or
  • Fluid retention (swelling of feet or lower legs) or
  • Heart disease or
  • High blood pressure or
  • Kidney disease or
  • Liver disease—Valdecoxib may make these conditions worse
  • Pain after coronary artery bypass graft (CABG) surgery—Higher risk of serious heart complications and infection in these patients. Valdecoxib should not be used.

Proper Use of This Medicine

Dosing—The following section is for information only, since the drug is no longer available.

  • Oral dosage form (tablets):
    • For dysmenorrhea (pain with your menstrual period)
    • For osteoarthritis
    • For rheumatoid arthritis

Storage—To store this medicine:

  • Keep out of the reach of children.
  • Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits .

Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine. Therefore, do not regularly drink alcoholic beverages while taking this medicine , unless otherwise directed by your doctor.

Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, sticky stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

Serious skin reactions can occur during treatment with valdecoxib. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores ulcers, white spots in mouth or on lips, or unusual tiredness or weakness.

Check with your doctor immediately if fever, drowsiness, itching of the skin, tiredness, nausea, or stomach pain occurs; these effects may be the first signs of liver toxicity .

Valdecoxib may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin, other nonsteroidal anti-inflammatory drugs, or sulfonamide-type drugs. Anaphylaxis requires immediate medical attention . The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once. Do not try to drive yourself. Call an ambulance, lie down, cover yourself to keep warm, and prop your feet higher than your head. Stay in that position until help arrives.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bloating or swelling of face, arms, hands, lower legs, feet; blood in urine; bloody, black or sticky stools; blurred vision; chills; decreased or painful urination; dizziness; fever; muscle aches and pains; nausea; nervousness; pale skin; pounding in the ears; rapid weight gain; severe stomach pain; tingling of the hands or feet; trouble breathing with exertion; unusual bleeding or bruising; unusual tiredness or weakness; vomiting of blood or material that looks like coffee grounds; yellow eyes or skin

Incidence not known

Blistering, peeling, loosening of skin; constipation; cracks in the skin; darkened urine; difficulty swallowing; fast heartbeat; hives; indigestion; itching, puffiness, or swelling of the eyelids or around the eyes, face, lips or tongue; itching; joint or muscle pain; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; loss of appetite; loss of heat from the body; nausea; pains in stomach, side, or abdomen, possibly radiating to the back; red, irritated eyes; red skin lesions, often with a purple center; red, swollen skin; scaly skin; shortness of breath; skin rash; sores, ulcers, or white spots in mouth or on lips; tightness in chest; vomiting; wheezing; yellow eyes or skin

Symptoms of overdose

Get emergency help immediately if any of the following symptoms of overdose occur

Bloody or black tarry stools; continuing thirst; dizziness; drowsiness; headache, severe or continuing; nausea and/or vomiting; shortness of breath; stomach pain; sudden decrease in the amount of urine; swelling of face, fingers, and/or lower legs; tightness in chest and/or wheezing; troubled breathing; unusual tiredness or weakness; vomiting of blood or material that looks like coffee grounds; weight gain

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

More common

Acid or sour stomach; belching; cough; diarrhea; ear congestion; headache; heartburn; indigestion; sore throat

Less common

Abdominal fullness; accidental injury; back pain; bloating in the abdomen; excess gas; rash; stuffy or runny nose

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 12/17/2001
Revised: 04/08/2005

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Typical mistypes for Valdecoxib
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