Celebrex is used to:

• relieve the signs and symptoms of osteoarthritis and rheumatoid arthritis in adults.
• reduce the number of colorectal polyps in patients with Familial Adenomatous Polyposis (FAP). FAP is an inherited disorder in which the rectum and colon are covered with many polyps. Celebrex should be used along with the usual care for FAP patients such as surgery and monitoring of the lower gastrointestinal tract.
• Celebrex has not been shown to reduce colorectal, duodenal or other FAP-related cancers. It is not known whether the effects of Celebrex will last after treatment is stopped. The efficacy and safety of Celebrex treatment in FAP patients beyond six months has not been studied. Therefore, the usual care of FAP patients should not be altered because of the concurrent administration of Celebrex. In particular, the frequency of routine endoscopic surveillance should not be decreased and prophylactic colectomy or other FAP-related surgeries should not be delayed.

Who should not take Celebrex?

You should not take Celebrex if you:

• have had an allergic-type reaction to sulfa drugs
• have had asthma, hives or allergic-type reactions after taking aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs). A few examples of NSAIDs are ibuprofen, naproxen, diclofenac, nabumetone, and ketoprofen.

Special Warnings with Celebrex:

Serious problems from stomach ulcers such as bleeding are recognized complications in people treated with NSAID’s. Similar problems have occurred in people treated with Celebrex, although very rarely. The likelihood of stomach problems increases the longer you take drugs like Celebrex. However, even short-term treatment is not without risk. These problems can happen without any warning, but in some people may cause symptoms such as gnawing or burning stomach pain, black or tarry stools, or vomiting. If this happens, stop taking Celebrex and call your health care provider right away.

Check with your health care provider. Celebrex may not be right for you, if you:

• have had ulcers or stomach bleeding
• have had asthma, hives or allergic-type reactions after taking aspirin or other NSAIDs
• have severe kidney problems
• have severe liver problems
• are pregnant

General Precautions with Celebrex:

Do not stop taking any medications that you have been prescribed without first talking to you doctor.

Serious problems such as liver damage have occurred in people treated with NSAIDs. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and dark urine. If this happens call your health care provider right away.

Celebrex can cause fluid retention and swelling in some patients. Check with your health care provider to see if Celebrex is right for you, if you:

• retain fluids
• have high blood pressure
• have heart failure

If you have asthma, you may have aspirin-sensitive asthma. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. Since such reactions to aspirin and other NSAIDs have occurred in aspirin-sensitive patients, Celebrex should not be given to aspirin-sensitive patients.

The safety and effectiveness of Celebrex in patients below the age of 18 years has not been determined.

Avoid taking Celebrex with antacids that contain calcium carbonate and magnesium/aluminum combination products, because they may reduce the amount of Celebrex your body absorbs.

What should I tell my doctor or health care provider?

• Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.
• Because certain medications may interact with NSAIDs or Celebrex, review all medications that you take with your health care provider, including those that you take without a prescription.
• Your health care provider may have to adjust your dose or monitor you more closely if you take:
  • certain blood pressure medications called ACE-inhibitors
  • furosemide
  • fluconazole
  • lithium
  • warfarin
  • aspirin

What are some possible side effects of Celebrex? (This is NOT a complete list of side effects reported with Celebrex. Your health care provider can discuss with you a more complete list of side effects.)  

Side effects can include:

• Headache
• Indigestion
• Upper respiratory tract infection
• Diarrhea
• Sinus inflammation
• Stomach pain
• Nausea

Rarely serious ulcers have occurred in patients taking Celebrex.

For more detailed information about Celebrex, ask your health care provider.

Link to Celebrex's Labeling 

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Dated posted: 10/8/99
Updated:  10/8/99
Revised: 10/31/00