The Celebrex (celecoxib) Report
Information on celebrex reaction, side effects, drug dosage, concerns & medication questions

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Celebrex

ADVERSE REACTIONS

Of the CELEBREX treated patients in the premarketing controlled clinical trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain. More than 8,500 patients have received a total daily dose of CELEBREX of 200 mg (100 mg BID or 200 mg QD) or more, including more than 400 treated at 800 mg (400 mg BID).

Approximately 3,900 patients have received CELEBREX at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more.

Adverse events from CELEBREX premarketing controlled arthritis trials: Regardless of causality, occurring in 2% of patients receiving CELEBREX from 12 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group.

In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving CELEBREX and 6.1% for patients receiving placebo.

Among the most common reasons for discontinuation due to adverse events in the CELEBREX treatment groups were dyspepsia and abdominal pain (cited as reasons for discontinuation in 0.8% and 0.7% of CELEBREX patients, respectively). Among patients receiving placebo, 0.6% discontinued due to dyspepsia and 0.6% withdrew due to abdominal pain.

The following adverse events occurred in 0.1 - 1.9% of patients regardless of causality.

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What are The Risks?

Celebrex and other NSAID medicines can cause serious problems such as:

  • Stomach ulcers that bleed. The chance of this serious problem increases the longer you take Celebrex, but it can also happen suddenly. Stop taking Celebrex and call your healthcare professional right away if you get a burning stomach pain, black bowel movements that look like tar, or vomit that looks like blood or coffee grounds.
     
  • Liver damage. Some of the warning signs of liver damage are nausea, vomiting, tiredness, loss of appetite, itching, yellow coloring of skin or eyes, “flu-like” symptoms and dark urine. If this happens, stop taking Celebrex and call your healthcare professional right away.
     
  • Kidney problems that include sudden kidney failure or worsening of kidney problems that you already have.
     
  • Fluid retention (holding of water in your body) and swelling. Fluid retention can be a serious problem if you have high blood pressure or heart failure.

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Who should not take Celebrex? 

Do not take Celebrex if you: 

  • have had an allergic-type reaction to sulfa medicines 
  • have had asthma, hives or allergic-type reactions after taking aspirin or other NSAID medicines 
  • are allergic to Celebrex or to any of the ingredients in Celebrex 

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 this type of reaction to aspirin and other NSAID medicines have happened in aspirin-sensitive patients, aspirin-sensitive patients should not take Celebrex. 

Special Warnings with Celebrex

Celebrex and other NSAID medicines can cause stomach ulcers that bleed. The chance of this serious problem increases the longer you take Celebrex and with higher doses of Celebrex. Stomach bleeding can also happen suddenly while you take Celebrex. Stop taking Celebrex and call your healthcare provider right away if you get: 

  • a burning stomach pain 
  • black bowel movements that look like tar 
  • vomit that looks like blood or coffee grounds 

Celebrex and other NSAID medicines can cause serious allergic reactions that include swelling of the face, lips, tongue or throat. These allergic reactions may cause problems with breathing, swallowing, and wheezing. Serious allergic skin reactions have also happened. 

General Precautions with Celebrex

Celebrex and other NSAID medicines can cause serious problems such as liver damage. Some of the warning signs of liver damage are nausea, vomiting, tiredness, loss of appetite, itching, yellow coloring of skin or eyes, “flu-like” symptoms and dark urine. If these happen, stop taking Celebrex and call your health care provider right away. 

Celebrex and other NSAID medicines can cause serious kidney problems that include sudden kidney failure or worsening of kidney problems that you already have. 

Celebrex and other NSAID medicines can cause fluid retention (holding of water in your body) and swelling. Fluid retention can be a serious problem if you have high blood pressure or heart failure. 

What are some possible side effects of Celebrex?

In addition to the serious side effects listed above, some common, but less serious side effects with Celebrex include: 

  • headache 
  • indigestion 
  • upper respiratory tract infection (a "cold") 
  • diarrhea 
  • sinus inflammation 
  • stomach pain 
  • nausea 

Source: FDA Celebrex Patient Information Sheet

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