Celecoxib (Generic for Celebrex) Approved by FDA

COX-2 Inhibitor for Osteoarthritis and Rheumatoid Arthritis

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The U.S. Food and Drug Administration (FDA) approved Celebrex (brand name) on December 31, 1998. The COX-2 inhibitor was approved for the treatment of osteoarthritis and rheumatoid arthritis. On May 30, 2014, the FDA announced the approval of the first generic versions of the drug, known as celecoxib.

Teva Pharmaceutical Industries has been approved to market celecoxib capsules in 50 mg., 100 mg., 200 mg., and 400 mg.

strengths with 180-day exclusivity on all except the 50 mg. strength. Mylan Pharmaceuticals, Inc. was approved to market the 50 mg. strength as well.

What Is Celecoxib?

Celecoxib is a COX-2 selective NSAID (nonsteroidal anti-inflammatory drug). COX-2 inhibitors are the class of drugs which also, at one time, included Bextra (valdecoxib) and Vioxx (rofecoxib). When Bextra and Vioxx were removed from the market, it was decided that Celebrex (celecoxib) could remain on the market with a Boxed Warning which was added to the label of all NSAIDs.

The Boxed Warning highlights the risk of heart attack or stroke, potentially fatal, that is associated with Celebrex and other NSAIDs. The risk increases for people with existing heart disease or those who have risk factors for heart disease, including high blood pressure, as well as for people who have taken NSAIDs for a long time The Boxed Warning also points out the risk of serious, potentially fatal, gastrointestinal bleeding that can occur with NSAID use.

Indications for Celebrex (celecoxib)

Aside from its use to relieve the signs and symptoms of osteoarthritis and rheumatoid arthritis in adults, Celebrex is also used to manage acute pain in adults and to reduce the number of colon and rectum growths in patients with Familial Adenomatous Polyposis.

Contraindications for Celebrex (celecoxib)

Patients who have had an allergic reaction to sulfa and aspirin-sensitive patients (those who have experienced hives, asthma, or allergic-type reactions after taking aspirin or other NSAIDs) should not take Celebrex or celecoxib.

Patients with a history of heart disease or those with risk factors for heart disease should heed the warnings and strongly consider other treatment options.

Common Side Effects Associated With Celebrex or Celecoxib

Some of the common side effects that may be associated with Celebrex include:

  • headache
  • indigestion
  • upper respiratory tract infection
  • diarrhea
  • sinusitis
  • sore throat
  • runny nose
  • abdominal pain or nausea
  • flatulence
  • peripheral edema
  • rash

Other Warnings and Precautions

Watch for signs of bleeding stomach ulcers if you take Celebrex, celecoxib, or any NSAID. Call your doctor if you notice black stool, vomit that looks like coffee grounds or bloody, or if you have burning stomach pain.

Celebrex, celecoxib, and other NSAIDs can potentially cause liver damage. Warnings signs for liver damage include nausea, vomiting, tiredness, loss of appetite, itching, yellow skin or eyes, dark urine, flu-like symptoms.

Kidney problems can occur with NSAID use. Sudden kidney failure or worsening of an existing kidney problem are possible.

Fluid retention can occur with NSAID use, and it can lead to serious consequences for those with high blood pressure or heart failure.

Pay attention to these warning signs and symptoms. If they occur, seek immediate medical attention.

Drug Interactions Associated With Celebrex or Celecoxib

Certain drugs can interact with Celebrex or celecoxib and may affect how they work. Always tell your doctor about other drugs you take. Drugs which can interact with Celebrex or celecoxib include:

  • ACE inhibitors (blood pressure medications)
  • furosemide
  • fluconazole or ketoconazole
  • lithium
  • phenytoin
  • warfarin
  • aspirin

Take Only as Directed

Take Celebrex or celecoxib according to the directions given to you with the prescription. There are potentially serious consequences which could result from an overdose, including breathing difficulties, coma, drowsiness, gastrointestinal bleeding, high blood pressure, kidney failure, nausea, sluggishness, stomach pain, and vomiting.


FDA Approves First Generic Versions of Celecoxib. FDA.gov. May 30, 2014.

Celebrex Prescribing Information. Pfizer. Revised January 2013.

Celebrex. PDRHealth. 2014.

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