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Safety Information

CELEBREX®(Celecoxib)

Indications and Clinical Use:

  • For relief of symptoms associated with:
    • Osteoarthritis
    • Adult Rheumatoid Arthritis
    • Ankylosing Spondylitis
  • For the short-term (≤7 days) management of moderate to severe acute pain in adults in conditions such as: musculoskeletal and/or soft tissue trauma including sprains; postoperative orthopaedic pain; pain following dental extraction

In those with increased risk of cardiovascular (CV) or gastrointestinal (GI) adverse events, consider first other management strategies that do NOT include use of NSAIDs.

Limit use to the lowest effective dose and the shortest possible duration to minimize potential risk for CV or GI adverse events.

CELEBREX does NOT treat clinical disease or prevent its progression.

Contraindications:

  • peri-operative setting of coronary artery bypass graft surgery
  • 3rd trimester of pregnancy
  • breastfeeding
  • severe uncontrolled heart failure
  • demonstrated allergic-type reactions to sulfonamides
  • history of asthma, urticaria, or allergic-type reactions after taking ASA or other NSAIDs
  • active gastric/duodenal/peptic ulcer, active GI bleeding
  • cerebrovascular bleedings
  • inflammatory bowel disease
  • severe liver impairment or active liver disease
  • severe renal impairment or deteriorating renal disease
  • known hyperkalemia
  • patients <18 years of age

Serious warnings and precautions:

  • Risk of CV adverse events: ischemic heart disease, cerebrovascular disease, congestive heart failure (NYHA II-IV)
    • Some NSAIDs are associated with increased incidence of CV adverse events which can be fatal
    • NSAIDs can promote sodium retention which can increase blood pressure and/or exacerbate congestive heart failure
  • Risk of GI adverse events: NSAIDs are associated with an increased incidence such as ulcers, perforation, obstruction and bleeding
  • Risk in pregnancy: caution in 1st and 2nd trimesters

Other relevant warnings and precautions:

  • Caution in concomitant use with anticoagulants
  • Not recommended for use with other NSAIDs (except low-dose ASA)
  • Risk in patients who are renally compromised
  • Blood pressure, renal and ophthalmologic monitoring
  • Concomitant warfarin use
  • Blood dyscrasias
  • Abnormal liver tests
  • Increased risk of hyperkalemia
  • Hypersentivity reactions: anaphylactoid, ASA-intolerance, NSAID cross-sensitivity, serious skin reactions
  • Neurologic adverse reactions
  • Blurred and/or diminished vision
  • Pneumonitis
  • May impair fertility
  • CYP2C9 poor metabolizers
  • Concomitant use with drugs that are metabolized by CYP2C9 or CYP2D6
  • Some NSAIDs associated with persistant urinary symptoms, hematuria or cystitis
  • Rarely, with some NSAIDs, aseptic meningitis

For more information:

Please consult the product monograph by clicking here for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this site.

® Pfizer Inc., used under license
CELEBREX ® G. D. Searle LLC, owner/Pfizer Canada Inc., Licensee