Celebrex - Side Effects & Drug Interactions

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Application site disorders:

Cellulitis, dermatitis contact, injection site reaction, skin nodule

Special senses:

Taste perversion

Urinary system:

Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus, urinary incontinence, urinary tract infection

Vision:

Blurred vision, cataract, conjunctivitis, eye pain, glaucoma

Other serious adverse reactions which occur rarely (estimated <0.1%), regardless of causality:

The following serious adverse events have occurred rarely in patients taking CELEBREX. Cases reported only in the post-marketing experience are indicated in italics.

Cardiovascular:

Syncope, congestive heart failure, ventricular fibrillation, pulmonary embolism, cerebrovascular accident, peripheral gangrene, thrombophlebitis, vasculitis

Gastrointestinal:

Intestinal obstruction, intestinal perforation, gastrointestinal bleeding, colitis with bleeding, esophageal perforation, pancreatitis, ileus

Liver and biliary system:

Cholelithiasis, hepatitis, jaundice, liver failure Hemic and lymphatic:

Thrombocytopenia, agranulocytosis, aplastic anemia, pancytopenia, leukopenia

Metabolic:

Hypoglycemia, hyponatremia

Nervous system:

Aseptic meningitis, ataxia, suicide

Renal:

Acute renal failure, interstitial nephritis

Skin:

Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

General:

Sepsis, sudden death, anaphylactoid reaction, angioedema

Safety Data from CLASS Study:

Hematological Events:

During this study (see Special Studies - Use with Aspirin), the incidence of clinically significant decreases in hemoglobin (>2 g/dL) confirmed by repeat testing was lower in patients on CELEBREX 400 mg BID (4-fold and 2-fold the recommended OA and RA doses, respectively, and the approved dose for FAP) compared to patients on either diclofenac 75 mg BID or ibuprofen 800 mg TID: 0.5%, 1.3% and 1.9%, respectively. The lower incidence of events with CELEBREX was maintained with or without ASA use (see CLINICAL STUDIES - Special Studies - Platelets).

Withdrawals/Serious Adverse Events: