Note: This document contains side effect information about celecoxib. Some dosage forms listed on this page may not apply to the brand name Celebrex.
Summary
Common side effects of Celebrex include: diarrhea, hypertension, and abnormal hepatic function tests. Other side effects include: abdominal pain, dyspepsia, gastroesophageal reflux disease, peripheral edema, vomiting, and increased liver enzymes. Continue reading for a comprehensive list of adverse effects.
Applies to celecoxib: oral capsules, oral solution, oral tablets containing celecoxib and amlodipine.
Warning
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Cardiovascular Risk
- Increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).1 500 502 508 Risk may occur early in treatment and may increase with duration of use.500 502 505 506 508 (See Cardiovascular Thrombotic Effects under Cautions.)
- Contraindicated in the setting of CABG surgery.1 508
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GI Risk
- Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).1 Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.1 Geriatric individuals and patients with history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.1 (See GI Effects under Cautions.)
Side effects include:
Adults: Abdominal pain, diarrhea, dyspepsia, headache, nausea, sinusitis, upper respiratory tract infection. Dysgeusia in those receiving celecoxib (the active ingredient contained in Celebrex) oral solution for migraine attack.
Children: Headache, fever, abdominal pain, cough, nasopharyngitis, nausea, arthralgia, diarrhea, vomiting.
For Healthcare Professionals
Applies to celecoxib: oral capsule, oral solution.
General
The most commonly reported adverse events included abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, and rash.[Ref]
Gastrointestinal
Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, flatulence, nausea
Rare (less than 0.1%): Intestinal obstruction, intestinal perforation, gastrointestinal bleeding, colitis with bleeding, esophageal perforation, pancreatitis, ileus, esophageal ulcer, gastric ulcer, duodenal ulcer
Frequency not reported: Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting[Ref]
Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting have been reported in 0.1% to 1.9% of patients taking celecoxib 100 to 200 mg twice a day or 200 mg once a day.
In the Celecoxib Long-Term Arthritis Safety Study (CLASS), complicated and symptomatic ulcer rates were 0.78% for all patients and 1.4% for patients 65 years and older at 9 months. For the subgroup on concomitantly on low-dose aspirin, these numbers were 2.19% and 3.06%, respectively.
Serious gastrointestinal toxicity such as bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms in patient taking nonsteroidal anti-inflammatory drugs. Celecoxib should be used with caution in patients with a prior history of ulcer disease or gastrointestinal bleeding. It is recommended that the lowest effective dose be administered for the shortest possible[Ref]
Cardiovascular
Common (1% to 10%): Peripheral edema
Uncommon (0.1% to 1%): Unstable angina, aortic valve incompetence, coronary artery atherosclerosis, sinus bradycardia, ventricular hypertrophy, deep vein thrombosis
Rare (less than 0.1%): Syncope, cardiac failure congestive, ventricular fibrillation, thrombophlebitis
Frequency not reported: Aggravated hypertension, angina pectoris, coronary artery disorder, myocardial infarction, arrhythmia, palpitation, tachycardia
Postmarketing reports: Vasculitis[Ref]
In studies of up to 3-years with several NSAIDs (COX-2 selective and nonselective), an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, were observed. It is unclear if the different NSAIDs pose a similar or different risk. The relative increase in events over baseline appeared similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, most likely due to their increased baseline rate. The increase in CV thrombotic risk was observed most consistently at higher doses. In the Adenoma Prevention with Celecoxib (APC) trial, a 3-fold increased risk for the composite endpoint of cardiovascular death, MI, or stroke was observed for the celecoxib 200 and 400 mg twice a day arms compared to placebo. This increase was mainly due to an increased incidence of MI. In the Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen or Naproxen (PRECISION) trial, celecoxib 100 mg twice a day was noninferior to naproxen 375 to 500 mg twice a day and ibuprofen 600 to 800 mg 3 times a day for the composite endpoint of cardiovascular death, nonfatal MI, and nonfatal stroke.
Aggravated hypertension, angina pectoris, coronary artery disorder, myocardial infarction, palpitation, tachycardia, and arrhythmia have been reported in 0.1% to 1.9% of patients taking celecoxib 100 to 200 mg twice a day or 200 mg once a day. In the long-term polyp prevention studies in which exposure to celecoxib was 400 to 800 mg per day for up to 3 years, unstable angina, aortic valve incompetence, coronary artery atherosclerosis, sinus bradycardia, ventricular hypertrophy, or deep vein thrombosis were reported in at least 0.1% of patients to less than 1% of patients.[Ref]
Nervous system
Common (1% to 10%): Dizziness, headache
Rare (less than 0.1%): Aseptic meningitis, ataxia, aggravated epilepsy
Frequency not reported: Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo, somnolence, taste perversion
Postmarketing reports: Cerebral hemorrhage, ageusia, anosmia[Ref]
Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo, taste perversion, and somnolence were reported in 0.1% to 1.9% of patients taking celecoxib 100 to 200 mg twice a day or 200 mg once a day.
In the long-term polyp prevention studies in which exposure to celecoxib was 400 to 800 mg per day for up to 3 years, cerebral infarction was reported in at least 0.1% of patients to less than 1% of patients.[Ref]
Dermatologic
Alopecia, dermatitis, nail disorder, photosensitivity reaction, pruritus, rash erythematous, maculopapular rash, skin disorder, dry skin, sweating increased, and urticaria were reported in 0.1% to 1.9% of patients taking celecoxib (the active ingredient contained in Celebrex) 100 to 200 mg twice a day or 200 mg once a day.[Ref]
Common (1% to 10%): Rash
Frequency not reported: Alopecia, dermatitis, nail disorder, photosensitivity reaction, pruritus, rash erythematous, maculopapular rash, skin disorder, dry skin, sweating increased, urticaria
Postmarketing reports: Erythema multiforme, dermatitis exfoliative, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), dermatitis bullous[Ref]
Hematologic
Ecchymosis, epistaxis, and thrombocytopenia were reported in 0.1% to 1.9% of patients taking celecoxib (the active ingredient contained in Celebrex) 100 to 200 mg twice a day or 200 mg once a day. The incidence of hemoglobin increases greater than 2 g/dL was 0.5% among patients treated with celecoxib 400 mg twice a day compared with 1.3% and 1.9% in patients receiving diclofenac 75 mg twice a day or ibuprofen 800 mg three times a day, respectively.
Mild prolongation of activated partial thromboplastin time (APTT) but not prothrombin time (PT) has been observed in pediatric patients with systemic onset juvenile rheumatoid arthritis (without active systemic features).[Ref]
Uncommon (0.1% to 1%): Anemia
Frequency not reported: Ecchymosis, epistaxis, thrombocytopenia, mild prolongation of activated partial thromboplastin time (APTT)
Postmarketing reports: Agranulocytosis, aplastic anemia, pancytopenia, leukopenia[Ref]
Hepatic
Borderline hepatic transaminase elevations (AST or ALT) described as greater than 1.2 times the upper limit of normal (ULN) and less than 3 x ULN were reported in 6% of treated patients (compared to 5% of placebo). Approximately 0.2% of treated patients had notable elevations of AST/ALT (compared to 0.3% of placebo).[Ref]
Common (1% to 10%): Borderline AST or ALT elevations
Rare (less than 0.1%): Cholelithiasis
Frequency not reported: Abnormal hepatic function
Postmarketing reports: Hepatitis, hepatitis fulminant, jaundice, hepatic failure, hepatic necrosis, cholestasis, hepatitis cholestatic, liver transplant, hepatic enzymes increased[Ref]
Respiratory
Common (1% to 10%): Pharyngitis, rhinitis, sinusitis, upper respiratory tract infection
Rare (less than 0.1%): Pulmonary embolism
Frequency not reported: Bronchitis, bronchospasm, aggravated bronchospasm, cough, dyspnea, laryngitis, pneumonia
Postmarketing reports: Pneumonitis[Ref]
Bronchitis, bronchospasm, aggravated bronchospasm, cough, dyspnea, laryngitis, and pneumonia were reported in 0.1% to 1.9% of patients taking celecoxib 100 to 200 mg twice a day or 200 mg once a day.[Ref]
Renal
Rare (less than 0.1%): Acute renal failure
Postmarketing reports: Tubulointerstitial nephritis, nephrotic syndrome, glomerulonephritis minimal lesion[Ref]
Psychiatric
Anxiety, depression, and nervousness were reported in 0.1% to 1.9% of patients taking celecoxib (the active ingredient contained in Celebrex) 100 to 200 mg twice a day or 200 mg once a day.[Ref]
Common (1% to 10%): Insomnia
Rare (less than 0.1%): Confusion
Frequency not reported: Anxiety, depression, nervousness
Postmarketing reports: Hallucination[Ref]
Ocular
Uncommon (0.1% to 1%): Vitreous floaters, conjunctival hemorrhage
Frequency not reported: Blurred vision, cataract, conjunctivitis, eye pain, glaucoma[Ref]
Blurred vision, cataract, conjunctivitis, eye pain, and glaucoma were reported in 0.1% to 1.9% of patients taking celecoxib 100 to 200 mg twice a day or 200 mg once a day. In the long-term polyp prevention studies in which exposure to celecoxib was 400 to 800 mg per day for up to 3 years, vitreous floaters or conjunctival hemorrhage was reported in at least 0.1% of patients to less than 1% of patients.[Ref]
Musculoskeletal
Uncommon (0.1% to 1%): Epicondylitis, tendon rupture
Frequency not reported: Arthralgia, arthrosis, bone disorder, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis[Ref]
Arthralgia, arthrosis, bone disorder, accidental fracture, myalgia, neck stiffness, synovitis, and tendinitis were reported in 0.1% to 1.9% of patients taking celecoxib 100 to 200 mg twice a day or 200 mg once a day. In the long-term polyp prevention studies in which exposure to celecoxib was 400 to 800 mg per day for up to 3 years, epicondylitis or tendon rupture were reported in at least 0.1% of patients to less than 1% of patients.[Ref]
Other
Asthenia fatigue, fever, hot flushes, influenza-like illness, cyst, and pain were reported in 0.1% to 1.9% of patients taking celecoxib (the active ingredient contained in Celebrex) 100 to 200 mg twice a day or 200 mg once a day.[Ref]
Frequency not reported: Asthenia fatigue, fever, hot flushes, cyst, pain
Postmarketing reports: Conjunctivitis[Ref]
Immunologic
Herpes simplex, herpes zoster, bacterial infection, fungal infection, soft tissue infection, viral infection, moniliasis, moniliasis genital, and influenza-like illness were reported in 0.1% to 1.9% of patients taking celecoxib (the active ingredient contained in Celebrex) 100 to 200 mg twice a day or 200 mg once a day.[Ref]
Rare (less than 0.1%): Gangrene
Frequency not reported: Herpes simplex, herpes zoster, bacterial infection, fungal infection, soft tissue infection, viral infection, moniliasis, moniliasis genital, influenza-like illness
Postmarketing reports: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), sepsis[Ref]
Oncologic
Breast fibroadenosis and breast neoplasm were reported in 0.1% to 1.9% of patients taking celecoxib (the active ingredient contained in Celebrex) 100 to 200 mg twice a day or 200 mg once a day.[Ref]
Frequency not reported: Breast fibroadenosis, breast neoplasm[Ref]
Hypersensitivity
Hypersensitivity was reported in 0.1% to 1.9% of patients taking celecoxib (the active ingredient contained in Celebrex) 100 to 200 mg twice a day or 200 mg once a day.[Ref]
Frequency not reported: Hypersensitivity
Postmarketing reports: Anaphylactic shock, anaphylactic reaction, angioedema[Ref]
Metabolic
Increased blood urea nitrogen, increased creatinine phosphokinase, diabetes mellitus, hypercholesterolemia, hyperglycemia, hypokalemia, non-protein nitrogen increased, creatinine increased, alkaline phosphatase increased, anorexia, and increased weight increase were reported in 0.1% to 1.9% of patients taking celecoxib (the active ingredient contained in Celebrex) 100 to 200 mg twice a day or 200 mg once a day.[Ref]
Uncommon (0.1% to 1%): Hyperkalemia
Frequency not reported: Increased blood urea nitrogen, increased creatinine phosphokinase, diabetes mellitus, hypercholesterolemia, hyperglycemia, hypokalemia, non-protein nitrogen increased, creatinine increased, alkaline phosphatase increased, weight increased, anorexia
Postmarketing reports: Hypoglycemia, hyponatremia[Ref]
Other
Uncommon (0.1% to 1%): Labyrinthitis
Very rare (less than 0.01%): Hearing decreased
Frequency not reported: Otitis media, deafness, ear abnormality, earache, tinnitus[Ref]
Otitis media, deafness, ear abnormality, earache, and tinnitus were reported in 0.1% to 1.9% of patients taking celecoxib 100 to 200 mg twice a day or 200 mg once a day. In the long-term polyp prevention studies in which exposure to celecoxib was 400 to 800 mg per day for up to 3 years, labyrinthitis was reported in at least 0.1% of patients to less than 1% of patients.[Ref]
Endocrine
Postmarketing reports: Impaired female fertility[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Ovarian cyst
Frequency not reported: Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus, dysmenorrhea, urinary incontinence, menstrual disorder, vaginal hemorrhage, vaginitis, prostatic disorder[Ref]
Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus, dysmenorrhea, urinary incontinence, menstrual disorder, vaginal hemorrhage, vaginitis, and prostatic disorder were reported in 0.1% to 1.9% of patients taking celecoxib 100 to 200 mg twice a day or 200 mg once a day. In the long-term polyp prevention studies in which exposure to celecoxib was 400 to 800 mg per day for up to 3 years, ovarian cyst was reported in at least 0.1% of patients to less than 1% of patients.[Ref]