Note: This document contains side effect information about celecoxib. Some dosage forms listed on this page may not apply to the brand name Elyxyb.

Applies to celecoxib: oral capsules, oral solution, oral tablets containing celecoxib and amlodipine.

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 Elyxyb) 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 Elyxyb) 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 Elyxyb) 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 Elyxyb) 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 Elyxyb) 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 Elyxyb) 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 Elyxyb) 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 Elyxyb) 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 Elyxyb) 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]