Celecoxib

Celecoxib Side Effects

In Summary

Commonly reported side effects of celecoxib 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to celecoxib: oral capsule

Along with its needed effects, celecoxib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking celecoxib:

More common

• Cough
• fever
• skin rash
• sneezing
• sore throat
• swelling of the face, fingers, feet, or lower legs

Less common or rare

• Abnormal growth in the breast
• arm, back, or jaw pain
• bloody or black, tarry stools
• blurred vision
• burning feeling in the chest or stomach
• burning or stinging of the skin
• burning, tingling, numbness, or pain in the hands, arms, feet, or legs
• chest pain or discomfort
• chest tightness or heaviness
• chills
• confusion
• congestion in the chest
• cramps
• diarrhea
• dry mouth
• earache
• fast or irregular heartbeat
• heartburn
• heavy bleeding
• heavy non-menstrual vaginal bleeding
• high blood pressure
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• loss of consciousness
• muscle aches and pains
• nausea
• nerve pain
• painful blisters on the trunk of body
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pale skin
• redness or swelling in the ear
• sensation of pins and needles
• soreness or redness around the fingernails and toenails
• stabbing pain
• stiff neck
• stomachache
• stomach pain (severe)
• sweating
• tenderness in the stomach area
• troubled breathing with exertion
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain
• vomiting
• vomiting of blood or material that looks like coffee grounds
• weakness
• wheezing

Incidence not known

• Area rash
• changes in skin color
• clay-colored stools
• dilated neck veins
• light-colored stools
• pale or a bluish color skin of the fingers or toes
• seizures
• slurred speech
• sores, welting, or blisters
• sudden and severe inability to speak
• unpleasant breath odor
• weakness in the arm or leg on one side of the body
• yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking celecoxib:

Symptoms of overdose

• Continuing thirst
• dizziness
• drowsiness
• headache, severe or continuing
• shortness of breath
• sudden decrease in the amount of urine
• troubled breathing
• weight gain

Some side effects of celecoxib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• gas
• headache
• heartburn
• inability to sleep
• pain or burning in the throat
• stuffy or runny nose

Less common

• Anxiety
• bleeding after defecation
• bloody or cloudy urine
• breast pain
• bone deformity
• buzzing or ringing noise in the ears
• change in sense of taste
• constipation
• decrease in height
• decreased appetite
• depression
• difficult, burning, or painful urination
• difficulty with moving or walking
• difficulty with swallowing
• excessive muscle tone, muscle tension, or tightness
• excessive tearing
• feeling of pressure
• hair loss
• hives
• hoarseness
• increased sweating
• infection
• inflammation
• itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site
• itching of the vagina or genital area
• joint or muscle pain or stiffness
• large, flat, blue, or purplish patches in the skin
• loss of energy or weakness
• loss of hearing
• muscle pain increased
• muscle stiffness
• nervousness
• numbness or tingling in the fingers or toes
• pain during sexual intercourse
• pain in the back, ribs, arms, or legs
• pounding heartbeat
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness or swelling in the arms or legs
• sensitivity of the skin to sunlight
• severe sunburn
• sleepiness
• straining while passing stool
• sudden sweating and feelings of warmth
• swelling
• swelling or inflammation of the mouth
• tenderness
• thick, white vaginal discharge with no odor or with a mild odor
• thinning of the hair
• trouble with swallowing
• troubled breathing
• uncomfortable swelling around anus
• unexplained weight loss
• voice changes
• warmth on the skin
• weakness or heaviness of the legs

Incidence not known

• Bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of sense of smell
• pain
• pinpoint red spots on the skin
• red or irritated eyes
• red skin lesions, often with a purple center
• shakiness and unsteady walk
• sores, ulcers, or white spots in the mouth or on the lips
• stomach cramps
• swelling of the neck
• tenderness
• trembling, or other problems with muscle control or coordination
• unsteadiness
• watery or bloody diarrhea

For Healthcare Professionals

Applies to celecoxib: oral capsule

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.

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

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

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

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.

Nervous system

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.

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

Dermatologic

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

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 100 to 200 mg twice a day or 200 mg once a day.

Hematologic

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

Ecchymosis, epistaxis, and thrombocytopenia 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. 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).

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).

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

Respiratory

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.

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

Renal

Rare (less than 0.1%): Acute renal failure

Postmarketing reports: Tubulointerstitial nephritis, nephrotic syndrome, glomerulonephritis minimal lesion

Psychiatric

Anxiety, depression, and nervousness 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.

Common (1% to 10%): Insomnia

Rare (less than 0.1%): Confusion

Frequency not reported: Anxiety, depression, nervousness

Postmarketing reports: Hallucination

Ocular

Uncommon (0.1% to 1%): Vitreous floaters, conjunctival hemorrhage

Frequency not reported: Blurred vision, cataract, conjunctivitis, eye pain, glaucoma

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.

Musculoskeletal

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.

Uncommon (0.1% to 1%): Epicondylitis, tendon rupture

Frequency not reported: Arthralgia, arthrosis, bone disorder, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis

Other

Frequency not reported: Asthenia fatigue, fever, hot flushes, cyst, pain

Postmarketing reports: Conjunctivitis

Asthenia fatigue, fever, hot flushes, influenza-like illness, cyst, and pain 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.

Immunologic

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: Sepsis

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 100 to 200 mg twice a day or 200 mg once a day.

Oncologic

Breast fibroadenosis and breast neoplasm 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.

Frequency not reported: Breast fibroadenosis, breast neoplasm

Hypersensitivity

Frequency not reported: Hypersensitivity

Postmarketing reports: Anaphylactic shock, anaphylactic reaction, angioedema

Hypersensitivity was reported in 0.1% to 1.9% of patients taking celecoxib 100 to 200 mg twice a day or 200 mg once a day.

Metabolic

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

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 100 to 200 mg twice a day or 200 mg once a day.

Other

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.

Uncommon (0.1% to 1%): Labyrinthitis

Very rare (less than 0.01%): Hearing decreased

Frequency not reported: Otitis media, deafness, ear abnormality, earache, tinnitus

Endocrine

Postmarketing reports: Impaired female fertility

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

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.