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Celecoxib Side Effects

In Summary

Commonly reported side effects of celecoxib include: hypertension, diarrhea, and abnormal hepatic function tests. Other side effects include: dyspepsia, vomiting, abdominal pain, gastroesophageal reflux disease, peripheral edema, and increased liver enzymes. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to celecoxib: oral capsule

In addition to its needed effects, some unwanted effects may be caused by celecoxib. In the event that any of these side effects do occur, they may require medical attention.

Severity: Major

You should check with your doctor immediately if any of these side effects occur when 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

If any of the following symptoms of overdose occur while taking celecoxib, get emergency help immediately:

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

Severity: Minor

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

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.[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.

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]

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.

Chronic use of celecoxib may increase the risk of serious adverse cardiovascular thrombotic events including myocardial infarction (MI). In the Adenoma Prevention with Celecoxib (APC) trial, the composite endpoint of cardiovascular death, MI, or stroke was 3.4 [95% confidence interval (CI; 1.4 to 8.5] and 2.8 [95% CI; 1.4 to 8.5] for celecoxib 400 mg twice a day and 200 mg twice a day, respectively, compared to placebo. Over 3 years, the cumulative rates for this composite endpoint were 3% (20/671) and 2.5% (17/685) of patients receiving 200 mg and 400 mg, respectively, compared to 0.9% (6/679) of placebo patients. The increase in drug-treated patients was mainly due to an increased incidence of myocardial infarction.[Ref]

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.[Ref]

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]

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[Ref]

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.[Ref]

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[Ref]

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).[Ref]

Hepatic

Abnormal hepatic function, AST and ALT increases 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]

Rare (less than 0.1%): Cholelithiasis
Frequency not reported: Abnormal hepatic function, AST and ALT increases
Postmarketing reports: Hepatitis, hepatitis fulminant, jaundice, hepatic failure, hepatic necrosis, cholestasis, hepatitis cholestatic, liver transplant, hepatic enzymes increased[Ref]

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.[Ref]

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]

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 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

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]

Uncommon (0.1% to 1%): Epicondylitis, tendon rupture
Frequency not reported: Arthralgia, arthrosis, bone disorder, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis[Ref]

Other

Frequency not reported: Asthenia fatigue, fever, hot flushes, cyst, pain
Postmarketing reports: Conjunctivitis[Ref]

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.[Ref]

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[Ref]

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.[Ref]

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.[Ref]

Frequency not reported: Breast fibroadenosis, breast neoplasm[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity
Postmarketing reports: Anaphylactic shock, anaphylactic reaction, angioedema[Ref]

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.[Ref]

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[Ref]

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.[Ref]

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.[Ref]

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]

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Celebrex (celecoxib)." Searle, Chicago, IL.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Not all side effects for celecoxib may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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