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Celecoxib Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 25, 2023.

Applies to celecoxib: oral capsule, oral solution.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

Risk of Serious Cardiovascular and Gastrointestinal EventsNSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.

This risk may occur early in the treatment and may increase with duration of use.Celecoxib is contraindicated in the setting of CABG surgery.NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

These events can occur at any time during use and without warning symptoms.

Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Oral route (solution)

Risk of Serious Cardiovascular and Gastrointestinal Events. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.

This risk may occur early in the treatment and may increase with duration of use.Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

These events can occur at any time during use and without warning symptoms.

Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Serious side effects of celecoxib

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, discomfort, tightness, or heaviness
  • chills
  • confusion
  • 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
  • trouble breathing
  • 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

Incidence not known

  • area rash
  • blistering, peeling, or loosening of the skin
  • changes in skin color
  • clay-colored stools
  • dilated neck veins
  • itching
  • joint or muscle pain
  • light-colored stools
  • pale or a bluish color skin of the fingers or toes
  • red irritated eyes
  • red skin lesions, often with a purple center
  • seizures
  • slurred speech
  • sores, welting, or blisters
  • sudden and severe inability to speak
  • ulcers or white spots in the mouth or on the lips
  • 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

Other side effects of celecoxib

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
  • change in sense of taste
  • gas
  • headache
  • heartburn
  • inability to sleep
  • loss of taste
  • 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
  • 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
  • uncomfortable swelling around anus
  • unexplained weight loss
  • voice changes
  • warmth on the skin
  • weakness or heaviness of the legs

Incidence not known

  • bleeding gums
  • 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
  • shakiness and unsteady walk
  • stomach cramps
  • swelling of the neck
  • tenderness
  • trembling, or other problems with muscle control or coordination
  • unsteadiness
  • watery or bloody diarrhea

Managing side effects (general information)

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

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

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

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 100 to 200 mg twice a day or 200 mg once a day.[Ref]

Hematologic

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

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]

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]

Renal

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]

Ocular

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]

Other

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

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]

Hypersensitivity

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

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]

Endocrine

Genitourinary

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."

2. (2001) "Product Information. Celebrex (celecoxib)." Searle

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

Frequently asked questions

Further information

Celecoxib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer