Celecoxib Side Effects

Brand Names: Celebrex

Please note - some side effects for Celecoxib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Celecoxib - for the consumer

Celecoxib

All medicines can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Celecoxib:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; sore throat; stomach upset; stuffy nose.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hearing loss; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

By body system

Gastrointestinal side effects

Gastrointestinal (GI) side effects have included nausea (3.5% to 9.09%), upper abdominal pain (7.32% to 10.4%), dyspepsia (2.8% to 8.8%), abdominal pain (1.3% to 8.5%), vomiting (less than or equal to 7.3%), diarrhea (4.9% to 10.5%), gastroesophageal reflux (4.7%), and flatulence (2.2%). Constipation, diverticulitis, dry mouth, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, hemorrhoids, hiatal hernia, melena, stomatitis, tenesmus, tooth disorder, intestinal obstruction, intestinal perforation, GI bleeding, colitis with bleeding, esophageal perforation, pancreatitis, cholelithiasis, and ileus have been reported in less than 2% of the patients. At least three cases of intestinal anastomotic ulceration have been reported. Serious GI toxicity such as GI hemorrhage and ulceration have been reported and possibly linked to some deaths.

Five of ten reported deaths in patients taking celecoxib were in individuals who suffered from stomach or GI bleeding or ulcers. The other deaths were attributed to heart attack, drug interaction and kidney disease. The 11 reported cases of GI hemorrhage resulted in hospitalization. Six cases of abdominal pain and swelling were also reported. It is unknown if celecoxib can be directly linked to the reported cases of death because many of the patients had concomitant illnesses and were taking other medications.

Some studies have shown a decrease in gastroduodenal endoscopic ulcers with celecoxib in comparison to a traditional NSAID. These ulcers are generally asymptomatic.

In the Celecoxib Long-term Arthritis Safety Study (CLASS) the estimated cumulative incidence of upper GI complicated and symptomatic ulcers among non-aspirin users (n equals 3105) given celecoxib 400 mg twice a day was 0.78% at nine months. This dosage was 2 to 4 times higher than the dosage approved by the FDA for osteoarthritis and rheumatoid arthritis, respectively. The estimated cumulative incidence of upper GI complicated ulcers was 0.32%.

Intestinal anastomotic ulceration has been reported by 3 of 58 patients in the familial adenomatous polyposis trial. These patients had prior intestinal surgery. Causality was not established.

Cardiovascular side effects

Safety data from the Celecoxib Long-term Arthritis Safety Study (CLASS) in which patients with osteoarthritis and rheumatoid arthritis were allowed to take concomitant low-dose aspirin (less than or equal to 325 mg/day) for cardiovascular prophylaxis indicated there were no significant differences between treatment groups (celecoxib vs. ibuprofen vs. diclofenac) in the overall incidence of serious CV thromboembolic adverse events, such as heart attack, stroke, and unstable angina. This was observed at doses of celecoxib 400 mg twice a day, ibuprofen 800 mg three times a day, and diclofenac 75 mg twice a day. The cumulative rates of such events in all patients at nine months for celecoxib, diclofenac, and ibuprofen were 1.2%, 1.4% and 1.1%, respectively. The rates for heart attacks in each of the three non-aspirin treatment groups were less than 0.2%. The incidence of hypertension and edema were similar across the three treatment groups. The rates of hypertension for celecoxib, diclofenac and ibuprofen were 2.4%, 4.2% and 2.5%, respectively.

Fatal and nonfatal cardiovascular events have been observed in a large colorectal cancer prevention trial (Adenoma Prevention with Celecoxib (APC)) conducted by the National Institute of Health (NIH). A 2.5 fold increased risk of major fatal and nonfatal cardiovascular events have been reported in patients taking celecoxib vs. placebo during a large cancer prevention trial sponsored by the NIH. The study was immediately halted, but patients will remain under observation through the remaining of the planned duration of the study (Spring of 2005).

Cardiovascular side effects including increased blood pressure have been reported in 3.9% to 13.4% of patients. Aggravated hypertension, syncope, congestive heart failure, ventricular fibrillation, pulmonary embolism, cerebrovascular accident, peripheral gangrene, angina pectoris, coronary artery disorder, myocardial infarction, palpitation, tachycardia, and thrombophlebitis have been reported in less than 2% of patients. Unstable angina, aortic valve incompetence, sinus bradycardia, and ventricular hypertrophy have been reported in 0.1% or greater to less than 1% of patients.

Nervous system side effects

Nervous system side effects have included headache (12.2% to 17%), dizziness (2%), and dizziness (excluding vertigo) (1.2% to 1.3%). Hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo, and ataxia have been reported in less than 2% of patients. Cerebral infarction has been reported in 0.1% or greater to less than 1% of patients. Ataxia, ageusia, anosmia, and suicide have been reported in less than 0.1% of patients. Aseptic meningitis has been reported in less than 0.1% of patients during postmarketing experience.

Dermatologic side effects

A 57-year-old man developed mucocutaneous lesions, painful red papules and plaques on the skin, and arthralgias of his wrist and knees after 1 week of treatment with celecoxib 100 mg twice daily. Symptoms improved after celecoxib was discontinued but these dramatically worsened upon rechallenge. This patient's onset and presentation of symptoms met the diagnosis criteria for Sweet's syndrome.

Toxic epidermal necrolysis has been reported in an 81-year-old woman seventeen days after the continuous use of celecoxib 200 mg/day.

Dermatologic side effects including rash, alopecia, dermatitis, nail disorder, photosensitivity reaction, pruritus, erythematous and maculopapular rash, increased sweating, urticaria, cellulitis, dry skin, and skin disorders have been reported in less than 2% of patients. Contact dermatitis, injection site reaction, and skin nodule have been reported 0.1% to 1.9% of patients. Leukocytoclastic vasculitis has been reported during postmarketing experience. A case of Sweet's syndrome has been reported, in addition to a case of toxic epidermal necrolysis.

Endocrine side effects

Endocrine side effects including diabetes mellitus, hypercholesterolemia, and hyperglycemia have been reported in less than 2% of patients. Hypoglycemia has been reported in less than 0.1% of patients.

Hematologic side effects

Hematologic side effects including decreased hematocrit, decreased hemoglobin, and prolonged activated partial thromboplastin time (APTT) have been reported in 3.9% to 13.4% of patients. Anemia, thrombocytopenia, and thrombocythemia, ecchymosis, and epistaxis have been reported in less than 2% of patients. Deep vein thrombosis has been reported in 0.1% or greater to less than 1% of patients. Aplastic anemia, pancytopenia, leukopenia, agranulocytosis, and fatal intracranial hemorrhage have been reported in less than 0.1% of patients. At least one case of acute methemoglobinemia has been reported.

Deep vein thrombosis has been reported in a 52-year-old man with a history of gout treated with celecoxib 200 mg per day.

Acute methemoglobinemia, manifested as an acute confusional state, was diagnosed in a 72-year-old man one month after receiving celecoxib for arthritis. Symptoms resolved following intensive medical care and discontinuation of the drug.

Hepatic side effects

Hepatic side effects including abnormal liver function tests and increased transaminase have been reported in 3.9% to 13.4% of patients. Increased SGOT, SGPT, and alkaline phosphatase have been reported in less than 2% of patients. Jaundice, liver failure, hepatitis, and cholelithiasis have been reported in less than 0.1% of patients. Rarely, cholestatic hepatitis has been reported. At least once case of celecoxib-induced combined hepato-nephrotoxicity has been reported.

Cholestatic hepatitis has been reported in a 54-year-old woman after taking celecoxib 200 mg daily for sacroiliac pain. Her first course of therapy which lasted 4 days provided pain relief, but she also reported a generalized pruritus. A week later when the pain recurred she restarted celecoxib. Two days later she reported dark urine, and five days later she developed jaundice.

A 56-year-old male with osteoarthritis experienced hepato-nephrotoxicity coincident with celecoxib therapy. He was administered a dose of 200 mg one to two tablets per day for osteoarthritic pain. His baseline laboratory at the time of celecoxib prescription showed BUN 16 mg/dL, Cr 1.0 mg/dL, ALT 23 U/L, AST 20 U/L, ALK 60 U/L, and total bilirubin 0.5 mg/dL. He was a nondrinker and nonsmoker with no known risk factors for renal or liver disease. Ten months after the administration of celecoxib, the patient described intermittent right upper quadrant pain, fatigue, and decreased appetite. His symptoms progressed to lethargy and jaundice, requiring hospitalization, over the course of two more months. Laboratory tests upon admission showed BUN 109 mg/dL, Cr 5.2 mg/dL, ALT 3 U/L, AST 17 U/L, ALK 77 U/L, and total bilirubin 32.4 mg/dL. Renal and liver biopsy specimens were obtained within 24 hours of admission and were suggestive of drug-induced toxicity. Celecoxib was discontinued and ensuing rapid symptomatic and biochemical improvement.

Renal side effects

Renal side effects have included increased blood creatinine phosphokinase (3.9% to 13.4%), increased BUN (less than 2%), and increased creatinine (less than 2%). Acute renal failure has been reported in less than 0.1% of patients. Acute interstitial nephritis (less than 0.1%), and membranous glomerulopathy have been reported during postmarketing experience. At least one case of renal papillary necrosis has been reported, in addition to a case of celecoxib-induced combined hepato-nephrotoxicity.

A 61-year-old woman with rheumatoid arthritis was diagnosed with renal papillary necrosis 10 months after the start of treatment with celecoxib 200 mg twice daily. Her symptoms of right flank pain and hematuria resolved after celecoxib treatment was stopped.

A 56-year-old male with osteoarthritis experienced hepato-nephrotoxicity coincident with celecoxib therapy. He was administered a dose of 200 mg one to two tablets per day for osteoarthritic pain. His baseline laboratory at the time of celecoxib prescription showed BUN 16 mg/dL, Cr 1.0 mg/dL, ALT 23 U/L, AST 20 U/L, ALK 60 U/L, and total bilirubin 0.5 mg/dL. He was a nondrinker and nonsmoker with no known risk factors for renal or liver disease. Ten months after the administration of celecoxib, the patient described intermittent right upper quadrant pain, fatigue, and decreased appetite. His symptoms progressed to lethargy and jaundice, requiring hospitalization, over the course of two more months. Laboratory tests upon admission showed BUN 109 mg/dL, Cr 5.2 mg/dL, ALT 3 U/L, AST 17 U/L, ALK 77 U/L, and total bilirubin 32.4 mg/dL. Renal and liver biopsy specimens were obtained within 24 hours of admission and were suggestive of drug-induced toxicity. Celecoxib was discontinued and ensuing rapid symptomatic and biochemical improvement.

Respiratory side effects

Respiratory side effects have included cough (8.5% to 9.1%), upper respiratory tract infection (8.1%), nasopharyngitis (6.9% to 7.3%), sinusitis (5%), dyspnea (2.8%), pharyngitis (2.3%), and rhinitis (2%). Bronchitis, bronchospasm, aggravated bronchospasm, laryngitis, and pneumonia have been reported in less than 2% of patients. At least one case of asthma attacks has been reported, in addition to a case of pulmonary infiltrates.

Asthma attacks have been reported in a 45-year-old woman with a known sensitivity to aspirin. On rechallenge under control conditions (15 mg dose) she developed a severe bronchospasm.

Pulmonary infiltrates have been reported in a 60-year-old woman one hour after receiving celecoxib for knee pain. Following arrival of the paramedics to her home, she was found diaphoretic and cyanotic, with blood pressure 230/80 mm Hg. She was hospitalized for 5 days.

Psychiatric side effects

Overt auditory hallucinations have been reported in a 78-year-old woman within 10 days of starting celecoxib 200 mg twice daily treatment for osteoarthritis pain. Symptoms disappeared on discontinuation of therapy and reappeared upon rechallenge.

Psychiatric side effects have included somnolence (0.1% to 1.9%), anorexia, anxiety, increased appetite, depression, nervousness, and auditory hallucinations.

Ocular side effects

The case of orange spots and case of jellybean-like area of vision loss centrally resolved within 72 hours of discontinuing the drug.

Ocular side effects including blurred vision, cataracts, conjunctivitis, and eye pain have been reported in less than 2% of patients. Vitreous floaters and conjunctival hemorrhage have been reported in 0.1% or greater to less than 1% of patients. At least one case of orange spots has also been reported, in addition to a case of jellybean-like area of vision loss centrally.

Musculoskeletal side effects

Musculoskeletal side effects including arthralgia have been reported in less than or equal to 8.5% of patients. Arthrosis, bone disorder, hypertonia, leg cramps, myalgia, neck stiffness, synovitis, and tendonitis have been reported in less than 2% of patients.

Genitourinary side effects

Genitourinary side effects have included proteinuria (3.9% to 13.4%) and hematuria (less than or equal to 13.4%). Albuminuria, cystitis, dysuria, renal calculus, urinary incontinence, urinary frequency, and urinary tract infection, breast fibroadenosis, and breast pain have been reported in less than 2% of patients. Ovarian cyst has been reported in 0.1% or greater to less than 1% of patients. Fibroadenosis, dysmenorrhea, menstrual disorder, vaginal hemorrhage, vaginitis, and prostatic disorder have been reported.

Other side effects

Other side effects including pyrexia have been reported in 10.4% to 11% of patients. Cyst has been reported in 01% to 1.9% of patients. Epicondylitis, tendon rupture, labyrinthitis have been reported in 0.1% or greater to less than 1% of patients. Sepsis and sudden death have been reported in less than 0.1% of patients. Asthenia, chest pain, edema, fatigue, hot flashes, influenza-like symptoms, pain, and taste perversion have been reported. Hearing and vestibular side effects have included deafness, ear abnormality, earache, and tinnitus.

Immunologic side effects

Immunologic side effects including abnormal urine analysis, bacteriuria, and positive blood culture have been reported in 3.9% to 13.4% of patients. Herpes zoster, herpes simplex, bacterial, viral, fungal, and soft tissue infections as well as moniliasis, and otitis media have been reported in less than 2% of patients. A case of allergic vasculitis has also been reported.

A case of fatal allergic vasculitis associated with celecoxib use has been reported in a 52-year-old man after 8 days of therapy.

Oncologic side effects

Oncologic side effects have included breast neoplasm.

Hypersensitivity side effects

Hypersensitivity side effects have rarely included anaphylactoid reactions and angioedema. Allergic reaction and aggravated allergy have been reported in 0.1 to 1.9% of patients. Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported in less than 0.1% of patients. At least one case of anaphylactic shock has been reported.

A 49-year-old man experienced adverse reactions after taking celecoxib for joint pain on three separate occasions. The reactions appeared within 30 to 60 minutes of taking the drug and became progressively worse each time. On the third occasion the reaction was clearly anaphylactoid in nature; therefore, the patient was not rechallenged with the drug. Anaphylactic shock occurred thirty minutes following the ingestion of celecoxib 200 mg capsule in a 39-year-old woman after not taking the drug for 2 months. She had been treated regularly with celecoxib for almost two years for severe mechanical dorsalgia. The patient recovered fully after receiving intramuscular epinephrine and intravenous methylprednisolone and dexchlorpheniramine.

Metabolic side effects

Metabolic side effects including increased blood glucose have been reported in 3.9% to 13.4% of patients. Increased weight, hypokalemia, increased alkaline phosphatase, and increased NPN have been reported in 0.1% to 1.9% of patients. Increased blood potassium, increased blood sodium, and decreased blood testosterone have been reported 0.1% or greater to less than 1% of patients. Hyponatremia has also been reported in less than 0.1% of patients.

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