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Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.
Celecoxib is used to treat pain or inflammation caused by many conditions such as arthritis, ankylosing spondylitis, and menstrual pain.
Celecoxib is used to treat juvenile rheumatoid arthritis in children who are at least 2 years old. It is also used in the treatment of hereditary polyps in the colon.
Celecoxib can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Celecoxib may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults. You should not take this medicine if you already have bleeding in your stomach or intestines.
You should not use celecoxib if you are allergic to it, or if you have:
an allergy to sulfa drugs; or
a history of asthma attack or severe allergic reaction after taking aspirin or an NSAID.
To make sure celecoxib is safe for you, tell your doctor if you have ever had:
a stomach ulcer, bleeding in your stomach or intestines;
heart disease, high blood pressure;
asthma;
bleeding problems;
liver or kidney disease; or
if you smoke or drink alcohol.
Taking celecoxib during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
This medicine may affect fertility (ability to have children) in women. Ask your doctor about this risk.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
Take celecoxib exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition.
You may take celecoxib with or without food.
If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture with water. You may save this applesauce mixture for later use in a refrigerator for up to 6 hours.
Store at room temperature away from moisture and heat.
Usual Adult Dose for Pain:
Acute pain: 400 mg initially, followed by 200 mg if needed on the first day. Then, 200 mg twice daily as needed.
Usual Adult Dose for Dysmenorrhea:
400 mg initially, followed by 200 mg if needed on the first day. Then, 200 mg twice daily as needed.
Usual Adult Dose for Osteoarthritis:
200 mg orally once daily or 100 mg orally twice daily.
Usual Adult Dose for Rheumatoid Arthritis:
100 to 200 mg orally twice daily.
Usual Adult Dose for Familial Adenomatous Polyposis:
400 mg orally twice daily with food.
Usual Adult Dose for Ankylosing Spondylitis:
200 mg orally once daily or 100 mg orally twice daily. If after 6 weeks of therapy no results are observed, a trial dose of 400 mg orally daily may be worthwhile. If no response is seen after 6 weeks, consideration should be given to alternate treatment options.
Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:
2 years or older:
10 to less than or equal to 25 kg: 50 mg orally twice daily
Greater than 25 kg: 100 mg orally twice daily
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid taking aspirin or other NSAIDs while you are taking celecoxib.
Avoid drinking alcohol. It may increase your risk of stomach bleeding.
Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to celecoxib (such as aspirin, ibuprofen, ketoprofen, or naproxen).
Get emergency medical help if you have signs of an allergic reaction to celecoxib (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.
Stop using this medicine and call your doctor at once if you have:
the first sign of any skin rash, no matter how mild;
heart problems - swelling, rapid weight gain, feeling short of breath;
signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
liver problems - nausea, stomach pain (upper right side), itching, tiredness, dark urine, jaundice (yellowing of the skin or eyes);
kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
Common celecoxib side effects may include:
stomach pain, heartburn, gas, diarrhea, constipation, nausea, vomiting;
swelling in your hands or feet;
dizziness; or
cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ask your doctor before using celecoxib if you take an antidepressant, steroid medicine, or medicine to treat or prevent blood clots. Taking certain medicines with an NSAID may increase your risk of a stomach ulcer or bleeding.
Many drugs can interact with celecoxib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use celecoxib only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Celecoxib (www.drugs.com/celecoxib.html).
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 ConsumerApplies to celecoxib: oral capsule
Oral route (Capsule)
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 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.
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
Less common or rare
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking celecoxib:
Symptoms of overdose
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
Less common
Incidence not known
For Healthcare Professionals
Applies to celecoxib: oral capsule
GeneralThe 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.
GastrointestinalCommon (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
CardiovascularCommon (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 systemLeg 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
DermatologicCommon (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.
HematologicUncommon (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).
HepaticBorderline 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
RespiratoryBronchitis, 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
RenalRare (less than 0.1%): Acute renal failure
Postmarketing reports: Tubulointerstitial nephritis, nephrotic syndrome, glomerulonephritis minimal lesion
PsychiatricAnxiety, 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
OcularUncommon (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.
MusculoskeletalArthralgia, 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
OtherFrequency 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.
ImmunologicRare (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.
OncologicBreast 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
HypersensitivityFrequency 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.
MetabolicUncommon (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.
OtherOtitis 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
EndocrinePostmarketing reports: Impaired female fertility
GenitourinaryCommon (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.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Celecoxib (www.drugs.com/celecoxib.html).
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