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Celecoxib

Generic Name: celecoxib (SEL e KOX ib)
Brand Names: CeleBREX

Medically reviewed by P. Thornton, DipPharm. Last updated on Dec 17, 2018.

In summary

Celecoxib is a COX-2 inhibitor nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation associated with arthritis and ankylosing spondylitis, and acute pain including period pain. It works by reducing the production of prostaglandins. It is available under the brand name Celebrex, and is also available as a generic.

Common side effects include: stomach pain, diarrhea, heartburn, gas, swelling of the hands or feet, dizziness, rash, and cold symptoms such as stuffy nose or sore throat.

What is celecoxib?

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.

Important Information

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.

Before taking this medicine

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.

How should I take celecoxib?

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.

Celecoxib dosing information Pro

Applies to the following strengths: 50 mg; 100 mg; 200 mg; 400 mg

Usual Adult Dose for Pain

Initial dose: Day 1: 400 mg orally once followed by an additional 200 mg orally if needed

Maintenance dose: 200 mg orally twice a day as needed

Comment:

  • Carefully consider benefits and risks.
  • The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.

Use: For the management of acute pain.

Usual Adult Dose for Dysmenorrhea

Initial dose: Day 1: 400 mg orally once followed by an additional 200 mg orally if needed

Maintenance dose: 200 mg orally twice a day as needed

Comment:

  • Carefully consider benefits and risks.
  • The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.

Use: For the treatment of primary dysmenorrhea.

Usual Adult Dose for Osteoarthritis

200 mg orally once a day OR 100 mg orally twice a day

Comments:

  • Carefully consider benefits and risks.
  • Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Use: For the relief of the signs and symptoms of osteoarthritis.

Usual Adult Dose for Rheumatoid Arthritis

100 or 200 mg orally twice a day

Comments:

  • Carefully consider benefits and risks.
  • Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Use: For the relief of the signs and symptoms of rheumatoid arthritis.

Usual Adult Dose for Ankylosing Spondylitis

200 mg orally once a day OR 100 mg orally twice a day

  • If no effect after 6 weeks, consider increasing daily dose to 400 mg daily
    Maximum dose: 400 mg per day

Comments:

  • Carefully consider benefits and risks.
  • If no effect is observed after 6 weeks at 400 mg per day, alternative treatments should be considered as a response is not likely.
  • Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Use: For the relief of the signs and symptoms of ankylosing spondylitis.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

Age: 2 years or older:

Weight: 10 kg to 25 kg: 50 mg orally twice a day

Weight: Greater than 25 kg: 100 mg orally twice a day

Comments:

  • Carefully consider benefits and risks.
  • The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
  • For pediatric patients who are CYP450 2C9 poor metabolizers, consider alternative treatment.

Use: For the relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years or older.

Renal Dose Adjustments

Severe renal impairment (CrCl less than 30 mL/min): Use is not recommended

Mild to moderate renal impairment: No dose adjustment recommended

Liver Dose Adjustments

Severe hepatic impairment: Use not recommended

Moderate hepatic impairment (Child-Pugh Class B): Reduce dose by 50%

Mild hepatic impairment: No dose adjustment recommended

Dose Adjustments

CYP450 2C9 Poor Metabolizers (known or suspected based on genotype or previous history or experiences with other CYP450 2C9 substrates):

  • Adults: Consider initiating treatment at one-half the lowest recommended dose
  • Pediatrics: Consider alternative treatment

Elderly: Weight greater than 50 kg: No dose adjustment recommended

Elderly, Weight less than 50 kg: Initiate therapy at the lowest recommended dose

Precautions

US BOXED WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

  • Cardiovascular Thrombotic Events: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
  • Gastrointestinal (GI) Bleeding, Ulceration, and Perforation: NSAIDs cause an increased risk of serious 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 peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

CONTRAINDICATIONS:

  • Known hypersensitivity to this drug (e.g., anaphylactic reactions and serious skin reaction), or any of the product excipients
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
  • Demonstrated allergic-type reactions to sulfonamides
  • In the setting of coronary artery bypass graft (CABG) surgery

Safety and efficacy have not been established in patients younger than 18 years except for those 2 to 17 years with Juvenile Rheumatoid Arthritis in which safety and efficacy have been established for up to 6 months.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

  • May take with or without food
  • For Patients with Difficulty Swallowing Capsules: Carefully sprinkle the entire contents of the capsule onto a level teaspoon of cool or room temperature applesauce and ingest immediately with water.

Storage requirements:

The sprinkled capsule contents on applesauce are stable for up to 6 hours when stored in the refrigerator [36F to 46F (2C to 8C)].

General:

  • Prior to initiating treatment, the potential benefits and risks of this drug should be weighed against other treatment options.
  • The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
  • This drug is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Monitoring:

  • Blood pressure should be monitored closely during initiation and throughout course of therapy.
  • Monitor for signs and symptoms of edema including worsening heart failure and cardiac ischemia
  • Monitor for signs/symptoms of gastrointestinal bleeding.
  • Monitor for rash.
  • Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.
  • Monitor blood counts, renal, and hepatic function periodically for patients receiving long-term therapy.

Patient advice:

  • Patients should seek medical advice for signs and symptoms of cardiovascular events, gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
  • Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding.
  • Patients should talk to their health care provider before they use over the counter analgesics.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking celecoxib?

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).

Pregnancy and breastfeeding data Pro

Celecoxib pregnancy warnings

Animal studies have revealed evidence of teratogenicity in rabbits and rats at doses approximately 2 to 6-fold human exposure, respectively, and pre- and post-implantation losses in rats at doses approximately 6-fold human exposure. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. Administration of NSAIDs during the latter part of pregnancy may cause premature closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation, and delay labor and delivery. There are no controlled data in human pregnancy.

NSAIDs may delay or prevent rupture of ovarian follicles which has been associated with reversible infertility in some women. The withdrawal of NSAID therapy should be considered in women with difficulties conceiving or who are undergoing investigation of infertility.

TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

UK: Use is contraindicated unless an effective method of contraception is being used
AU and US: Avoid use in the third trimester; first and second trimester, use only if the potential benefit outweighs potential risk

AU TGA pregnancy category: B3
US FDA pregnancy category: C up to 30 weeks gestation
US FDA pregnancy category: D from 30 weeks gestation and onward

Comment: This drug should not be used starting at 30 weeks gestation as it may cause premature closure of the ductus arteriosus.

See references

Celecoxib breastfeeding warnings

AU and UK: Breastfeeding is not recommended
US: Caution is recommended

Excreted into human milk: Yes

Limited data has shown this drug is excreted into human milk in low levels. The averaged calculated daily dose in an exclusively breastfed infant is estimated to be 10 to 40 mcg/kg/day. In 2 breastfed infants (17 and 22 months of age) whose mothers were taking celecoxib 200 mg orally twice daily for many weeks, blood samples taken 4 hours after a maternal dose were undetectable (less than 10 mcg/L).

See references

Celecoxib side effects

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:

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.

Celecoxib side effects by body system Pro

Applies to celecoxib: oral capsule

General

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.
  • 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

  • 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]
  • 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]
  • 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

  • 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]
  • 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[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

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]

What other drugs will affect celecoxib?

Ask your doctor before using celecoxib if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

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.

Celecoxib drug interactions Pro

Further information

Remember, 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.

More about celecoxib

Drug monograph Pro

Prescribing information Pro

Side effects 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

References for pregnancy information

  1. "Product Information. Celebrex (celecoxib)." Searle, Chicago, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Celebrex (celecoxib)." Searle, Chicago, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
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