Pharmacy author: Omudhome Ogbru, PharmD
What Is Celebrex?
Celebrex (celecoxib) is a nonsteroidal anti-inflammatory drug (NSAID) used for the relief of pain, fever, swelling, and tenderness caused by arthritis. Celebrex is also used for familial FAP, acute pain, and menstrual cramps.
What Are Side Effects of Celebrex?
Common side effects of Celebrex include
- headache,
- abdominal pain,
- indigestion,
- diarrhea,
- nausea,
- upset stomach,
- bloating,
- gas,
- dizziness,
- nervousness,
- headache,
- runny or stuffy nose,
- sore throat,
- skin rash, and
- insomnia.
Celebrex may cause serious stomach and intestinal ulcers.
Dosage for Celebrex
The recommended dose of Celebrex (celecoxib) is 200 to 400 mg daily. Celebrex may interact with other nonsteroidal anti-inflammatory drugs (NSAIDs), other cold/allergy/pain medicine that contains NSAIDs, antidepressants, blood thinners, diuretics (water pills), fluconazole, lithium, heart or blood pressure medications, or ACE inhibitors. Tell your doctor all medications and supplements you use.
What Drugs, Substances, or Supplements Interact with Celebrex?
Celebrex (celecoxib) should not be used in late pregnancy because there is a risk of heart defects in the newborn. Tell your doctor if you are pregnant or plan to become pregnant while using Celebrex.
Celebrex During Pregnancy and Breastfeeding
Taking Celebrex during the last 3 months of pregnancy may harm a fetus. Celebrex passes into breast milk and may affect a nursing baby. Consult your doctor before breastfeeding.
Additional Information
Our Celebrex (celecoxib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.

SLIDESHOW
What Is Rheumatoid Arthritis (RA)? Symptoms, Treatment, Diagnosis See Slideshow3 pharmacies near 20147 have coupons for CeleBREX (Brand Names:Celebrex for 50MG)
Get emergency medical help if you have signs of an allergic reaction (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 celecoxib 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 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.
Read the entire detailed patient monograph for Celebrex (Celecoxib)

QUESTION
The term arthritis refers to stiffness in the joints. See AnswerSIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Of the CELEBREX-treated patients in the pre-marketing controlled clinical trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain. More than 8,500 patients received a total daily dose of CELEBREX of 200 mg (100 mg twice daily or 200 mg once daily) or more, including more than 400 treated at 800 mg (400 mg twice daily). Approximately 3,900 patients received CELEBREX at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more.
Pre-Marketing Controlled Arthritis Trials
Table 1 lists all adverse events, regardless of causality, occurring in ≥2% of patients receiving CELEBREX from 12 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group. Since these 12 trials were of different durations, and patients in the trials may not have been exposed for the same duration of time, these percentages do not capture cumulative rates of occurrence.
Table 1: Adverse Events Occurring in ≥2% of CELEBREX Patients from Pre-marketing Controlled Arthritis Trials
CBX N=4146 |
Placebo N=1864 |
NAP N=1366 |
DCF N=387 |
IBU N=345 |
|
Gastrointestinal | |||||
Abdominal Pain | 4.1% | 2.8% | 7.7% | 9.0% | 9.0% |
Diarrhea | 5.6% | 3.8% | 5.3% | 9.3% | 5.8% |
Dyspepsia | 8.8% | 6.2% | 12.2% | 10.9% | 12.8% |
Flatulence | 2.2% | 1.0% | 3.6% | 4.1% | 3.5% |
Nausea | 3.5% | 4.2% | 6.0% | 3.4% | 6.7% |
Body as a whole | |||||
Back Pain | 2.8% | 3.6% | 2.2% | 2.6% | 0.9% |
Peripheral Edema | 2.1% | 1.1% | 2.1% | 1.0% | 3.5%` |
Injury-Accidental | 2.9% | 2.3% | 3.0% | 2.6% | 3.2% |
Central, PeripheralNervous system | |||||
Dizziness | 2.0% | 1.7% | 2.6% | 1.3% | 2.3% |
Headache | 15.8% | 20.2% | 14.5% | 15.5% | 15.4% |
Psychiatric | |||||
Insomnia | 2.3% | 2.3% | 2.9% | 1.3% | 1.4% |
Respiratory | |||||
Pharyngitis | |||||
Rhinitis | 2.3% | 1.1% | 1.7% | 1.6% | 2.6% |
Sinusitis | 2.0% | 1.3% | 2.4% | 2.3% | 0.6% |
Upper Respiratory | 5.0% | 4.3% | 4.0% | 5.4% | 5.8% |
Infection | 8.1% | 6.7% | 9.9% | 9.8% | 9.9% |
Skin | |||||
Rash | 2.2% | 2.1% | 2.1% | 1.3% | 1.2% |
CBX = CELEBREX 100 mg to 200 mg twice daily or 200 mg once daily; NAP = Naproxen 500 mg twice daily; DCF = Diclofenac 75 mg twice daily; IBU = Ibuprofen 800 mg three times daily. |
In placebo-or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving CELEBREX and 6.1% for patients receiving placebo. Among the most common reasons for discontinuation due to adverse events in the CELEBREX treatment groups were dyspepsia and abdominal pain (cited as reasons for discontinuation in 0.8% and 0.7% of CELEBREX patients, respectively). Among patients receiving placebo, 0.6% discontinued due to dyspepsia and 0.6% withdrew due to abdominal pain.
The Following Adverse Reactions Occurred In 0.1% To 1.9% Of Patients Treated With CELEBREX (100 mg To 200 mg Twice Daily Or 200 mg Once Daily)
Gastrointestinal: Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, vomiting
Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disorder, myocardial infarction
General: Hypersensitivity, allergic reaction, chest pain, cyst NOS, edema generalized, face edema, fatigue, fever, hot flushes, influenza-like symptoms, pain, peripheral pain
Central, peripheral nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, paresthesia, vertigo
Hearing and vestibular: Deafness, tinnitus
Heart rate and rhythm: Palpitation, tachycardia
Liver and biliary: Hepatic enzyme increased (including SGOT increased, SGPT increased)
Metabolic and nutritional: blood urea nitrogen (BUN) increased, creatine phosphokinase (CPK) increased, hypercholesterolemia, hyperglycemia, hypokalemia, NPN increased, creatinine increased, alkaline phosphatase increased, weight increased
Musculoskeletal: Arthralgia, arthrosis, myalgia, synovitis, tendinitis
Platelets (bleeding or clotting): Ecchymosis, epistaxis, thrombocythemia,
Psychiatric: Anorexia, anxiety, appetite increased, depression, nervousness, somnolence
Hemic: Anemia
Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, cough, dyspnea, laryngitis, pneumonia
Skin and appendages: Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, skin dry, sweating increased, urticaria
Application site disorders: Cellulitis, dermatitis contact
Urinary: Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus
The Following Serious Adverse Events (Causality Not Evaluated) Occurred In <0.1% Of Patients
Cardiovascular: Syncope, congestive heart failure, ventricular fibrillation, pulmonary embolism, cerebrovascular accident, peripheral gangrene, thrombophlebitis
Gastrointestinal: Intestinal obstruction, intestinal perforation, gastrointestinal bleeding, colitis with bleeding, esophageal perforation, pancreatitis, ileus
General: Sepsis, sudden death
Liver and biliary: Cholelithiasis
Hemic and lymphatic: Thrombocytopenia
Nervous: Ataxia, suicide [see DRUG INTERACTIONS]
Renal: Acute renal failure
The Celecoxib Long-Term Arthritis Safety Study
[See Clinical Studies]
Hematological Events
The incidence of clinically significant decreases in hemoglobin (>2 g/dL) was lower in patients on CELEBREX 400 mg twice daily (0.5%) compared to patients on either diclofenac 75 mg twice daily (1.3%) or ibuprofen 800 mg three times daily 1.9%.
The lower incidence of events with CELEBREX was maintained with or without aspirin use [see CLINICAL PHARMACOLOGY].
Withdrawals/Serious Adverse Events
Kaplan-Meier cumulative rates at 9 months for withdrawals due to adverse events for CELEBREX, diclofenac and ibuprofen were 24%, 29%, and 26%, respectively. Rates for serious adverse events (i.e., causing hospitalization or felt to be life-threatening or otherwise medically significant), regardless of causality, were not different across treatment groups (8%, 7%, and 8%, respectively).
Juvenile Rheumatoid Arthritis Study
In a 12-week, double-blind, active-controlled study, 242 JRA patients 2 years to 17 years of age were treated with celecoxib or naproxen; 77 JRA patients were treated with celecoxib 3 mg/kg twice daily, 82 patients were treated with celecoxib 6 mg/kg twice daily, and 83 patients were treated with naproxen 7.5 mg/kg twice daily. The most commonly occurring (≥5%) adverse events in celecoxib treated patients were headache, fever (pyrexia), upper abdominal pain, cough, nasopharyngitis, abdominal pain, nausea, arthralgia, diarrhea and vomiting. The most commonly occurring (≥5%) adverse experiences for naproxen-treated patients were headache, nausea, vomiting, fever, upper abdominal pain, diarrhea, cough, abdominal pain, and dizziness (Table 2). Compared with naproxen, celecoxib at doses of 3 and 6 mg/kg twice daily had no observable deleterious effect on growth and development during the course of the 12-week double-blind study. There was no substantial difference in the number of clinical exacerbations of uveitis or systemic features of JRA among treatment groups.
In a 12-week, open-label extension of the double-blind study described above, 202 JRA patients were treated with celecoxib 6 mg/kg twice daily. The incidence of adverse events was similar to that observed during the double-blind study; no unexpected adverse events of clinical importance emerged.
Table 2: Adverse Events Occurring in ≥5% of JRA Patients in Any Treatment Group, by System Organ Class (% of patients with events)
System Organ Class Preferred Term |
All Doses Twice Daily | ||
Celecoxib 3 mg/kg N=77 |
Celecoxib 6 mg/kg N=82 |
Naproxen 7.5 mg/kg N=83 |
|
Any Event | 64 | 70 | 72 |
Eye Disorders | 5 | 5 | 5 |
Gastrointestinal | 26 | 24 | 36 |
Abdominal pain NOS | 4 | 7 | 7 |
Abdominal pain upper | 8 | 6 | 10 |
Vomiting NOS | 3 | 6 | 11 |
Diarrhea NOS | 5 | 4 | 8 |
Nausea | 7 | 4 | 11 |
General | 13 | 11 | 18 |
Pyrexia | 8 | 9 | 11 |
Infections | 25 | 20 | 27 |
Nasopharyngitis | 5 | 6 | 5 |
Injury and Poisoning | 4 | 6 | 5 |
Investigations* | 3 | 11 | 7 |
Musculoskeletal | 8 | 10 | 17 |
Arthralgia | 3 | 7 | 4 |
Nervous System | 17 | 11 | 21 |
Headache NOS | 13 | 10 | 16 |
Dizziness (excl vertigo) | 1 | 1 | 7 |
Respiratory | 8 | 15 | 15 |
Cough | 7 | 7 | 8 |
Skin & Subcutaneous | 10 | 7 | 18 |
* Abnormal laboratory tests, which include: Prolonged activated partial thromboplastin time, Bacteriuria NOS present, Blood creatine phosphokinase increased, Blood culture positive, Blood glucose increased, Blood pressure increased, Blood uric acid increased, Hematocrit decreased, Hematuria present, Hemoglobin decreased, Liver function tests NOS abnormal, Proteinuria present, Transaminase NOS increased, Urine analysis abnormal NOS |
Other Pre-Approval Studies
Adverse Events from Ankylosing Spondylitis Studies
A total of 378 patients were treated with CELEBREX in placebo-and active-controlled AS studies. Doses up to 400 mg once daily were studied. The types of adverse events reported in the AS studies were similar to those reported in the OA/RA studies.
Adverse Events from Analgesia and Dysmenorrhea Studies
Approximately 1,700 patients were treated with CELEBREX in analgesia and dysmenorrhea studies. All patients in post-oral surgery pain studies received a single dose of study medication. Doses up to 600 mg/day of CELEBREX were studied in primary dysmenorrhea and post-orthopedic surgery pain studies. The types of adverse events in the analgesia and dysmenorrhea studies were similar to those reported in arthritis studies. The only additional adverse event reported was post-dental extraction alveolar osteitis (dry socket) in the post-oral surgery pain studies.
The APC And PreSAP Trials
Adverse Reactions From Long-term, Placebo-controlled Polyp Prevention Studies
Exposure to CELEBREX in the APC and PreSAP trials was 400 mg to 800 mg daily for up to 3 years [see Special Studies: Adenomatous Polyp Prevention Studies].
Some adverse reactions occurred in higher percentages of patients than in the arthritis pre-marketing trials (treatment durations up to 12 weeks; see Adverse events from CELEBREX pre-marketing controlled arthritis trials, above). The adverse reactions for which these differences in patients treated with CELEBREX were greater as compared to the arthritis pre-marketing trials were as follows:
CELEBREX (400 to 800 mg daily) |
Placebo | |
N = 2285 | N = 1303 | |
Diarrhea | 10.5% | 7.0% |
Gastroesophageal reflux disease | 4.7% | 3.1% |
Nausea | 6.8% | 5.3% |
Vomiting | 3.2% | 2.1% |
Dyspnea | 2.8% | 1.6% |
Hypertension | 12.5% | 9.8% |
Nephrolithiasis | 2.1% | 0.8% |
The following additional adverse reactions occurred in ≥0.1% and <1% of patients taking CELEBREX, at an incidence greater than placebo in the long-term polyp prevention studies, and were either not reported during the controlled arthritis pre-marketing trials or occurred with greater frequency in the long-term, placebo-controlled polyp prevention studies:
Nervous system disorders: Cerebral infarction
Eye disorders: Vitreous floaters, conjunctival hemorrhage
Ear and labyrinth: Labyrinthitis
Cardiac disorders: Angina unstable, aortic valve incompetence, coronary artery atherosclerosis, sinus bradycardia, ventricular hypertrophy
Vascular disorders: Deep vein thrombosis
Reproductive system and breast disorders: Ovarian cyst
Investigations: Blood potassium increased, blood sodium increased, blood testosterone decreased
Injury, poisoning, and procedural complications: Epicondylitis, tendon rupture
Postmarketing Experience
The following adverse reactions have been identified during post approval use of CELEBREX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure
Cardiovascular: Vasculitis, deep venous thrombosis
General: Anaphylactoid reaction, angioedema
Liver and biliary: Liver necrosis, hepatitis, jaundice, hepatic failure
Hemic and lymphatic: Agranulocytosis, aplastic anemia, pancytopenia, leucopenia
Metabolic: Hypoglycemia, hyponatremia
Nervous: Aseptic meningitis, ageusia, anosmia, fatal intracranial hemorrhage
Renal: Interstitial nephritis
Read the entire FDA prescribing information for Celebrex (Celecoxib)
Read the Celebrex User Reviews »
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