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CELECOXIB

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Celecoxib Adverse Events Reported to the FDA Over Time

How are Celecoxib adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Celecoxib, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Celecoxib is flagged as the suspect drug causing the adverse event.

Most Common Celecoxib Adverse Events Reported to the FDA

What are the most common Celecoxib adverse events reported to the FDA?

Vomiting
117 (1.31%)
Diarrhoea
107 (1.2%)
Nausea
104 (1.16%)
Atrial Fibrillation
101 (1.13%)
Renal Failure Acute
92 (1.03%)
Myocardial Infarction
91 (1.02%)
Dehydration
80 (.9%)
Death
79 (.88%)
Pyrexia
79 (.88%)
Dyspnoea
77 (.86%)
Anaemia
70 (.78%)
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Loss Of Consciousness
63 (.71%)
Dizziness
62 (.69%)
Fall
58 (.65%)
Rash
58 (.65%)
Pain
57 (.64%)
Hypotension
56 (.63%)
Pneumonia
56 (.63%)
Gastrointestinal Haemorrhage
55 (.62%)
Asthenia
54 (.6%)
Renal Failure
54 (.6%)
Somnolence
50 (.56%)
Cerebral Infarction
49 (.55%)
Drug Ineffective
49 (.55%)
Cerebrovascular Accident
48 (.54%)
Cardiovascular Disorder
47 (.53%)
Headache
47 (.53%)
Drug Eruption
46 (.51%)
Completed Suicide
45 (.5%)
Abdominal Pain
44 (.49%)
Cardiac Failure
44 (.49%)
Drug Interaction
44 (.49%)
Interstitial Lung Disease
44 (.49%)
Syncope
43 (.48%)
Fatigue
42 (.47%)
Gastric Ulcer
41 (.46%)
Liver Disorder
41 (.46%)
Cardiac Arrest
40 (.45%)
Osteoarthritis
40 (.45%)
Renal Impairment
40 (.45%)
Pulmonary Embolism
39 (.44%)
Sepsis
39 (.44%)
Haemoglobin Decreased
38 (.43%)
Arthralgia
37 (.41%)
Chest Pain
37 (.41%)
Respiratory Failure
37 (.41%)
Atrial Flutter
36 (.4%)
Blood Pressure Decreased
36 (.4%)
Haematemesis
36 (.4%)
Malaise
36 (.4%)
Platelet Count Decreased
36 (.4%)
Pruritus
36 (.4%)
Oedema Peripheral
35 (.39%)
Blood Creatinine Increased
34 (.38%)
Constipation
32 (.36%)
Urticaria
32 (.36%)
Coma
31 (.35%)
Decreased Appetite
31 (.35%)
Diabetes Mellitus
31 (.35%)
Alanine Aminotransferase Increased
30 (.34%)
Melaena
30 (.34%)
Stevens-johnson Syndrome
30 (.34%)
Abdominal Pain Upper
29 (.32%)
Anaphylactic Shock
29 (.32%)
Aspartate Aminotransferase Increase...
29 (.32%)
Face Oedema
28 (.31%)
Thrombocytopenia
28 (.31%)
Acute Myocardial Infarction
27 (.3%)
Arrhythmia
27 (.3%)
Tachycardia
27 (.3%)
Asthma
26 (.29%)
Chills
26 (.29%)
Condition Aggravated
26 (.29%)
Disseminated Intravascular Coagulat...
26 (.29%)
Pain In Extremity
26 (.29%)
Tremor
26 (.29%)
Drug Hypersensitivity
25 (.28%)
Feeling Abnormal
25 (.28%)
Coronary Artery Disease
24 (.27%)
Deep Vein Thrombosis
24 (.27%)
Dysarthria
24 (.27%)
Urinary Tract Infection
24 (.27%)
Back Pain
23 (.26%)
Blood Pressure Increased
23 (.26%)
Febrile Neutropenia
23 (.26%)
Gastroenteritis
23 (.26%)
Hypoaesthesia
23 (.26%)
Neutropenia
23 (.26%)
Oxygen Saturation Decreased
23 (.26%)
Pulmonary Oedema
23 (.26%)
Angina Pectoris
22 (.25%)
Colitis
22 (.25%)
Hypertension
22 (.25%)
Ischaemic Cardiomyopathy
22 (.25%)
Jaundice
22 (.25%)
Toxic Epidermal Necrolysis
22 (.25%)
White Blood Cell Count Increased
22 (.25%)
Confusional State
21 (.24%)
Convulsion
21 (.24%)
Cardiac Failure Congestive
20 (.22%)
Stomatitis
20 (.22%)

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This graph shows the top adverse events submitted to the FDA for Celecoxib, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Celecoxib is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Celecoxib

What are the most common Celecoxib adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Celecoxib, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Celecoxib is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Celecoxib According to Those Reporting Adverse Events

Why are people taking Celecoxib, according to those reporting adverse events to the FDA?

Rheumatoid Arthritis
1324
Osteoarthritis
749
Drug Use For Unknown Indication
666
Arthritis
294
Pain
293
Product Used For Unknown Indication
170
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Arthralgia
158
Back Pain
117
Ill-defined Disorder
83
Ankylosing Spondylitis
46
Inflammation
41
Psoriatic Arthropathy
41
Non-small Cell Lung Cancer
40
Analgesic Therapy
36
Cancer Pain
29
Breast Cancer
28
Antiinflammatory Therapy
27
Musculoskeletal Pain
24
Prostate Cancer
21
Colorectal Cancer Metastatic
21
Prophylaxis
19
Spinal Osteoarthritis
19
Fibromyalgia
17
Colon Cancer
16
Adenomatous Polyposis Coli
16
Periarthritis
15
Pain Management
15
Ovarian Cancer
14
Somatoform Disorder
13
Pain In Extremity
13
Metastases To Bone
12
Tendonitis
11
Medulloblastoma
11
Depression
11
Metastatic Renal Cell Carcinoma
10
Multiple Myeloma
10
Juvenile Arthritis
10
Neoplasm Prophylaxis
9
Pancreatic Carcinoma
9
Polyp
8
Neck Pain
8
Gout
8
Glioblastoma Multiforme
8
Arthropathy
8
Knee Arthroplasty
7
Spinal Compression Fracture
7
Intervertebral Disc Disorder
7
Osteoporosis
7
Bladder Transitional Cell Carcinoma
7
Myalgia
7
Compression Fracture
7

Drug Labels

LabelLabelerEffective
CelebrexBryant Ranch Prepack02-OCT-98
CelebrexRebel Distributors Corp.10-JUL-09
CelebrexA-S Medication Solutions LLC01-SEP-09
CelebrexBlenheim Pharmacal, Inc.25-NOV-09
CelebrexUnit Dose Services01-APR-11
CelebrexPD-Rx Pharmaceuticals, Inc.01-APR-11
CelebrexUnit Dose Services01-APR-11
CelebrexPD-Rx Pharmaceuticals, Inc.01-APR-11
CelebrexSTAT RX USA LLC13-MAY-11
CelebrexCardinal Health26-MAY-11
CelebrexKeltman Pharmaceuticals Inc.06-JUN-11
CelebrexLake Erie Medical & Surgical Supply DBA Quality Care Products LLC22-NOV-11
CelebrexH.J. Harkins Company, Inc.14-DEC-11
CelebrexSTAT Rx USA LLC27-JAN-12
CelebrexAphena Pharma Solutions - Tennessee, Inc.19-JUN-12
CelebrexLake Erie Medical & Surgical Supply DBA Quality Care Products LLC31-AUG-12
CelebrexAidarex Pharmaceuticals LLC12-SEP-12
CelebrexBryant Ranch Prepack23-OCT-12
CelebrexPhysicians Total Care, Inc.23-OCT-12
CelebrexG.D. Searle LLC Division of Pfizer Inc04-JAN-13
CelebrexREMEDYREPACK INC. 20-FEB-13
CelebrexREMEDYREPACK INC. 21-FEB-13
CelebrexREMEDYREPACK INC. 01-MAR-13
CelebrexCardinal Health24-APR-13
CelebrexCardinal Health24-APR-13

Celecoxib Case Reports

What Celecoxib safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Celecoxib. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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