75/100 · Elevated
Manufactured by Viatris Specialty LLC
Celecoxib Adverse Events Show High Serious Reaction Rate
402,054 FDA adverse event reports analyzed
Last updated: 2026-05-12
CELECOXIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. Based on analysis of 402,054 FDA adverse event reports, CELECOXIB has a safety score of 75 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for CELECOXIB include DRUG INEFFECTIVE, PAIN, ARTHRALGIA, FATIGUE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CELECOXIB.
Celecoxib has a safety concern score of 75 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 402,054 adverse event reports for this medication, which is primarily manufactured by Viatris Specialty Llc.
The most commonly reported adverse events include Drug Ineffective, Pain, Arthralgia. Of classified reports, 70.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (70.2%) indicates significant safety concerns.
Pain and related conditions are the most frequently reported reactions. A wide range of reactions suggests diverse safety issues.
Patients taking Celecoxib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Celecoxib is contraindicated in patients with a history of myocardial infarction and should be used with caution in patients with cardiovascular disease. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Celecoxib received a safety concern score of 75/100 (elevated concern). This is based on a 70.2% serious event ratio across 128,078 classified reports. The score accounts for 402,054 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 83,059, Male: 35,014, Unknown: 543. The most frequently reported age groups are age 60 (2,282 reports), age 64 (2,210 reports), age 63 (2,083 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 128,078 classified reports for CELECOXIB:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Celecoxib is contraindicated in patients with a history of myocardial infarction and should be used with caution in patients with cardiovascular disease.
If you are taking Celecoxib, here are important things to know. The most commonly reported side effects include drug ineffective, pain, arthralgia, fatigue, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before starting Celecoxib, especially if you have a history of cardiovascular disease. Report any unusual symptoms to your healthcare provider promptly. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor Celecoxib for safety, and updates may lead to changes in labeling or restrictions.
The FDA has received approximately 402,054 adverse event reports associated with Celecoxib. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Celecoxib include Drug Ineffective, Pain, Arthralgia, Fatigue, Nausea. By volume, the top reported reactions are: Drug Ineffective (17,637 reports), Pain (12,292 reports), Arthralgia (10,924 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Celecoxib.
Out of 128,078 classified reports, 89,969 (70.2%) were classified as serious and 38,109 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Celecoxib break down by patient sex as follows: Female: 83,059, Male: 35,014, Unknown: 543. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Celecoxib adverse events are: age 60: 2,282 reports, age 64: 2,210 reports, age 63: 2,083 reports, age 56: 2,070 reports, age 61: 2,011 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Celecoxib adverse event reports is Viatris Specialty Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Celecoxib include: Drug Hypersensitivity, Off Label Use, Diarrhoea, Headache, Rheumatoid Arthritis. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Celecoxib to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Celecoxib has a safety concern score of 75 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High percentage of serious adverse events (70.2%) indicates significant safety concerns.
Key safety signals identified in Celecoxib's adverse event data include: Myocardial infarction and cerebrovascular accident are serious cardiovascular events.. Multiple gastrointestinal issues, including pneumonia and diarrhea, are reported.. Psychiatric symptoms like depression and anxiety are also common.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Celecoxib is contraindicated in patients with a history of myocardial infarction and should be used with caution in patients with cardiovascular disease. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Celecoxib.
Consult a healthcare provider before starting Celecoxib, especially if you have a history of cardiovascular disease. Report any unusual symptoms to your healthcare provider promptly.
Celecoxib has 402,054 adverse event reports on file with the FDA. Pain and related conditions are the most frequently reported reactions. The volume of reports for Celecoxib reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Celecoxib for safety, and updates may lead to changes in labeling or restrictions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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