Drug Safety Information for CELEBREX (Celecoxib)

FDA Safety-related Labeling Changes for CELEBREX (CELECOXIB) Rx Drug: Safety Information Link

Adverse Drug Reactions for CELEBREX* (Celecoxib)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CELEBREX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Myocardial infarction6466
2Drug ineffective4229
3Cerebrovascular accident4145
4Pain*3720
5Nausea*2609
6Arthralgia2492
7Dyspnoea2326
8Cardiovascular disorder2206
9Fatigue2030
10Dizziness1996
11Headache*1978
12Depression1948
13Pain in extremity1880
14Hypertension1760
15Diarrhoea*1716
16Chest pain1709
17Drug hypersensitivity1701
18Fall1685
19Anxiety*1602
20Rash*1539

* This side effect also appears in "Top 10 Side Effects of CELEBREX " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CELEBREX
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Arthritis*27195
2Product used for unknown indication17030
3Rheumatoid arthritis*11400
4Pain*10420
5Osteoarthritis*9859
6Arthralgia*6769
7Ill-defined disorder4387
8Back pain*3937
9Inflammation1800
10Fibromyalgia*1448

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for CELEBREX

Total Reports Filed with FDA: 255329


Number of FDA Adverse Event Reports by Patient Age for CELEBREX

Total Reports Filed with FDA: 255329*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Celecoxib (Celebrex, Celecoxib)

Charts are based on 255329 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and CELEBREX Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.