FDA Adverse Events Summary for VIOXX* (Rofecoxib)
(based on 327721 reports filed with the FDA between 2004 and 2012)
These charts and graphs provide data on adverse effects and events attributed to VIOXX. They are based on FDA Adverse Event reports received through the FDA Adverse Event Reporting System (FAERS) program.
Adverse Event Reports are submitted 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). 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.
Top 20 Adverse Effects Associated with VIOXX
(reported in FDA Medwatch Reports)
|Side Effect||# of FDA Reports|
|5||Coronary artery disease||4625|
|16||Cardiac failure congestive||2741|
|17||Acute myocardial infarction||2397|
|18||Transient ischaemic attack||2352|
* This side effect also appears in "Top 10 Side Effects of VIOXX " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking VIOXX
(associated with FDA Medwatch Reports)
|Reason||# of FDA Reports|
|9||Pain in extremity||2857|
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for VIOXX
Total Reports Filed with FDA: 327721
Number of FDA Adverse Event Reports by Patient Age for VIOXX
Total Reports Filed with FDA: 327721*
Note: * Reports include 55,178 reports of unknown age.