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
1Myocardial infarction19251
2Cerebrovascular accident14275
3Chest pain5842
5Coronary artery disease4625
6Cardiovascular disorder4433
8Cardiac disorder3760
13Angina pectoris3103
15Pulmonary embolism2770
16Cardiac failure congestive2741
17Acute myocardial infarction2397
18Transient ischaemic attack2352

* 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
4Back pain*14162
5Rheumatoid arthritis*12575
7Neck pain3525
9Pain in extremity2857

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

Types of Adverse Events for VIOXX

Total Reports Filed with FDA: 327721

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Male Patients
Female Patients
Unknown Patients

Number of FDA Adverse Event Reports by Patient Age for VIOXX

Total Reports Filed with FDA: 327721*

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Note: * Reports include 55,178 reports of unknown age.

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Rofecoxib (Vioxx, Refecoxib)

FDA Search on VIOXX

Click to go back to search results and VIOXX Reviews .

More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program).

Analytics of FDA Adverse Event Reports Provided by Druginformer.com
Visit   DrugInformer.com more on VIOXX's side effects.