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Center for Veterinary Medicine
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Adverse Drug Experience Reporting

Veterinary Adverse Drug Experience (ADE) Reports


Any reference to a commercial product, process, service, or company is not an endorsement or recommendation by the U.S. government, the Department of Health and Human Services, FDA or any of its components. FDA is not responsible for the contents of any off-site Internet information referenced by or linked to the agency's internet site.

The information provided using this Internet page is only intended to be General Summary Information to the Public. It is not intended to take the place of either the written law or regulations. For an authoritative source, the FDA Regulations are published in the Code of Federal Regulations (CFR), and are available in book format from the Superintendent of Documents, U.S. Government Printing Office.

These reports include domestic adverse drug experience reports submitted to the Center for Veterinary Medicine (CVM or the Center) that CVM has determined to be at least "possibly" drug related. Since 2000, only serious and unexpected ADEs in Periodic Reports are included in the database. The on-line database is expected to be updated monthly for expedited (fifteen day) reports for drugs approved within the previous three years, but not more than yearly for periodic (annual) reports.

The Center's adverse drug experience (ADE) process takes into consideration confounding factors such as:

  • Dosage

  • Concomitant drug use

  • The medical and physical condition of animals at the time of treatment

  • Environmental and management information

  • Product defects

  • Extra-label-uses

However, the specifics of these complex factors cannot be addressed in these reports

Web Page Updated by mdt - November 21, 2005, 2:12 PM ET

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