From: 10-OCT-2014 To: 15-MAR-2015 - FAERS data have limitations, including the following. There is no certainty that the reported event was actually due to the product. Reports are often incomplete - a blank field means that no data were provided. FDA does not receive reports on all adverse events that occur with a product. Many factors can influence whether or not an event will bereported, therefore, FAERS data cannot be used to compare products or calculate how frequently an event occurs in the U.S. population. #hepatitis
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<p>FDA Adverse Event Reporting System (FAERS)
Freedom of Information Act (FOIA)
Product Active Ingredient:
FDA Received Date:
Number of Pages:
Disclaimer: Submission of a safety report does not constitute an
admission that medical personnel, user facility, importer, distributor,
manufacturer or product caused or contributed to the event. The
information in these reports has not been scientifically or otherwise
verified as to a cause and effect relationship and cannot be used to
estimate the incidence of these events.
*. â€œMedDRAÂ® Versionâ€ refers to the name and version of the dictionary in use at the time the cases were retrieved from the FDA Adverse Event Reporting System
(FAERS). MedDRA Medical Dictionary for Regulatory Activities (MedDRAÂ®) is a medical terminology developed under the support of the International Conference
on Harmonization (ICH) and is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). MedDRA is used
by FDA, other regulatory agencies, and pharmaceutical manufacturers to code adverse events, medication errors and other information associated with the use of
medical products. A MedDRAÂ® Preferred Term (PT) is used to standardize a â€œmedical conceptâ€ in a report. For example, a report of â€œheart attackâ€ or â€œmyocardial
infarctâ€ are standardized to the same Preferred Term, â€œMyocardial Infarctionâ€. MedDRA is updated twice a year.
**. â€œTotal Casesâ€ reflects the number of individual patient case reports associated with the product of interest that were submitted to FDA within the specified time
period. A case consists of an initial report and any follow-up reports submitted to FDA. Because FDA may receive reports on the same patient from more than one
source, some of these cases may be duplicate patient reports.
MedDRAÂ® Version* :
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