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* About FAERS: The FDA Adverse Event Reporting System (FAERS) is used by FDA for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance to reporting regulations and responding to outside requests for information. Reporting of adverse events is a voluntary process, and not every report is sent to FDA and entered into FAERS. The FAERS database may contain duplicate reports, the report quality is variable, and many factors may influence reporting (e.g., media attention, length of time a drug is marketed, market share). For these reasons, FAERS case reports cannot be used to calculate incidence or estimates of risk for a particular product or compare risks between products.