FDA Adverse Event Reporting System: Harvoni

FDA Adverse Event Reporting System: Harvoni , updated 6/16/15, 2:56 AM

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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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