Frequently Asked Questions
What is an Adverse Event Case?
-
An Adverse Event
CASE
consists of 1 or more Adverse Event
REPORTs.
Each REPORT provides initial or followup information on the CASE (e.g., When was the FDA notified? What manufacturer was notified? etc.). - Each REPORT contains 0 or more listings of DRUG DATA (e.g., What is the name of the drug? How much drug was given, etc.).
- Each DRUG DATA listing contains 1 or more DRUG INDICATIONS (i.e., What is the drug indicated for?).
- Each DRUG DATA listing also contains 0 or more THERAPIES (e.g., How long was the drug used in this case?).
- Each REPORT lists 0 or more OUTCOMES (i.e., What was the general outcome for the patient? e.g. Hospitalization, Death, etc.).
- Each Adverse Event REPORT lists 0 or more REACTIONS (i.e., What specific reactions were noted in the report? e.g. Dizziness, bronchitis, etc.).
- Each Adverse Event REPORT has 0 or more REPORT SOURCES (Who filed the report?).
How many Adverse Event Cases are Searchable with FDAble?
There are more than 1.992 million Adverse Event Cases spanning from October 1,
1997 to April 30, 2008. The FDA supplies data quarterly, with the 1st Quarter of
2008 being the most current public release.

