About Side Effect Reports Data

The side effect reports (a.k.a. adverse event reports) in our database comprise the reports submitted to the FDA during a reasonably recent and representative sample period. The current sample period is from October 2011 until September 2012 and includes over 600,000 reports. This information is not vetted and should not be considered as verified clinical evidence.

It is imporatnt to understand that while this information is potentially useful when analyzed properly (e.g. for post-marketing analysis of drug side effects), it can be easily overinterpreted or misinterpreted, especially by individuals nor versed in medical statistics. For example, a large number of reported side effects for a particular drug may sometimes be more reflective of the large number prescriptions written rather than of unusually high incidence of side effect.

It is also important to understand that the causative relation between a drug and its FDA-reported side effects is only suspected, not proven. In some cases, a patient may be on multiple drugs, all of which may get reported as a suspected side-effect cause even though only one (or none) may actually be responsible.