The FDA guidance document on the presentation of information in the “Adverse Reactions” section of the drug label offers a framework for selecting, characterizing and organizing adverse event information.6 The document suggests that ADEs that occur at the same rate as placebo, should generally not be included. Vague terms such as “common,” “rare,” “infrequent,” or “frequent” should be avoided unless linked to specific frequencies. An example of a specified frequency for “common” ADEs would be those that occurred in at least 10% of treated patients and at a rate at least twice that of placebo. Furthermore, ADEs should be reported in a hierarchical manner, with those that occurred with higher frequency first, followed by those that caused therapy discontinuation and those that occurred with lower frequency but were serious (eg, fatal, life threatening, or caused or prolonged hospitalization). In all cases, only those ADEs for which there is plausible causality should be included.