From: Usability and consistency of harm information in drug product descriptions: a matched comparison of data between the United States (US) and Europe
Median # harms reported (range)
Median # harms reported only in one document(range)
Median # median # of the same harms reported by both documents (range)
SmPC
114
(56, 265)
43
(20, 181)
75
(36, 104)
USPI
200
(65, 425)
168
(38, 336)