Table 3.

Distribution of suspected drugs (total and OL prescription by age) by seriousness of SADR in children in Brazil between 2008-2013.

Seriousness classification	Number of drugs
	Total	Prescribed as OL (%)	P value
Death	89	26 (29%)	0.043*
Life threatening	239	50 (21%)
Prolonged hospitalization	306	89 (29%)
Congenital abnormalities	3	2 (67%)
Persistent or significant disability	31	12 (39%)
Medically important events	1561	385 (25%)
Total	2229	564 (25%)

OL, Off-label; SADR, Serious Adverse Drug Reaction. Values in parenthesis are percentages. *Statistically significant at level of P < 0.05 (Chi Square test).