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Table 3 Ten most frequently reported reactions according to age group

From: Characteristics of pediatric adverse drug reaction reports in the Japanese Adverse Drug Event Report Database

a. < 10 years (n = 18,022)
 Seizure, n (%)390 (2.2)
 Anaphylactic reaction, n (%)374 (2.1)
 Abnormal behavior, n (%)374 (2.1)
 Hepatic function abnormal, n (%)336 (1.9)
 Pyrexia, n (%)319 (1.8)
 Anaphylactic shock, n (%)271 (1.5)
 Stevens-Johnson syndrome, n (%)246 (1.4)
 Rash, n (%)229 (1.3)
 Erythema multiforme, n (%)195 (1.1)
 Drug eruption, n (%)156 (0.9)
b. 10–19 years (n = 15,157)
 Abnormal behavior, n (%)419 (2.8)
 Anaphylactic shock, n (%)353 (2.3)
 Anaphylactic reaction, n (%)333 (2.2)
 Pyrexia, n (%)236 (1.6)
 Seizure, n (%)223 (1.5)
 Hepatic function abnormal, n (%)220 (1.5)
 Stevens-Johnson syndrome, n (%)175 (1.2)
 Drug reaction with eosinophilia and systemic symptoms, n (%)171 (1.1)
 Pancreatitis acute, n (%)170 (1.1)
 Rash, n (%)169 (1.1)
  1. Note: The terms are as described in Japanese version 21.0 of MedDRA®