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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®