Table 4 Age-stratified analysis of demographical parameters and the five drug substances and ADRs reported most frequently
Age groups | 0–1 month (n = 2451) | 2 month-1 year (n = 2302) | 2–3 years (n = 1537) | 4–6 years (n = 1929) | 7–12 years (n = 5384) | 13–17 years (n = 7251) |
|---|---|---|---|---|---|---|
Demographical parameters | ||||||
female | 40.2% (n = 986) | 39.0% (n = 898) | 43.5% (n = 669) | 40.8% (n = 787) | 37.9% (n = 2042) | 54.8% (n = 3972) |
male | 54.2% (n = 1329) | 52.6% (n = 1212) | 50.4% (n = 775) | 54.5% (n = 1049) | 59.2% (n = 3186) | 43.0% (n = 3119) |
unknown | 5.5% (n = 136) | 8.3% (n = 192) | 6.1% (n = 93) | 4.8% (n = 93) | 2.9% (n = 156) | 2.2% (n = 160) |
The five drug substances most frequently reported as suspected in the respective age group a | ||||||
1. | venlafaxine (6.2%; n = 152) | palivizumab b (16.3%; n = 376) | ibuprofen (3.7%; n = 57) | ibuprofen (3.7%; n = 71) | methylphenidate (11.6%; n = 625) | methylphenidate (6.1%; n = 440) |
2. | lamotrigine (5.5%; n = 134) | levetiracetam (2.9%; n = 66) | amoxicillin (3.1%; n = 48) | methylphenidate (3.3%; n = 64) | atomoxetine (4.5%; n = 241) | isotretinoin (2.8%; n = 204) |
3. | citalopram (5.1%; n = 124) | ibuprofen (2.3%; n = 52) | cefaclor (3.0%; n = 46) | valproinic acid (2.7%; n = 53) | etanercept (2.6%; n = 138) | etanercept (2.6%; n = 190) |
4. | quetiapine (4.2%; n = 104) | valproinic acid (2.0%; n = 45) | salbutamol (2.9%; n = 45) | oxcarbazepine (2.3%; n = 44) | insulin aspartate (1.8%; n = 96) | dienogest (2.6%; n = 187) |
5. | sertraline (4.0%; n = 98) | topiramate (1.9%; n = 44) | valproinic acid (2.8%; n = 43) | amoxicillin (2.2%; n = 43) | ibuprofen (1.8%; n = 96) | levonorgestrel (2.6%; n = 185) |
The five ADRs most frequently reported in the respective age group a | ||||||
1. | foetal exposure during pregnancy (16.3%; n = 400) | foetal exposure during pregnancy (6.8%; n = 156) | vomiting (9.3%, n = 143) | vomiting (8.0%; n = 155) | urticaria (6.6%; n = 358) | suicide attempt (6.7%; n = 487) |
2. | atrial septal defect (14.4%; n = 352) | respiratory syncytial virus infection (6.6%; n = 151) | accidental exposure to product by child (8.3%; n = 127) | urticaria (6.6%; n = 127) | dyspnoea (6.2%; n = 334) | nausea (5.8; n = 419) |
3. | premature baby (12.2%; n = 298) | vomiting (5.7%; n = 131) | accidental overdose (5.9%; n = 91) | pyrexia (5.0%; n = 97) | vomiting (5.5%; n = 296) | dyspnoea(5.4%; n = 395) |
4. | small for dates baby (9.7%; n = 238) | accidental exposure to product by child (4.1%; n = 95) | pyrexia (5.3%; n = 82) | rash (4.9%; n = 95) | nausea (5.2%; n = 279) | intentional overdose (5.3%; n = 387) |
5. | neonatal respiratory distress syndrome (6.9%; n = 169) | pyrexia (4.1%; n = 94) | urticaria (5.3%; n = 82) | pruritus (4.7%; n = 91) | anaphylactic reaction (4.4%; n = 239) | vomiting (5.1%; n = 368) |