Study characteristics
| Country | Study period | Duration (months) | Population | Age (years) | System (% of ADRs) | Therapeutic class (% of ADRs) |
| ADRs in hospitalised children | ||||||
| Norway12 | 1996 | 5 | 579 | 0–16 | CNS (28), gastrointestinal (27), skin (11) | Anti-infective agents (9), anti-asthmatics (7), CNS drugs (7) |
| France17 | 1998 | 0.25 | 227 | NR | Gastrointestinal (83), rash (17) | NR |
| Brazil18 | 2001 | 5 | 265 | 0–14 | Skin (49), endocrine (15), gastrointestinal (11) | Anti-infective agents (53), systemic hormones (23), CNS drugs (17) |
| Germany19 | 2001 | 8 | 156 | 0–18 | Gastrointestinal (25), leukocyte (14), liver and biliary (10), metabolic (10) | Anti-infective agents (44), CNS drugs (19), antineoplastics (16) |
| Germany20 | NR | 6 | 375 | 0–18 | Gastrointestinal (22), leukocyte (17), skin (13), metabolic (11) | NR |
| Nigeria21 | 2006 | 6 | 682 | 0–10 | Skin (50), general (20), CNS (20) | NR |
| ADRs leading to hospital admission | ||||||
| Norway12 | 1996 | 5 | 919 | 0–16 | NR | NR |
| France17 | 1998 | 0.25 | 260 | 0–7 | CNS (75), gastrointestinal (25) | CNS drugs (50), analgesics (50) |
| Sri Lanka22 | 2002 | 11 | NR | NR | NR | NR |
| Nigeria21 | 2006 | 6 | 682 | 0–10 | NR | NR |
| ADRs in outpatient children | ||||||
| France17 | 1998 | 0.25 | 1192 | 0–4 | Skin (50), general (25), gastrointestinal (25) | Antibiotics (75), vaccines (25) |
| France23 | 2000–1 | 4 | 1419 | 0–16 | Gastrointestinal (40), skin (30), CNS (15) | Antibiotics (45), vaccines (15) |
ADR, adverse drug reaction; NR, not reported.