Table 1.
Characteristics of psychological and/or behavioural ADR cases related to glucocorticoids, recorded in FPD, in patients <18 years old, from 1 January 1985 to 30 March 2007
| Characteristics | Values |
|---|---|
| Spontaneous reports, n | 95 |
| ‘Serious’ cases, n (%) | 15 (15.9) |
| ADRs, n (%) | 136 (100) |
| Agitation or excitation | 59 (43.4) |
| Sleep disturbances | 25 (18.4) |
| Psychotic symptoms | 11 (8.1) |
| Maniac symptoms | 11 (8.1) |
| Mental disorders | 9 (6.6) |
| Food behaviour disorders | 8 (5.9) |
| Confusional symptoms | 8 (5.9) |
| Age, years | 5.9 ± 5.1 |
| Gender (male), n (%) | 46 (48.4) |
| Patients ≤6 years old, n (%) | 57 (60.0) |
| Prescription or administration errors, n (%) | 29 (30.5) |
| Overdose | 16 (16.8) |
| High dose | 13 (13.7) |
| Therapeutic indications with high dose, n (%) | 13 (13.7) |
| Supratherapeutic dose | 5 (5.3) |
| High dose | 8 (8.4) |
| Administration route, n (%) | |
| Oral | 72 (69.9) |
| Intravenous | 13 (12.6) |
| Inhaled | 10 (11.7) |
ADR, adverse drug reaction; FPD, French Pharmacovigilance Database.