Table 4.
Overview of adverse drug reactions that only are reported in adults and not in children and vice versa
| Age group | ADR (PTName) | Number of reports | ROR | Lower limit ROR | Upper limit ROR | Described in SmPC |
|---|---|---|---|---|---|---|
| Child | Enuresis | 3 | 27.50 | 8.35 | 90.62 | No |
| Growth retardation | 4 | 26.85 | 9.53 | 75.68 | Yes | |
| Mood swings | 3 | 16.67 | 5.15 | 53.99 | Yes | |
| Adult | Anosmia | 55 | 48.12 | 35.66 | 64.93 | Yes |
| Chorioretinopathy | 3 | 40.20 | 11.62 | 139.07 | Yes | |
| Dry throat | 9 | 13.78 | 6.99 | 27.14 | Yes | |
| Eye infection | 4 | 15.47 | 5.59 | 42.86 | No | |
| Glaucoma | 6 | 15.91 | 6.91 | 36.61 | Yes | |
| Hypogeusia | 10 | 23.26 | 12.05 | 44.88 | Yes | |
| Hypomania | 3 | 12.83 | 3.99 | 41.28 | Yes | |
| Hyposmia | 8 | 73.45 | 32.62 | 165.37 | Yes | |
| Intraocular pressure increased | 8 | 15.38 | 7.48 | 31.65 | Yes | |
| Migraine with aura | 4 | 13.19 | 4.79 | 36.34 | No | |
| Nasal dryness | 5 | 14.80 | 5.96 | 36.79 | Yes | |
| Parosmia | 25 | 20.36 | 13.44 | 30.86 | Yes | |
| Pharyngitis | 8 | 10.29 | 5.04 | 20.99 | Yes | |
| Wheezing | 4 | 10.73 | 3.92 | 29.38 | Yes |
ADR adverse drug reaction, PTname Preferred Term name of Medical Dictionary for Regulatory Activities [12], ROR reporting odds ratio, SmPC summary of product characteristics