Table 2 Description of ICSRs for children in the ATC code R03DC. All ICSRs concerned the substance montelukast.
From: Individual case safety reports in children in commonly used drug groups – signal detection
Age (years) | Dose (mg/day) | Treatment duration (when known) | ADR | SPC (Yes/No) |
|---|---|---|---|---|
4 | 4 | - | Night mares | Yes |
3 | 4 | - | Sleep disorders | Yes |
3 | 4 | - | Cranial nerve lesion | No |
4 | 4 | 2 years | Haemorrhage | Yes |
Pruritus | Yes | |||
Abdominal pain | Yes | |||
Rectal pain | No | |||
2 | 4 | - | Fever | No |
Fatigue | Yes | |||
Rash | No | |||
1 | 4 | 4 days | Anxiety | No |
3 | 4 | - | Night mares | Yes |
Aggressiveness | Yes | |||
2 | 4 | 4 days | Aggressiveness | Yes |
3 | 4 | continuing | Night mares | Yes |
3 | 4 | 2 doses | Asthma aggravated | No |
2 | 4 | 11 days | Rash | No |
Pruritus | Yes | |||
Sleep disorder | Yes | |||
Night mares | Yes | |||
1 | 4 | 2 weeks | Anxiety | No |
Sleep disorder | Yes | |||
6 | 5 | 8 weeks | Xerophthalmia | No |
5 | 4 | 3 weeks | Appetite increased | No |
8 | 5 (on demand) | 5 weeks | Leucopenia | No |
Red blood cell disorder | No | |||
14 | 10 | 2 years | Arthralgia | Yes |
Myalgia | Yes |