2006-03-08 - Male - 11 Years old
196309
| Adverse reaction report number | 196309 |
| Latest AER version number | 0 |
| Market authorization holder AER number | 20060205931 |
| Initial received date | 2006-03-08 |
| Latest received date | 2007-01-30 |
| Age | 11 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Other Health Professional |
| Source of report | MAH |
| Report outcome | Not recovered/not resolved |
| Serious report? | Yes |
Reason for seriousness
| Death | |
| Disability | |
| Cogenital anomaly | |
| Life threateting | |
| Hospitalization | Yes |
| Other medically important |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 54 Milligram | 1 every 1 Day(s) | 3 Month(s) | |
| CONCERTA | TABLET (EXTENDED-RELEASE) | Suspect | Unknown | 36 Milligram | 1 every 1 Day(s) | 9 Month(s) |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Cerebral infarction | |
| Confusional state | |
| Decreased appetite | |
| Diplopia | |
| Fatigue | |
| Muscular weakness | |
| Sleep disorder | |
| Somnolence | |
| Urinary incontinence | |