2006-09-12 - Male - 6 Years old
205976
| Adverse reaction report number | 205976 |
| Latest AER version number | 0 |
| Market authorization holder AER number | N/A |
| Initial received date | 2006-09-12 |
| Latest received date | 2006-09-12 |
| Age | 6 Years |
| Gender | Male |
| Weight | 22 Kilograms |
| Type of report | Spontaneous |
| Reporter type | Physician |
| Source of report | Other |
| Report outcome | Recovered/resolved |
| Serious report? | Yes |
Reason for seriousness
| Death | |
| Disability | |
| Cogenital anomaly | |
| Life threateting | Yes |
| Hospitalization | |
| 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 | Oral | 10 Milligram | every 1 Day(s) | 14 Day(s) | |
| CONCERTA | TABLET (EXTENDED-RELEASE) | Concomitant | Oral | 27 Milligram | 106 Day(s) | ||
| RISPERDAL | NOT SPECIFIED | Drug used to treat AE | Oral | 1 Milligram | 2 every 1 Day(s) |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Euphoric mood | |
| Hypomania | |
| Insomnia | |
| Psychomotor hyperactivity | |