2004-03-18 - Male - 9 Years old
167150
| Adverse reaction report number | 167150 |
| Latest AER version number | 0 |
| Market authorization holder AER number | SUS1200300549 |
| Initial received date | 2004-03-18 |
| Latest received date | 2004-03-18 |
| Age | 9 Years |
| Gender | Male |
| Weight | 30 Kilograms |
| Type of report | Special Access Program |
| Reporter type | Physician |
| Source of report | MAH |
| Report outcome | Unknown |
| Serious report? | Yes |
Reason for seriousness
| Death | |
| Disability | |
| Cogenital anomaly | |
| Life threateting | |
| Hospitalization | |
| Other medically important | Yes |
| 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 | 1 every 1 Day(s) | 4 Day(s) |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Agitation | |
| Self-injurious ideation | |