2005-11-28 - Male - 13 Years old
193716
| Adverse reaction report number | 193716 |
| Latest AER version number | 0 |
| Market authorization holder AER number | SUS1200500838 |
| Initial received date | 2005-11-28 |
| Latest received date | 2005-12-08 |
| Age | 13 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Physician |
| Source of report | MAH |
| Report outcome | Death |
| Serious report? | Yes |
Reason for seriousness
| Death | Yes |
| Disability | |
| Cogenital anomaly | |
| Life threateting | |
| 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 | 20 Milligram | 14 Day(s) | ||
| RISPERIDONE (JANSSEN-ORTHO) | NOT SPECIFIED | Concomitant |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Completed suicide | |