2012-12-19 - Not specified - 5 Years old
490694
| Adverse reaction report number | 490694 |
| Latest AER version number | 0 |
| Market authorization holder AER number | ALL1201206020 |
| Initial received date | 2012-12-19 |
| Latest received date | 2012-12-19 |
| Age | 5 Years |
| Gender | Not specified |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Physician |
| Source of report | MAH |
| Report outcome | Unknown |
| 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 | Oral | Off label use | |||
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Oral | Product used for unknown indication | |||
| VYVANSE | CAPSULE | Suspect | Oral | Off label use | |||
| VYVANSE | CAPSULE | Suspect | Oral | Product used for unknown indication |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Psychomotor hyperactivity | |