2008-01-08 - Male - 12 Years old
300004
| Adverse reaction report number | 300004 |
| Latest AER version number | 0 |
| Market authorization holder AER number | SPV1200705018 |
| Initial received date | 2008-01-08 |
| Latest received date | 2008-01-08 |
| Age | 12 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Physician |
| Source of report | MAH |
| Report outcome | Recovered/resolved |
| 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 | 30 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | |
| FLUOXETINE | NOT SPECIFIED | Concomitant | Unknown |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Facial pain | |
| Grimacing | |
| Oculogyric crisis | |