2008-04-22 - Male - 9 Years old
302061
| Adverse reaction report number | 302061 |
| Latest AER version number | 0 |
| Market authorization holder AER number | SPV1200800798 |
| Initial received date | 2008-04-22 |
| Latest received date | 2008-04-22 |
| Age | 9 Years |
| Gender | Male |
| Weight | 30 Kilograms |
| 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 | Suspect | Unknown | 20 Milligram | 0 Month(s) | Attention deficit/hyperactivity disorder | ||
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 15 Milligram | 44 Day(s) | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Aggression | |
| Drug ineffective | |
| Suicidal ideation | |