2009-12-04 - Male - 11 Years old
334399
| Adverse reaction report number | 334399 |
| Latest AER version number | 2 |
| Market authorization holder AER number | SPV1200902396 |
| Initial received date | 2009-12-04 |
| Latest received date | 2010-02-24 |
| Age | 11 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 | Suspect | Oral | 5 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | ||
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 10 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Depressed mood | 3 Month(s) |
| Depression | 3 Month(s) |
| Suicidal ideation | 3 Month(s) |