2008-05-05 - Male - 14 Years old
303560
| Adverse reaction report number | 303560 |
| Latest AER version number | 0 |
| Market authorization holder AER number | N/A |
| Initial received date | 2008-05-05 |
| Latest received date | 2008-05-05 |
| Age | 14 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Consumer Or Other Non Health Professional |
| Source of report | Community |
| Report outcome | Recovered/resolved |
| Serious report? | No |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 10 Month(s) | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Aggression | |
| Decreased appetite | |
| Drug ineffective | |
| Dry mouth | |
| Headache | |
| Insomnia | |
| Malaise | |
| Negative thoughts | |