2008-06-27 - Male - 11 Years old
308204
| Adverse reaction report number | 308204 |
| Latest AER version number | 0 |
| Market authorization holder AER number | SPV1200701401 |
| Initial received date | 2008-06-27 |
| Latest received date | 2008-06-27 |
| Age | 11 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Consumer Or Other Non Health Professional |
| Source of report | MAH |
| Report outcome | Unknown |
| 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 | 1 Dosage forms | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Abnormal behaviour | |
| Depressed mood | |
| Drug ineffective | |
| Insomnia | |
| Nervousness | |
| Pallor | |
| Tic | |
| Weight decreased | |