2012-12-12 - Female - 34 Years old
484043
| Adverse reaction report number | 484043 |
| Latest AER version number | 0 |
| Market authorization holder AER number | N/A |
| Initial received date | 2012-12-12 |
| Latest received date | 2012-12-12 |
| Age | 34 Years |
| Gender | Female |
| 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? | Yes |
Reason for seriousness
| Death | |
| Disability | |
| Cogenital anomaly | |
| Life threateting | |
| Hospitalization | Yes |
| Other medically important |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| ADDERALL XR 10MG | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 40 Milligram | 1 every 1 Day(s) | 9 Month(s) | Attention deficit/hyperactivity disorder |
| ADDERALL XR 20MG | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 40 Milligram | 1 every 1 Day(s) | 9 Month(s) | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Amnesia | |
| Decreased appetite | |
| Disturbance in attention | |
| Energy increased | |
| Impaired driving ability | |
| Impulse-control disorder | |
| Insomnia | |
| Paranoia | |
| Psychotic disorder | |
| Weight decreased | |