2011-04-29 - Male - 22 Years old
367848
| Adverse reaction report number | 367848 |
| Latest AER version number | 0 |
| Market authorization holder AER number | SPV1201100650 |
| Initial received date | 2011-04-29 |
| Latest received date | 2011-04-29 |
| Age | 22 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? | 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 30MG | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 90 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | |
| ADDERALL XR 30MG | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 90 Milligram | 1 every 1 Day(s) | Major depression |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Delirium | |
| Depressed level of consciousness | |
| Feeling drunk | |
| Prescribed overdose | |
| Psychotic disorder | |