2009-07-08 - Male - 10 Years old
326976
| Adverse reaction report number | 326976 |
| Latest AER version number | 0 |
| Market authorization holder AER number | N/A |
| Initial received date | 2009-07-08 |
| Latest received date | 2009-07-08 |
| Age | 10 Years |
| Gender | Male |
| Weight | 61 Pounds |
| Type of report | Spontaneous |
| Reporter type | Consumer Or Other Non Health Professional |
| Source of report | Community |
| 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 15MG | Suspect | Oral | 20 Milligram | 1 every 1 Day(s) | 14 Day(s) | Attention deficit/hyperactivity disorder | |
| ADDERALL XR 15MG | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 15 Milligram | 1 every 1 Day(s) | 10 Day(s) | Attention deficit/hyperactivity disorder |
| OMEGA - 3 | NOT SPECIFIED | Concomitant | Unknown |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Eye movement disorder | |
| Headache | |
| Memory impairment | |
| Sleep disorder | |
| Unresponsive to stimuli | |