2005-10-25 - Male - 6 Years old
192513
| Adverse reaction report number | 192513 |
| Latest AER version number | 0 |
| Market authorization holder AER number | SUS1200500787 |
| Initial received date | 2005-10-25 |
| Latest received date | 2005-10-25 |
| Age | 6 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Pharmacist |
| 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 | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 25 Milligram | 1 every 1 Day(s) |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Agitation | |
| Hallucination | |
| Insomnia | |