2015-03-10 - Male - 15 Years old
900271818
| Adverse reaction report number | 900271818 |
| Latest AER version number | 1 |
| Market authorization holder AER number | CA201501732 |
| Initial received date | 2015-03-10 |
| Latest received date | 2015-06-05 |
| Age | 15 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Physician |
| Source of report | MAH |
| Report outcome | Recovered/resolved |
| 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 | 15 Milligram | 1 every 1 Day(s) | 1 Day(s) | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Hallucination, auditory | 2 Day(s) |
| Mental impairment | 2 Day(s) |
| Speech disorder | 2 Day(s) |
| Tic | 2 Day(s) |
| Tremor | 2 Day(s) |
| Wrong technique in product usage process | 2 Day(s) |