2009-09-08 - Male - 5 Years old
329564
| Adverse reaction report number | 329564 |
| Latest AER version number | 0 |
| Market authorization holder AER number | N/A |
| Initial received date | 2009-09-08 |
| Latest received date | 2009-09-08 |
| Age | 5 Years |
| Gender | Male |
| Weight | 44 Pounds |
| Type of report | Spontaneous |
| Reporter type | Physician |
| Source of report | Community |
| Report outcome | Recovered/resolved |
| Serious report? | No |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 10 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Hyperhidrosis | |
| Insomnia | |
| Lethargy | |
| Somnolence | |