2013-12-11 - Male - 3 Years old
900043110
| Adverse reaction report number | 900043110 |
| Latest AER version number | 0 |
| Market authorization holder AER number | ALL1-2013-08317 |
| Initial received date | 2013-12-11 |
| Latest received date | 2013-12-11 |
| Age | 3 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Pharmacist |
| Source of report | MAH |
| Report outcome | Not recovered/not resolved |
| Serious report? | No |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| ADDERALL XR | Suspect | Oral | Attention deficit/hyperactivity disorder | ||||
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Oral | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Drug ineffective | |
| Product use issue | |