2013-09-16 - Female - 13 Years old
900027297
| Adverse reaction report number | 900027297 |
| Latest AER version number | 1 |
| Market authorization holder AER number | ALL1-2013-06009 |
| Initial received date | 2013-09-16 |
| Latest received date | 2013-10-07 |
| Age | 13 Years |
| Gender | Female |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Consumer Or Other Non Health Professional |
| 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 | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 40 Milligram | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Crying | |
| Drug ineffective | |
| Emotional distress | |
| Hyperphagia | |
| Malaise | |
| Overdose | |
| Psychomotor hyperactivity | |