2016-01-06 - Male
900611467
| Adverse reaction report number | 900611467 |
| Latest AER version number | 0 |
| Market authorization holder AER number | CA201516964 |
| Initial received date | 2016-01-06 |
| Latest received date | 2016-01-06 |
| Age | N/A |
| Gender | Male |
| 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 | Suspect | Oral | 50 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | ||
| VYVANSE | CAPSULE | Suspect | Oral | 40 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | |
| VYVANSE | CAPSULE | Suspect | Oral | 60 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | |
| VYVANSE | CAPSULE | Suspect | Oral | 100 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | |
| CLONAZEPAM | Concomitant | Oral | 1 Milligram | 2 every 1 Day(s) | Anxiety | ||
| LORAZEPAM | Concomitant | Oral | 1 every 1 Day(s) | Social anxiety disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Drug effect incomplete | |
| Headache | |
| Insomnia | |
| Overdose | |
| Prescribed overdose | |