2013-04-30 - Male - 16 Years old
520318
| Adverse reaction report number | 520318 |
| Latest AER version number | 0 |
| Market authorization holder AER number | N/A |
| Initial received date | 2013-04-30 |
| Latest received date | 2013-04-30 |
| Age | 16 Years |
| Gender | Male |
| Weight | 64 Kilograms |
| Type of report | Spontaneous |
| Reporter type | Physician |
| Source of report | Community |
| Report outcome | Recovered/resolved |
| Serious report? | Yes |
Reason for seriousness
| Death | |
| Disability | |
| Cogenital anomaly | |
| Life threateting | |
| Hospitalization | Yes |
| Other medically important |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| ADDERALL XR 25MG | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 25 Milligram | 1 every 1 Day(s) | 1 Day(s) | Attention deficit/hyperactivity disorder |
| ATROVENT | NOT SPECIFIED | Concomitant | |||||
| FLOVENT | NOT SPECIFIED | Concomitant |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Abdominal pain | |
| Chest pain | |
| Dry mouth | |
| Dyskinesia | |
| Dysstasia | |
| Dystonia | |
| Hyperhidrosis | |
| Mydriasis | |
| Tachycardia | |