2010-01-07 - Male - 10 Years old
336042
| Adverse reaction report number | 336042 |
| Latest AER version number | 1 |
| Market authorization holder AER number | 2009315405 |
| Initial received date | 2010-01-07 |
| Latest received date | 2010-01-26 |
| Age | 10 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? | Yes |
Reason for seriousness
| Death | |
| Disability | |
| Cogenital anomaly | |
| Life threateting | |
| Hospitalization | |
| Other medically important | Yes |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| ADDERALL XR | Suspect | Unknown | 25 Milligram | Attention deficit/hyperactivity disorder | |||
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 30 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | |
| ZELDOX | CAPSULE | Suspect | Oral | 20 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Drug interaction | |
| Phobia | |
| Tic | |