2009-10-14 - Male - 11 Years old
331512
| Adverse reaction report number | 331512 |
| Latest AER version number | 0 |
| Market authorization holder AER number | SPV1200901974 |
| Initial received date | 2009-10-14 |
| Latest received date | 2009-10-14 |
| Age | 11 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Pharmacist |
| Source of report | MAH |
| Report outcome | Unknown |
| 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 | Suspect | Unknown | 15 Milligram | Attention deficit/hyperactivity disorder | |||
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 10 Milligram | 1 every 1 Day(s) | 2 Year(s) | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Eye pruritus | |
| Lacrimation increased | |