2009-07-29 - Male - 7 Years old
327714
| Adverse reaction report number | 327714 |
| Latest AER version number | 2 |
| Market authorization holder AER number | SPV1200901539 |
| Initial received date | 2009-07-29 |
| Latest received date | 2009-09-04 |
| Age | 7 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Pharmacist |
| Source of report | MAH |
| 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 10MG | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 10 Milligram | 5 Month(s) | Attention deficit/hyperactivity disorder | |
| MELATONIN | NOT SPECIFIED | Concomitant | Unknown | ||||
| PROZAC | CAPSULE | Concomitant | Unknown | ||||
| ZELDOX | CAPSULE | Concomitant | Unknown |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Seizure | 210 |