2003-11-21 - Male - 12 Years old
158274
| Adverse reaction report number | 158274 |
| Latest AER version number | 0 |
| Market authorization holder AER number | US03034 |
| Initial received date | 2003-11-21 |
| Latest received date | 2003-11-21 |
| Age | 12 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Special Access Program |
| Reporter type | Other Health Professional |
| Source of report | MAH |
| Report outcome | Unknown |
| Serious report? | Yes |
Reason for seriousness
| Death | |
| Disability | |
| Cogenital anomaly | |
| Life threateting | Yes |
| Hospitalization | |
| Other medically important |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 20 Milligram | every 1 Day(s) | ||
| PAXIL | TABLET | Concomitant | Unknown | 20 Milligram | every 1 Day(s) | ||
| RISPERDAL | NOT SPECIFIED | Concomitant | Unknown | 0.5 Milligram | every 1 Day(s) |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Seizure | |