2013-12-11 - Male - 10 Years old
900043562
| Adverse reaction report number | 900043562 |
| Latest AER version number | 1 |
| Market authorization holder AER number | ALL1-2013-08447 |
| Initial received date | 2013-12-11 |
| Latest received date | 2013-12-30 |
| Age | 10 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Pharmacist |
| Source of report | MAH |
| Report outcome | Unknown |
| Serious report? | No |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| ADDERALL XR | Suspect | Oral | 1 Year(s) | Attention deficit/hyperactivity disorder | |||
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 25 Milligram | Attention deficit/hyperactivity disorder | ||
| PREDNISONE | Concomitant | Unknown | Product used for unknown indication |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Drug ineffective | |