2009-08-11 - Male - 7 Years old
328310
| Adverse reaction report number | 328310 |
| Latest AER version number | 1 |
| Market authorization holder AER number | SPV1200901625 |
| Initial received date | 2009-08-11 |
| Latest received date | 2009-08-12 |
| Age | 7 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 | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 15 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | |
| CONCERTA | TABLET (EXTENDED-RELEASE) | Concomitant | Unknown | ||||
| METHYLPHENIDATE | NOT SPECIFIED | Concomitant | Unknown |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Drug ineffective | |