2009-04-20 - Male - 7 Years old
322216
| Adverse reaction report number | 322216 |
| Latest AER version number | 0 |
| Market authorization holder AER number | SPV1200900603 |
| Initial received date | 2009-04-20 |
| Latest received date | 2009-04-20 |
| Age | 7 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Consumer Or Other Non Health Professional |
| 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 | Unknown | 40 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | ||
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 30 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | |
| DEXEDRINE | NOT SPECIFIED | Concomitant | Unknown |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Drug effect decreased | |
| Inappropriate schedule of product administration | |
| Initial insomnia | |
| Insomnia | |
| Prescribed overdose | |