2008-08-12 - Female - 15 Years old
309989
| Adverse reaction report number | 309989 |
| Latest AER version number | 1 |
| Market authorization holder AER number | SPV1200801682 |
| Initial received date | 2008-08-12 |
| Latest received date | 2008-09-09 |
| Age | 15 Years |
| Gender | Female |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Physician |
| Source of report | MAH |
| Report outcome | Unknown |
| Serious report? | Yes |
Reason for seriousness
| Death | |
| Disability | |
| Cogenital anomaly | |
| Life threateting | |
| Hospitalization | |
| Other medically important | Yes |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| ADDERALL XR 10MG | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 10 Milligram | 1 every 1 Day(s) | 5 Month(s) | Attention deficit/hyperactivity disorder |
| ADDERALL XR 30MG | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 30 Milligram | 1 every 1 Day(s) | 6 Month(s) | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Aggression | |
| Depression | |
| Drug ineffective | |
| Feelings of worthlessness | |
| Intentional self-injury | |
| Personality change | |
| Prescribed overdose | |
| Self-injurious ideation | |
| Skin laceration | |
| Social avoidant behaviour | |
| Suicidal ideation | |