2012-03-27 - Male - 17 Years old
423853
| Adverse reaction report number | 423853 |
| Latest AER version number | 0 |
| Market authorization holder AER number | ALL1201201490 |
| Initial received date | 2012-03-27 |
| Latest received date | 2012-03-27 |
| Age | 17 Years |
| Gender | Male |
| Weight | 70 Kilograms |
| Type of report | Spontaneous |
| Reporter type | Pharmacist |
| Source of report | MAH |
| Report outcome | Unknown |
| Serious report? | Yes |
Reason for seriousness
| Death | |
| Disability | |
| Cogenital anomaly | |
| Life threateting | |
| Hospitalization | Yes |
| 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 | 820 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | |
| DICYCLOMINE HYDROCHLORIDE USP | NOT SPECIFIED | Concomitant | |||||
| RISPERDAL | NOT SPECIFIED | Concomitant |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Heart rate increased | |
| Hyperhidrosis | |
| Intentional overdose | |
| Palpitations | |