2012-10-30 - Male - 19 Years old
475571
| Adverse reaction report number | 475571 |
| Latest AER version number | 1 |
| Market authorization holder AER number | ALL1201205212 |
| Initial received date | 2012-10-30 |
| Latest received date | 2012-11-08 |
| Age | 19 Years |
| Gender | Male |
| Weight | 57 Kilograms |
| 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 | 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 | 50 Milligram | 1 every 1 Day(s) | 5 Year(s) | Attention deficit/hyperactivity disorder |
| CLINDOXYL GEL | GEL | Concomitant | |||||
| DIFFERIN - GEL TOP 0.1% | GEL | Concomitant |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Bundle branch block right | |
| Chest pain | |
| Dizziness | |
| Fatigue | |
| Musculoskeletal pain | |
| Orthostatic hypotension | |
| Overdose | |
| Painful respiration | |
| Pneumothorax | |
| Presyncope | |
| Withdrawal syndrome | |